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HIV/STI Surveillance for CAREC Member Countries Participant Manual October 2007 Acknowledgements This pilot manual was prepared by the Caribbean Epidemiology Centre (CAREC) in collaboration with: the United State Department of Health and Human Services, Centers for Disease Control and Prevention (HHS-CDC), Global AIDS Program (GAP) Surveillance Team the University of California at San Francisco (UCSF), Institute for Global Health, AIDS Research Institute through the University Technical Assistance Program (UTAP) with CDC/GAP. This workshop is sponsored by the following partners of the CAREC Special Programme on Sexually Transmitted Infections: the United State Department of Health and Human Services, Centers for Disease Control and Prevention (HHS-CDC) PANCAP—Global Fund and World Bank Projects CAREC thanks the workshop participants, national epidemiologists, surveillance officers and other public health professionals from the following countries: Trinidad & Tobago, Guyana, Turks & Caicos, Anguilla, Antigua & Barbuda, Barbados, British Virgin Islands, Dominica, Grenada, Montserrat, St. Lucia, St. Kitts & Nevis. Funding for the initial creation of this manual was provided in part by the United States Agency for International Development and PANCAP. HIV/STI Surveillance for CAREC Member Countries Table of Contents Unit 1, The Global HIV/AIDS Situation and the HIV/AIDS Epidemic in the Caribbean Overview Introduction Trends (CAREC Surveillance data, 1982-2003) Summary Unit 1 Exercises Unit 2, Biology, Transmission, Natural History, Prevention and Treatment of HIV Infection and AIDS Overview Introduction Biology of HIV HIV Transmission and Natural History Spectrum of Disease Following HIV Infection Prevention Transmission of HIV/AIDS HIV/AIDS Treatment Summary Unit 2 Exercises Unit 3, Overview of Public Health Surveillance Overview Introduction Public Health Surveillance Surveillance Terms Past Approaches to Communicable Disease Surveillance CAREC Regional Communicable Disease Surveillance System Major Changes in the Regional Communicable Disease Surveillance System Legal Basis Strategic and Operational Plans Reporting Chain Data Transfer Analysis and Interpretation Dissemination of Information Use of Data and Information Monitoring and Evaluation Summary Annex 3.1. Syndromes and Communicable Diseases under Regional Surveillance Unit 4, HIV Case Surveillance Introduction What is Third Generation Surveillance? Section 4.1: HIV Case Surveillance 3 8 8 9 14 17 18 20 20 22 22 24 33 33 36 38 39 42 42 43 43 46 48 49 50 50 51 51 53 53 54 55 56 57 58 60 60 60 65 HIV/STI Surveillance for CAREC Member Countries Table of Contents, continued Introduction to HIV Case Surveillance The Relationship Between the Natural History of HIV and Surveillance History of HIV/AIDS Case Surveillance Sources of HIV Case Surveillance Reports Section 4.1 Exercises Section 4.2: Clinical Staging and Surveillance Case Definitions for HIV Infection Introduction to Clinical Staging and Surveillance Case Definitions for HIV infection History of Clinical Staging and HIV/AIDS Case Surveillance Definitions Linking HIV Clinical Staging, ART Use, and HIV Case Surveillance Section 4.2 Exercises Section 4.3: Components of an HIV Case Surveillance System Introduction to an HIV Case Surveillance System Defining Reportable Events Case Finding Case Report Form Unit 4 Summary Unit 4 Case Study Annex 4.1. WHO clinical staging of HIV/AIDS for adults and adolescents with confirmed HIV infection Annex 4.2. Revised WHO clinical staging of HIV/AIDS for infants and children with confirmed HIV Infection Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years) Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children Unit 5, Monitoring Surveillance System Quality Overview Introduction What Surveillance Systems Describe Evaluating Surveillance Systems Evaluation Process Data Flow in the Caribbean Region Measuring Completeness Measuring Timeliness Measuring Validity Planning for Future Evaluations Summary 4 66 66 69 73 74 76 78 78 83 85 86 86 87 87 92 96 97 109 110 112 122 134 134 135 135 138 139 143 143 147 149 152 153 HIV/STI Surveillance for CAREC Member Countries Table of Contents, continued Unit 5 Exercises Unit 6, Surveillance for Sexually Transmitted Infections (other than HIV) Section 6.1: Overview of STI Surveillance Introduction STI Surveillance and HIV Epidemic State STI Aetiologies versus STI Syndromes Symptomatic and Asymptomatic STIs Case Definitions Components of STI Surveillance Systems Levels of STI Surveillance - Basic, Intermediate and Advanced Components of STI Surveillance Systems – In Detail Universal STI Reporting Prevalence Assessment and Monitoring Assessing STI Syndrome Aetiologies Behavioural and Biological Surveillance Surveys Monitoring of Anti-Microbial Resistance of STI Pathogens Section 6.2: Case Reporting, Data Management and Analysis Planning Your Data Collection Collecting Data Entering and Analysing Data Summary Annex 6.1. Caribbean Epidemiology Centre Quarterly STI Reporting Form Annex 6.2. CAREC Surveillance Case Definitions for Sexually Transmitted Infections (STIs) Definition of STI, by Syndromes Definitions of STI, by Aetiology Unit 7, Confidentiality and Data Security Overview Introduction Addressing Ethical Issues Unique Identifiers—Name versus Codes: Balancing Risks and Benefits Confidentiality Guidelines for Confidentiality and Data Security Guiding Principles Policies Responsibilities Training Physical Security 5 154 156 156 158 159 160 161 163 164 164 167 167 169 171 174 176 178 179 180 182 185 189 190 190 191 196 196 198 198 199 204 204 205 206 211 212 213 HIV/STI Surveillance for CAREC Member Countries Table of Contents, continued Data Security Data Movement Access Control Summary Unit 7 Exercises Annex 7.1. Additional Laptop Security Considerations Annex 7.2. Additional Security and Policy Considerations Annex 7.3. Sample Employee Confidentiality Agreement/Oath Annex 7.4. Attachment G: Using Surveillance Data to Document Need and Initiate Referrals Unit 8, Analysis, Interpretation, and Dissemination of HIV Surveillance Data Overview Introduction Communicating HIV Data Formats for Disseminating HIV Data Types of Analyses HIV Surveillance Report Annual HIV Epidemiologic Profile Recommended Analyses Programme Monitoring Data Unit 8 Exercises Appendix A, References Appendix B, Abbreviations and Glossary Appendix C, Useful Links Appendix D, Answers to Warm-Up Questions and Case Studies Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries Appendix F, Regional Surveillance Indicators and Data Appendix G, Regional Reporting Requirements HIV/AIDS and STI 6 216 217 221 231 232 234 238 243 244 256 258 258 265 266 267 270 272 273 275 278 A-1 B-1 C-1 D-1 E-1 F-1 G-1 HIV/STI Surveillance for CAREC Member Countries 7 HIV/STI Surveillance for CAREC Member Countries Unit 1 The Global HIV/AIDS Situation and the HIV/AIDS Epidemic in the Caribbean Overview What this unit is about This unit gives an overview of the global situation with regard to the HIV epidemic, and highlights the effects of the epidemic on the Caribbean. We will mostly consider recent data from UNAIDS and CAREC. Warm-up questions 1. True or false? Almost 40 million people worldwide are infected with HIV. True False 2. What region of the world has been most affected by HIV/AIDS, with an infection prevalence of over 30% in some countries? 3. Which region of the world has the second-highest HIV prevalence? 4. What region in the Caribbean has been most affected by HIV/AIDS? 5. The major factor that accounts for the prevalence rates of HIV/AIDS in the Caribbean is: a. b. c. d. e. injection drug use women’s status and inability to influence partners’ behaviour heterosexual transmission blood exposure from unsafe medical practises all of the above 8 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this unit, you should: have an understanding of the overall HIV/AIDS situation in the world be able to describe the main features of the HIV/AIDS situation in the Caribbean. Worldwide Epidemic The HIV epidemic continues to grow worldwide. UNAIDS estimated that 38.6 million [33.4 million-46.0 million] people worldwide were living with HIV at the end of 2005. An estimated 4.1 million [3.4 million–6.2 million] became newly infected with HIV and an estimated 2.8 million [2.4 million-3.3 million] lost their lives to AIDS. Overall, the HIV incidence rate (the proportion of people who have become infected with HIV) is believed to have peaked in the late 1990s and to have stabilised subsequently, despite increasing incidence in several countries. Figure 1.1. The global HIV epidemic, 1990-2005. Discussing the graph You can see from Figure 1.1 above that global HIV prevalence (the proportion of people living with HIV) appears to be levelling off; however, the numbers of people living with HIV have continued to rise. 1. What could be the causes of each phenomenon? 9 HIV/STI Surveillance for CAREC Member Countries Factors that affect HIV prevalence Worldwide, a variety of factors account for the prevalence of HIV, including the following: high prevalence of other sexually transmitted infections (STIs) increases the risk of acquiring and transmitting HIV limited access to STI management limited access to, or social non-acceptance of, condoms war and civil disturbance cultural/ethnic practises, such as polygamy and wife inheritance women’s low status and inability to influence their partners’ behaviour low literacy rates increasing urbanisation, migration, mobilisation and separation of families as a result of poverty and/or other social circumstances low level of political commitment to the prevention and control of HIV/AIDS exposure to blood from unsafe medical practises and/or traditional practises. Africa Africa remains the global epicentre of the AIDS pandemic. South Africa’s AIDS epidemic—one of the worst in the world—shows no evidence of a decline. An estimated 5.5 million [4.9 million–6.1 million] people were living with HIV in 2005. An estimated 18.8% [16.8%–20.7%] of adults (15–49 years) were living with HIV in 2005. Almost one in three pregnant women attending public antenatal clinics were living with HIV in 2004, and trends over time show a gradual increase in HIV prevalence. There are no clear signs of declining HIV prevalence elsewhere in southern Africa. In Swaziland, national adult HIV prevalence is estimated at 33.4% [21.2%–45.3%]. Botswana’s epidemic is equally serious, with national adult HIV prevalence estimated at 24.1% [23.0%–32.0%] in 2005. Lesotho’s epidemic seems to be relatively stable at very high levels, with an estimated national adult HIV prevalence of 23.2% [21.9%– 24.7%]. In many areas of West Africa, rates are between 5%-10%. The numbers for East and Central Africa are between these two. Among the notable new trends are the recent declines in national HIV prevalence in two subSaharan African countries (Kenya and Zimbabwe), and urban areas of Burkina Faso, alongside indications of significant behavioural change— including increased condom use, fewer partners and delayed sexual debut. Except for Sudan, national adult HIV prevalence in the countries of the Middle East and North Africa is very low, and does not exceed 0.1%. 10 HIV/STI Surveillance for CAREC Member Countries Africa, continued However, available data suggest that the epidemics are growing in several countriesincluding Algeria, Islamic Republic of Iran, Libyan Arab Jamahiriya and Morocco. Across the region, an estimated 64 000 [38 000– 210 000] people were newly infected with HIV in 2005, bringing the total number of people living with the virus to some 440 000 [250 000–720 000]. Sudan accounts for fully 350 000 [170 000–580 000] of those people. Figure 1.2. HIV prevalence among adults in Africa, 1990 and 2005. Source: UNAIDS, 2006. Figure 1.3. HIV epidemic in sub-Saharan Africa, 1985 – 2005. 11 HIV/STI Surveillance for CAREC Member Countries Eastern Europe and Asia Latest estimates show some 8.3 million [5.7 million–12.5 million] people (2.4 million among adult women [1.5 million–3.8 million]) were living with HIV in Asia at the end of 2005—more than two-thirds of them in one country, India. Approximately 650 000 [390 000–1.1 million] people in China were living with HIV in 2005. Injecting drug users (of whom there are at least one million registered in the country) account for almost half (44%) the people living with HIV. The overlapping risks of injecting drug use and unprotected sex feature in several other epidemics in Asia. The HIV epidemics remain relatively limited in Bangladesh, the Philippines, Indonesia and Pakistan, although each of these countries risks a more serious epidemic if prevention methods are not improved. An especially troubling situation has emerged in the easternmost province of Papua, which borders on Papua New Guinea, where a serious HIV epidemic is underway. The epidemics in Eastern Europe and central Asia continue to expand. Some 220 000 [150 000–650 000] people were newly infected with HIV in 2005, bringing to about 1.5 million [1.0 million–2.3 million] the number of people living with HIV—a twenty-fold increase in less than a decade. The epidemic’s death toll is rising sharply, too. AIDS killed an estimated 53 000 [36 000–75 000] adults and children in 2005—almost twice as many as in 2003. Increasingly large numbers of women are being infected with HIV. The majority of people living with HIV in Eastern Europe and central Asia are in two countries: the Ukraine, where the annual number of new HIV diagnoses keeps rising, and the Russian Federation, which has the biggest AIDS epidemic in all of Europe. 12 HIV/STI Surveillance for CAREC Member Countries Latin America In Latin America, some 140 000 [100 000–420 000] people were newly infected with HIV in 2005, bringing the number of people living with the virus to 1.6 million [1.2 million–2.4 million] The region’s biggest epidemics are in the countries with the largest populations, notably Brazil, which is home to more than one-third of the people living with HIV in Latin America. The most intense epidemics, however, are underway in the smaller countries of Belize and Honduras, in each of which more than 1.5% or more of adults were living with HIV in 2005. Oceania While HIV infection levels remain low across Oceania, Australia’s longestablished AIDS epidemic is not dissipating, and Papua New Guinea’s relatively young but already serious epidemic accounts for more than 90% of all HIV infections reported in Oceania to date outside of Australia and New Zealand. The Caribbean The Caribbean’s epidemics—and the response of each country to the AIDS epidemic—vary considerably in extent and intensity. HIV infection levels have decreased in urban parts of Haiti and in the Bahamas, and have remained stable in neighbouring Dominican Republic and Barbados. Expanded access to antiretroviral treatment in the Bahamas and Barbados appears to be reducing AIDS deaths, as well. However, such progress has not been enough to undo the Caribbean’s status as the second-mostaffected region in the world. AIDS is the leading cause of death among adults (15–44 years) and claimed an estimated 27 000 [18 000–37 000] lives in 2005. (UNAIDS, 2006) Overall, fewer than one in four (23%) persons in need of antiretroviral therapy was receiving it in 2005. National adult HIV prevalence exceeds 2% in Trinidad and Tobago, and 3% in the Bahamas and Haiti. As the epidemic has spread throughout the Caribbean, the primary mode of sexual transmission has changed from being predominantly homosexual to a mosaic of homosexual, bisexual and heterosexual epidemics. Injecting drug use is responsible for a minority of HIV infections and contributes significantly to the spread of HIV only in Bermuda. The epidemic is also shifting to younger populations—in particular, to young females. Among the 12 territories with a generalised epidemic in the Caribbean, 10 of them are CAREC Member Countries (CMCs). The remaining two countries, Haiti and the Dominican Republic, share the Hispaniola Island, which is the epicentre of the HIV epidemic in the Americas (CSR Supplement, 2003). 13 HIV/STI Surveillance for CAREC Member Countries Trends (CAREC Surveillance data, 1982–2003) Data used for this report are based on quarterly reports or year-end summaries submitted by nineteen CMCs. No reports were received from Aruba; combined HIV/AIDS data were received from the Netherlands Antilles. As data for 2004 and 2005 are only available for a small number of countries, this review covers the period from 1982 to 2003. During the period from1982 to 2003, a cumulative total of 25 854 AIDS cases were reported to CAREC by 19 of its 21 CMCs. The distribution of cases among CMCs was as follows: Jamaica - 31%, Bahamas - 17%, Trinidad and Tobago - 20%, Guyana - 11%, Barbados - 7%, Suriname 7%, St. Vincent and the Grenadines - 2%, and Bermuda - 2%. The remaining CMCs (except Aruba and the Netherlands Antilles) individually reported less than one percent of the total. The first case of AIDS in the CMCs was recorded in Jamaica in 1982, and the general trend since then has been an increasing one, from 669 cases in 1990 to 2 638 cases in 2003 [as shown in Figure 1.3]. Incomplete reports from some relatively large countries (for example, Barbados, Belize and Suriname) were mainly responsible for the decrease in 2000-2002. The rate of the spread of HIV (and subsequently AIDS) shows a variety of trends in the different member countries. This is the result of a number of factors, including the stage of the epidemic in each country, the primary mode(s) of transmission, the strength of the HIV/AIDS control programme and the availability of antiretroviral drugs. In Jamaica, the trend has been a steadily increasing one, from one case in 1982 to 70 cases in 1990, to a high of 1070 cases in 2003. Trinidad and Tobago and the Bahamas, which reported higher numbers than Jamaica in 1990-1993, have shown a slower rate of increase, with indications of a plateau in 1996/97 and subsequent declines. Antigua and Barbuda, Dominca, Grenada and St. Lucia have all reported fewer than 20 cases per year, while Anguilla, Montserrat, the British Virgin Islands, the Cayman Islands and St. Kitts and Nevis have individually reported fewer than 10 cases per year. 14 HIV/STI Surveillance for CAREC Member Countries Trends (CAREC Surveillance data, 1982 – 2003), continued Reported (Confirmed) Cases of AIDS by Year Figure 1.3. Reported of AIDS by year, CAREC member Countries CAREC Membercases All(confirmed) 1982 - 2005 1982-2005. countries, 3000 incomplete reporting 2000 1500 1000 500 20 05 20 04 20 03 20 02 20 01 20 00 19 99 19 98 19 97 19 96 19 95 19 94 19 93 19 92 19 91 19 90 19 89 19 88 19 87 19 86 19 85 19 84 19 83 0 19 82 No. of Reported Cases 2500 Year During the period under review, the HIV/AIDS epidemic in the Caribbean changed from occurring mostly in males, to a male-to-female ratio of 1:1.4 in 2003. In the year 1985, out of 138 total AIDS cases reported by CMCs, 28 (20%) were in females. In the year 1990, out of 669 total AIDS cases reported by CMCs, 211 (32%) were in females. As shown in Figure 1.4, on the next page, in 2003, of 2 638 total reported AIDS cases, 1 102 (42%) were in females. 15 HIV/STI Surveillance for CAREC Member Countries Trends (CAREC Surveillance data, 1982 – 2003), continued Figure 1.4. Reported AIDS cases in the Caribbean region, 1982-2003. Source: AIDS reports from CMCs, accessed from the CAREC Reporting Tool for AIDS at: http://carec.net/index.html on 11th May 2006 16 HIV/STI Surveillance for CAREC Member Countries Trends (CAREC Surveillance data, 1982 – 2003), continued Table 1.1 shows the age distribution of reported AIDS cases for the years 1985, 1990, 1995, 2000 and 2003. The 20-49 year age group is the most affected, accounting for over 65% of cases annually. Table 1.1: Reported AIDS cases by age group in 1985, 1990, 1995, 2000 and 2003. Age (years) 1985 1990 1995 2000 2003 ≤1 1-4 5-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 ≥ 50 Unknown Total 8 9 1 3 14 28 27 16 8 1 10 11 136 21 14 6 13 74 110 120 87 57 46 64 57 669 33 36 14 21 128 234 312 256 192 129 201 24 1580 32 106 38 29 128 279 309 338 245 220 284 222 2230 20 56 34 30 150 290 404 383 321 234 366 350 2638 Source: AIDS reports from CMCs, accessed from the CAREC Reporting Tool for AIDS at: http://carec.net/index.html on 11th May 2006. Although heterosexual transmission of HIV has been steadily increasing over the years and is the major mode of transmission, other routes, like MSM (men having sex with men) and MTCT (mother-to-child transmission) have also been consistently responsible for a significant number of AIDS cases. However, unlike in some other parts of the world (like North America and Europe), HIV transmission due to intravenous drug use is not responsible for a large number of AIDS cases in the CMCs. While there is under-reporting, there is cautious optimism that the AIDS epidemic in some CMCs has reached or is reaching a plateau. For more detailed AIDS data, please visit CAREC Reporting Tool for AIDS at: http://carec.net/index.html Summary HIV/AIDS has become a major developmental problem, affecting every country world-wide and the Caribbean region in particular, where the epidemic is second in magnitude only to that in sub-Saharan Africa. It should, however, be noted that there are substantial differences in the extent and intensity of the epidemic in individual countries in the Caribbean. 17 HIV/STI Surveillance for CAREC Member Countries Unit 1 Exercises Warm-up review Take a few minutes now to look back at your answers to the warm-up questions at the beginning of the unit. Make any changes you want to. Small group discussion Get into small groups by country, region or district to discuss these questions. 1. Which regions or districts are most affected by the HIV/AIDS epidemic in your country? 2. What might be the factors contributing to the high rate of HIV in these provinces or districts? Apply what you’ve learned/ case study Try this case study. We’ll discuss the answers in class. Cariba is a Caribbean nation that had its earliest cases of AIDS recognised in 1982. Data below are based on estimates of HIV prevalence by parish. HIV prevalence (%) by parish, Cariba, 1995-2002. Parish St. Mary Kingstown Arima St. James Yotown 1995 1998 .2 0.5 1.0 1.1 0.4 2000 0.5 0.7 2.0 5.6 0.9 2002 1.0 0.9 2.7 2.0 1.3 a. What parish has historically had the greatest proportion of its population infected with HIV? b. What are prominent recent trends? c. In 2002, which parish had the highest prevalence? Is the epidemic increasing or decreasing in this parish? 18 1.1 1.0 2.9 2.8 1.2 HIV/STI Surveillance for CAREC Member Countries 19 HIV/STI Surveillance for CAREC Member Countries Unit 2 Biology, Transmission, Natural History, Prevention and Treatment of HIV Infection and AIDS Overview What this unit is about Extensive research has shown that HIV is the virus that causes AIDS. This unit discusses HIV types and the prevention and treatment of HIV infection and AIDS. Warm-up questions 1. Which body cells does HIV infect? a. respiratory cells b. skin cells c. red blood cells d. white blood cells 2. How many major strains of HIV exist? 3. Which of the following is not a method of HIV transmission? b. sexual intercourse c. casual physical contact d. blood exchange e. mother to foetus transmission 4. What type of infectious agent is HIV? a. bacterium b. virus c. prion d. none of the above 5. True or false? HIV infection and the onset of AIDS occur simultaneously. True False 6. Which region of the world has the greatest diversity of HIV sub-types, making the development of one unique treatment or vaccine difficult? 20 HIV/STI Surveillance for CAREC Member Countries Warm-up questions, continued 7. Which of the following is associated with increased risk of sexual transmission of HIV? a. failure to use a male or female condom b. a greater number of sexual partners c. a high viral load in an infected partner d. all of the above 8. True or false? The presence of existing sexually transmitted infections (STIs) increases the risk of acquiring HIV during sexual intercourse. True False 9. List the three main types of antiretroviral drugs used to treat HIV infection. a. b. c. 10. Which of the following fatal opportunistic infections commonly occur(s) in AIDS patients? a. herpes zoster b. fungal infections c. tuberculosis (TB) d. all of the above 11. True or false? A vaccine for the prevention of HIV infection is currently available. True False 12. True or false? Some STIs, such as chlamydia, are biologically more easily acquired by young women, making them more susceptible to HIV infection. True False 13. _____________ is the term used to describe the treatment to prevent or suppress infection. 21 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this unit you should be able to: explain the basic biology of HIV describe HIV transmission routes understand the importance of concurrent STIs in increasing risk of HIV transmission discuss the natural history of HIV and list the major opportunistic infections that occur among AIDS patients describe the major elements of HIV prevention and control programmes recognise that HIV is treated with antiretroviral drugs and that treatment involves prevention and treatment of opportunistic infections. Biology of HIV The virus Since AIDS was first recognised in 1981, extensive research has shown that HIV is the virus that causes AIDS. HIV is a retrovirus, a family of viruses that carry their genetic information on a single strand of RNA. HIV infects a number of different cells in the body. Most important are two classes of white blood cells that are involved with protecting the body against infection: CD4+ lymphocytes macrophages As the number of these cells is depleted because of viral destruction, patients become immunodeficient, meaning their immune systems are insufficient to ward off infections. They develop opportunistic infections and certain cancers, which may be infectious in origin. Opportunistic infections are illnesses that usually do not occur in persons with healthy immune systems. HIV types The epidemiology of HIV sub-type distribution and their evolution worldwide are critical for several reasons, including: for vaccine development to trace transmission among individuals and track the spread of the virus through countries. 22 HIV/STI Surveillance for CAREC Member Countries HIV types, continued Two major types of HIV have been recognised: HIV-1 and HIV-2. Table 2.1 summarises the differences between the two types: Table 2.1. Characteristics of HIV-1 and HIV-2. HIV-1 HIV-2 Primarily confined to West Geographic Worldwide Africa, although cases have distribution been reported in Europe, Asia, and Latin America Subtypes Major group, M, is classified into 10 subtypes; additional highly divergent strains are known as group O Five genetic sub-types Natural history More easily transmitted, and faster progression to AIDS Less easily transmitted than HIV-1, and slower progression to AIDS Discussing the table a. Which type is more widespread, HIV-1 or HIV-2? b. Which type of HIV is transmitted more easily, HIV-1 or HIV-2? c. Which type of HIV progresses more quickly to AIDS? Differences in distribution At present, specific sub-types are found more frequently in certain countries or regions of the world. Because people move within and between countries, it is likely that multiple sub-types of HIV-1 will appear in most countries. Sub-types A, C and D of HIV-1 are most frequently found in subSaharan African countries, but all sub-types along with group O strains have been identified. The greatest diversity of HIV strains has been found in sub-Saharan Africa, which has also been the region most severely affected by the epidemic. HIV-1 is the prevalent strain in the Caribbean. 23 HIV/STI Surveillance for CAREC Member Countries HIV Transmission and Natural History How HIV is transmitted Both HIV-1 and HIV-2 are transmitted in the same ways. Figure 2.1 details the primary methods of HIV transmission in the Caribbean. The predominant route of transmission in countries with generalised epidemics (that is, an epidemic where HIV is firmly established in the general population) is through unprotected heterosexual intercourse or homosexual intercourse between men. There are no documented cases of sexual transmission between women. Sexual transmission accounts for the majority of HIV transmission in the Caribbean. HIV is also transmitted through blood, blood products and donated organs or semen. Blood-borne transmission, also known as parenteral transmission, occurs primarily through the use of inadequately sterilised needles, syringes or other skin-piercing instruments and through the transfusion of infected blood. HIV may be transmitted from an infected mother to her foetus or infant during pregnancy, delivery or when breastfeeding. Figure 2.1. Category of transmission in reported AIDS cases in CMCs, 1982-2002. Source: Status and Trends: Analysis of the Caribbean HIV/AIDS Epidemic, 1982-2002. CAREC/PAHO 2004 Discussing the figure Look at Figure 2.1 and answer the following questions. a. What is the most common mode of transmission in the Caribbean? b. Which type accounts for 11% of HIV transmission in the Caribbean? 24 HIV/STI Surveillance for CAREC Member Countries How HIV is transmitted Figure 2.2 shows the HIV infection process. HIV infection begins when specific attachment proteins on the envelope of the HIV virus (known as glycoprotein (gp) 120 and gp 160) bind to CD4 receptors located on the cell membranes of human T-helper lymphocytes and macrophages (two types of white blood cells) and a few other types of cells. This binding reaction allows HIV to fuse with the T-helper lymphocyte or macrophage. The HIV genetic material is reverse-transcribed and integrates with the cell’s DNA. Reverse-transcription is the process by which HIV’s genetic material (RNA) is transformed into DNA, which allows it to fuse with the host’s genetic material (DNA). The cell produces the components of new HIV viruses, which are then released to infect additional cells. Figure 2.2. HIV infection process of a T-helper lymphocyte. 25 HIV/STI Surveillance for CAREC Member Countries Discussing the figure Look at Figure 2.2, on the previous page, and answer the following questions: a. What process enables the HIV virus to enter the T-lymphocyte? b. Where are the new HIV components produced? Factors affecting HIV transmission HIV transmission depends on a variety of biological, behavioural and epidemiological factors. Together these factors are usually referred to as infectivity. Infectivity refers to the probability of an organism being transmitted from an infected person to an uninfected person. We will consider these two essential questions: What are the inter-relationships between HIV and STIs? What risk factors determine whether an STI or HIV will be transmitted through a sexual exposure? STI and HIV interrelationship Over the course of the HIV epidemic, we have begun to understand the complex inter-relationships between STIs and sexually transmitted HIV. Behavioural factors – Both STIs and HIV can be sexually transmitted by vaginal, anal and oral intercourse. The risk of HIV transmission is generally greatest for anal intercourse and least for oral intercourse. Epidemiological factors – Populations with high rates of STIs have high rates of sexually transmitted HIV. Host factors – The presence of STIs causes local immunologic changes in the mucous membranes of the genital track, and, in the case of genital ulcers, cause tears in the protective layer of skin. These changes make it easier to acquire and transmit HIV. 26 HIV/STI Surveillance for CAREC Member Countries Risk factors for HIV infection The three primary biological factors that influence the transmission and acquisition of HIV infection are: the amount of virus to which an uninfected person is exposed the type/duration of exposure host factors that protect uninfected persons against infection. 1. Amount of virus Definition: Viral load refers to the amount of virus present in blood, semen, cervicovaginal fluids and amniotic fluid of the infected person. The amount of virus is higher in some body fluids than in others. When a person is exposed to fluids with a high viral load, he or she has a higher risk of being infected than if exposed to fluids with a lower viral load. In general, viral load is higher in blood and genital fluids than in oral fluids. Viral load in blood can be measured with an HIV viral-load blood test. Higher viral loads in the blood generally correspond to higher viral loads in genital fluids (semen and vaginal secretions). The viral load varies during the clinical course of disease. It is highest in the early and late stages of disease. Effective treatment with antiretroviral therapy (that is, drugs used to fight HIV infection) lowers the viral load in blood and may lower it in genital fluids. 27 HIV/STI Surveillance for CAREC Member Countries Risk factors for HIV infection, continued 2. Type and duration of exposure The type and duration of exposure affects the risk of HIV transmission. Consider these factors: Direct exposure to HIV-infected blood (for example, through blood transfusions) carries a greater chance of transmission than exposure to an infected person’s semen or vaginal secretions. Sexual exposure risk is increased with the following: o the presence of white blood cells and inflammation o the duration of exposure. The risk of acquiring HIV is proportional to a person’s risk of being exposed sexually to HIV. This means that a person’s risk of HIV is determined primarily by the risk of having an infected partner. Persons whose primary sexual partner is infected have the greatest probability of infection through repeated sexual exposure to this primary partner. The risk of acquiring HIV infection increases with the number of exposures to an infected person. An uninfected person repeatedly exposed to an infected person is at greater risk, over time, of being infected, than someone exposed only once. For example, an infected wife’s uninfected husband is at greater risk if he has sex with her 100 times over a year than if he has sex with an infected sex worker one time during that year. Among persons with multiple sexual partners, the greater the number of partners an individual has, the greater his or her likelihood of having intercourse with someone with HIV infection. Anal intercourse carries a higher risk of infection than vaginal intercourse, and vaginal intercourse is substantially riskier than oral intercourse. Uncircumcised men have a higher risk of acquiring HIV infection than circumcised men because: o infected vaginal fluids are held in contact with mucosal surfaces under the uncircumcised foreskin longer o the foreskin often contains large numbers of white blood cells that HIV can infect. 28 HIV/STI Surveillance for CAREC Member Countries Risk factors for HIV infection, continued 3. Host factors Host factors also affect the risk of infection. Genetic/immunologic: The risk of transmission from an infected man to an uninfected woman during intercourse may be slightly higher than the risk of transmission from an infected woman to an uninfected man. Factors that may contribute to a higher risk of transmission from a man to a woman include the following: o STIs and HIV in semen can remain viable for up to 72 hours following ejaculation. o In contrast, very small amounts of cervico-vaginal fluids are introduced into the male partner’s urethra during sex. Thus, the male is only exposed during the act of intercourse, an average of 20 minutes. o The cervix and the opening of the cervical canal have greater surface area than the male urethra. Persons with genetic mutations for the HIV co-receptor are less susceptible to HIV infection. Presence of STIs: The co-existence of inflammatory (such as gonorrhoea or chlamydia) or ulcerative (such as syphilis, chancroid or herpes simplex type 2) sexually transmitted infections (STIs) increases the risk for acquiring HIV infection. 29 HIV/STI Surveillance for CAREC Member Countries How STIs increase HIV risk The process by which STIs increase the risk of transmitting and acquiring HIV infection is described below and shown in Figure 2.3: STIs destroy cells in the epithelium at the site of infection in the genital tract (for instance, the urethra in men or the cervix in women). This partially or completely exposes the sub-mucosal layer of the mucous membrane and forms ulcerations. The ulcerations can be seen on examination of the patient or can be detected microscopically. The ulceration results in an inflammatory immune response. The immune system cells that come in response to the infection include, among others, cells that HIV can target. These cells are: o T-helper lymphocytes o macrophages. These cells contain CD4 receptors and are present in the sub-mucosa and on the surface of the mucous membranes. Figure 2.3. How STIs increase the risk of HIV transmission. Discussing the figure Look at Figure 2.3, and answer the following questions: a. How do STIs increase the risk of HIV transmission? b. What does HIV do once it has entered the sub-mucosal membrane? 30 HIV/STI Surveillance for CAREC Member Countries STIs increase risk of acquiring and transmitting HIV As shown in Table 2.2, STIs affect both HIV-infected and HIV-uninfected persons. Table 2.2. The effect of STIs on HIV-infected and HIV-uninfected patients. HIV Status Effect of STIs Infected Uninfected Increases the recruitment of HIV-infected cells, such as T-helper lymphocytes and macrophages, to the surface of the mucous membranes Increases the recruitment of cells that can be infected by HIV, such as T-helper lymphocytes and macrophages, to the surface of the mucous membranes, thereby increasing susceptibility to HIV transmission Destroys epithelial layer through ulceration and exposes sub-mucosal tissues that contain target cells (that is, cells that can be infected by HIV) Discussing the table Looking at Table 2.2, discuss the following questions: a. How would ulceration increase the risk of acquiring HIV? b. What causes the recruitment of HIV target cells to the surface of mucous membranes? 31 HIV/STI Surveillance for CAREC Member Countries Can controlling STIs decrease HIV transmission? Three large randomised controlled community trials have been conducted in Africa. The purpose of the trials was to assess the impact of intensive STI control and treatment programmes on HIV transmission. In the Mwanza district of Tanzania, improved STI syndromic management and public health programmes led to a decrease in HIV transmission compared to usual care. This study was conducted when the STI prevalence was high and the HIV prevalence was low but increasing rapidly in Tanzania. Overall, HIV incidence was 42% lower in communities that received improved STI services compared to those that continued with the usual levels of STI services. Two other STI control trials were conducted in Uganda, in areas of high but stable or declining HIV incidence and moderate or lower STI prevalence. These found different results from the trial in Tanzania. o In the Rakai study, azithromycin, ciprofloxacin and metronidazole were used to control STIs, but this did not lead to a decrease in HIV transmission. o In the Masaka trial, improved syndromic case management and public health STI management also failed to decrease HIV transmission. Both of the Ugandan studies were conducted during the time of stable or declining HIV transmission in Uganda. Possible reasons for discrepancy Why did the study results not agree? The discrepancy is probably due to the nature of the HIV epidemic in each area during the time when the STI programme improvements were made. The difference may also be due to the types and prevalence of STIs in those communities. For example, the prevalence of genital ulcer disease was relatively low in Uganda at the time of these trials. Still, some conclusions can be made: Large-scale improvements in STI control programmes are likely to have the greatest impact on HIV during the early phase of an HIV epidemic in a given community or population. During this time period, STI control programmes may lead to substantial reductions in new HIV infections. 32 HIV/STI Surveillance for CAREC Member Countries Possible reasons for discrepancy, continued When HIV infection rates are stable or declining, STI control programmes may be less effective in decreasing HIV transmission in a community or population. Treatment implications For clients of STI clinics, risk of transmitting and acquiring HIV infection can be reduced if clinicians are trained to: provide HIV behavioural risk-reduction counselling and testing to all patients diagnosed with an STI screen HIV-infected patients for STIs treat both symptomatic and asymptomatic STIs provide treatment to sexual partners. Spectrum of Disease following HIV Infection AIDS is the late stage of HIV infection. AIDS is characterised by a severely weakened immune system that can no longer ward off lifethreatening infections and cancers. The risk for AIDS is related to the length of HIV infection. Without antiretroviral therapy, the vast majority of HIV-infected individuals will eventually develop AIDS. Prior to antiretroviral therapy (ART; that is, drugs used to fight infection by retroviruses), the average time from HIV infection to onset of clinical AIDS in North American patients was 10 years. The advent of effective ART has considerably reduced the rate of progression to AIDS in areas where these drugs are accessible. It has also been associated with changes in the types of opportunistic infections that appear with AIDS. Overall, in the Caribbean, fewer than one in four (23%) of the people in need of antiretroviral therapy were receiving treatment in 2005. Preventing Transmission of HIV/AIDS Prevent sexual transmission The best long-term solution for controlling the HIV/AIDS epidemic is a low-cost, highly effective vaccine, but one will not be available in the near future. Therefore, the best options remain changes in behaviour and a handful of prevention technologies. 33 HIV/STI Surveillance for CAREC Member Countries Prevent sexual transmission, continued The goal of prevention is to decrease the risk for HIV transmission from infected to uninfected individuals. The basic approach to prevention involves: decreasing the risk of being exposed by avoiding sexual intercourse with an infected person decreasing the risk of transmission, if exposed. Basic approach The most basic approach to prevention, other than abstinence, is to delay age of sexual debut decrease the numbers of sexual partners consistently use male and female condoms undergo voluntary testing and counselling to know your HIV status identify and appropriately treat STIs avoid blood-borne transmission. Table 2.3. Avoiding blood-borne transmission of HIV. Method of How to prevent transmission Transfusion sterilising or not re-using needles screening blood and blood products for HIV prior to administration Re-use of needles and sterilisation of surgical instruments surgical instruments (including those used in circumcision, without sterilisation tattooing and scarification) sterilising or not re-using needles Needlestick injuries to universal precautions for healthcare healthcare workers workers (for example, use of gloves and eyewear, proper disposal of needles) post-exposure prophylaxis for healthcare workers exposed (depending on level of risk) In some parts of the world, the principal means of parenteral transmission has been the sharing of needles and syringes by illegal drug users. Discussing the table Look at Table 2.3 to answer these questions: a. List three ways that healthcare workers can protect themselves from infection. b. Is illegal drug injection a problem in your country? 34 HIV/STI Surveillance for CAREC Member Countries Prevent mother-to-child transmission Perinatal transmission is HIV transmission during pregnancy, childbirth and breastfeeding. Study results vary, but in 1999 they suggested that the rate of mother-to-child transmission of HIV is around 25 to 30% in the Caribbean. (Sixty-six percent of that transmission occurs during pregnancy and delivery and 34% through breastfeeding). A short-course antiretroviral regimen given to the mother and the newborn baby substantially reduces the risk of transmission. Cuba’s prevention of mother-to-child transmission of HIV programme is among the most effective in the world and has kept the total number of babies born with HIV to date below 100. HIV-infected mothers can avoid the risk of transmission through infected breast milk by using breast-milk substitutes. However, significant health risks are associated with this practise, including: malnutrition exposure to other infections. WHO/UNICEF/UNAIDS have developed several documents that address HIV and breastfeeding. A summary of their recommendations follows: When replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected mothers is recommended. Otherwise, exclusive breastfeeding is recommended during the first months of life. All HIV-infected mothers should receive counselling about the risks and benefits of various infant-feeding options. Whatever a mother decides, she should be supported in her choice. When HIV-infected mothers choose not to breastfeed from birth or stop breastfeeding later, they should be provided with specific guidance and support for at least the first two years of the child’s life to ensure adequate replacement feeding. Breastfeeding should be discontinued as soon as feasible. This is known as “early weaning,” and it should take into account local circumstances, nutritional considerations, the individual woman’s situation and the risks associated with replacement feeding. 35 HIV/STI Surveillance for CAREC Member Countries HIV/AIDS Treatment Antiretroviral drugs Antiretroviral drugs are used to treat HIV infection. In the past, the high cost of these drugs meant that they were rarely used in the Caribbean and sub-Saharan Africa. Several agencies are now making funds available for antiretroviral and other therapies. These organisations include the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Bank Multisectoral AIDS Plan (MAP) and the United States President’s Emergency Plan for HIV/AIDS Relief (PEPFAR). There are three classes of first-line antiretroviral drugs: nucleoside reverse transcriptase inhibitors (NRTIs) non-nucleoside reverse transcriptase inhibitors (nNRTIs) protease inhibitors (PIs). The regimens recommended for use in the Caribbean include a combination of three antiretroviral drugs. If available, tests for the level of CD4+ cells and plasma viral load (a measure of how much HIV is replicating in the body) can be used to make judgments about when to begin therapy. Treatment will most likely start when patients develop clinical symptoms from their immunodeficiency or reach a CD4+ cell count of fewer than 350 cells per mm3. Preventing and treating opportunistic infections In addition to antiretroviral drugs, the treatment of HIV infection includes diagnosis, prophylaxis (treatment to prevent or suppress infection) and treatment of selected opportunistic infections. Anti-tuberculosis (TB) drugs extend the lives of patients with both HIV and TB. Cotrimoxazole prophylaxis has been used successfully to prevent the onset of opportunistic infections in HIV-infected patients. Vaccines are available for some potential opportunistic infections, such as pneumococcal disease. 36 HIV/STI Surveillance for CAREC Member Countries Preventing and treating opportunistic infections, continued New prevention strategies are being explored. Some strategies that are currently undergoing development/research trials include: male circumcision cervical barriers pre-exposure prophylaxis with antiretroviral drugs herpes suppression microbicides HIV vaccines. The results of some of these studies could be available within the next two years. Additionally, a wide range of promising HIV prevention approaches are in late-stage clinical trials. Male circumcision Researchers have long observed that countries with higher rates of male circumcision have lower rates of HIV infection. In 2005, the first randomised efficacy trial of male circumcision for HIV prevention, conducted in South Africa, showed that circumcised men were 60% less likely than uncircumcised men to become infected with HIV from female partners. Three additional efficacy trials of male circumcision are underway in Kenya and Uganda to assess the applicability of the South African findings in other settings and populations, and to determine if male circumcision also reduces the risk of HIV transmission from men to their female partners. Results are expected in 2007. Cervical barriers Researchers hypothesise that cervical barriers such as diaphragms, which are currently used for contraception, may help protect women from HIV and other sexually transmitted diseases. An efficacy trial of the diaphragm for HIV prevention is nearing completion in South Africa and Zimbabwe, and results are expected in 2007. Pre-exposure prophylaxis with antiretrovirals Research in animals suggests that antiretroviral drugs used for HIV treatment may also be effective in preventing infection in HIV-uninfected adults, an approach called pre-exposure prophylaxis, or PrEP. Efficacy trials of this approach are underway in Botswana, Peru and Thailand. Results could be available as early as 2008. 37 HIV/STI Surveillance for CAREC Member Countries Herpes suppression Herpes, which infects up to 70% of people in some parts of sub-Saharan Africa, can triple the risk of HIV acquisition, as well as increasing the risk of transmission to others. The inexpensive, off-patent drug acyclovir is approved for herpes suppression, and two trials are being conducted in Africa, Latin America and the U.S. to test the efficacy of suppressing herpes to lower HIV risk. Results are expected in 2007 and 2008. Microbicides Microbicides are topical substances, such as gels or creams, that can be applied to the vagina or rectum to reduce HIV transmission. In 2007, two phase III studies of one candidate microbicide were stopped prematurely because in one of the studies, there was a higher number of HIV infection in the active group compared with the placebo group. Currently, there are three other phase III microbicide studies underway; results from some of these trials could be available by 2008. In addition, a number of secondgeneration microbicide candidates—which specifically target HIV or molecules of the cells it infects—are in earlier stages of research, and could complete clinical trials within 10 years. HIV vaccines The best long-term hope for HIV prevention is a vaccine, but developing an effective vaccine has proven to be a highly complex scientific challenge. Most experts predict that it could be 10 years or more before an HIV vaccine candidate is shown to be effective. An effective vaccine will likely need to stimulate two types of immune response, but most of the vaccine candidates developed to date are designed to target only one arm of the immune system. Currently, 30 HIV vaccine candidates are in clinical trials, including two in advanced efficacy or proof-of-concept trials. Summary HIV is a virus that can be transmitted sexually, parenterally or perinatally. However, there are precautions to prevent each type of transmission, including condom use, needle sterilisation and short-course antiretroviral treatment during pregnancy. Treatment includes antiretroviral drugs and the prevention and treatment of opportunistic infections. 38 HIV/STI Surveillance for CAREC Member Countries Unit 2 Exercises Warm-up review Take a few minutes now to look back at your answers to the warm-up questions at the beginning of the unit. Make any changes you want. Small group discussion Get into small groups by country, region or province to discuss these questions. 1. What is the predominant type of HIV in your country, HIV-1 or HIV-2? 2. What are the risk factors associated with sexual transmission of HIV in your country? 3. What are the most common opportunistic infections in your country? 4. What are the major HIV prevention programmes that are operating in your country? Of those programmes, what proportion of the population do they reach? 39 HIV/STI Surveillance for CAREC Member Countries Apply what you’ve learned/ case study Try this case study. We will discuss the answers in class. Cariba has experienced rapid expansion of the HIV epidemic. Prevention programmes to date have focused primarily on prevention of mother-tochild transmission. Examine the data and answer the questions. Incidence of various STIs over time, Cariba. 2000 Gonorrhoea* Syphilis* Reported cases of urethritis from STI clinic HIV incidence (estimated) 2001 2002 5.0 2.1 2 987 12.8 4.5 3 452 23.5 16.4 6 784 2.0% 4.3% 5.0% * Cases per 1 000, population 15-49 years a. Do you think that sexually transmitted infections (STIs) may be playing an important role in the spread of HIV infection? Why? b. Would an STI prevention programme be an important part of the country’s HIV control efforts? c. Given the HIV incidence in Cariba, what do you think will happen to tuberculosis rates in the next several years, and why? 40 HIV/STI Surveillance for CAREC Member Countries 41 HIV/STI Surveillance for CAREC Member Countries Unit 3 Overview of Public Health Surveillance Overview What this unit is about To achieve HIV prevention and control, HIV/AIDS control programmes need information on infection trends and on demographic and behavioural characteristics of the affected population in a geographic area. This information is being collected through surveillance systems. This unit discusses the techniques of public health surveillance. Warm-up questions 1. Which of the following terms indicates the number or proportion of persons in a population who have a disease at a given point in time? a) b) c) d) sensitivity prevalence negative predictive value none of the above 2. True or false? One-time cross-sectional surveys are valid methods of HIV surveillance. True False 3. Match the following terms with their definitions: ___ laboratory-based reporting a. surveillance system in which the reports of cases come from clinical laboratories as opposed to healthcare practitioners or hospitals b. clinical and laboratory characteristics that a patient must have to be counted as a case for surveillance purposes ___ case definition 4. Which of the following terms indicates the number of persons who develop a disease within a specified time period? a) b) c) d) specificity positive predictive value incidence none of the above 42 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this unit you should be able to: describe the components of a surveillance system define sentinel surveillance, laboratory-based surveillance, and case definitions define incidence and prevalence. What is surveillance? Surveillance is the systematic, regular collection of information on the occurrence, distribution and trends of a specific infection, disease or other health-related event. Surveillance must occur on an ongoing basis, with sufficient accuracy and completeness for data analysis and dissemination that can lead to effective prevention and control of that infection, disease or health-related event. Public Health Surveillance Surveillance events Surveillance involves the following main components: the systematic collection, analysis and evaluation of morbidity and mortality reports and other relevant data timely and regular distribution of information about the trends and patterns of disease to those who need to know use of the information for disease prevention and control measures. An important part of the definition is that surveillance systems involve ongoing collection and use of health data. In other words, one-time crosssectional surveys are not surveillance. Information loops A surveillance system is an information loop or cycle that involves: healthcare providers public health agencies the public. 43 HIV/STI Surveillance for CAREC Member Countries Information loops, continued The cycle begins when cases of disease occur. It is complete when information about these cases is made available and used for prevention and control of the disease. The analysed and interpreted data must be communicated to the people and agencies that need to use them. Figure 3.1 shows the information loop. Figure 3.1. The flow of surveillance data Discussing the figure Refer to Figure 3.1 and think about how HIV surveillance is conducted in your country. (You may also choose a different disease.) For each block in the loop, write one or two events that might occur. On the next page ‘Reporting’ has been done as an example. 44 HIV/STI Surveillance for CAREC Member Countries Discussing the figure, continued Reporting: 1. Laboratory reports laboratory result of Cryptococcus neoformans to treating physician. 2. Notification form for patient with cryptococcal meningitis is sent from hospital to health department. Analysis and interpretation: 1. 2. Dissemination/utilisation 1. 2. Intervention 1. 2. 45 HIV/STI Surveillance for CAREC Member Countries Surveillance Terms Information from surveillance is used to make decisions about the best ways to prevent and control the disease. The term ‘surveillance’ implies information for action. We will review some basic surveillance terms. Universal case reporting - A surveillance system in which all cases of a disease are reported. Sentinel surveillance - A surveillance system in which reports are obtained from certain selected facilities or populations. Sentinel surveillance can apply both to reports of cases of disease or to periodic surveys, such as antenatal HIV surveys. Laboratory-based reporting - A surveillance system in which the reports of cases come from clinical laboratories instead of physicians, other healthcare practitioners or hospitals. Case definition - The clinical and laboratory characteristics that a patient must have to be counted as a case for surveillance purposes. Prevalence - The proportion of persons in a population who have a disease or condition at a given point in time. Incidence - The number of persons who develop a disease or condition within a specified time period. Incidence is expressed as a rate with the time period in the denominator. Passive surveillance - A passive system refers to data generated without solicitation, intervention or contact by the health agency carrying out the surveillance. Other agencies initiate reporting. Example: normal disease case reporting by health facilities. Active surveillance - The organisation conducting surveillance initiates procedures to obtain reports. Example: making telephone calls or visits to health facilities to obtain information. 46 HIV/STI Surveillance for CAREC Member Countries Relationship between disease and case definition There is a relationship between disease and case definition. Look at table 3.1 and the four terms after it. Table 3.1 Relationship between disease and case definition. True disease Present Absent Total Case definition Definition met a b a+b Definition not met c d c+d Total a+c b+d N Sensitivity – Referring to table 3.1 above, the ability of a case definition or laboratory test to predict true disease (a/(a+c)). Specificity - The ability of a case definition or laboratory test to predict absence of true disease (d/(b+d)). Positive predictive value - The proportion of persons meeting a case definition and having a positive laboratory test who have true disease (a/(a+b)). Negative predictive value - The proportion of persons not meeting a case definition, and having a negative laboratory test who do not have true disease (d/(c+d)). Discussing the table Examine the table and definitions above and answer the following questions: a. For a given case definition, a = 10, b = 10, c = 30 and d = 150. Determine the specificity of this case definition. b. Using these numbers, what is the negative predictive value of the case definition? What does this figure represent? 47 HIV/STI Surveillance for CAREC Member Countries Past Approaches to Communicable Disease Surveillance Generally, limitations of communicable disease surveillance systems in some Caribbean countries are as follows: Duplication of effort: Vertical or categorical surveillance systems established to report a single disease as a component of specific disease intervention programmes. This results in duplication of effort and resources. Delay in reporting: Health workers fail to report index cases of epidemic-prone diseases in a timely manner. This delay in reporting the earliest suspected cases significantly slows identification of outbreaks and impedes the effectiveness of response. Inadequate data collection, analysis, use and dissemination. Collection, analysis, utilisation and dissemination of surveillance data are inadequate. Usually, surveillance data are passed from facilities through to national level without adequate analysis. Feedback is also generally inadequate. Lack of integrated training. Little attention has been given to combining surveillance training activities to increase efficiency. As a result, each programme organises programme-specific training courses (including surveillance) for the same health personnel. Lack of evaluation. Inadequate attention has been given to the evaluation of programmes using surveillance data. Many resources are invested in interventions that are not adequately evaluated. Lack of laboratory involvement and co-ordination. Involvement of laboratories in the surveillance system is inadequate. Neither national nor inter-country laboratory networks have been established to fulfil important public health functions, including the confirmation of cases and outbreaks when the specificity of clinical diagnosis is low. Lack of supervision. Supervisory support, completeness and timeliness of reporting are generally inadequate. 48 HIV/STI Surveillance for CAREC Member Countries CAREC Regional Communicable Disease Surveillance System In 2000-2001, CAREC and its member countries recognised that many attributes of the system, such as timeliness, accuracy and usefulness, needed to be improved. The need for revision of the regional communicable disease surveillance system was further recognised as the process of revision of the International Health Regulations (currently taking place) progressed. In 2002, the CAREC Scientific Advisory Committee (SAC)1 supported the desire of member countries and CAREC to provide accurate and timely reports on health threats and diseases in the region. Realising that this process will likely identify further areas for rationalisation and improvement, SAC recommended that CAREC and national programmes exchange information as needed on a country-bycountry basis. SAC also recommended that CAREC prepare to provide additional training and capacity building both at the national level and CAREC level to initiate agreed-upon changes. In 1986, heads of government in English-speaking Caribbean countries approved a CCH initiative, a mechanism for health development through increasing collaboration and promoting technical cooperation among countries in the Caribbean. Communicable diseases were identified as one of the eight priority areas in this initiative. As such, effective communicable disease surveillance is necessary in order to achieve the goals of the CCH initiative and to monitor the CCH indicators in this area. Most of CAREC’s member countries will soon be part of the CARICOM Single Market and Economy (CSME), which will allow free movement of CARICOM goods, services, people and capital throughout the Caribbean community and facilitate more homogenous economic performance across CARICOM member states. Effective communicable disease surveillance, which promotes disease prevention and control, will support the implementation of CSME. 1 SAC membership includes Ministers of Health from CAREC member countries and representatives from PAHO, CARICOM, other regional health institutions, regional universities, London School of Hygiene and Tropical Medicine, US CDC and Health Canada. 49 HIV/STI Surveillance for CAREC Member Countries Major Changes in the Regional Communicable Disease Surveillance System 1. Expansion of syndromic surveillance and discontinuation of reporting of suspected cases of diseases 2. Weekly reporting of syndromes only, not specific diseases (with the exception of diseases requiring immediate reporting under the existing WHO regulations and regional protocols) 3. Four-weekly reporting of age- and sex-specific confirmed cases of selected diseases 4. Quarterly, case-based reporting of TB 5. Systematic and standardised outbreak reporting 6. The identification of a minimum dataset for laboratory surveillance and the expansion of laboratory surveillance 7. Enhanced regional feedback from CAREC 8. Harnessing advancements in ICT to enhance surveillance efforts 9. Promoting an integrated interdisciplinary approach to surveillance and response Legal Basis All CAREC member countries are WHO member states and, as such, are signatory to the International Health Regulations (currently under revision), which will require all member states to report all potential public health emergencies of international concern to WHO. Regional surveillance is mandated under the multilateral agreement between CAREC and its member countries and is implemented through the annual meetings of Chief Medical Officers, Caribbean National Epidemiologists, Laboratory Directors and Programme Managers, who agree upon surveillance systems and contribute to revisions and amendments. This supports the CCH initiative for the prevention and control of communicable diseases. The multilateral agreement also mandates that surveillance activities shall be co-ordinated with the surveillance programmes of PAHO/WHO. 50 HIV/STI Surveillance for CAREC Member Countries Legal Basis, continued All member countries have legislation and/or regulations governing the reporting of communicable diseases, which state the conditions that are nationally reportable by law. However, legislation is outdated in many countries and needs to be revised. Strategic and Operational Plans A national policy on communicable disease surveillance is critical for guiding planning and implementation activities and supports the sustainability of the system. At both the national and regional level, there should be strategic and operational plans for communicable disease surveillance. These plans must address all components of the system (as indicated in Figure 3.2), namely: surveillance structure—guides and regulates the system surveillance quality—monitors quality of the system and indicates the extent to which system objectives are being met core functions—components of the system support functions—essential for sustainability of the system. Reporting Chain In-country healthcare providers, such as health centres, hospitals, laboratories and private physicians (as identified by each country) are responsible for the transmission of communicable disease data to the national level. In some countries, healthcare providers report data directly to the national level. In others, they report to an intermediary regional/district/parish level that reports to the national level. At the national level, the office of the National Epidemiologist is responsible for the transmission of data, information and public health emergencies (as outlined in International Health Regulations) to CAREC. The office of the National Epidemiologist, in collaboration with the national surveillance and response team, is also responsible for the dissemination of information within each country. At the regional level, CAREC is responsible for the dissemination of data and information to PAHO/WHO and other stakeholders and partners, including member countries. The conceptual framework of surveillance and response systems for communicable diseases is presented in Figure 3.2 on the next page. 51 HIV/STI Surveillance for CAREC Member Countries Reporting Chain, continued Figure 3.2. Conceptual framework of surveillance and response systems. • Policy • Laws, legislation, regulations • IHR compliance • Surveillance strategy • Data flow between levels • Networking/partnership Surveillance structure • Case detection • Registration • Confirmation • Reporting • Data analysis/interpretation • Epidemic preparedness • Response and control • Feedback Core functions Disease/Health Problem for surveillance and response Surveillance quality • Timeliness • Completeness • Usefulness • Sensitivity • Specificity • Simplicity • Flexibility • Acceptability • Reliability • Positive predictive value • Representativeness Support functions • Standards and guidelines • Training • Supervision • Communication • Resources (including logistics) • Coordination 52 HIV/STI Surveillance for CAREC Member Countries Reporting Chain, continued The reporting chain and feedback levels are outlined schematically in figure 3.3. Figure 3.3. Reporting and feedback levels. In-country healthcare providers In-country regional level Data Feedback National level Stakeholders CAREC Partners Data Transfer Data are transferred from the district/parish/regional level, as specified by the country. Data are transferred from the national level to CAREC either electronically or via fax, and CAREC disseminates data to PAHO/WHO and other stakeholders and partners electronically. CAREC recommends that countries should utilise appropriate ICT for data storage and transfer. Analysis and Interpretation At the national level, each country is responsible for data validation, analysis and interpretation for its own country. CAREC is responsible for conducting regional analyses and interpretation of data received from the countries. CAREC is also responsible for following up with countries to validate data and investigate unusual reports and changing disease trends. 53 HIV/STI Surveillance for CAREC Member Countries Dissemination of Information At the national level, each country is responsible for the dissemination of the following feedback within its own country and to other key stakeholders: feedback from communicable disease surveillance HIV/AIDS/STI annual report. At the national level, each country is also responsible for disseminating relevant Health Alerts within its own country, and for contributing information to Carisurvnet, a secure listserv that serves as an electronic communication tool for member countries. CAREC is responsible for producing and disseminating the following regional feedback: weekly updates on syndromes (including EPI) posted on the CAREC website CSR: quarterly reports on specific diseases, TB updates, outbreaks, articles and regional news and announcements CSR supplements: two annually with detailed reports on specific issues CAREC annual report, containing details of the work of the Centre for the period, including a summary of outbreaks for the year and an HIV/AIDS/STIs update CAREC alerts: public health alerts and regional and international information of interest, produced as necessary. These documents are available on the CAREC website (www.carec.org). Additionally, CAREC is responsible for exchanging data and information with other regional and international networks, such as the WHO internetbased system for the global surveillance of dengue (DengueNet) and the European Working Group for Legionella Infections (EWGLI). CAREC is also responsible for maintaining Carisurvnet, the listserv for member countries. 54 HIV/STI Surveillance for CAREC Member Countries Use of Data and Information Nationally, countries should use data and information for: direct action for prevention and control (for example, therapy, prophylaxis, outbreak control) programme planning priority setting and resource allocation evaluation and monitoring research. Regionally, CAREC should use data and information for: initiating appropriate activities (for example, outbreak investigations, control activities, development of guidelines) evaluation and monitoring supporting the planning, monitoring and evaluation of CAREC’s five regional communicable disease programmes, namely: - EPI programme - Special programme on STIs - TB programme - Leprosy programme - Food-borne disease programme research. CAREC is also responsible for working with countries to appropriately package information for different audiences, such as the media, politicians and the general public, as well as for presentation in the scientific literature. 55 HIV/STI Surveillance for CAREC Member Countries Monitoring and Evaluation WHO definitions of monitoring and evaluation are as follows: Monitoring is the routine (continuous) tracking of the performance of surveillance and response systems. Evaluation is the periodic assessment of changes in targeted results (objectives) that can be attributed to a surveillance and response system. National and regional communicable disease surveillance systems must be routinely monitored using appropriate indicators. The regional surveillance indicators and data are listed in Appendix F: Regional Indicators. Laboratory indicators are listed in the CAREC Laboratory User Manual and programme-specific indictors are listed in the respective programme manuals. It is essential to monitor all components of the system (as indicated in Figure 3.2), namely: surveillance structure surveillance quality (as per Unit 5, it is essential to monitor at least timeliness and completeness) core functions support functions. Routine system monitoring may require minor or major system adjustments or indicate the need for an evaluation. The regional communicable disease surveillance system should be evaluated every three years by a group consisting of representatives from CAREC, member countries and other appropriate stakeholders and/or partners. This evaluation will include a review and rationalisation of the syndromes and diseases under surveillance. Each national communicable disease surveillance system should be evaluated every six to seven years. CAREC is responsible for coordinating these evaluations and they should be conducted in collaboration with countries and other relevant partners. All evaluations should aim to describe the system and assess four major components: Surveillance structure, core functions, support functions, and surveillance quality. CAREC is responsible for the development of standard evaluation tools and indicators for the region. 56 HIV/STI Surveillance for CAREC Member Countries Summary Surveillance is the collection of data relevant to public health, which can be analysed to guide prevention and treatment programmes. Sentinel surveillance involves the collection of more detailed data from a smaller sample of sites, while laboratory-based reporting occurs when case reports come from laboratories instead of health facilities. Prevalence is the proportion or number of persons in a certain population who have a particular disease, while incidence measures new infections during a specific time period. The Caribbean Epidemiology Centre (CAREC) maintains and provides norms and forms for the reporting, monitoring and investigation of diseases and outbreaks. Regular feedback and exchange of information is facilitated by an internet-based, secure listserv (Carisurvnet), weekly surveillance updates, quarterly CAREC Surveillance Reports (CSRs), surveillance summaries and supplements and public health alerts. Training in surveillance and outbreak investigation is used to develop national capacity. Laboratory support for surveillance and response is provided in a variety of ways, including early identification of changing disease trends and outbreaks, the provision of reference testing services and antimicrobial resistance monitoring. Within the limits of resources available, the Centre sometimes provides information technology (IT) support, such as training and computers. CAREC conducts advocacy with national and regional policymakers on the importance of surveillance and resources needed for it. Finally, periodic evaluations of the quality of national surveillance systems are conducted, and feedback and technical assistance are provided to aid revision and strengthening. 57 HIV/STI Surveillance for CAREC Member Countries Annex 3.1. Syndromes and Communicable Diseases under Regional Surveillance Note: Due to the potential for international spread, conditions marked with ** are to be reported both immediately and either weekly or monthly as indicated IMMEDIATE NOTIFICATION **Cholera **Plague **Yellow Fever (Urban or Sylvatic) **Severe Acute Respiratory Syndrome **Outbreaks/Clusters/Unusual events WEEKLY DATA COLLECTION Syndromes (aggregate data): Acute Flaccid Paralysis Fever and haemorrhagic symptoms Fever and neurological symptoms Fever and respiratory symptoms (ARI) < 5 yrs Fever and respiratory symptoms (ARI) ≥ 5 yrs Fever and rash Gastroenteritis < 5 year olds Gastroenteritis ≥ 5 year olds Undifferentiated fever <5 Undifferentiated fever ≥ 5 yrs QUARTERLY DATA COLLECTION (Age and sex specific): HIV AIDS Urethral Discharge Gonorrhoea Chlamydia Non-Specific Urethritis (NSU) Genital Ulcer Syphilis LGV HSV Chancroid Vaginal Discharge Gonorrhoea Chlamydia Trichomonas Bacterial Vaginosis Others Ophthalmia Neonatorum Gonorrhoea Chlamydia Others Congenital Syphilis No syndrome, but laboratory test positive (serology positive) Syphilis HSV Chlamydia FOUR-WEEKLY DATA COLLECTION Confirmed cases (Age and sex specific): Campylobacter Chicken Pox (Varicella) Cholera** Ciguatera poisoning Congenital Rubella Syndrome Dengue fever Dengue Haemorrhagic Fever/Shock Syndrome Diphtheria E. coli (pathogenic) Influenza Leprosy (Hansen's Disease) Leptospirosis Malaria Measles Meningitis due to Haemophilus influenzae Meningococcal Infection due to Neisseria meningitidis Mumps Pertussis Plague** Pneumonia due to Haemophilus influenzae Pneumonia due to Streptococcus pneumoniae Poliomyelitis Rabies Rotavirus Rubella Salmonellosis Shigellosis Severe Acute Respiratory Syndrome** Tetanus Tetanus (neonatal) Tuberculosis (pulmonary) Tuberculosis (extra-pulmonary) Typhoid and Paratyphoid Fevers Viral Encephalitis / Meningitis Viral Hepatitis A Viral Hepatitis B Yellow Fever (urban or sylvatic)** 58 HIV/STI Surveillance for CAREC Member Countries 59 HIV/STI Surveillance for CAREC Member Countries Unit 4 HIV Case Surveillance Unit 4 structure The unit is divided into three sections. The sections are convenient blocks of material for a single study session. A final case study is provided for use upon completing all units. This section focuses on case surveillance of HIV infection required for basic level HIV surveillance. Introduction At the beginning of the AIDS epidemic, CAREC promoted the use of the UNAIDS First Generation HIV/AIDS surveillance guidelines. The guidelines were focused on the reporting of AIDS cases and implementation of periodic and regular HIV sero-prevalence surveys (surveys that estimate HIV prevalence by testing blood for HIV antibody) among different population sub-sets. However, after 10 years of their implementation, serious shortcomings were identified, creating the need for the development of the Second Generation HIV/AIDS surveillance guidelines. These guidelines, created by WHO/UNAIDS in 2000, added three essential elements to the first generation HIV/AIDS surveillance guidelines: reporting of persons diagnosed with HIV infection classification of countries based on the level of the HIV epidemic to be used as a guide for the nature of the national response to the epidemic behavioural surveillance surveys (BSS) to improve monitoring of behaviours that put individuals at risk of contracting HIV. But, since the HIV epidemic is a rapidly evolving one, gaps were identified in the Second Generation HIV/AIDS surveillance guidelines as well. These gaps were addressed in the CAREC Third Generation HIV/AIDS/STI surveillance guidelines. CAREC developed these Third Generation guidelines after numerous regional and international consultations on a new regional HIV/AIDS/STI surveillance framework. This framework puts emphasis on survey methodologies and minimum data requirements from each of its four components: 60 HIV/STI Surveillance for CAREC Member Countries Third Generation HIV/AIDS/STI Surveillance, continued 1. Epidemiological (HIV, AIDS and STI surveillance, AIDS mortality data, periodic STI and HIV sero-prevalence surveys among different population sub-groups, HIV molecular epidemiology and STI and HIV antimicrobial resistance surveys) 2. Behavioural surveillance (periodic sexual behaviour surveys among sub-groups, using quantitative and qualitative methods) 3. Audits of coverage and quality of care for STI patients and people living with HIV/AIDS 4. Evaluation of specific prevention and control programmes (such as prevention of mother-to-child transmission). Information from such activities will allow national HIV/AIDS control programmes to: better understand and monitor sexual behaviours and practises driving the HIV/AIDS epidemic in a country or within a country better assess HIV/AIDS/STI trends over time direct public health actions to target vulnerable groups and the most prevalent risk behaviours measure coverage and quality of care for people living with HIV/AIDS and STI patients assess the impact of HIV/AIDS prevention and control programmes. Current HIV/AIDS surveillance systems Current HIV/AIDS/STI surveillance systems are heavily based on case reporting (surveillance system in which persons who are identified as meeting the case definition are reported to public health authorities) of AIDS, syndromic surveillance(surveillance system in which a diagnosis of the infection is made through the presence of symptoms using a standard case definition) of STI and a few HIV sero-surveys to determine HIV point prevalence (the amount of a particular disease present in a population at a single point in time) among pregnant women. In each country, each new AIDS case is reported to the National Epidemiologist or, in some instances, to the National AIDS Programme Co-ordinator. The reporting form usually includes information on name (or coded identifier), age, sex, address, marital status, socio-economic status, reported mode of transmission, date of HIV diagnosis and date of AIDS diagnosis. Sexual behaviour (number of partners, use of condoms, contact with sex workers, sexual orientation) and clinical information (major and minor signs, indicator disease) are sometimes also reported, as requested on 61 HIV/STI Surveillance for CAREC Member Countries Current HIV/AIDS surveillance systems, continued country reporting forms. In most cases, the same form is used to report HIV diagnosis and AIDS. Limited information is available on who fills out the forms, and where and when this occurs. From the individual reports, the Epidemiology Units or National AIDS Programmes report aggregate data to CAREC using a quarterly reporting form that gathers information on sex, age groups and reported mode of transmission. Although AIDS is internationally notifiable, some countries do not have a clear national policy on AIDS reporting. Evaluations of the national surveillance systems, conducted by CAREC, have shown that the level of under-reporting of AIDS cases varies from country to country, ranging from 10% to 70%, with an overall level of under-reporting in CMCs estimated to be about 35%. This high level of under-reporting is related to the weaknesses of the surveillance systems. This is influenced by various factors, including multiple case definitions, lack of standardisation of systems and lack of human resources. Among many lessons, it was recognised that there is a need: to standardise and simplify surveillance systems for HIV and other STIs to conduct training on “basic” HIV/STI surveillance to address issues of confidentiality and data security. The lessons learned will be addressed in this workshop. What is Third Generation Surveillance? Third generation surveillance seeks to answer the following questions: Who has the conditions? When did they get them? Where do they live? How have they put themselves at risk of contracting HIV and STIs? How many reported cases need treatment? HIV/STI surveillance systems should be based on scientifically sound and well-known case definitions and well-established indicators for monitoring the epidemic and evaluating impact of interventions. They should also include orderly consolidation and evaluation (Quality Assurance) of data, and prompt dissemination to those who need to know. 62 HIV/STI Surveillance for CAREC Member Countries Purpose of a comprehensive surveillance system A comprehensive HIV/STI surveillance system is one that: collects, analyses and publishes accurate and timely epidemiological, behavioural and care information monitors the spread (incidence, prevalence and underlying behaviours and factors) and the impact (health and social) of these conditions contributes to a better understanding of the magnitude of diseases, risk behaviours, and the care and treatment coverage for individuals suffering from these conditions contributes to a better understanding of the disease trends in different vulnerable groups and in different socio-economic strata and geographic areas provides timely and accurate data for public health planning supports health planners and decision-makers to plan and evaluate the impact of interventions and programmes (such as safer sex practises, reduction in incidence or prevalence of diseases, quality of care) enhances interventions to treat and decrease spread of infection. The surveillance strategy should address core epidemiological, behavioural and care information systems. These systems should be responsive to the country’s data needs for priority conditions such as HIV and other STIs. The overall aim of HIV/STI surveillance is to provide health planners and decision-makers with appropriate information to reduce spread, morbidity and mortality from HIV-infection and other STIs. This will also reduce costs associated with treatment of advanced disease, human suffering and death. Levels of surveillance systems Along with the differences between countries of the Caribbean—in population sizes, economic circumstance, geography, etc.—capacities in terms of HIV/STI surveillance differ greatly. In an effort to provide guidance and to standardise systems across member countries, CAREC has described three levels of surveillance systems—basic, intermediate and advanced. These are described in Table 4.1. 63 HIV/STI Surveillance for CAREC Member Countries Table 4.1 Components of basic, intermediate and advanced surveillance systems. Basic Surveillance System Surveillance component Data source HIV case surveillance Laboratories (public & private) (all WHO clinical stages and Public health facilities (hospitals, health centres) deaths) PMTCT sites VCT (public, private, mobile sites) private physicians major private institutions hospices vital registration TB clinics, hospitals, control programmes HIV sero-prevalence HIV sero-prevalence data amongst pregnant women surveillance Intermediate Surveillance System All the above, plus: Surveillance component Data source HIV sero-prevalence High-risk groups surveillance Behaviour surveillance General population* surveys/BSS Youth* (*depending on the epidemic High-risk groups state and the risk groups) Other Surveys amongst PLWHA re: quality of care, stigma and discrimination Advanced Surveillance System All of the above, plus: Surveillance component Data source Special surveys HIV resistance monitoring and surveillance Viral genotyping Other special studies 64 HIV/STI Surveillance for CAREC Member Countries Section 4.1: HIV Case Surveillance What this section is about This section provides an overview of the history, purpose and importance of HIV case surveillance. It explains: the natural history of HIV disease and the points in the course of disease that are important to monitor for surveillance purposes the history of case reporting and how changes in HIV testing methods and HIV treatments have affected reporting recommendations and practises the purpose of HIV case surveillance how other types of HIV programmes can provide data for surveillance purposes. Warm-up questions 1. What are the key differences between HIV sero-surveillance and HIV case surveillance? 2. True or false? Reporting of all HIV tests performed on women coming in for antenatal care is a component of AIDS case reporting. True False 3. Which of the following is NOT a purpose of advanced HIV disease/AIDS case reporting? a. Determining the burden of disease attributable to advanced HIV disease/AIDS in the region b. Assessing trends in advanced HIV disease/AIDS cases c. Providing information on the opportunistic infections associated with AIDS cases d. Measuring HIV incidence 4. List four stages in the natural history of HIV disease that are target points for HIV case surveillance. 5. List three reasons for conducting HIV case surveillance. 6. Which stage in the life cycle of HIV requires use of special (not routine) laboratory tests? 65 HIV/STI Surveillance for CAREC Member Countries Introduction to HIV Case Surveillance What you will learn By the end of this unit, you should be able to: describe the stages in the natural history of HIV disease that are important for surveillance purposes describe the primary purposes of conducting HIV case surveillance describe the differences between HIV case surveillance, advanced HIV disease case surveillance, AIDS case surveillance and HIV serosurveillance list four types of HIV-related programmes that can report cases to an HIV case surveillance system. The Relationship Between the Natural History of HIV and Surveillance Natural history of HIV and target points for surveillance HIV infection produces a disease that lasts for many years. Shortly after becoming infected, an individual may experience signs and symptoms of this initial infection (called primary HIV infection). These signs and symptoms may include fever, muscle aches and swollen glands. Often these symptoms go unnoticed by the infected person. Some people do not experience any symptoms or signs of primary HIV disease. Following primary infection, most HIV-infected persons are without symptoms for several years. Over time, the immune system of infected persons weakens and this results in the development of HIV-related illnesses. The end-stage of disease has been called AIDS. Prior to antiretroviral therapy (ART), the average time from HIV infection to onset of clinical AIDS in North American patients was 10 years. Without ART, the duration between HIV infection and onset of AIDS is shorter in developing countries than in North America. The advent of effective ART has considerably reduced the rate of progression to AIDS in areas where these drugs are available. It has also been associated with changes in the types of opportunistic infections that appear with AIDS. 66 HIV/STI Surveillance for CAREC Member Countries Natural history of HIV and target points for surveillance, continued In order to fully understand the HIV epidemic, several key stages in the disease should be monitored. These include: HIV incidence (that is the number or rate of new HIV infections) HIV prevalence (that is the number or rate of all persons living with HIV during a specified time period, regardless of how long they have been infected or whether or not they are aware of their infection) The incidence of advanced HIV disease (or AIDS) The prevalence of advanced HIV disease (or AIDS) Deaths from advanced HIV disease (or AIDS). Measuring each of these points in the course of HIV disease provides for a complete HIV surveillance system. These data can be used to determine the need for prevention or medical interventions and to assess of the impact of such programmes. However, in resource-constrained settings, it is often difficult to include all of these target points in the surveillance system. In those areas where not all of these points can be counted, efforts should be made to obtain information on as many of these as possible. Measurement of HIV incidence In order to know the direction of the HIV epidemic, it is important to have information on the number or rate of new HIV infections occurring in the population. Effective HIV prevention programmes should result in a decrease in the transmission of HIV. Although only a few methods exist for measuring HIV transmission and these methods are far from perfect, there are some tests that can be done to estimate the number and rate of new HIV infections. One method is the BED assay, a serologic test that uses a modified version of a standard HIV test. Although it is not used to diagnose new HIV infections, it is being used as a surveillance tool. A different and more widely used method of measuring HIV transmission is monitoring of trends in HIV prevalence among the youngest women attending antenatal clinics—for example, females aged 15 to 24 years old. This use of sentinel HIV sero-surveillance has been the most common way of estimating HIV incidence in developing countries. Though difficult to measure accurately, methods to estimate the number and rate of new HIV infections are valuable and are likely to become an increasingly important component of HIV surveillance. 67 HIV/STI Surveillance for CAREC Member Countries Measurement of HIV prevalence HIV prevalence is the number of persons living with HIV infection during a specified time period. This includes persons with any stage of HIV disease (newly acquired infections, long-standing asymptomatic infections, late-stage disease including AIDS). Prevalence includes HIVinfected persons who may not be aware of their infection. Prevalence does not include HIV-infected persons who have died. It is difficult to have a complete and accurate count of all persons infected with HIV. As a result, prevalence is often estimated. HIV prevalence estimates can be done using a variety of data sources including HIV/AIDS case surveillance systems, HIV sero-surveys and special studies. In developing countries, sentinel sero-surveys of women attending antenatal clinics have been the most frequently used data for prevalence estimates. Measurement of advanced HIV disease/AIDS incidence Obtaining an accurate and complete count of persons with advanced HIV disease/AIDS is important as a way to anticipate need for medical care and other support services. These data can also be used as a measure of the success of treatment of HIV disease at earlier stages. In countries where ART is becoming increasingly available, the number of persons with advanced HIV disease/AIDS should decline, even in the face of ongoing HIV transmission. Counting persons with advanced HIV disease/AIDS is done through case surveillance. Persons with advanced HIV disease/AIDS are symptomatic and, if they seek care, can be reported from healthcare facilities. Measurement of HIV-related mortality Deaths from AIDS have dropped dramatically in countries where antiretroviral treatment has been widely used. Thus, tracking deaths from advanced HIV disease/AIDS is an important measure of the success of treatment programmes. In addition, understanding the proportion of deaths from HIV-related disease and the age groups most severely affected is an important measure of the magnitude of the problem. However, in order to accurately count and track trends in HIV-related deaths, countries must have well-functioning vital statistics registries. Alternative methods for mortality surveillance exist and can be used in countries in which vital statistics registries need major strengthening. 68 HIV/STI Surveillance for CAREC Member Countries History of HIV/AIDS Case Surveillance The start of AIDS case surveillance In 1981, surveillance began for a newly recognised constellation of diseases now known as AIDS. AIDS has been characterised by a set of diseases (called AIDS-defining opportunistic illnesses). The U.S. Centers for Disease Control and Prevention (CDC) developed a surveillance case definition for this syndrome that was based entirely on the presence of one or more of these AIDS-defining illnesses. Over time, it was determined that AIDS was the result of infection with HIV, and in 1985, a serologic test for HIV was developed and rapidly became widely available. The inclusion of diagnosis of HIV infection became an integral part of the AIDS case definition in the United States. As the epidemic grew, countries established their own surveillance systems for this new condition. The World Health Organization’s (WHO) Global Programme on AIDS (GPA) assumed global co-ordination and technical leadership for surveillance, including the development of clinical and surveillance case definitions. The initial WHO AIDS case definition (Bangui) was based entirely on the presence of AIDS-defining illnesses. However, as HIV testing became available in developing countries, the WHO AIDS case definition was expanded in 1994 to include serologic results. In some countries, the expanded case definition has not been used consistently because of: inadequacy of HIV testing reagents poor laboratory infrastructure lack of training of health personnel lack of quality control procedures. 69 HIV/STI Surveillance for CAREC Member Countries Previous WHO Recommendations Previously, WHO had recommended two approaches to AIDS case surveillance; universal and sentinel case reporting. In universal AIDS case reporting, all healthcare facilities reported patients with AIDS using the integrated disease surveillance, in which a standard report form is used to collect aggregate data on all reportable communicable diseases. The goal with universal reporting was to streamline reporting practises and to minimise duplication of effort. WHO also recommended that sentinel AIDS case reporting be conducted as a complementary activity to universal AIDS case surveillance. In sentinel AIDS case surveillance, a few diligent healthcare facilities were selected to report detailed information on the AIDS cases they treated. Sentinel AIDS case surveillance provided more information on AIDS cases than did universal AIDS case surveillance, but the former only included AIDS cases from selected facilities. Consequently, universal AIDS case surveillance provided a more complete count of the number of AIDS cases, while sentinel AIDS case surveillance provided more detailed information on AIDS cases. Current need for HIV case surveillance ART has dramatically altered the natural history of HIV disease. Antiretroviral medications delay progression from HIV disease to the advanced stages of HIV disease and reduce HIV-related mortality. In fact, one measure of the success of ART programmes is an unchanging (or increasing) HIV prevalence with a concurrent decrease in AIDS incidence and HIV-related deaths. Prior to the widespread use of ART, AIDS case surveillance could provide a reasonable estimate of the prevalence of HIV infection (including asymptomatic HIV disease, as well as advanced HIV disease and AIDS). The expected reduction in AIDS incidence in the presence of expanded use of ART means that AIDS case surveillance cannot provide a stable way of monitoring the HIV epidemic. An additional change that supports the need for movement to HIV surveillance is the expanded availability of HIV testing, including use of rapid HIV tests. As HIV testing in developing countries becomes more widespread, it provides the opportunity to monitor HIV infections that may occur prior to the development of AIDS. In other words, asymptomatic HIV-infected persons can also be monitored. Expansion of AIDS case surveillance to include persons with HIV infection who have 70 HIV/STI Surveillance for CAREC Member Countries Current need for HIV case surveillance, continued not developed late stage HIV disease (AIDS) may provide a more complete picture of the HIV epidemic. Thus, there are two significant reasons to conduct HIV case surveillance: to provide a complete count or estimate of the number of persons with HIV infection to measure the effectiveness of treatment programmes and other interventions. Several factors must be in place for an HIV case surveillance system to work. These are: people at risk for HIV infection must be tested people must feel that there is a benefit to getting an HIV test people who are receiving HIV tests must feel that their privacy will be protected. Outputs of HIV case surveillance Accurate, timely and complete information on persons with HIV infection is required to: determine the burden of disease attributable to HIV in the country/region assess trends in incidence and prevalence of HIV infection and disease determine the burden and impact of HIV on health services provide information on the opportunistic infections associated with advanced HIV disease determine the characteristics and risk factors (transmission categories) of persons with HIV infection use data from HIV surveillance for: o advocacy o resource mobilisation and allocation o programme planning for prevention, support, care and treatment o targeting interventions to appropriate sub-populations o monitoring and evaluation. 71 HIV/STI Surveillance for CAREC Member Countries Surveillance terminology It is important to note that HIV case surveillance is not the same thing as HIV sero-surveillance. These systems have different goals and different uses; they are complementary, not competing. A complete surveillance system will have both. Table 4.2 explains HIV surveillance terminology. Table 4.2. HIV Surveillance terminology. HIV sero-surveillance (also called HIV seroprevalence) HIV case surveillance measures the prevalence of HIV infection using serological survey methods does not report on individual patients reports persons diagnosed with HIV infection, regardless of clinical stage or immunological status Discussing the table Looking at Table 4.2, answer the following questions: a. Which clinical stages are included in HIV case surveillance? b. What is one difference between HIV case surveillance and HIV serosurveillance? 72 HIV/STI Surveillance for CAREC Member Countries Sources of HIV Case Surveillance Reports Programme data and case surveillance data Patient information collected at programmes that provide service or care to persons with HIV infection can be used in two different ways: as a source of information for the completion of HIV case surveillance reports as a source of data to supplement HIV case surveillance data and data from HIV sero-prevalence surveys in annual HIV/AIDS epidemiological profiles and other such reports. Programme data can provide information for HIV case surveillance if: programmes collect and retain patient-level information systems are in place (at facilities that do HIV diagnosis) to record that cases have been reported to the surveillance programme programme staff are trained on how to report cases and have access to case surveillance forms (passive surveillance method) or surveillance officers provide assistance in completing case report forms (active surveillance). In addition, case reporting is more likely to occur if surveillance officers: meet with programme managers to discuss the importance of case surveillance, provide case surveillance forms and conduct training adequately assure the security and confidentiality of case information (particularly if cases are reported using patient names) provide regular feedback to the healthcare workers/providers regarding the results from case surveillance. Supplemental programme monitoring data may be obtained from: voluntary counselling and testing sites: data on numbers tested and percent HIV-infected programmes for prevention of HIV transmission from mother to child: data on number of women tested, percent positive, percent of positives provided with ART, percent of babies tested for HIV, percent of babies with HIV infection care and treatment programmes: data on persons receiving HIV support, care and ART treatment, data on survival time after start of treatment, early warning indicators for emergence of HIV drug resistance, etc. services for orphans and vulnerable children. 73 HIV/STI Surveillance for CAREC Member Countries Programme data and case surveillance data, continued To ensure efficient use of time and resources, those programmes that serve the largest number of HIV-infected persons should be targeted for assisting with case reporting. Ideally, these sites would be used for active case reporting. Section 4.1 Exercises Warm-up review Take a few minutes now to look back at your answers for the warm-up questions at the beginning of the unit. Make any changes you want. Small group discussion Get into small groups to discuss these questions. 1. Which AIDS case definition has been used in your country, the Bangui definition, the WHO expanded case definition or something else? Discuss the utility of this case definition. Has it undergone any changes in the past? If yes, when and why? 2. Does your country have a functional HIV and/or AIDS case surveillance system? Specify which system exists. 3. If your country is not conducting HIV and/or AIDS case surveillance, discuss why. 4. If your country does have an HIV or AIDS case surveillance system: a. Who does the reporting and from what types of facilities? b. How have the data from the system been used? 5. Is HIV case surveillance conducted in your country? 6. Describe existing challenges in your country that affect efficient HIV case surveillance. What are some possible solutions for these challenges? 74 HIV/STI Surveillance for CAREC Member Countries Apply what you’ve learned/ case study Work on this case study independently. 1. You are the national surveillance officer in Cariba, which is estimated to have one of the highest prevalence rates of HIV in the region. The national AIDS control programme is interested in expanding and improving its surveillance programme, and the CAREC epidemiologist is conducting country visits to discuss ways of improving surveillance. During your meeting with the CAREC epidemiologist, you are asked to suggest additional surveillance activities in your country that you believe could be implemented and successful. Describe what these activities would be. 2. The CAREC epidemiologist has indicated that there is interest in using data collected from HIV and other care programmes for HIV case surveillance. What programmes would you suggest using? 75 HIV/STI Surveillance for CAREC Member Countries Section 4.2: Clinical Staging and Surveillance Case Definitions for HIV infection What this unit is about This unit provides an overview of the history and purpose of clinical staging and surveillance case definitions for HIV infection. It includes: a brief history of the clinical staging system and surveillance case definitions for HIV infection a description of the recent (2006) WHO HIV clinical staging criteria and criteria the presumptive and definitive diagnoses a description of the recent (2006) WHO surveillance case definitions an explanation of the link between HIV clinical staging, antiretroviral treatment recommendations, and HIV case surveillance Warm-up questions 1. True or false? In the revised (2006) adult and paediatric WHO HIV clinical staging systems, there are four clinical stages. True False 2. True or false? The revised (2006) WHO advanced HIV infection case definition includes the same clinical stages for adults and infants. True False 3. List the three options for HIV case surveillance that are recommended in the revised (2006) WHO guidelines. 8. True or false? The clinical criteria included in the revised (2006) WHO advanced HIV infection surveillance case definition only include definitive diagnosis of clinical events. True 76 False HIV/STI Surveillance for CAREC Member Countries Warm-up questions, continued 9. List four reasons why HIV clinical staging systems were developed. 10. True or false? Previous surveillance case definitions in developing countries focused only on stage 4 (AIDS). True 77 False HIV/STI Surveillance for CAREC Member Countries Introduction to Clinical Staging and Surveillance Case Definitions for HIV infection What you will learn By the end of this unit, you should be able to: describe the revised (2006) WHO HIV clinical staging criteria and the presumptive and definitive criteria describe the revised (2006) WHO surveillance case definitions explain the link between HIV clinical staging, antiretroviral treatment recommendations and HIV case surveillance. History of Clinical Staging and HIV/AIDS Case Surveillance Definitions Previous clinical staging criteria Clinical staging criteria for HIV and AIDS were developed to: provide uniformity for clinical evaluation of persons with HIV infection act as an indicator of prognosis guide clinical management of patients help study the natural history of HIV infection. The Walter Reed staging classification system was developed in 1986 for use in United States military personnel. This staging system included both clinical and laboratory manifestations of HIV disease. The inclusion of a laboratory component and the list of AIDS opportunistic illness in the Walter Reed staging classification system worked well in developed countries, but were not suitable for developing countries. To provide a clinical staging system that could be used worldwide, the WHO convened a panel of experts in 1989 and developed the 1990 staging system for adults that was based primarily on clinical criteria. A paediatric staging system was adopted in 2003. 78 HIV/STI Surveillance for CAREC Member Countries Previous surveillance case definitions The initial WHO AIDS surveillance case definition (Bangui) was developed in 1986 and was designed for use in developing countries. It was modified in 1989 to include HIV serologic criteria for use in areas with laboratory capacity. It was further modified in 1994 in response to changes in the European Centres for Disease Control and Prevention surveillance case definitions. The WHO has not previously developed a surveillance case definition for HIV disease alone (that is, persons with HIV infection who do not meet the surveillance case definition of AIDS). Updated clinical staging system The increased availability of ART has resulted in the need for an updated HIV clinical staging system that: harmonises the 2002 three-stage paediatric staging system with the 1990 four-stage adult system includes stages at which prophylactic and antiretroviral therapy should be considered and recommended Anticipating wider distribution of ART, WHO convened a panel of experts in 2004 to develop updated clinical staging systems for adults and children. Regional consultations were held throughout 2005, including one at PAHO in October, 2005. The revisions to clinical staging systems were adopted in 2006. The revisions are intended to capture the treatable nature of HIV infection in the presence of ART. Clinical staging should be done at the time of initial HIV diagnosis, upon entry into clinical care for HIV infection and at each clinical visit. Table 4.3. WHO clinical classification of established HIV-infection. HIV-associated symptomatology WHO Clinical Stage Asymptomatic 1 Mild symptoms 2 Advanced symptoms 3 Severe symptoms 4 The 2006 WHO clinical staging criteria and presumptive and definitive criteria for recognising HIV-related clinical events in adults and children can be found in Annexes 6.1 through 6.4, as shown in Table 4.4, on the next page. 79 HIV/STI Surveillance for CAREC Member Countries Updated clinical staging system, continued Table 4.4. Unit 4 annexes on WHO clinical staging of HIV/AIDS and presumptive and definitive criteria of HIV/AIDS-related clinical events. Annex Information provided 4.1 WHO clinical staging of HIV/AIDS for adults and adolescents with confirmed HIV infection (2006) 4.2 WHO clinical staging of HIV/AIDS for infants and children with confirmed HIV infection (2006) 4.3 Presumptive and definitive criteria for recognising HIV/AIDSrelated clinical events in HIV-infected adults and adolescents (2006) 4.4 Presumptive and definitive criteria for recognising HIV/AIDSrelated clinical events in HIV-infected children (2006) The revised staging systems include: presumptive clinical diagnoses that can be made in the absence of sophisticated laboratory tests definitive clinical criteria, which require confirmatory laboratory tests. With expansion of laboratory capacity in developing countries, including those in the Caribbean, the WHO developed an immunologic classification system for HIV infection. These criteria are based upon the known decline in CD4 cells with the progression of HIV disease. Listed below are the age-related values and associated degree of immunodeficiency. Note that for children under 5 years of age, the CD4 percent rather than absolute count should be used. Table 4.5. WHO immunologic classification of established HIV-infection (2006). Age-related CD4 values < 11 months (CD4+ %) 12 – 34 months (CD4+ %) 36-59 months (CD4+ %) ≥ 5 yrs (mm/3) > 35 > 30 > 25 > 500 Mild 30 - 35 25 – 30 20 – 25 350−499 Advanced 25 - 29 20−24 15−19 200−349 <25 <20 <15 <200 or <15% HIV-associated immunodeficiency None/not significant Severe 80 HIV/STI Surveillance for CAREC Member Countries Updated surveillance case definitions Changes to the clinical staging of HIV infection, combined with the expanded use of ART, have resulted in a need to revise case surveillance recommendations. Previous case definitions have focused exclusively on reporting persons who met the Bangui or expanded AIDS case definition. WHO now recommends that reporting be expanded to cover the entire spectrum of HIV disease; that is, HIV case surveillance. WHO recommends that countries standardise their reporting practises. Countries may report: all HIV cases (clinical stages 1-4) cases with advanced HIV disease (clinical stages 3 and 4) cases with AIDS (clinical stage 4). There are two significant reasons to conduct HIV case surveillance: to provide a complete count or estimate of the number of persons with HIV infection (because AIDS case reporting does not include asymptomatic HIV-infected persons) to measure the effectiveness of treatment programmes and other interventions. For HIV case surveillance, WHO recommends that HIV cases diagnosed and not previously reported in that country should be reported using a standard case definition such as those presented in Table 4.6 Table 4.6. WHO case surveillance definitions (2006). Adults and adolescents and children > 18 months Positive HIV antibody testing (rapid or laboratory based EIA). This is usually confirmed using a second HIV antibody test (rapid or laboratory-based EIA) that relies on different antigens of different operating characteristics than the initial test. The antibody test can be confirmed by virologic testing as well. And / or Positive virologic test for HIV or its components (HIV-RNA or HIV-DNA or ultrasensitive HIV p24 antigen) confirmed by a second virologic test obtained from a separate specimen taken at a different time period. Children aged below 18 months Positive virologic test for HIV or its components (HIV-RNA or HIV-DNA or Ultrasensitive HIV p24 antigen) confirmed by a second virologic test obtained from a separate specimen taken more than four weeks after birth. 81 HIV/STI Surveillance for CAREC Member Countries Updated surveillance case definitions, continued Countries reporting cases of advanced HIV disease should do so using a standard case definition, such as the one presented in Table 4.7. Reporting should include those persons with advanced HIV disease who were not previously reported in that country. Reporting should be done at the time the person is initially diagnosed with advanced HIV disease. Table 4.7. WHO advanced HIV case definitions (2006). Category Advanced HIV in infants, children, adults and adolescents with documented HIV infection Children > 6 years, adolescents and adults with documented HIV infection Children < 6 years with documented HIV infection Clinical/immunological criteria Presumptive or definitive diagnosis of any one stage 3 or 4 condition (as defined in annex 2.3 and 2.4). CD4 count less than 350/ mm3. %CD4 < 30 in those less than 11 months of age %CD4 < 25 in those aged 12-35 months %CD4 < 20 in those aged 35-59 months. AIDS case surveillance is not required in countries that conduct reporting of advanced HIV infection. Countries reporting cases of AIDS should use the most recent WHO case definition (clinical stage 4 or CD4 count less than 200 or less than 15%). Reporting should include those persons with AIDS who were not previously reported in that country. Reporting should be done at the time the person is initially diagnosed with AIDS. Reporting of primary HIV infection There is no standard case definition of primary HIV infection. However, primary HIV infection is of great importance, particularly since it represents recently acquired HIV infection and because persons with primary HIV infection are highly contagious. Persons with primary HIV infection may present with profound transient lymphopaenia (including low CD4) and opportunistic infections, but these infections should not be confused with clinical staging events associated with established HIV infection. Primary HIV infection can be identified by recent appearance of HIV antibody or by identifying viral products (HIV- 82 HIV/STI Surveillance for CAREC Member Countries Reporting of primary HIV infection, continued RNA or HIV-DNA and/or ultrasensitive HIV p24 antigen) with negative (or weakly reactive) HIV antibody. It is anticipated that the Centers for Disease Control and Prevention will develop a case definition for reporting of persons with primary HIV infection. This should facilitate the reporting of primary HIV infection in the United States and elsewhere. Until that time, persons with primary HIV infection can be reported as having HIV infection (Clinical Stage I). Linking HIV Clinical Staging, ART Use, and HIV Case Surveillance Initiating ART Clinical staging and CD4 counts/percents can be used to determine the best time to begin antiretroviral treatment The WHO has developed separate treatment recommendations for use in areas in which CD4 testing is available and areas in which such testing is not available. The WHO antiretroviral treatment recommendations for adults and adolescents are detailed in Table 4.8. Table 4.8. WHO antiretroviral treatment recommendations for adults and adolescents. If CD4 testing is: WHO ART recommendation for adults and adolescents WHO clinical stage 4 (AIDS), regardless Available of their CD4 count WHO clinical stage 3 whose CD4 count is <350 cells/mm3 WHO clinical stages 1 or 2 when the CD4 count is < 200 cells/mm3 Not available WHO clinical stage 4 (AIDS) regardless of total lymphocyte count WHO clinical stage 3, regardless of total lymphocyte count WHO clinical stages 2 with a total lymphocyte count < 1200 cells/mm3 83 HIV/STI Surveillance for CAREC Member Countries Linking staging, ART use, and case reporting As described on the previous page, clinical staging is used: to determine the best time to begin treatment for HIV disease as a key component of the surveillance case definitions. Systems in which advanced HIV disease is reported (clinical stages 3 and 4) can provide information on the number of patients eligible for ART, whereas HIV case surveillance (reporting of all clinical stages), can provide information on the proportion of HIV diagnoses that are eligible for ART. The link between staging, ART use and case reporting is useful for surveillance purposes. HIV case surveillance is generally done by healthcare providers, usually from hospitals and clinics that provide ART. Thus, patients who are receiving care at these facilities will have their clinical stage determined. This is particularly useful in those countries in which reporting of advanced HIV disease or AIDS case reporting is conducted. In those settings, persons on ART are likely to include those who should be reported to the public health authorities. The new clinical staging system, HIV treatment recommendations, and surveillance case definition and reporting recommendations should facilitate optimal care of HIVinfected persons and improve case reporting. 84 HIV/STI Surveillance for CAREC Member Countries Section 4.2 Exercises Warm-up review Take a few minutes now to look back at your answers for the warm-up questions at the beginning of the unit. Make any changes you want. Small group discussion Get into small groups to discuss these questions. 1. Discuss the changes made in 1989 and 1994 to the WHO AIDS surveillance case definition (Bangui)? Why were these changes made? 2. In 2006, the WHO adopted an updated HIV/AIDS clinical staging system and surveillance case definition. Why was an updated HIV/AIDS clinical staging system necessary? 3. What does the revised staging system include? 4. Although there is no standard case definition for primary HIV infection, what can be learned from reports of persons with primary HIV infection? Apply what you’ve learned/ case study Work on this case study independently. 1. As an HIV surveillance officer for Cariba, you are charged with standardising the country’s HIV reporting practises. What processes would you implement to insure that HIV case surveillance is standardised? 2. Cariba recently began providing free antiretroviral therapy to HIVinfected individuals and uses the WHO antiretroviral treatment recommendations to determine the best time to begin antiretroviral therapy. a. In the Northern District of Cariba, CD4 testing is available. What are the WHO recommendations for when adults and adolescents should begin ART? b. In the Western District of Cariba CD4, testing is not available. What are the WHO recommendations for when adults and adolescents should begin ART? 85 HIV/STI Surveillance for CAREC Member Countries Section 4.3: Components of an HIV Case Surveillance System Introduction to an HIV Case Surveillance System What you will learn By the end of this section, you should: have knowledge of case definitions for surveillance purposes be able to list potential HIV reporting sources be able to describe the difference between active and passive surveillance systems know the variables on a case report form and be able to incorporate the elements of case definitions into your country’s notifiable disease list. The primary functions of HIV surveillance programmes are to monitor the epidemic and provide data for prevention efforts. The data can also be used to plan for treatment programmes by projecting the number of persons who will need HIV care and treatment. The roles and responsibilities of the national HIV surveillance programme are discussed later in this section. Figure 4.3 shows events that should be monitored during a case’s disease. Monitoring each of these events will provide data to assist in planning prevention and care and treatment programs. Figure 4.3. Monitoring the spectrum of HIV disease. Sentinel Events HIV exposure (children) HIV infection 1st positive HIV test 1st CD4 test 1st viral load Test Advanced HIV disease (1st CD4 T-cell count <350 cells/µl or WHO clinical stage 3 diagnosis) AIDS (1st CD4 T-cell count <200 cells/µl or WHO clinical stage 4 diagnosis) Death 86 HIV/STI Surveillance for CAREC Member Countries Defining Reportable Events HIV case definitions Countries should standardise HIV case definitions for surveillance purposes. All persons meeting the case definition should be reported to the national surveillance programme. See Tables 4.6 and 4.7 for the surveillance case definitions. Notifiable condition or reportable events Once HIV case definitions are finalised, work with appropriate staff to incorporate the elements of the case definitions in to the country’s notifiable disease list. There is also a need to train healthcare staff on the reportable sentinel events for the notifiable disease. For example, all HIVrelated tests could be reportable to the surveillance unit. This would include positive HIV EIA, western blots, viral load or CD4 tests. Case Finding Identifying reporting sources Surveillance programmes should identify reporting sources where HIV diagnosis, care and treatment occur. Reporting sources should include public and private clinics, healthcare programs, and hospitals. The following are some examples of reporting sources: laboratories healthcare clinics (health centres) ART treatment clinics TB clinics voluntary HIV counselling and testing sites hospice (initially) hospitals blood banks programmes prevention of mother-to-child HIV transmission vital statistics registries. Educating providers Providers of case information should be educated regarding reporting requirements, including laws and regulations, case definitions, specific data elements, case surveillance forms, laboratory reports, and timeliness of reporting. 87 HIV/STI Surveillance for CAREC Member Countries Educating providers, continued Report sources must identify liaison(s) or contact person(s) who will be responsible for case surveillance and explain to him/her/them how the data will be used for programme planning. Disseminating surveillance data back to the providers will also assist with timely case reports. It is important to pay special attention to training providers on reportable events, how to report (case surveillance form) and what to report (the variables on the case surveillance form). It is important that providers understand all the variables on the case report form. Obtaining risk information is always challenging; developing display charts/posters can assist providers to accurately collect this critical piece of information. Ways to identify cases New cases of HIV infection are found by both passive and active surveillance. The definitions of active and passive surveillance are: Active surveillance: surveillance activity where the public health surveillance staff regularly contact reporting facilities (hospitals, clinics, physician offices, laboratories) to identify potential/suspect HIV cases. Passive surveillance: surveillance activity that is initiated by persons at the health facilities—that is, the surveillance office receives HIV case reports from physicians, laboratories, or other individuals or institutions without regularly contacting the reporting sources. Comprehensive case (surveillance) information may be contained in documents obtained by both active and passive surveillance. For example, the surveillance office may receive an electronic laboratory report through passive reporting. However, for complete case information, surveillance office staff may contact or travel to the diagnostic or treatment facilities to obtain the additional data items not provided on laboratory reports. Laboratoryinitiated reporting Identify all laboratories in your geographic area. If positive HIV EIA/WB or CD4 or viral load tests are reportable, work with the labs to develop a system where they can report cases to the surveillance unit in a confidential and timely manner. Special efforts should be made to automate systems as much as possible, so as not to cause unnecessary burden to the staff members. This will be critical to ensuring timely reporting of cases. 88 HIV/STI Surveillance for CAREC Member Countries Laboratory initiated reporting, continued There is a minimum set of information the lab should provide for each case. This set of information allows the surveillance unit to follow up with the provider to complete the case report form. These are: patient’s name or code sex date of birth lab identifier specimen collection date date of test type of test test result requester/provider name and telephone number. Following up with provider Once a positive HIV test has been reported to the surveillance unit, the surveillance officer can follow up with the provider to obtain the remaining information on the case surveillance form. Updating case information It is important to update case information through disease progression from asymptomatic infection through to advanced HIV infection, AIDS and death. Note: The HIV database needs to hold longitudinal data on cases without overwriting case information. Duplicate cases The surveillance system should be able to correctly distinguish newly reported persons from persons previously reported. Failing to properly link newly submitted case reports to previously reported cases leads to overcounting; incorrect linking of duplicate reports can result in undercounting and contamination of existing records with data from another case. Because doctors, hospitals, laboratories, and other sources may be required to report all HIV diagnoses whether or not they are newly identified, duplicate case reporting within a country may not be identified during routine case entry into the surveillance database (that is, duplicate case reports may not be readily identified as such). Eliminating duplicate reports on a regular basis is an important component of maintaining a reliable surveillance database and ensures accurate case counts at the national levels. 89 HIV/STI Surveillance for CAREC Member Countries Mandatory variables for counting a cases A minimum set of information must be available in order to count a patient as an HIV case. The mandatory variables required to count a case include: case identifier (name or code) sex date of birth date of diagnosis (specimen collection date or date of diagnosis by healthcare provider) test result date date of death (essential to accurately count the number of persons with HIV). As an HIV case may be reported from multiple sources or from the same source multiple times, having a minimum set of required information allows the national surveillance unit to accurately match an individual to his/her record and ensure that each HIV case is only counted once. This is of particular importance when a previously reported patient progresses through the stages to advanced HIV disease, AIDS and death. Identifying missed cases Missed cases can be identified from: anecdotal comments of cases not being reported timeliness assessments that show cases reported more than six months after the diagnosis date finding unreported cases by reviewing death certificates matches with other databases assessments of completeness of reporting from particular providers (See Unit 5). Reporting chain Each country must determine the reporting chain for HIV case reports. This may involve forwarding report forms from healthcare providers to a sub-national level, but ultimately HIV case reports should be sent to the national surveillance unit, where a complete database should be housed. This will allow de-duplication of cases reported from several sources, thereby giving a more accurate picture of the HIV situation for the country. At the national level, the office of the National Epidemiologist is responsible for the transmission of aggregate reports to CAREC. 90 HIV/STI Surveillance for CAREC Member Countries Roles and responsibilities Roles and responsibilities of reporting sources: complete one HIV case surveillance form for each person newly diagnosed with HIV infection complete an HIV case surveillance form for each person who experiences a change in clinical status (for example, clinical diagnosis of HIV-advanced disease or AIDS, CD4 count less than 350, etc—see Figure 4.7) complete an HIV case surveillance form for each HIV-infected person who dies (and include cause of death, if available) submit forms to sub-national or national level surveillance unit, as per reporting chain for the country (under confidential cover, see Unit 7) record each instance of case reporting to the surveillance unit on patient’s clinical record. Roles and responsibilities of the national HIV surveillance programme: solicit, receive, review and file HIV case surveillance forms on a timely basis ensure case surveillance forms are filled out completely, accurately and clearly evaluate each form to determine whether the case meets the criteria for HIV diagnosis evaluate each case report to establish whether it contains enough information for determination of clinical stage (documentation of the clinical stage, clinical information that can be used to determine clinical stage, or immunological information, such as CD4 count/percent) ensure that minimum data elements are documented (that is, demographic characteristics, geographic region, risk information, diagnosis date and report date) conduct follow-up investigations on cases of epidemiologic importance maintain a complete and accurate HIV surveillance database that is secure and accessible only to authorised personnel identify reporting sources, provide an active liaison with physicians and institutions reporting cases, abstract medical records to generate case reports when necessary, and supply routine feedback to providers in cases reported analyse, interpret and disseminate HIV surveillance data critically assess the performance of the surveillance programmes through ongoing monitoring of surveillance activity. 91 HIV/STI Surveillance for CAREC Member Countries Case Report Form Purpose of an HIV case surveillance form The purpose of the case surveillance form is to standardise the information that is collected on all reported HIV cases. An HIV case surveillance form is designed to: collect information that promotes understanding of HIV infection, morbidity and mortality facilitate reporting an HIV case (person diagnosed with HIV) define minimum variables to be collected standardise collecting of variables. Timing of HIV case surveillance A patient should be reported when: the person is diagnosed with HIV infection, regardless of clinical status an HIV patient progresses to clinical stage 3 or CD4 less than 350 (advanced HIV disease) an HIV patient progresses to clinical stage 4 or CD4 less then 200 (AIDS) an HIV-infected person dies. Elements of a case surveillance form The elements of a case surveillance form include the following: A. Information for tracking of reporting Date form completed (with report date) Date received by national surveillance unit Type of report: new or update B. Information concerning the person reporting the case Name of reporting source facility Name of person reporting the case Address of person reporting the case Telephone number of person reporting the case Email address of person reporting the case C. Information concerning the diagnosis facility Name of diagnosing facility Facility record number Address of diagnosing facility Diagnosis facility type 92 HIV/STI Surveillance for CAREC Member Countries Elements of a case surveillance form, continued D. Information concerning the patient Patient first name* Patient’s last name* Patient’s maiden name, if applicable * Patient’s coded identifier (if used)* Date of birth* (actual or estimated) Sex* Current city/town of residence Current country of residence Country of birth Current pregnancy status (for females only) Current (vital) status: Alive, dead, unknown Date of death, if applicable Cause of death: HIV related or other/unknown E. Risk factors/exposures Sex with males(s) Sex with female(s) Sex with person(s) of known HIV-positive status Sex with sex worker(s) Injected non-prescription drugs Perinatal exposure to HIV Received transfusion(s) of blood, blood products or clotting factors Received a transplant of tissue or organ or artificial insemination Occupational exposure while working in a healthcare setting or laboratory, or provided safety or emergency services F. Laboratory results Type(s) of confirmatory HIV-positive test Date specimen was obtained from patient* Test result dates* Date healthcare provider received confirmed HIV result G. Clinical/immunological information Date of first WHO HIV clinical stage 1 or 2 diagnosis Date of first WHO HIV clinical stage 3 diagnosis Date of first WHO HIV clinical stage 4 diagnosis Date of specimen collection for first CD4 test Date of specimen collection for first CD4 count <350 Date of specimen collection for first CD4 count <200 * These variables are required for a case to be counted. 93 HIV/STI Surveillance for CAREC Member Countries Completing a case surveillance form Anyone who provides services to an HIV-infected patient may complete an HIV case surveillance form. HIV infected persons access diagnostic, support, care and treatment from the following facilities/programmes: programmes for prevention of mother-to-child HIV transmissions voluntary counselling and testing facilities tuberculosis clinics general health clinic antenatal clinics clinics for Sexually Transmitted Infections (STI) private healthcare provider facilities that provide antiretroviral therapy laboratories Note: Laboratories may have a different mechanism of reporting HIV cases than other health providers, and may not have access to the minimum data elements to count a case. You should establish reporting procedures mechanism with your laboratories to ensure timely reporting of HIV cases. Modifying and piloting the case surveillance form Generic HIV case surveillance forms are shown in Appendix H. This form should be modified and piloted for use in your country, using the CAREC guidelines that specify minimum variables that must be retained in order to ensure standardisation across countries. You must ensure that the language used in your case surveillance form is relevant to your country and that the flow and layout of the document is understandable and user-friendly. Providing education and instructions on how to complete the surveillance form is essential to achieve accurate and standardised case surveillance. 94 HIV/STI Surveillance for CAREC Member Countries Protection of confidentiality To achieve acceptance of HIV case surveillance, national and sub-national surveillance programs must ensure the confidentiality of patient information and must have the public’s trust in that confidentiality. Confidentiality is essential, not only for effective surveillance, but also to protect patients’ rights to privacy and prevent any potential for disclosure or discrimination. In addition to the potential for adverse consequences for the individual, any breach of confidentiality from the HIV surveillance registry could impact the public’s confidence in public health systems and compromise the completeness of case surveillance (See Unit 7 on Confidentiality and Data Security). 95 HIV/STI Surveillance for CAREC Member Countries Summary HIV surveillance includes a variety of activities that provide information about: o the number and characteristics of persons with HIV, advanced HIV disease, and AIDS o the impact of antiretroviral therapy o the impact that treatment has on HIV/AIDS-related and mortality. The WHO recently revised the surveillance case definition and clinical staging system to include the following components: o advanced HIV disease includes clinical stages 3 and 4 o AIDS (clinical stage 4) can continue to be reported o countries should move toward reporting of all HIV cases, regardless of the clinical stage. Focal persons for communicable disease surveillance must be identified at each level: health facility, sub-national (if applicable) and national. A standardised reporting format must be developed for use at all levels: reporting health facilities, sub-national (if applicable) and national level. Sample forms and guidelines for modification are provided in Appendix H. Data should be analysed, interpreted and used at the local level for public health action, as well as at national level. With expanded efforts to provide antiretroviral therapy (ART) to persons with advanced HIV disease, HIV surveillance activities can include monitoring the number of persons receiving ART and the impact of ART on morbidity and mortality. Improvements in the recording of vital events provide the opportunity to document deaths caused by HIV disease. 96 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study You are the new HIV programme director in Cariba. Cariba has conducted antenatal sero-surveillance for many years, and the results from those surveys have been used to estimate the HIV prevalence in the country. The prevalence in young adults in Cariba is estimated to be 3% in urban areas. HIV case surveillance has been recommended, but only a few facilities have reported HIV cases. Because of the high HIV prevalence, it is assumed that the prevalence of AIDS is also very high. Cariba has received additional resources that are to be used for providing HIV-infected patients with ART. Because of its high prevalence, Central Province, which has a large urban area, has been selected as a site that will offer ART. The provision of ART to HIV-infected patients is co-ordinated by your colleague (Dr. MB), the clinical care co-ordinator. To begin planning for treating patients, you set up a meeting with Dr. MB. Together you decide that the initial focus should be on conducting surveillance for persons with advanced HIV disease. How would you go about doing this? You and Dr. MB must make decisions regarding how ART should be provided in Central Province. You both agree to follow the WHO treatment guidelines. What are the WHO criteria for initiating ART? You and Dr. MB decide to offer ART at three clinics in Central Province and at the medical college there. How will this affect your plans for advanced HIV disease case surveillance? What are some initial steps that should be taken prior to offering ART? 97 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued What are the outcomes that you think should be monitored in order to evaluate the impact that ART is having on patients with HIV? What methods can be used to measure the impact of ART on mortality? Five years have passed. You meet with Dr. MB to discuss producing a surveillance report. Take the following data and develop a report. You should use the data to develop figures and tables and explanatory text for each figure or table. Data from advanced HIV disease case reporting. Year 2008 2009 2010 2011 2012 Number of cases 450 623 757 650 576 Data from advanced HIV disease case reporting are available for three years. Reporting was from three facilities and the data obtained had more detail. 98 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility A, Year: 2005 Total reported: 142 Sex Male Female 65 77 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 16 122 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month(intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 60 99 47 98 53 68 20 73 15 36 44 60 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility A, Year: 2006 Total reported: 257 Sex Male Female 125 132 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 12 198 28 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 77 100 156 230 156 204 25 42 29 11 24 32 58 93 2 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility A, Year: 2007 Total reported: 289 Sex Male Female 112 173 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 10 228 38 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 75 101 202 253 178 256 38 64 38 15 44 35 78 89 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility B, Year: 2005 Total reported: 138 Sex Male Female 60 76 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 10 112 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 65 102 42 102 50 72 180 70 8 39 43 65 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility B, Year: 2006 Total reported: 243 Sex Male Female 96 144 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 10 206 13 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 68 103 166 225 158 208 45 52 13 21 29 38 56 98 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility B, Year: 2007 Total reported: 274 Sex Male Female 12 144 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 9 239 48 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 65 104 205 238 157 246 28 75 34 26 49 46 79 78 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility C, Year: 2005 Total reported: 89 Sex Male Female 43 51 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 6 80 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 48 105 27 68 43 48 16 33 9 31 39 52 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility C, Year: 2006 Total reported: 178 Sex Male Female 74 91 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 13 154 11 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 59 106 147 166 142 154 23 33 21 13 38 68 1 63 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Facility C, Year: 2007 Total reported: 238 Sex Male Female 110 128 Transmission category Mother To Child Injection Drug Use Homosexual/Bisexual Blood Or Blood Products Heterosexual Other (Please Specify) DNK 9 212 Clinical features Weight loss 10% / abnormally slow growth Chronic diarrhoea 1 month Prolonged fever 1 month (intermittent or constant) Persistent cough 1 month Generalised pruritic dermatitis History of herpes zoster Oropharyngeal candidiasis Chronic progressive or disseminated herpes simplex virus Generalised lymphadenopathy Recurrent episodes of severe pneumonia Kaposi’s sarcoma Cryptococcal meningitis Tuberculosis Invasive cervical cancer Disabling neurologic impairments Treatment Antiretroviral/HAART Prophylaxis Anti-TB prophylaxis or treatment Treatment for opportunistic infections Number of deaths: 62 107 197 233 165 213 27 53 31 9 2 9 40 55 68 86 HIV/STI Surveillance for CAREC Member Countries Unit 4 Case Study, continued Data from routine HIV testing of TB patients. Reporting was from five sites. Year 2004 2005 2006 2007 Number of TB patients 569 479 510 499 108 Number tested for HIV 547 445 503 489 Number HIV+ 270 238 214 189 HIV/STI Surveillance for CAREC Member Countries Annex 4.1. WHO clinical staging of HIV/AIDS for adults and adolescents with confirmed HIV infection. 109 HIV/STI Surveillance for CAREC Member Countries Annex 4.2. Revised WHO clinical staging of HIV/AIDS for infants and children with confirmed HIV infection. 110 HIV/STI Surveillance for CAREC Member Countries Annex 4.2. Revised WHO clinical staging of HIV/AIDS for infants and children with confirmed HIV infection, continued 111 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIVinfected adults and adolescents (older than 15 years) 112 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 113 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 114 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 115 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 116 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 117 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 118 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 119 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 120 HIV/STI Surveillance for CAREC Member Countries Annex 4.3. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected adults and adolescents (older than 15 years), continued 121 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIVinfected children. 122 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 123 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 124 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 125 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 126 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 127 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 128 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 129 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 130 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 131 HIV/STI Surveillance for CAREC Member Countries Annex 4.4. Presumptive and definitive criteria for recognising HIV/AIDS-related clinical events in HIV-infected children, continued 132 HIV/STI Surveillance for CAREC Member Countries 133 HIV/STI Surveillance for CAREC Member Countries Unit 5 Monitoring Surveillance System Quality Overview What this unit is about The periodic evaluation of surveillance systems for sexually transmitted infections (STIs), HIV or AIDS is necessary in order to maintain: a responsive and relevant system of monitoring shifting disease trends effective disease control and management interventions This unit discusses how to conduct an effective evaluation with emphasis on evaluating the completeness, timeliness, and validity (or accuracy) of the data collected in the surveillance system. Warm-up questions 1. List three aspects of a disease under surveillance that an effective surveillance system should monitor. 2. List two methods to measure completeness of case reporting. 3. List two methods to report the timeliness of case reporting. 134 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this unit you should be able to: Describe three elements of a disease under surveillance that a surveillance system should monitor define three key surveillance system attributes list tasks for evaluating a surveillance system describe methods to measure the completeness, timeliness, and accuracy of your surveillance system. Purpose of public health surveillance Public health surveillance is conducted in order to describe a disease that is determined to be of public health importance. Surveillance is done to guide public health intervention (such as prevention, treatment, control). Why evaluate? Once you’ve set up an HIV/AIDS surveillance system, you want to make sure that it remains effective as the epidemic shifts over time. If your system is no longer effective, you will not have the right information to control HIV/AIDS. What Surveillance Systems Describe Describing public health conditions Public health surveillance is done to address important public health diseases so that effective control measures can be put into place. In order to describe the condition under surveillance, the surveillance system must be able to describe the condition by: person place time 135 HIV/STI Surveillance for CAREC Member Countries Describing the person The surveillance system should be able to describe the characteristics of persons affected by the condition in terms that are relevant to the condition. For HIV infection, these characteristics should include at least the following information: date of birth sex transmission mode. Public health reporting may include collecting patient names. In those situations where a patient must be contacted by public health authorities, there must be some mechanism enabling this to occur. In addition, persons with HIV infection are diagnosed only once. In other words, patients are not cured of these conditions and, therefore, cannot be re-infected. For a country (or city or district) to have an accurate count of persons with HIV infection, there must be a mechanism in place that can distinguish previously reported persons from newly reported ones. Keep in mind that a person may be reported to the public health authorities more than once. This might occur if a patient changes the place where he or she receives medical care. Therefore, case reports of persons with HIV infection must include a case identification code (patient name or unique code). The same code will be used throughout each country, and ideally throughout the CAREC member countries. You might also consider collecting information on the following additional characteristics: marital status educational level achieved employment status. The decisions regarding which characteristics to gather information on will depend upon the setting in which surveillance is conducted. For example, in some countries, information on marital status is not considered necessary to understand who is affected by HIV/AIDS. Describing place Documenting information on where people with HIV/AIDS live is done by collecting information that describes where the patient lives and receives care at the time of diagnosis with HIV infection. This information includes: residence (e.g., city/district/country of diagnosis) facility of diagnosis (the type of facility as well as its name and address) facility that submitted the case report. 136 HIV/STI Surveillance for CAREC Member Countries Describing time Monitoring trends in HIV tells us whether the epidemic is getting better or worse; monitoring trend in AIDS in the era of universal access to antiretroviral treatment tells us whether treatment efforts are effective in reducing morbidity. To accurately describe these trends, case reports of persons with HIV infection must include: date of HIV diagnosis date of diagnosis of HIV advanced disease (WHO clinical stage 3) or AIDS (WHO clinical stage 4) date of case report. The date of diagnosis is used to understand the actual trends in the disease while the date of report is used as a way of understanding the bias caused by delays in reporting. Both of these dates are necessary in order to evaluate your surveillance system. Collecting information specific to HIV/AIDS The HIV epidemic presents unique challenges to public health. For example, reports of persons with HIV infection tell us about persons who are infected and when they were diagnosed, but do not give us information on when HIV infection was actually acquired. Although there are now laboratory methods that can be used to narrow the time period during which infection was likely to occur, these are not routinely done in the Caribbean region. Clinical information can be used to gain some understanding of how far in the course of disease a person was diagnosed. This is done by collecting information on clinical markers of advanced disease. Advanced HIV disease can be determined by: clinical HIV stage 3 or 4 low CD4 cell counts < 350 cells/mm3. The recommended clinical information to collect on persons reported with HIV infection includes: the earliest CD4 count date of the earliest CD4 test clinical stage at diagnosis (this allows for distinguishing HIV disease, advanced HIV disease and AIDS) any HIV disease-specific treatment currently or previously used (such as antiretroviral treatment, prophylactic treatments, or treatment of opportunistic infections) HIV viral load results (earliest and its date) may also be considered. 137 HIV/STI Surveillance for CAREC Member Countries Ensuring accurate collection of surveillance data A number of factors contribute to the accuracy and completeness of information collected on persons diagnosed with HIV/AIDS. These include: the clarity of surveillance forms the quality of training and supervision of persons who complete surveillance forms the care exercised in data management. Evaluating Surveillance Systems Purpose of evaluation Comprehensive guidelines have been developed that address methods used to evaluate surveillance systems. System evaluation provides information to improve services and delivery. Specific objectives of ongoing surveillance system evaluations may include the following: to appraise and prioritise the disease events to be kept under surveillance to assess how the system can detect and report these diseases to assess the quality of the epidemiologic information produced to assess how the system can respond to these diseases to assess how surveillance results affect disease control and policy to identify which elements of the system can be enhanced in order to improve the quality of information Figure 5.1. Elements of a well-focused evaluation. 138 HIV/STI Surveillance for CAREC Member Countries Discussing the figure Look at Figure 5.1, on the previous page, and answer the following questions: a. List the possible outcomes of a well-focused evaluation. b. What are other potential uses of the results of an evaluation not listed in the figure above? Evaluation Process Six evaluation tasks The evaluation process is organised into a series of discrete tasks that are summarised, then described, below. For more detail, refer to the following resources: Guidelines for the Evaluation of HIV/AIDS/STI Surveillance Systems in CAREC Member Countries (CAREC 2004), available on CD and at http://www.catin.org/publications.htm Updated Guidelines for Evaluating Public Health Surveillance Systems (Centers for Disease Control and Prevention, 2001), available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5013a1.htm. The six tasks for evaluating a surveillance system are: 1. Engage the stakeholder groups in the evaluation. Stakeholders are those with an interest in the surveillance activities. 2. Describe the surveillance system to be evaluated. 3. Focus the evaluation design. 4. Gather credible evidence regarding the performance of the surveillance system. 5. Justify and state conclusions and make recommendations. 6. Ensure use of evaluation findings and share lessons learned. Each of these tasks is described on the next page. 139 HIV/STI Surveillance for CAREC Member Countries Task 1, Engage stakeholders Stakeholders include: public health practitioners healthcare providers data providers and users representatives of affected communities governments at the district, province and national levels professional and private non-profit and donor organisations. Stakeholders may want to define the questions to be addressed by the surveillance system evaluation. They may also want to decide how to use the findings from the evaluation. Therefore, they should be involved in the planning stages of the evaluation. Examples of ways to engage stakeholders: Meet individually with the key people listed above. Invite participants to join the evaluation team. Task 2, Describe the system Describe the surveillance system to be evaluated: Describe the public health importance of the health-related event under surveillance. Include indices of frequency, indices of severity, disparities associated with the health-related event, costs, preventability and public interest. Describe the purpose and operation of the system. Include objectives, planned uses of data, case definition, where in the organisation the system resides and the level of integration with other systems. Draw a flow chart of the system and the components of the system. Describe the resources used to operate the system, such as funding sources, personnel requirements, travel and supplies. Task 3, focus the design To focus the evaluation design: Determine the specific purpose of the evaluation. Identify stakeholders who will receive findings. Consider what will be done with the information generated from the evaluation. Specify the questions that will be answered by the evaluation. Determine standards for assessing the performance of the system. 140 HIV/STI Surveillance for CAREC Member Countries Task 4, gather evidence Gather credible evidence regarding the performance of the surveillance system. Listed below are the key attributes of a surveillance system. In a comprehensive evaluation, each of these should be described and evaluated. Describe the following system attributes: Simplicity - Is the surveillance system as simple and as easy to operate as possible? Flexibility - Can the surveillance system respond and adapt to new situations? Data quality - Are the data recorded in the surveillance system complete and valid (that is, have they been collected and verified so that they more accurately portray the actual epidemic)? Acceptability - Are people and organisations willing to participate in the surveillance system? Consider patients, healthcare providers and clinics, and district and provincial health departments. Sensitivity - What proportion of cases does the surveillance system detect? Can the system detect outbreaks? Can it monitor changes in the number of cases over time? Positive predictive value - Does the system have a high positive predictive value? That is, is there a high probability that cases identified by the system are actually cases of HIV infection? Representativeness - Are the prevalence data generated representative of the actual occurrence of cases over time and the distribution in the population by place and person? Timeliness - Is the system able to provide data in a timely manner? Stability - Does the system collect, manage and provide data properly without failure? Is the system operational when needed? Task 5, state conclusions State and justify conclusions and make recommendations. Justify conclusions through appropriate analysis, synthesis, interpretation and judgment of the gathered evidence. Make recommendations for improvements as modifications to or continuations of the public health surveillance system. 141 HIV/STI Surveillance for CAREC Member Countries Task 6, share lessons learned To share evaluation findings and lessons learned: Develop strategies for communicating the findings from the evaluation. Tailor recommendations to relevant audiences. Recommendations for improvements should be distributed to all partners and sites involved in sentinel surveillance. Focusing the evaluation in CAREC countries Although all of the attributes described in this unit should be evaluated periodically (for example, every three to five years), CAREC recommends that member countries evaluate the following three attributes on an annual basis. completeness (sensitivity) timeliness validity Standards for each of these attributes should be determined and each time the surveillance system is evaluated, it should be measured against the standards. Table 5.1. Standards for CAREC member countries. Data quality indicators Standards Completeness 85% Timeliness 66% within 6 months of diagnosis in year 1 of HIV case surveillance 85% within 1 year of diagnosis Validity 90% These standards can be increased over time as the surveillance system becomes stronger. Each of these three attributes should be monitored to assess how well the case reporting system is achieving its objectives. This not only improves your local surveillance system, but also prepares your system for national or Caribbean regional inspections. 142 HIV/STI Surveillance for CAREC Member Countries Data Flow in the Caribbean Region Local to national Understanding the flow of case information is necessary in order to evaluate the surveillance system effectively. In the Caribbean, the flow of case information occurs: from the healthcare facilities (clinics, hospitals and government/ private physician offices) to parish/county/district/health region level, as appropriate for the country from district/county/parish to the national level from the national level to the Caribbean regional level (CAREC). Measuring Completeness Measuring the true frequency of HIV infection /AIDS incidence Completeness of reporting measures the proportion of all true cases that are reported to the surveillance system. This definition of completeness should not be confused with measuring the completeness of information that is collected on a case report form. Ensuring that a case report form is filled out correctly and completely is an important component of a high quality surveillance system and will be discussed as part of evaluating the validity of case data. Methods to measure completeness Completeness of reporting should be evaluated for a specified time period, such as one year. You can measure completeness of reporting in one of two ways: 1. expanding surveillance activities to find (and report) any missed cases 2. estimating the proportion of all cases that were reported in a specified time period, using a capture-recapture methodology. Expanding case finding Expanding case finding has the benefit of both measuring the completeness of reporting and of identifying missed cases that can be reported and added into the surveillance system. 143 HIV/STI Surveillance for CAREC Member Countries Expanding case finding, continued Expanding case finding can be done by: increasing active surveillance activities identifying a secondary database to examine for missed cases Some examples of increasing active surveillance activities include: visiting healthcare facilities from which passive reports have been received and reviewing the clinic records for missed cases reviewing laboratory records at a facility to identify laboratory tests done that are likely to be indicative of HIV/AIDS, such as CD4 tests, HIV antibody or viral load tests or tests for Pneumocystis carinii. Identifying a secondary database to match against previously reported cases can be challenging in certain settings. It requires that: reported cases be maintained in an electronic database that lists each case separately and includes a name or unique identifier the secondary database includes persons with HIV infection and lists each individual separately by the same identifier as the HIV/AIDS case registry the secondary database has sufficient information to identify a person with HIV infection. Examples of secondary databases that have been used for identifying missed cases and measuring the completeness of reporting include: vital registries of deaths in which the cause of death is listed (and would include HIV and /or AIDS) a registry of patients receiving HIV-disease-related medications. To calculate the completeness of reporting, divide the number of reported cases by the number of reported cases plus the missed cases (the total of known cases). Usually completeness is presented as a percent. Number of previously reported cases Number of previously reported cases + newly identified (that is, missed) cases Either of these methods is likely to result in the identification of cases that were not reported. Once these cases have been identified they should be reported. 144 HIV/STI Surveillance for CAREC Member Countries Capture-recapture methods Capture-recapture is a method that estimates the completeness of reporting but does not identify missed cases to report. This system can be used in areas in which reports from multiple sources that concern a single individual with HIV infection are received at the surveillance unit. For example, consider reports that pertain to one person received from: laboratory reporting case reporting from a clinic case reporting from a hospital. The capture-recapture methodology assumes that if all of the reports are collected, this represents the true universe of cases. To help conceptualise how this method works, consider the following example, in which HIV case reporting is done using a unique code and that case reports come from several sources. A database is developed, into which all reports concerning all HIVinfected persons are recorded. The first column represents five distinct individuals reported with HIV. The next two columns are facilities from which reports are received. One might be a clinic, another might be a laboratory, etc. A ‘1’ means that a report on this person was received from this site. A ‘0’ means that a report was not received from this facility. Table 5.2. Example of case reports from two facilities. Case number X239 H750 S000 W298 T298 Facility A 1 0 1 0 0 Facility B 0 0 1 1 1 Use this information to develop a 2X2 table, as follows: Reported from: Facility B Yes No Facility A Yes No a b c x In this table, ‘a’ represents the cases reported from both sources, ‘b’ are the cases reported only from Facility B, ‘c’ are the cases reported only from Facility A, and ‘x’ represents missed cases. Then, ‘x’ can be estimated by the following formula: (bc)/a. Once ‘x’ is determined, the 145 HIV/STI Surveillance for CAREC Member Countries Capture-recapture methods, continued total number of estimated cases and completeness of reporting can be calculated. Here are the results, using the example of case reports from Facilities A and B. Reported from: Facility B Yes No Facility A Yes No 2 2 1 x (2X1)/2=1 Thus, X =1. Our total number of cases is the sum of all boxes. This equals 6. The completeness of reporting is the number of counted cases divided by the total estimated cases. In our example, this is 5/6 or 0. 83. Completeness is usually presented as a percent. So in this example, completeness is 83.3%. Capture-recapture can also be used in a single setting. In this situation, two time periods are used. For example, instead of Facility A we would collect reports from a single clinic for six months (January through June). These reports would be recorded. Reports from the same clinic will be collected for the period July through December. In this situation your record log would look like this. Case number X239 H750 S000 W298 T298 Reports from Jan-June 1 0 1 0 0 Reports from July-Dec 0 0 1 1 1 The analysis would be conducted as described for reports from two different clinics. Although these examples provide the conceptual aspects to capturerecapture, there are a number of assumptions that must be made. One of these is that the reports must all be independent from one another. We know that in this situation, case reports are not independent. Therefore, for an accurate estimate of the completeness of reporting, adjustments must be made. A number of statistical tests can be used to determine the 146 HIV/STI Surveillance for CAREC Member Countries Capture-recapture methods, continued interaction between reporting sites and to develop appropriate adjustments to the analysis. References regarding use of capture-recapture methods for estimating completeness of reporting are listed at the end of this unit. Measuring Timeliness Definition and importance Timeliness refers to how soon after diagnosis of the condition under surveillance the case was reported to the authorities (for example, the Minister of Health). In order for surveillance data to be useful in the implementation of effective prevention and control measures, health officials must know about diseases in a timely fashion. Timeliness can be measured as the median time between diagnosis of HIV or AIDS and receipt of the case report form. In addition, timeliness can be measured as the proportion of cases that are received within a specified time period from diagnosis to receipt of report. Typically, when measured in this way, timeliness is calculated as the proportion of cases reported within three, six, or 12 months of diagnosis. International standard for timeliness Reporting forms and the reporting process will be designated by your national Ministry of Health. To meet CAREC and international standards: 66% of cases should be reported within 6 months of diagnosis 85% of cases should be reported within a year of diagnosis. How to measure timeliness We need two variables from the set of variables listed above to measure timeliness: the date the case was diagnosed the date the case was reported. If you have these two variables, you can calculate timeliness. Table 5.3, on the next page, shows the steps to do this. 147 HIV/STI Surveillance for CAREC Member Countries How to measure timeliness, continued Table 5.3. Determine the timeliness of case reporting. Step 1 2 Do this… Calculate completeness of reporting at 12 months after the diagnosis year. If completeness is ≥85%, then go to Step 2. (A high rate of completeness is necessary, because when reporting is not 100% timeliness will be overestimated.) Calculate time (number of months) from diagnosis to report: (report date) - (diagnosis date) OR [(year of report)*12) + month] - [((year of diagnosis)*12) + month] For example, report date is May 2004 and diagnosis date is November 2003. The time interval (in months) is [(2004*12) + 5] - [(2003*12) + 11] = 6 months 3 4 Determine the number of cases with a time to report ≤6 months. Calculate timeliness of case reporting: Number of cases diagnosed within a year and reported within 6 months of diagnosis Number of cases diagnosed and reported for that diagnosis year Timeliness can also be calculated as the median time between the date of diagnosis and the date of report. In this calculation, completeness of reporting should be at least 85% and the timeliness should be calculated for a specified time period, as described for calculating the proportion of cases reported within six or 12 months. 148 HIV/STI Surveillance for CAREC Member Countries Laboratory reporting timeliness Laboratory reporting of HIV infection differs from case reporting from healthcare facilities. In general, laboratory reporting provides notification to public health authorities of a person with HIV infection, but does not contain the detailed information collected in a case report form. However, laboratory reporting is an important element of HIV case reporting, and its timeliness should be determined separately from the timeliness of receipt of the case report form. When you are assessing timeliness of reporting from a specific source, such as mandated laboratory reporting, completeness is not taken into account. Here’s the calculation: Number of (reportable HIV-related) tests received within (7) days of test date during specified time period All tests reported during same period Measuring Validity Definition and importance Validity measures the extent to which the information on the case report form matches information in the patient record at the health facility. Validity can be thought of as a measure of the ‘truth,’ assuming that the patient’s record at the healthcare facility is correct. How to check accuracy Measuring the validity of information collected in the case report forms is done by re-abstracting data on previously reported cases and comparing the information contained in the original and re-abstracted forms. Table 5.4, on the next page, gives top level steps for re-abstraction. 149 HIV/STI Surveillance for CAREC Member Countries How to check accuracy, continued Table 5.4. Re-abstraction study steps. Step Do this… 1 Choose a person not previously involved with the data or site to do the reabstraction check. This person should work for the national surveillance programme and should be familiar with the case report forms and methods for reviewing clinic records, abstracting data and completing the case report form 2 Randomly choose a sample of cases at a site. 3 At the site, go back to patient records (using the unique identification number) for those chosen as the sample. 4 Compare the information (variables) in the record with MOH records. 5 Record the accuracy of the variables on your national form. Scheduling re-abstraction studies For re-abstraction studies, you will need to match case surveillance information to medical record information. The timeframe for reabstracting should be one day to six months after the initial case report. The timeframe chosen will vary depending on the nature of a country’s recordkeeping (that is, name or code). Sampling may also be based on an earlier report year, but it may be difficult to obtain medical records for cases diagnosed several years earlier. Avoid re-abstracting on the same day as the original abstraction, because bias may be introduced if staff members know re-abstracting is immediately to follow. The nature of medical records is changing in the Caribbean. Because archive data may not be available in the future, re-abstracting should be done in a timely manner. Once a re-abstraction programme is established, all programmes should routinely re-abstract demographic, risk factor, laboratory and clinical data from a representative sample of records once a year to assess the quality and validity of national information. 150 HIV/STI Surveillance for CAREC Member Countries Sampling strategy A simple or stratified random sample should be used. Stratification may be used if re-abstraction is to be done at several distinct facilities. Ideally, all health facilities from which case reports were submitted will be included in the sample. Sample size is calculated once before the beginning of the re-abstraction study using the prior year's reported case count as a proxy for the expected reported case count. Sampling of cases may occur throughout the year to accommodate the intended sampling frame and stay within the re-abstracting period of one to six months after original abstraction. The size of the sample should take into consideration the number of case report forms to review, as well as time and resource constraints. While a sample of 5% - 10% is usually adequate, in countries with fewer than 100 cases, it is recommended to include all cases. Data collection The re-abstracted data are collected on hard copy or electronic case report forms that indicate the data elements to be abstracted. Re-abstracted forms must be clearly marked as duplicates. Staff conducting the re-abstraction: should be aware of the case records that need to be abstracted, but should not review the original case report form should work backward from the date when the initial case report form was completed and re-abstract the data should make sure that the case identification number/code is included in the form used for the re-abstraction. In some situations, the person who is re-abstracting data may come across new information to add to the case report form. Generally, this would be something new in the patient’s clinic record. For example, the patient may have started antiretroviral therapy since the time the initial case report form was completed. The new information can (and should) be collected and added into the document-based surveillance database. In order to keep the new information separate from the evaluation of the validity of reporting, collect the new information on a separate case report form (that must have the patient’s unique identification number/code.) 151 HIV/STI Surveillance for CAREC Member Countries Planning for Future Evaluations Regional monitoring According to the Interim Policy Guidelines for Regional Communicable Disease Surveillance System for CAREC member countries (Feb 2005), a regional communicable disease surveillance system should be evaluated every three years by CAREC representatives, member countries and stakeholders and/or partners. This evaluation will include a review and rationalisation of the syndromes and diseases under surveillance. Each national communicable disease surveillance system should be evaluated every six to seven years. CAREC is responsible for coordinating these evaluations, but they will be conducted in collaboration with countries and partners. All evaluations should aim to describe the system and assess the three surveillance attributes discussed in this unit. CAREC is responsible for the development of standard evaluation tools and indicators for the region. Guidance from CAREC Currently, many CAREC member countries have paper-based systems, but as countries have resources to switch, databases will be used to track cases and develop reports. In preliminary planning discussions, the intention is that the database will include calculations and reports, such as a Timeliness Report, Completeness Report and an Accuracy Report. Additional reports will be needed. For example: an HIV case-reporting database will include everyone (by case ID, not name) reported with HIV a patient monitoring database will record how many are on treatment. If the two databases are compared, we will have a list of who is not on treatment, making it relatively easy to compare by case ID if that patient should be in treatment. The treatment determination is based on clinical stage and CD4 count. Therefore, some patients should not be in treatment yet. 152 HIV/STI Surveillance for CAREC Member Countries Class discussion Think about the surveillance methods currently used in your district/country and answer the following questions. a. What methods have been used to measure completeness of reporting? b. What methods can you implement that would provide a better estimate of the completeness of reporting? c. What are the limitations to the methods previously used and those that might be undertaken in the future? Summary You need to evaluate your HIV/AIDS surveillance system to make sure it remains effective as the epidemic changes over time. The evaluation process includes six tasks: engaging stakeholders, describing the surveillance system, focusing the evaluation design, gathering evidence on the system’s performance, stating conclusions, and recommendations and share lessons learned. 153 HIV/STI Surveillance for CAREC Member Countries Unit 5 Exercises Warm-up review Take a few minutes now to look back at your answers for the warm-up questions at the beginning of the unit. Make any changes you want. Small group discussion Get into small groups by country, region or province to discuss these questions. 1. Has there been a formal evaluation of the HIV/AIDS surveillance system in your country? If so, which parts of the surveillance system were evaluated? 2. What was the result of the evaluation? What problems were identified? 3. How were the results shared with district surveillance staff and clinics? 4. How was the surveillance system modified as a result of the evaluation? 154 HIV/STI Surveillance for CAREC Member Countries Apply what you’ve learned/ case study Try this case study. We will discuss your answers in class. Inyo County is in the coastal area of Country X and has the country’s major port city. A British university has been conducting studies of commercial sex workers in the port city for nearly a decade. For the last five years, they have been conducting serial sero-prevalence surveys for HIV and syphilis. You are the National Surveillance Officer for Inyo County. You are asked by the Ministry to evaluate these special studies to determine if the Ministry should take over sponsorship of the studies and include them in the provincial sentinel surveillance system. Now answer the questions below. Look back in the unit for more information if you wish. a. How would you start your evaluation? b. On what would you focus in your evaluation? c. What criteria would you use to assess the performance of the system? d. What would you recommend? 155 HIV/STI Surveillance for CAREC Member Countries Unit 6 Surveillance for Sexually Transmitted Infections (other than HIV) Section 6.1 Overview of STI Surveillance What this unit is about This unit gives an overview of the components of sexually transmitted infection (STI) surveillance and explains how the data from STI surveillance can be used. Warm-up questions 1. True or false? Some elements of an STI surveillance system are more important for HIV surveillance activities. Others are more important for STI control programme activities. True False 2. True or false? STI surveillance data can serve as an indicator of trends in HIV risk behaviours. True False 3. True or false? Aetiologic reporting of syphilis (by stage), gonorrhoea and chlamydia is considered a basic surveillance activity in the Caribbean. True False 4. Which of the following is not a component of an STI surveillance system? a. b. c. d. STI universal case reporting STI sentinel surveillance systems STI testing and treatment STI prevalence assessment and monitoring 5. True or false? In generalised HIV epidemics, prevalence assessments should include monitoring gonorrhoea and chlamydia. True 156 False HIV/STI Surveillance for CAREC Member Countries Warm-up questions, continued 6. True or false? An STI surveillance system includes conditions that are newly acquired, as well as those that represent past infections. True False 7. In ___________________ reporting, STI cases are reported by the specific microbial organism that caused the STI, while in syndromic reporting, STI cases are reported by the clinical syndrome with which the patient presents. 157 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this section, you should: be able to describe methods of conducting STI surveillance be able to describe how STI surveillance data can be used in understanding HIV epidemics have an understanding of aetiologic and syndromic reporting understand basic, intermediate and advanced STI surveillance. STI and HIV inter-relationship There is a complex inter-relationship between STIs and sexually transmitted HIV: Behavioural factors – Both STIs and HIV can be sexually transmitted by vaginal, anal and oral intercourse. The risk of HIV transmission is generally greatest for anal intercourse and least for oral intercourse. Epidemiological factors – Populations with high rates of STIs have high rates of sexually transmitted HIV. Host factors – The presence of STIs causes local immunologic changes in the mucous membranes of the genital track, and, in the case of genital ulcers, cause tears in the protective layer of skin. These changes make it easier to acquire and transmit HIV. How STI surveillance data are used STI surveillance data can be used for a variety of purposes related to the monitoring, prevention, control and allocation of resources for STIs and HIV. For example, the data can be used to: assess the overall burden of STIs monitor trends in recently acquired STIs provide information necessary for physicians to treat STI patients and their sex partners provide information to assist in planning and managing STI and HIV prevention and control programme efforts provide data for the purposes of advocacy and resource mobilisation and for programme planning, targeting, monitoring and evaluation serve as a marker of HIV risk behaviours monitor the number of people infected with HIV who develop an STI, which is a marker of risky behaviours. 158 HIV/STI Surveillance for CAREC Member Countries STI Surveillance and HIV Epidemic State The role that STI surveillance can play in HIV surveillance differs depending on the state of the HIV epidemic. It is important to recognise that the type of HIV epidemic in a given area may change over time. WHO describes three different types of HIV epidemics. Table 6.1 details the different states of HIV epidemics and the benefits of STI surveillance for each. Table 6.1. State of HIV epidemic and benefit of STI surveillance. HIV epidemic state Benefits of STI surveillance an early warning system for HIV Low-level epidemic: HIV prevalence has not infection and emergence of HIV in consistently exceeded 5% in any new groups or new geographical group. areas an evaluation tool for HIV prevention programmes Concentrated epidemic: HIV prevalence consistently exceeds 5% in one or more groups with high-risk behaviour. HIV prevalence is less than 1% in pregnant women. Generalised epidemic: HIV prevalence is consistently greater than 1% in pregnant women. a marker for the emergence of HIV in new groups a marker of how successful prevention programmes have been in high-risk populations a marker of how successful prevention programmes have been in the general population Discussing the table Look at Table 6.1 and answer the following questions: a. For which epidemic state(s) can STI surveillance be used to determine the effectiveness of HIV prevention programmes? b. If HIV prevalence in Cariba is 6% in one population sub-group and 0.5% in pregnant women, what epidemic state is Cariba experiencing? 159 HIV/STI Surveillance for CAREC Member Countries STI Aetiologies versus STI Syndromes Reporting of sexually transmitted infections can be based on the aetiology or presenting syndrome. These are described and compared below, with a discussion of their advantages and disadvantages. Aetiologic reporting In aetiological case reporting, the specific STI (for example, gonorrhoea) is reported. Aetiologic reporting requires laboratory confirmation of diagnoses and is, therefore, only possible where well-developed systems of laboratory diagnosis are incorporated into routine STI clinical case management. In some countries of the Caribbean, the use of laboratory services for diagnosis is frequently not available for routine care. Syndromic reporting Syndromic case reporting relies on examining a patient and identifying a syndrome (that is, a group of symptoms that are characteristic of a specific condition, reported by a patient and detected in an examination). The limitations of syndromic case reporting are: The syndromes are not specific to a particular pathogen. Laboratory studies are required to determine which organisms are causing the symptoms. Only urethral discharge in men and non-vesicular genital ulcers in men and women are likely to reflect recent infection. They are, therefore, important for detecting trends in STI incidence. Syndromic reports are a poor tool for assessing disease burden among women. Clinical infection is not always readily apparent in women compared to men, so syndromic case reporting may underestimate disease burden in women. When possible, STI prevalence assessment and monitoring should be undertaken as a supplement to case reporting. Table 6.2 shows the relationship between STI syndromes and aetiologies. 160 HIV/STI Surveillance for CAREC Member Countries Table 6.2. The relationship between syndromes and aetiologies. STI Possible aetiology syndrome Urethral caused by Neisseria gonorrhoeae and Chlamydia discharge trachomatis other possible infectious agents include Trichomonas vaginalis, Ureaplasma urealyticum and Mycoplasma spp. Genital ulcer caused by syphilis, chancroid, lymphogranuloma (nonvenereum, granuloma inguinale or atypical types of genital vesicular) herpes reporting only non-vesicular genital ulcers excludes most herpes infections, which are most often the result of prior infection Source: UNAIDS/WHO Working Group on Global HIV/AIDS/STI Surveillance. Guidelines for Sexually Transmitted Infections Surveillance. Geneva: World Health Organization, Communicable Disease Surveillance and Response, 1999. Available at www.who.int/hiv/pub/me/en/GuidelinesforSTISurveillance1999_English.pdf Discussing the table Look at Table 6.2., above, and answer the following questions: a. Which STI syndrome can be caused by N. gonorrhoeae and C. trachomatis? b. What are some of the limitations of reporting vaginal discharge? Symptomatic and asymptomatic STIs Incident versus prevalent cases To accurately calculate incidence and prevalence, the STI surveillance system needs to identify: which STIs are newly acquired which may have been present for a long time. To identify these conditions, it is important to understand the role of symptomatic and asymptomatic infections. Some STIs produce symptoms rapidly after infection. Other STIs may be asymptomatic. 161 HIV/STI Surveillance for CAREC Member Countries Incident versus prevalent cases, continued Symptomatic infections are recently acquired and represent true incident cases. Herpes simplex virus is an exception to this rule. Because its symptoms can recur without new infection, it is not possible to determine if the infection is newly acquired or longstanding. Symptomatic STIs include: chancroid gonorrhoea early syphilis chlamydia. Asymptomatic infections do not produce clinical symptoms. They can be present for a long time (often months or even years), without the patient knowing he or she is infected. For this reason, asymptomatic infections cannot be used to measure incidence. They can, however, be used to measure prevalence. Asymptomatic STIs include: latent syphilis (although there can be symptoms associated with tertiary syphilis) chronic H. simplex virus type 2 (HSV-2) chlamydia gonorrhoea. Differences between men and women Women have symptoms less often than men, especially for gonorrhoea and chlamydia. Their asymptomatic infections can only be detected by laboratory tests. In general, reporting of male urethritis (inflammation of the urethra) and male and female non-vesicular genital ulcer disease can be considered to represent recently acquired infections. Based on the above information, consider the following information when interpreting STI surveillance data: Diagnoses of urethral discharge in men and non-vesicular ulcers in men and women reflect recently acquired infections. Non-vesicular ulcers are caused by syphilis and chancroid. Vesicular ulcers are usually caused by H. simplex virus and may represent an infection that occurred in the past. However, the vesicles may easily be scraped off, leaving an ulcer. This makes it difficult to make a clinical diagnosis of herpes. 162 HIV/STI Surveillance for CAREC Member Countries Case Definitions Diagnosis of STI syndromes should be based on standard case definitions (Annex 1). A case definition is standard terminology for deciding whether a person has a particular disease using clinical and/or laboratory criteria. Uniform case definitions should be used throughout the country to allow data gathered from the reporting systems to be compared. When a clinician makes and records a diagnosis, he or she must do so according to the standard case definition. This helps record officers or other designated staff to tally correctly. If a clinician counts cases that do not meet the standard case definitions, this might overestimate STI incidence. At the health-facility level, record clerks and persons preparing surveillance reports should be knowledgeable of the standard case definitions. They will determine whether or not the diagnosis meets the case definition. Cases should only be recorded if they meet the standard case definition, and not simply based on the assigned diagnosis. You should be aware that the syndromes used for surveillance purposes are only a sub-set of syndromes that would be identified in clinical care. 163 HIV/STI Surveillance for CAREC Member Countries Components of STI Surveillance Systems Third-generation surveillance Third-generation surveillance uses a variety of methods and tools to gain a more thorough understanding of the country’s HIV epidemic. These are based on a country’s needs and resources. The components of an effective STI surveillance system include routine data collection and special studies, such as: STI universal case reporting, where all cases of a particular disease are reported to health authorities. Universal case reporting can be either aetiologic or syndromic. Universal STI reporting, where data on cases diagnosed at health facilities are aggregated by age, gender and location (for example, place of residence, health facility, region, county, etc). This can be either aetiologic or syndromic. Additional STI surveillance techniques: o STI prevalence assessment and monitoring o combined STI/HIV and behavioural surveillance surveys o monitoring anti-microbial resistance of STI pathogens o assessing STI syndrome aetiologies o monitoring and assessing healthcare access, usage and quality for STI management. Levels of STI Surveillance – Basic, Intermediate and Advanced Three levels of STI surveillance are described here: Basic-level STI surveillance activities should be undertaken in areas with limited resources and/or weak surveillance systems. Intermediate-level STI surveillance activities can be conducted in countries with well-established surveillance systems and good laboratory infrastructure to support testing. Advanced-level STI surveillance activities can be conducted in countries with more extensive resources, well-developed laboratories and strong surveillance systems. 164 HIV/STI Surveillance for CAREC Member Countries CAREC recommendations Table 6.3. Three levels of STI surveillance, and recommendations for trends analyses and data reporting to CAREC. Surveillance Data source Recommendation for component trends analysis and reporting Basic-level surveillance system laboratories Collect and analyse Routine syndromic (public and aggregate data on a quarterly reporting of: urethral discharge private) basis, by age group, gender vaginal/endocervical public health and area of residence/health discharge facilities facility. genital ulcers (hospitals and ophthalmia health centre) Send quarterly reports to neonatorum STI clinics CAREC. ANC clinics Routine aetiologic testing and reporting of: syphilis in pregnant women congenital syphilis Periodic surveys for aetiologies (for example, every three years). Intermediate-level surveillance system laboratories Aetiologic reporting of: gonorrhoea (public and chlamydia private) trichomonas public health bacterial vaginosis facilities syphilis (hospitals and Herpes simplex health centre) virus STI clinics lymphogranuloma ANC clinics venereum chancroid congenital syphilis ophthalmia neonatorum 165 Collect and analyse aggregate data on a quarterly basis, by age group, gender, and area of residence/health facility. Send quarterly reports to CAREC. HIV/STI Surveillance for CAREC Member Countries Table 6.3. Three levels of STI surveillance, and recommendations for trends analyses and data reporting to CAREC, continued Advanced-level surveillance system Population surveyed Routine aetiologic will depend on reporting of : Behavioural and epidemic state and risk biological HIV/STI groups surveillance surveys Antibiotic resistance testing Surveys for quality of care/treatment The frequency of surveys will depend on the objectives, epidemic state and available resources. An example As an example, think about the STI surveillance components that would be needed in the following situation. Cariba has a nearly perfect reporting system for STIs diagnosed syndromically in public health facilities. Although the existing surveillance infrastructure provides good data on the annual burden of STI syndromes in public health facilities, additional information is necessary to estimate the true population burden of STIs and how the STIs relate to HIV. To do this, the country would need special studies to establish: how many STI patients seek care from government or private health facilities how many seek STI care from other providers (for example, private clinics, traditional medicine or pharmacies) or medicate themselves which organisms are causing specific STI syndromes which medications should be used to treat the different STIs what behaviours are contributing to the spread of STIs. Small group discussion Get into small groups to discuss these questions. 1. What are the most common STIs in your country? 2. Describe the current ongoing surveillance for STIs in your country? 3. How does the STI surveillance system in your country relate to the HIV/AIDS surveillance systems that currently exist? 166 HIV/STI Surveillance for CAREC Member Countries An example Reports of STI case reporting from Cariba. Assume that the population size has not changed between 2000 and 2003. Table 6.4. Reports of STI case reporting from Cariba. STI condition 2000 2001 2002 Male urethral discharge 2 529 28 95 2 978 Male non-vesicular genital ulcer 642 783 749 Female non-vesicular genital ulcer 534 697 630 2003 2 985 769 690 Look at the STI data provided in the table. a. What do the data suggest about the trends in the incidence and prevalence of these conditions in Cariba? b. What do these data suggest about trends in HIV risk behaviours? c. What additional data would you be interested in reviewing to assess burden of STI infection and incidence of STI infection in the province, and why would you be interested? Components of STI Surveillance Systems – in detail Universal STI Reporting Types of reports used In universal reporting, minimal data elements about STIs are collected from all health facilities in the country. The minimum data include information such as STI syndrome or aetiology by age group and gender. Advantages and disadvantages The advantages and disadvantages of universal reporting for STIs are outlined in Table 6.5 167 HIV/STI Surveillance for CAREC Member Countries Table 6.5. Advantages and disadvantages of universal STI reporting. Advantages Disadvantages It is the most readily available source of STI surveillance data. It provides data that are easy to collect from health facilities. It provides data on the burden of STIs at the health facility level, important for planning health services. When consistent, it can be used to track populationlevel STIs trends. It is based on recognition of symptoms and thus provides a poor assessment of the true disease burden among women (compared with men, STIs are more often asymptomatic in women). It does not provide a direct estimate of the population burden of STIs because people with asymptomatic infection do not realise they are infected, so they do not seek care. It is affected by fluctuations in health-seeking behaviours of the population not related to the burden of disease (for example, availability of drugs or introduction of user fees at clinics). Discussing the table Look at Table 6.5 and answer the following questions: a. Why does universal reporting provide poor assessment of disease burden among women? b. Does universal reporting provide a direct estimate of the population burden of STIs? Why or why not? 168 HIV/STI Surveillance for CAREC Member Countries Prevalence Assessment and Monitoring Definition and terms Here are some of the terms used in prevalence assessment and monitoring: Prevalence of a disease or infection—the proportion of people in a population who have the disease or infection at a specified time. Prevalence monitoring—following prevalence trends over time to see if they are increasing or decreasing. STI prevalence assessment and monitoring—using surveys to determine what percentage or how many people have STIs when compared to the total population. Prevalence assessment is a major component of STI surveillance. This core surveillance function is similar to HIV sero-prevalence surveys, and includes collecting blood or urine for identification of STIs as well as basic demographic information about the person tested. Information obtained through prevalence assessments can be used to understand which groups are at greater risk for infection or resistance. Assessments determine demographic information about populations at risk. This information is used to describe a population. When prevalence and trends are identified, appropriate treatment can be planned. Prevalence assessments are usually planned at the national level as one of the following: part of a combined STI/HIV behavioural survey part of a national HIV sero-prevalence survey a standalone project. The STIs that can be included in surveys are: syphilis gonorrhoea chlamydia Herpes simplex virus hepatitis B 169 HIV/STI Surveillance for CAREC Member Countries Objectives of assessment and monitoring The main purposes of STI prevalence assessment and monitoring are to: identify population sub-groups with high prevalence of STIs monitor trends in STI prevalence among defined populations. Prevalence assessments are used in various situations: In prevalence assessment and monitoring, interventions (such as screening and treatment) are part of the surveillance activity. Prevalence assessment may also be performed as part of a study. These studies are designed to obtain data for programme planning. Often, STI prevalence is monitored in routinely screened, defined populations. For example, women are routinely screened for syphilis during antenatal care or delivery. The main purpose of screening at antenatal clinics is detection and treatment of STIs. Determination of prevalence is not the main goal. Programme planning STI prevalence data are of great use in HIV and STI programme planning, management and evaluation. They are used to: develop national estimates of STIs identify population sub-groups at high risk for HIV infection (as evidenced by high rates of STIs) guide funding and resource allocation for STI and HIV prevention programmes monitor effectiveness of STIs and HIV prevention programmes intervene in the transmission of STIs through screening and treatment. Prevalence trends may be altered by changes in the population being screened for several reasons: different types of clinics; for example, an STI clinic may get different results than a clinic serving the general population change in the population's health-seeking behaviour change in criteria used to select persons for screening change in diagnostic tests, especially for chlamydia, which often vary in sensitivity and specificity. Any changes should be recorded and taken into account in the interpretation of trend data. 170 HIV/STI Surveillance for CAREC Member Countries Assessing STI Syndrome Aetiologies Determining the micro-organisms that cause genital discharge and genital ulcer disease is an important STI surveillance activity. This assessment of aetiologies of STI syndromes is especially important in countries where STI syndromic management and case reporting are usually performed. Knowing the organisms that account for the STI syndromes allows the STI control programmes to recommend effective treatment. The national HIV/STI control programme typically organises and carries out an STI syndrome aetiology assessment. These surveys are conducted to assess the relative contributions of the major STI pathogens, such as: the syndrome of genital discharge (urethral discharge in men and vaginal/endocervical discharge in women, caused by gonorrhoea, chlamydia and others) the syndrome of genital ulcer disease in men and women (syphilis, chancroid and HSV-2). Syndrome aetiologies should be reassessed every two to three years, or more frequently if the need arises. For example, if there is a new outbreak of genital ulcer disease, your reassessment of which micro-organisms are causing disease would happen earlier. Objectives The main purposes of assessing syndrome aetiologies are to: provide data for guiding STI syndromic treatment assist in the interpretation of syndromic case reports and the assessment of disease burden due to specific pathogens design or modify guidelines for treating urethral discharge and genital ulcers. Laboratory requirements A microbiologist experienced in STI diagnostic tests should develop laboratory protocols for determining which organisms are causing the symptoms. Laboratories should also have quality assurance and control protocols in place. The range of diagnostic tests that may be used is broad. Many new tests are being developed. Selection of the test to use will depend upon local availability of resources. 171 HIV/STI Surveillance for CAREC Member Countries Laboratory requirements, continued Table 6.6, below, summarises the general types of laboratory tests that may be used for assessing syndrome aetiologies: Table 6.6 Laboratory tests for specific STI syndromes. Syndrome Corresponding laboratory tests Genital discharge Microscopy (Gram stain of urethral discharge to identify Gram-negative diplococci bacteria, primarily N. gonorrhoeae) Gonorrhoea and chlamydia testing: o culture for N. gonorrhoeae o direct fluorescent antigen and enzyme-linked immunoassay (EIA) for C. trachomatis o amplified (such as PCR or strand displacement amplification) and nonamplified nucleic-acid-based tests for both pathogens Genital ulcer disease Syphilis serologic testing (non-treponemal and treponemal) Dark field, direct fluorescent antibody test for syphilis Culture for H. ducreyi HSV-2 culture or antigen detection test Polymerase chain reaction (PCR) for T. pallidum, H. ducreyi and HSV-2 available in some settings Discussing the table Looking at Table 6.6, answer the following questions: a. For which syndrome is it appropriate to perform microscopy? b. How would you test for syphilis in genital ulcer disease? 172 HIV/STI Surveillance for CAREC Member Countries Testing procedures Selection of populations for assessing syndrome aetiologies depends on the number of cases available for examination at a single site. Syndrome aetiologies should ideally be assessed in: different types of populations populations with high rates of disease populations with low rates of disease different geographic locations. If your country has limited resources, begin with an assessment of genital discharge and genital ulcer disease at a single specialised STI clinic. The clinic should: have well-trained personnel who can perform high-quality Gram stain and microscopy be able to perform syphilis serologic testing. In many countries, reliable dark field microscopy is unavailable. Collaborate with a well-equipped laboratory to assess the contribution of chlamydia to urethral discharge. Further assess the contribution of chancroid and herpes to genital ulcer disease. Also keep in mind that: Syphilis serologic testing alone provides an incomplete assessment of genital ulcer aetiology. This is because many patients with chancroid and HSV-2 ulcers can have reactive syphilis serologic tests from previously treated or untreated (latent) infections. A substantial proportion (10%-30%) of patients with primary syphilis will not yet have developed a serologic response to infection. Sample size The sample size depends on the specific aetiology and the expected prevalence of pathogens. A minimum sample size of 50 or 100 specimens from consecutive patients with the specified syndrome (or other type of systematic sample) will provide adequate information for useful analyses. Analysis It is important to analyse STI data separately for each specific disease rather than reporting findings together. For example, cases of gonorrhoea should be analysed separately from cases of syphilis. The frequency of the various STI and risk behaviours should then be calculated and analysed by: 173 HIV/STI Surveillance for CAREC Member Countries Analysis, continued gender age group geographic area marital status other relevant characteristics. These tests should be anonymous, so there is no way to give results to individual patients. But if for any reason these tests are conducted in such a way that the results could be linked back to the individual, patients need to be given results and treated. Summary Assessing syndrome aetiologies provides information on the relative contributions of different pathogens to the main STI syndromes. This guides STI syndromic treatment and assists in the interpretation of syndromic case reports. Behavioural and Biological Surveillance Surveys Behavioural surveys of certain high-risk groups and of the general population are an integral part of third-generation surveillance. They can be combined with HIV sero-prevalence surveys. Behavioural surveys can also be combined with STI prevalence surveys done along with HIV testing. These combined STI/HIV behavioural surveillance surveys collect data that compare patients’ high-risk behaviour with the presence of STIs and HIV. Behavioural surveys Behavioural surveys use questionnaires to examine the prevalence of behaviours associated with HIV transmission. In these surveys, prevalence is the number of people who have a certain behaviour (usually within a specified time period) divided by the total number of people who answered the question. Behavioural surveys may be conducted as part of: national health and demographic surveys HIV behavioural surveillance or HIV sero-surveillance in high-risk populations. In behavioural surveys, you interview people about their sexual and other high-risk behaviours that are associated with an elevated risk of STI or HIV infection. 174 HIV/STI Surveillance for CAREC Member Countries Data elements Use consistent data elements to determine risk behaviour. Use behavioural survey questions, such as: the number of sexual partners in the past three or 12 months new sexual partners in the past three months condom use at the last sexual intercourse with someone other than a regular sexual partner alcohol or drug use in the past 12 months giving or receiving money for sex in the past 12 months. When used with behavioural surveys, HIV and STI testing assess risk behaviours and HIV and STI burden in high-risk and bridging populations, as well as in the general population. Bridging populations include people in high-risk groups who have sex with people of lower risk in the general population. An example of this might be a female commercial sex worker having sex with her boyfriend, who does not have other high-risk behaviours. Choosing STIs for behavioural surveys When you are choosing which STI to test for in a combined STI/HIV and behavioural survey, consider two things: the laboratory infrastructure development in the country the type of populations under study. These assessments almost always include HIV testing. Summary Combined STI/HIV and behavioural surveys combine STI and HIV prevalence assessments with behavioural surveys. These can be done in the general population or in specific high-risk populations. 175 HIV/STI Surveillance for CAREC Member Countries Monitoring of Anti-Microbial Resistance of STI Pathogens Why monitor for resistance? Drugs are routinely used to treat STI infections. This has led to increasing rates of resistance. Resistance is the alteration of a pathogen that makes it non-responsive to a particular anti-microbial agent. Simply put, the drug being used no longer controls or eliminates the infection. Resistance monitoring entails examining in the laboratory the effectiveness of various anti-microbial agents in inhibiting the growth of N. gonorrhoeae. In resistance monitoring, various concentrations of a given anti-microbial agent are used to determine the minimum concentration of that agent required to stop the organism from growing. Depending on the concentration of the anti-microbial agent required to inhibit growth, the organism can be classified as sensitive, intermediate or resistant to a particular anti-microbial agent. Usually the organism is checked for sensitivity against several different anti-microbials, often from different classes. As an example of how to monitor anti-microbial resistance, we will discuss N. gonorrhoeae, a core component of STI surveillance. Resistance monitoring is done to: obtain the data necessary for developing and revising treatment guidelines detect newly emerging resistance. It is also important to monitor N. gonorrhoeae to ensure that the medication given to a patient with a gonococcal infection will cure the infection. Effective treatment for gonorrhoea: relieves the signs and symptoms and achieves microbiologic cure in individual patients prevents complications of pelvic inflammatory disease, chronic pelvic pain and infertility in women reduces the risk of HIV transmission by decreasing the presence of white blood cells at the cervix and urethra interrupts transmission of N. gonorrhoea. Laboratory requirements Surveillance surveys for anti-microbial resistance of STI pathogens are usually organised and conducted by the national HIV/STI control programme. Sites are chosen that have healthcare facilities with well176 HIV/STI Surveillance for CAREC Member Countries Laboratory requirements, continued trained staff and laboratory expertise. Only selected sites will have the capacity to conduct these types of surveillance activities. In our example of monitoring N. gonorrhoeae and selecting anti-microbial drugs for susceptibility testing, give priority to drugs commonly used for treating gonococcal infections. A laboratory performing susceptibility testing for N. gonorrhoeae should be able to accomplish the following tasks: culture the organism perform biochemical and serologic confirmatory tests perform minimum inhibitory concentration (MIC) agar dilution testing of anti-microbial agents. If the national reference laboratory does not have this capacity, it may send isolates to a regional laboratory in another country for testing. An isolate is a culture of bacteria or other cells. Regional networks supported by WHO Collaborating Centres have been established in several WHO regions to conduct anti-microbial susceptibility testing for N. gonorrhoeae. National reference laboratories are encouraged by WHO and UNAIDS to participate in these centres' programmes of quality control and assessment. Frequency of assessment The assessment of anti-microbial resistance should be performed at least once a year. When feasible, it is best to sample isolates on an ongoing basis rather than during only one month or quarter per year. For example, you can test 20 isolates per month at each sentinel site throughout the year. Ongoing sampling makes it more likely that newly emerging resistance or large changes in patterns of resistance will be detected early. If trends in susceptibility are to be reliably monitored over time, variations in the sentinel sites and sampling procedures should be minimised. Summary In view of the increasing rates of drug-resistant pathogens worldwide, it is important for each country to monitor anti-microbial resistance in Neisseria gonorrhoeae as a core component of STI surveillance. 177 HIV/STI Surveillance for CAREC Member Countries Section 6.2. Case Reporting, Data Management and Analysis What this section is about This section discusses sexually transmitted infection (STI) case reporting and the information flow from health facilities through the sub-national and national levels. It also reviews how to handle and analyse data. Warm-up questions 1. Match the STI data analysis parameter with its description by putting a letter in each blank: ___ Analysis by place ___ Analysis by time ___ Analysis by person a. Annual analysis of data could show an annual trend of disease stratified by age group and gender. b. Analysis to detect if there are any trends in case reports over time and any inferences that can be made. c. Analysis to provide information about where clustering of disease might be occurring and any inferences that can be made. 2. True or false? Interpretation of STI trends should be made independently from STI control programmes and the healthcare system. True False 3. The national level should send STI summary reports to CAREC: a. weekly b. monthly c. quarterly d. annually 4. The national surveillance officers are responsible for: a. checking data for inconsistencies b. forwarding the results to the CAREC c. following up with any health facility site that has missing or inconsistent data d. all of the above 5. List three ways to handle surveillance data so that patient confidentiality is protected. a. b. c. 178 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this section you should be able to: describe how to plan your data collection and ensure confidentiality describe the flow of data from health facilities to the district and the national level discuss the roles and responsibilities of each person involved in data handling at each level discuss the analysis of STI data. Planning Your Data Collection Data management system The national level should develop forms that all sites will use, as well as co-ordinating training. A data management system should be developed at the national level. Clear lines of reporting must be specified. The roles of different workers, from the health facilities or sentinel sites through to the national level, should be clearly defined. The data management system should clearly explain how surveillance officers at both the sub-national and national levels: receive data record data check the data for completeness and consistency. The national level should also design a method for the submission of the reports by mail, regular direct pick-up from the sites, hand delivery, email, web-based submission and so on. 179 HIV/STI Surveillance for CAREC Member Countries Confidentiality and security All STI surveillance data must be handled to ensure patient confidentiality (the protection of a patient’s personally identifying information) and privacy. Specifically: train staff who record, store and report surveillance data in the importance of privacy and confidentiality of each patient’s data develop a written confidentiality policy for your surveillance and STI control programme protect the integrity of STI data to ensure that they cannot be modified restrict access to the data either through use of passwords or restricted access to computers lock all raw data in filing cabinets remove all personal identifying information before you report data from one level to another keep patients’ personal identifying information only at the health facility where it was collected, and do not allow unauthorised disclosure of the personal identifying information. Secure the data to protect it from harm or loss. Back up on an external drive or CD-ROM every time data are added or edited. All STI data are confidential. The computer hardware should be password-protected. Access should be limited to data entry personnel. Provide safe cabinets for storing hard copies of forms or registers. Lock the cabinets and restrict access to authorised personnel only. Collecting Data At the health facilities STI data collection should be an integral part of STI case management. Everyone involved must have clearly defined duties. The data collection process should interfere as little as possible with the patient’s care and case management. The data required should be data that are usually collected during case management. Data should be recorded on outpatient cards and transferred to the patient register and standard reporting forms. One individual needs to take responsibility for the actual reporting so that reports are made on time. A supervisor needs to ensure that the data are ready before they are sent to the sub-national or national levels. If personnel at sub-national levels have queries regarding the data, these queries should be investigated and answered. 180 HIV/STI Surveillance for CAREC Member Countries Health facility process Here is the step-by-step process undertaken at the health facilities: 1. The doctor, midwife or nurse who diagnoses and provides care for the patient: is responsible for identifying cases and recording medical and demographic data onto patients’ charts must record the diagnoses according to standard case definitions to help record officers or other staff to correctly tally at the end of the month. 2. Depending on data requirements for reporting, the information may be transferred directly to standard reporting forms from the patients’ charts. 3. STI cases should be tabulated on a regular basis, usually weekly. Data entry clerks should be knowledgeable about the STI case definitions so they can decide whether or not a particular patient meets the definition if there is any question. The data entry clerk or other trained staff member: abstracts data from the patients’ charts onto the patient register or tally sheets only includes patients presenting for the first visit with a current episode of STI makes separate entries for each syndrome (because some patients will have more than one syndrome, this will result in a slight overestimation of the total number of people with STIs, but will yield a more reliable estimate of the magnitude and trends of the individual syndromes) transfers weekly totals from tally sheets, to standard monthly/quarterly reporting forms, to sub-national or national level makes a zero entry if there were no cases of a specific syndrome during that month/quarter (do not leave the space blank) so the district level will know the report is complete. 4. In some cases, the facility will include several clinics or sites. In that case, a supervising doctor or nurse should: review weekly tallies from the health facility make their comments and have problems investigated before the reports are submitted to sub-national/national authorities. 6. The final reporting forms should be copied. A copy should be sent to the sub-national/national level while the original is kept on file at the health facility. Note: reports should be signed and dated by the reviewing supervisory doctor/nurse at the facility. 181 HIV/STI Surveillance for CAREC Member Countries At the subnational level When a responsible officer at the sub-national level carefully reviews facility forms, the quality of data received at the national level is high. Of course, the better the data quality, the better the national level can make decisions that will affect every health facility. Sub-national-level data checking and editing should focus on: checking for completeness of data ensuring that all the variables indicated on the data collection forms are appropriately filled inconsistencies (for example, STIs in very young or old patients). The reviewing surveillance officer should follow up with any health facility site that has missing or inconsistent data. This should be done before forwarding the forms to the regional or national level. The officer combines the totals from all the reporting health facilities: If computers and software are available, a data entry clerk will enter data into a computerised database. If these resources are not available, data entry is done at the national level. A copy of the health facility reports should be kept at the sub-national level. The sub-national reporting forms should state the number of health facilities with complete reports. The original sub-national summary totals should be sent to the national level, following clear reporting lines. Annex 4.2 provides a sample form for this. At the national level Check inconsistent data with the reporting sites. At the regional and national levels (depending on your country resources), a trained data entry clerk will enter reports into a computerised database. Then the data are analysed. Entering and Analysing Data Data entry Data should be double-entered (that is, entered twice) to avoid errors. Alternatively, use software such as Epi Info™, which combines data entry with validation. Consider the following points regarding data entry (next page): 182 HIV/STI Surveillance for CAREC Member Countries Data entry, continued Even if you use a data entry edit programme, data still need to be carefully checked before analysis. A simple frequency tabulation can be run after data are entered to recheck for implausible values. Other ways to ensure correct data entry include: o placing a tick or cross on forms once they have been entered o printing out data in the form of a table to check whether the data are logical (for example, women should not be reported with urethral discharge). Data analysis In third-generation HIV surveillance, STI case reporting is used as a proxy for HIV transmission. This is because STIs are transmitted in the same way as sexually transmitted HIV and because programmes that target prevention of sexually transmitted HIV should also prevent transmission of STIs. Several STI syndromes quickly manifest in symptoms and can represent recently acquired infection. These may indicate trends in HIV incidence as well. Surveillance of the main STI syndromes—male urethral discharge syndrome, female vaginal discharge, male non-vesicular genital ulcer disease and female non-vesicular genital ulcer disease—can, therefore, serve two functions: indicate where HIV transmission could be occurring (for instance, a geographical area or a population group) indicate where HIV prevention programmes are failing (if the rates of STIs are rising) or succeeding (if the rates of STIs are falling). The analysis of STI data usually takes place at the national level at the epidemiology or surveillance unit where analysis of surveillance data on all priority diseases is done. Collaboration between this unit and the HIV/STI control programme is essential. Analyse data by these categories to identify the sites that are not reporting consistently: reporting site type of facility district/parish/county gender age group Also, analyse data separately for each syndrome (if syndromic case reporting is conducted) or for each disease (if aetiologic case reporting is conducted). STI data analysis should generally focus on three parameters: person, place or time. Table 6.7 explains these parameters. 183 HIV/STI Surveillance for CAREC Member Countries Type of analysis By person By place By time Table 6.7. Types of STI data analysis. Description annual analysis of data to show trends in specific syndromes in the case of aetiologic surveillance, diseases stratified by age group and gender analysis to provide information about where clustering of disease might be occurring and any inferences that can be made stratified analysis by region or geographical area to show if there are significant differences between places analysis to detect if there are any trends in reports over time and if any inferences can be made (for example, incidence increasing or decreasing) data for a specific quarter should be compared with the same quarter in the previous year Discussing the table Looking at Table 6.7, answer the following questions: a. Does analysis by person allow you to track STI trends in specific age groups? How would this aid HIV prevention programmes? b. Does analysis by place allow you to detect any trends in reports over time? How would this aid HIV prevention programmes? Interpreting trends Be careful when you are interpreting STI trends. Interpretation of trends should not be made outside the context of STI control programmes or the healthcare system. In order to accurately interpret STI trends, you must think about the following factors: factors related to health-seeking behaviour, such as opening of additional healthcare facilities, availability or unavailability of medications or introduction of user fees factors affecting reporting practises, such as changes in staffing or training of the staff handling case reporting and data changes in case definitions or quality of services. If there are unexpected fluctuations, officers at the national or regional level should investigate by contacting the sites. 184 HIV/STI Surveillance for CAREC Member Countries Analysing universal site data The magnitude of STIs by category and trends should help in drawing preliminary conclusions about the burden of STIs. At all levels of analysis, the data should be clearly summarised in tables, graphs or charts, so they are easily understood. In this way, trends or patterns are identified. In summary Surveillance data collection occurs at the health facility level, while data processing takes place at the sub-national and national levels. It is extremely important to ensure patient confidentiality. STI data analysis should generally focus on three parameters: person, place or time. Summary Important points If surveillance data show that STI transmission is occurring, then HIV transmission is likely occurring as well. World Health Organization estimates that 340 million new, curable STI cases occurred globally in 1999. Of these, 69 million (20.3%) occurred in the Caribbean. There are two different ways to diagnose and manage STI cases. These are syndromic diagnosis and reporting, and aetiologic diagnosis and reporting. In syndromic diagnosis, four syndromes are used for STI surveillance. In aetiologic diagnosis, an exact microbiologic diagnosis is given (for example, gonorrhoea). Diagnosis of STI syndromes should be based on standard case definitions, which use readily identifiable and consistent clinical criteria. Uniform case definitions should be used throughout the country to enable comparability of the data arising from the reporting systems. Only curable STIs with acute onset and short duration, such as gonorrhoea, chlamydia, chancroid, trichomoniasis, primary and secondary syphilis, and the syndromes they cause are important as a tool for assessing STI incidence and prevalence. 185 HIV/STI Surveillance for CAREC Member Countries Important points, continued Some components of an STI surveillance system are more important for surveillance purposes (for example, STI case or aggregate reporting sentinel surveillance, and combined STI/HIV behavioural surveillance surveys). Other STI surveillance components are more important for STI control programme activities. For example: o assessing syndrome aetiologies o anti-microbial resistance monitoring. The most feasible STI surveillance system in the Caribbean is STI universal reporting and or STI sentinel surveillance. The STI reporting process involves healthcare providers reporting numbers of persons with new episodes of STIs over a given time period to public health authorities from the parish/county level up to the national level. In universal STI reporting, minimum data on STI cases are collected from all the health facilities in the country. STI surveillance can occur through universal STI reporting, sentinel STI surveillance, or a combination of the two. At sentinel surveillance sites, more data on STI cases are recorded and reported. Trends from these sites are used to infer trends of STIs in other health facilities. The major advantage of this system is that higher quality and more consistent information is obtained. Sentinel surveillance produces higher quality and more consistent surveillance data than universal reporting, at lower cost. However, you cannot assume that sentinel surveillance data are representative of the general population, while you can make that assumption with universal reporting data. In countries using the syndromic approach to STI treatment, it is important to monitor the actual aetiologies of urethral discharge syndrome in men, and genital ulcer diseases in men and women. These findings are used to refine national STI treatment guidelines. Prevalence assessment is the determination of prevalence of certain STIs by laboratory testing among persons screened in defined populations. Prevalence monitoring is the monitoring of trends in prevalence over time. Combined STI/HIV and behavioural surveys combine STI and HIV prevalence assessments with behavioural surveys. These can be done in the general population (as in DHS+) or in specific high-risk populations. 186 HIV/STI Surveillance for CAREC Member Countries Small group discussion Get into small groups to discuss these questions. 1. Describe the system for forwarding STI surveillance reports from the health facility level to the national level in your country. Describe what happens to the forms at each level and indicate the responsible officers. 2. What core data elements are required for reporting through the STI universal reporting system? Apply what you’ve learned/ case study Try this case study. We’ll discuss the answers in class. You are the national STI surveillance officer for Cariba. You rely primarily on syndromic surveillance using a universal reporting system. You have noticed an increase in the number of reported cases of male nonvesicular genital ulcer disease in the St. James Parish, one of five districts in the country. Number of reported cases of male non-vesicular genital ulcer disease by district and year, Cariba. Parish Year 1998 1999 2000 2001 2002 2003 40 42 38 54 45 38 St. Mary 60 70 72 84 65 58 Kingstown 47 50 42 40 41 39 Arima 53 87 76 95 107 197 St. James 49 49 36 72 65 48 Yotown a. What are some possible causes of this increase? Arima and Yotown, parishes that border St. James, are primarily rural areas, whereas St. James has an urban centre with a recently refurbished and expanded health centre. b. Could these differences between the parishes account for the increase in STI cases in St. James? c. How would you investigate this? 187 HIV/STI Surveillance for CAREC Member Countries Apply what you’ve learned/case study, continued You examine all syphilis tests done at the clinic for one month. Demographic data, including parish of residence, are available. The table below shows your findings: Results of sentinel syphilis screening by parish of residence, Cariba. Parish of Positive Total tested Percentage residence syphilis tests positive 10 60 Arima 25 150 St. James 3 80 Yotown d. Calculate the prevalence by parish of residence. How could these data be used for STI control? For HIV control? 188 HIV/STI Surveillance for CAREC Member Countries Annex 6.1. Caribbean Epidemiology Centre Quarterly STI Reporting Form YEAR …….…………………..……….. Quarter REPORTING PERIOD: 1 2 3 4 DATE OF REPORTING: STI prevalence rate in populations concluded during this period among specific groups: NAME OF COUNTRY: UNIT/ PROGRAMME: Study group: Total number of STI cases reported during this period: Blood donors Pregnant women MSM % % % Others (indicate) : Name: SYNDROMES AETIOLOGIES AGE GROUPS Sex 10 - 14 Urethral discharge (Males only) Gonorrhoea Chlamydia Non-Specific Urethritis (NSU) Unknown Syphilis LGV Genital ulcer (Males & females) HSV Chancroid Unknown Vaginal discharge (Females only) Gonorrhoea Chlamydia Trichomonas Bacterial Vaginosis Others Unknown Syphilis No syndrome, but laboratory test positive (Males & females) (serology positive) HSV Chlamydia Other FCSW 1 Name of STI : 15 –19 20 - 24 25 - 49 50+ % %: Age &/or Sex2 unknown TOTAL M M M M M F M F M F M F M F F F F F F F M F M F M F M F TOTAL INFANTS Ophthalmia Neonatorum TOTAL Gonorrhoea Chlamydia Other Unknown Congenital Syphilis HSV: Herpes Simplex Virus Infections (Only the first episode should be reported) LGV: Lymphogranuloma venereum 1 FCSW: Female Commercial Sex Workers Indicate disease under study e.g. chlamydia, syphilis 2 MSM: Men who have Sex with Men Count based on persons to avoid duplication (for example if an individual’s age and gender are not known, they must be only counted once) 189 HIV/STI Surveillance for CAREC Member Countries Annex 6.2. CAREC Surveillance Case Definitions for Sexually Transmitted Infections (STIs) Definition of STI, by Syndromes BACTERIAL VAGINOSIS Bacterial vaginosis, previously known as nonspecific vaginitis or Gardnerella vaginitis, is the most common cause of vaginal discharge. This clinical syndrome is now recognised as a polymicrobial superficial vaginal infection involving a loss of the normal lactobacilli and an overgrowth of anaerobes. While commonly found in increased numbers in women with bacterial vaginosis, G. vaginalis is not invariably present. G. vaginalis has been reported in 16 to 42 percent of women with no signs or symptoms of vaginitis. CONFIRMED CASE Clinically confirmed: At least three of these criteria must be present for diagnosis o Homogeneous vaginal discharge (colour and amount may vary) o Presence of clue cells (greater than 20%) o Amine (fishy) odour when potassium hydroxide solution is added to vaginal secretions (commonly called the "whiff test") o Vaginal pH greater than 4.5 o Absence of the normal vaginal lactobacilli. GENITAL ULCER SYNDROME This clinical syndrome is an indicator of sexually transmitted infection. CONFIRMED CASE Clinically confirmed: Any male or female with ulcers or vesicles present in the anogenital region: scrotum, penis, vulva, vagina, cervix, perianal area, or inner thighs with or without regional lymphadenopathy. LYMOHOGRANULOMA VENEREUM Infection with L1, L2, or L3 serovars of Chlamydia trachomatis is sexually transmitted and may result in a Genital Ulcer Syndrome. CONFIRMED CASE Laboratory confirmed: a case of Genital Ulcer Syndrome (see case definition) with isolation of C. trachomatis, serotype L1, L2, or L3 from a clinical specimen by cell culture or direct antigen, PCR or LCR methods from a genital ulcer. 190 HIV/STI Surveillance for CAREC Member Countries OPHTALMIA NEONATORUM This clinical syndrome without specific aetiological laboratory diagnosis may be an indicator of sexually transmitted infections among childbearing females. CONFIRMED CASE Clinically confirmed: Any infant with acute redness and swelling of conjunctiva of one or both eyes, with purulent discharge in the first month of life following vaginal delivery. URETHRAL DISCHARGE (GENITAL DISCHARGE SYNDROME) This clinical syndrome is an indicator of sexually transmitted infection. CONFIRMED CASE Clinically confirmed: Any male with urethral discharge that is cloudy or opaque, viscous or sticky, appearing at the urethral meatus spontaneously or after milking the urethra. VAGINAL DISCHARGE (GENITAL DISCHARGE SYNDROME) This clinical syndrome is an indicator of sexually transmitted infection. CONFIRMED CASE Clinically confirmed: Any female with mucopurulent (yellowish), exudative endocervical discharge present on speculum examination. Definitions of STI, by Aetiology CHANCROID Infection with Haemophilus ducreyi is sexually transmitted and may result clinically in a Genital Ulcer Syndrome. CONFIRMED CASE Laboratory confirmed case: A case of Genital Ulcer Syndrome (see case definition) with isolation of H. ducreyi from a clinical specimen by culture, antigen detection or DNA amplification. 191 HIV/STI Surveillance for CAREC Member Countries CHLAMYDIAL INFECTIONS Infections caused by Chlamydia trachomatis can be sexually transmitted and may result in urethritis, epididymitis, cervicitis, acute salpingitis (pelvic inflammatory disease), proctitis, or other syndromes (see Lymphogranuloma Venereum). Infection may be asymptomatic. CONFIRMED CASE Laboratory confirmed: Detection of C. trachomatis by cell culture, direct antigen, PCR or LCR methods from an intraurethral (male) or endocervical swab (female). CHLAMYDIAL INFECTIONS (NEONATAL) Perinatal infections with Chlamydia trachomatis may result in Ophthalmia neonatorum, and acute inflammatory condition of the conjunctiva among newborns. It could also result in acute pneumonia among newborns and infants. CONFIRMED CASE Laboratory confirmed: a case of O. neonatorum (see case definition) with detection of C. trachomatis by cell culture or direct antigen method from conjunctival exudate or pseudomembrane. GONOCOCCAL INFECTION (NEONATAL) Perinatal infection with Neisseria gonorrhoeae may result in Opthalmia neonatorum, an acute inflammatory condition of the conjunctiva among newborns. CONFIRMED CASE Laboratory confirmed: A case of O. neonaturum (see case definition) with isolation of N. gonnorhoeae from an eye swab. HERPES SIMPLEX VIRUS INFECTIONS (GENITAL) Infection with herpes simplex virus (HSV) types 1 or 2 may be sexually transmitted and may result in recurrent episodes of a Genital Ulcer Syndrome. Because of its chronic evolvement, only an initial episode of genital herpes should be reported. PROBABLE CASE A Genital Ulcer Syndrome (see case definition) with clear vesicles on an erythematous base in the anogenital area and no previous documentation of such an occurrence. 192 HIV/STI Surveillance for CAREC Member Countries CONFIRMED CASE Laboratory confirmed: A probable case with isolation of HSV1 or HSV2 from clinical specimen by culture or DNA detection by multiplex PCR. HIV INFECTION CONFIRMED CASE Laboratory confirmed: The diagnosis of HIV infection is based on laboratory confirmation using one or more of the following: In adults and children over 18 months: Repeatedly reactive screening tests for HIV antibody by an approved testing algorithm (e.g., double enzyme linked assay (ELISA) followed by Western Blot if necessary) in persons aged more than 18 months. Direct identification of virus in host tissues by virus isolation through Culture or Polymerase Chain Reaction: PCR or HIV antigen detection (p24 antigen). In children younger than 18 months: In cases of HIV positive mothers, their children may carry maternal antibodies for up to 18 months. In order to make a definitive diagnosis of HIV infection, viral material needs to be demonstrated by, for instance, a PCR test or p24Ag. Such a test should be done at least twice, at one month and at four months of age. The second PCR test should take place between four and six months of age. In the absence of diagnostic facilities for these tests, HIV infection in infants born to HIV positive mothers is defined as the persistence of HIV antibodies beyond the age of 18 months. Antibody testing in the absence of breastfeeding should be carried out every three to six months until two consecutive negative results or to age 18 months, if infection is ruled out by two consecutive non-reactive antibody tests. In the special case that a non-reactive infant has been exposed to breastmilk of an HIV positive mother, HIV testing of that child should take place three months after breastfeeding is stopped. SYPHILIS Syphilis is a complex sexually transmitted infection with a highly variable clinical course resulting from initial infection with Treponema palidum. Congenital syphilis may result from untreated women becoming pregnant and infecting their offspring. CONFIRMED CASE (PRIMARY SYPHILIS) 193 HIV/STI Surveillance for CAREC Member Countries SYPHILIS, CONTINUED Laboratory confirmed: A case of Genital Ulcer Syndrome (see case definition) with laboratory confirmation: Nontreponemal (VDRL/RPR) and treponemal (MHATP/TPHA or FTA) reactive serology when no history of previous syphilis or treponemal infection OR four-fold increase in titre over the last known non-treponemal (VDRL/RPR) test OR demonstration of Treponema pallidum from a chancre or in aspirated material from a regional lymph node by dark field, fluorescent antibody, or equivalent microscopic methods. SUSPECTED CASE (SECONDARY SYPHILIS) An individual with any of the following: localised or diffused mucocutaneous lesions generalised lymphadenopathy alopecia loss of eyelashes and lateral third of eyebrows, iritis, splenomegaly. CONFIRMED CASE (SECONDARY SYPHILIS) Laboratory confirmed: A confirmed case is a suspected case with laboratory confirmation: Non-treponemal (VDRL/RPR) and (MHATP/TPHA or FTA) reactive serology OR Non-treponemal (VDRL/RPR) serology titre greater than or equal to 1:8 OR demonstration of Treponema pallidum from a chancre or in aspirated material from a regional lymph node by darkfield, fluorescent antibody, or equivalent microscopic methods. CONFIRMED CASE (OTHER SYPHILIS: SEROLOGICAL SYPHILIS) Laboratory confirmed: An individual who does not meet the criteria for primary, secondary or congenital syphilis with the following diagnosis laboratory confirmation: Non-treponemal (VDRL/RPR) and/or treponemal (MHATP/TPHA or FTA) reactive serology with no known previous treatment for syphilis OR four-fold rise in non-treponemal (VDRL/RPR) serology titre. LATENT AND TERTIARY SYPHILIS Their diagnosis is done occasionally through mother-to-child transmission of syphilis and generally through clinical manifestations, such as cardiovascular abnormalities (thoracic 194 HIV/STI Surveillance for CAREC Member Countries SYPHILIS, CONTINUED aortic aneurysm and aortic insufficiency), skin lesions (localised gumma formation) and neurologic manifestations, (general paresis, tabes dorsalis and focal neurologic signs) as well as skeleton, testis and cartilage dysfunction and abnormalities. PROBABLE CASE (CONGENITAL SYPHILIS) An infant (live or still birth) born to a woman with a diagnosis of syphilis who: is untreated OR does not have documentation of treatment OR did not have an expected decrease in serology titre after treatment OR was treated one month or less before delivery OR was treated with non-penicillin therapy OR an infant (live or stillbirth) with clinical evidence of congenital syphilis on physical examination or long bones X-ray OR an infant with a non-treponemal (VDRL/RPR) serology titre which is four-fold greater than the mother’s titre PROBABLE CASE (CONGENITAL SYPHILIS) Laboratory confirmed: A probable case with Laboratory confirmation: Demonstration of Treponema pallidum by darkfield microscopy, fluorescent antibody, or other specific stains from nasal discharges or skin lesions, or in placental, umbilical cord or autopsy material of a neonate. TRICHOMONAS VAGINALIS Although there are more than 100 species of Trichomonas, only three of them affect humans. Trichomonas vaginalis is the species responsible for urogenital tract infection. Trichomonas vaginalis is the most frequent parasitic sexually transmitted infection among women. The infection among men is generally asymptomatic. Infection with Trichomonas may result in genital discharge syndrome. CONFIRMED CASE Laboratory confirmed: The diagnosis is made by direct microscopic observation of motile characteristic parasites. The preparation consists of adding physiological saline solution to a swab of vaginal secretions and analysing under a light microscope (100x). Other methods of identification exist, such as culture (Diamond’s modified medium); antigen detection (Direct Enzyme Immunoassay and Fluorescent Direct Immunoassay); and the DNA detection by PCR. These expensive methods should be used only in aetiologic surveys to determine pathogens circulating and to adapt national STI treatment algorithms. 195 HIV/STI Surveillance for CAREC Member Countries Unit 7 Confidentiality and Data Security Overview What this unit is about Persons with HIV infection and persons and groups at increased risk for HIV are vulnerable to a number of social, legal and physical harms. Because of this, surveillance and special studies need to address a unique set of ethical issues. This unit discusses those issues and facilitates a more uniform approach to common ethical issues relating to HIV surveillance. Warm-up questions 1. True or false? Because of the urgent need to treat and prevent HIV infection, issues such as confidentiality and informed consent do not need to be addressed. True False 2. The principle of ‘beneficence’ refers to minimising risk to individuals in the areas of: a. physical risk b. psychological harm c. stigmatisation d. all of the above 3. True or false? Providing large monetary or in-kind incentives is an ethical way to ensure that more participants agree to give informed consent. True False 4. True or false? In low-level epidemics, information about HIV infection in high-risk or marginalised groups should be widely publicised to prevent further spread of the disease. True False 5. The process by which potential threats to confidentiality are discussed with subjects before they decide to participate is known as ___________________. 196 HIV/STI Surveillance for CAREC Member Countries Warm-up questions, continued 6. List three potential risks to participants in a behavioural surveillance study. a. b. c. 7. True or false? Surveillance is an academic exercise. Investigators should not become involved as advocates in the communities in which they work. True False 8. List two types of programmes or services that can be developed as a result of surveillance activities. a. b. 9. If _______________ about HIV infection is violated, subjects may suffer discrimination and stigmatisation. They may even be subject to criminal charges. a. b. c. d. privacy informed consent confidentiality beneficence 10. True or false? In unlinked anonymous testing, informed consent is not obtained. Some information identifying the sample with the patient remains. True False 197 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this unit you should be able to: discuss the ethical principles of respect for persons, beneficence, and justice in the context of HIV surveillance of high-risk populations identify potential harms caused by HIV and behavioural surveillance identify potential benefits resulting from HIV and behavioural surveillance describe issues of confidentiality and how they relate to HIV surveillance. Addressing Ethical Issues What are the issues? People and groups with increased risk for HIV infection are vulnerable to a number of social, legal and physical harms. Because of this vulnerability and the stigma (mark of disgrace or shame) attached to the disease, surveillance and special studies need to address a unique set of ethical issues. These include: elevated risk of harm for people in high-risk populations, especially if their behaviour is illegal or stigmatised confidentiality (protecting personal information of a study participant) informed consent (the permission granted by a participant after she has been informed about the details of the study) access to prevention and care services. Three ethical principles Ethical issues don’t always have clear right or wrong answers, but three universally accepted ethical principles exist. 1. Respect for persons requires public health officers and biomedical research investigators to see study subjects not just as passive sources of data, but as persons whose rights and welfare must be protected. 2. Beneficence refers to balancing the benefits and risks to individuals. This includes not only physical risk, but also risk of psychological harm and stigmatisation. 3. Justice means that risks and benefits from studies should be distributed fairly and evenly in populations. These ethical principles should be applied within the context of public health surveillance for HIV. 198 HIV/STI Surveillance for CAREC Member Countries Confidentiality and data security HIV surveillance is the joint responsibility of many participants in the healthcare system. Among the participants are national and sub-national surveillance programmes; public and private institutions providing clinical, counselling, and laboratory services; individual healthcare providers; persons at risk for HIV infection; and persons with HIV infection. The ability of surveillance programmes to collect, store, use and transmit sensitive HIV case information in a secure and confidential manner is central to the programme's acceptability and success. The dynamic nature of information technology is a critical consideration in developing security policies and procedures that will be used to meet the requirements and standards described in these guidelines. The HIV surveillance system was created before the development of technologies such as laptops, portable external storage devices and the internet, all of which can be potential sources for security breaches. Now, all Ministries of Health should routinely assess the changing world of computer technology and adjust security policies and procedures to protect against potential new risks. Unique Identifiers—Names versus Codes: Balancing Risks and Benefits Ethical considerations In many regions and countries, especially those with low-level and concentrated (the epidemic state in which HIV has spread to a high level in a defined sup-population, but is not well-established in the general population) epidemics, the central surveillance activity is reporting cases of HIV infection or persons diagnosed with AIDS. Nations may consider implementing or modifying their surveillance HIV reporting systems. To do so, they must decide whether or not such systems should employ names, unique identifiers or anonymous codes. The UNAIDS guidelines for public health and HIV surveillance ask you to consider the following questions: Who will be required to report? What clinical information and personal identifiers will they report? To whom will they report? How will the proposed system contribute to a more accurate characterisation of the HIV/AIDS epidemic? 199 HIV/STI Surveillance for CAREC Member Countries Ethical considerations, continued What is known about the completeness of reporting for other notifiable conditions, including those that bear some stigma? How can such experience be used to anticipate the willingness to cooperate on the part of those who will be required to report? Given the limits of all reporting systems (such as error rates and failures to report), how will data derived from the proposed reporting system be merged with those derived from other sources, such as blinded sero-prevalence studies, to provide the most accurate epidemiological picture that is achievable given the available resources? Fear of stigmatisation Infected persons in the general population and high-risk groups have a legitimate fear of the reaction of the larger society based on past reactions. These groups may include: sex workers injection drug users prisoners mobile populations men who have sex with men. If people fear information about their behaviour or their HIV status will be used against them, they will either try to confuse investigators or refuse to participate in monitoring studies. Successful surveillance in marginalised populations depends on minimising participation bias by assuring: informed consent absolute confidentiality thoughtful plans about how data generated will be used and disseminated. Discussion What are three ways someone might be harmed if their HIV-positive status becomes known? a. b. c. 200 HIV/STI Surveillance for CAREC Member Countries Low-level and concentrated epidemic considerations One of the greatest challenges for surveillance in low-level and concentrated epidemics is gaining access to high-risk groups to track behaviour and infection. High-risk group members are very often marginalised. Sometimes their behaviour is illegal. An effective surveillance system requires that populations with elevated incidence or prevalence of HIV be identified, then be accessible for: regular monitoring of behaviour risk markers HIV infection. In high-risk populations, many successful surveillance efforts focus on clinics and educational programmes designed to meet the needs of the people most vulnerable to HIV and its impact. These clinics provide services to the high-risk population. In doing so, they provide a sentinel site where sero-surveillance can be conducted. Where sentinel sites do not exist, community members may advise and participate in designing and carrying out cross-sectional biological and behavioural surveys. Such efforts have been invaluable to successful surveillance in the past. In low-level epidemics, give careful consideration to whether or not to publicise information about HIV infection and related behaviour of marginalised groups to a wider audience. Experience has shown that in the early stages of the epidemic, the general public’s reaction to information about HIV infection in high-risk behaviour populations may be to call for restrictive and prohibitive measures. Such measures simply drive risk behaviour further underground, making prevention and care programmes more difficult, which encourages the spread of the virus. 201 HIV/STI Surveillance for CAREC Member Countries Low-level and concentrated epidemic considerations, continued Table 6.1 describes some of the potential harms caused by HIV surveillance. Table 6.1. Potential harms caused by HIV surveillance. Type of Harm Result public attack spousal/partner abuse Physical domestic violence Legal Social arrest prosecution (especially with highrisk populations) disclosure to family workplace discrimination loss of employment isolation loss of healthcare services Discussing the table Examine Table 6.1 and answer the following questions: a. What are two types of social harm that HIV surveillance may accidentally cause? b. Arrest is classified as which type of harm? Generalised epidemic considerations In surveillance of generalised epidemics, there is less focus on highestrisk populations, such as sex workers. In countries where monitoring is done primarily through anonymous unlinked sero-surveillance activities, risks to individuals are typically low. Given the stigmatised nature of HIV infection in many countries, risk of social discrimination and violence are quite real. Case reporting or surveys and programmatic activities, such as voluntary counselling and testing, may diagnose individuals with HIV infection and give them their results. Individuals may disclose these results themselves or be identified during programme activities. This may put them at risk for social harm and violence from spouses, sexual partners or others. Surveillance activities must protect data that individually identifies infected patients. Great care must be taken to protect those data from public release. 202 HIV/STI Surveillance for CAREC Member Countries Generalised epidemic considerations, continued More subtle is the risk of labelling certain sub-groups within the general population, such as members of a particular racial or ethnic group who have increased rates of HIV infection. This can lead to discrimination, stigmatisation and other forms of harm. Take care to avoid inadvertently stigmatising groups or sub-regions. Benefits Participating in surveillance holds benefits to society as a whole, especially to highly impacted populations and HIV-infected individuals. Surveillance is not an academic exercise. It is intended to be used as part of a comprehensive programme to prevent and treat HIV. Participating investigators often become advocates for additional prevention and treatment services for the communities they are surveying. Discussion What are three benefits of HIV and behavioural surveillance for your country? a. b. c. Potential benefits of HIV surveillance HIV surveillance has numerous potential benefits to a community, including: guiding HIV prevention and care programmes guiding STI and other services raising public awareness of and sympathy for burden of disease in the population reducing stigma and effecting social change, especially around HIV infection special situations for certain high-risk populations, such as STI clinics specifically for sex workers or men who have sex with men HIV treatment services for prisoners. 203 HIV/STI Surveillance for CAREC Member Countries Confidentiality Why it is important Confidentiality protects subjects from adverse consequences that may arise if their personal information is known, such as their: HIV positive status sexual preference. If confidentiality about HIV infection is violated, subjects may suffer discrimination, stigma or arrest. Public health officers must maintain the confidentiality of each individual’s records to guard against inadvertent disclosure. Laws and confidentiality Much of HIV surveillance entails special studies. In some countries, laws may exist that protect individually identified research results from discovery during legal proceedings. This is done to encourage participation in high-risk behaviour research. Be aware of the particular provisions in the laws of your country that may: complicate participation by certain individuals; for example, the age of legal adulthood may affect results from female sex workers under a certain age require reporting of individuals with HIV infection minimise risk to participants, such as those that protect study results from discovery. Discuss potential threats to confidentiality with participants, as well as measures that you will take to minimise them. This is part of the informed consent process. Guidelines for Confidentiality and Data Security The following guidelines on confidentiality and data security have been adapted from The CDC HIV Surveillance Programme Technical Guidance for HIV/AIDS Surveillance Programmes, Volume III: Security and Confidentiality Guidelines, 2006. 204 HIV/STI Surveillance for CAREC Member Countries Guiding Principles The five guiding principles listed below are the backbone upon which all programme requirements and security considerations have been built. Guiding Principle 1 HIV surveillance information and data will be maintained in a physically secure environment. Refer to sections related to ‘Physical Security’ and ‘Removable and External Storage Devices.’ Guiding Principle 2 Electronic HIV surveillance data will be held in a technically secure environment, with the number of data repositories and individuals permitted access kept to a minimum. Operational security procedures will be implemented and documented to minimise the number of staff who have access to personal identifiers and to minimise the number of locations where personal identifiers are stored. Refer to sections ‘Policies,’ ‘Training,’ ‘Data Security,’ ‘Access Control,’ ‘Laptops and Portable Devices,’ and ‘Removable and External Storage Devices.’ Guiding Principle 3 Individual surveillance staff members and persons authorised to access case-specific information will be responsible for protecting confidential HIV surveillance information and data. Refer to sections ‘Responsibilities,’ ‘Training,’ and ‘Removable and External Storage Devices.’ Guiding Principle 4 Security breaches of HIV surveillance information or data will be investigated thoroughly, and sanctions imposed as appropriate. Refer to the section on ‘Security Breaches.’ Guiding Principle 5 Security practises and written policies will be continuously reviewed, assessed, and as necessary, changed to improve the protection of confidential HIV surveillance information and data. Refer to the sections on ‘Policies’ and ‘Security and Confidentiality Programme Requirement Checklist.’ 205 HIV/STI Surveillance for CAREC Member Countries Policies Requirement 1 Policies must be in writing. Requirement 1 relates to Guiding Principle 2 (GP-2). Requirement 2 A policy must name the individual who is the Overall Responsible Party (ORP) for the security system. (GP-2) The rationale is to increase accountability and help ensure that the individual knows his/her responsibilities as ORP. Requirement 3 A policy must describe methods for the review of security practises for HIV surveillance data. Included in the policy should be a requirement for an ongoing review of evolving technology to ensure that data remain secure. (GP-5) Requirement 4 Access to and uses of surveillance information or data must be defined in a data release policy. (GP-2) Requirement 5 A policy must incorporate provisions to protect against public access to raw data or data tables that include small denominator populations that could be indirectly identifying. (GP-2) Data release policies outline the types of data that can be released and who is authorised to receive the data. For example, when matching HIV cases to cases in other data stores (e.g., TB, STI, or vital statistics), the policy should specify what the purpose is, how this is done, who performs the matching, what results are released, how the results should be stored, and who receives the results. This policy establishes the rules to be implemented to ensure that information is allowed to flow within the information system and across system boundaries only as authorised. Data release, by definition, suggests that information about an HIV-infected individual is available for distribution. A data release policy has to balance the inherent purpose of HIV surveillance data with the confidentiality of any HIV-infected individual reported for surveillance purposes. Therefore, any HIV surveillance data release policy must be written with two questions in mind. First, which data elements can be released about any case patient that would not identify the individual if pieced together? Second, what purposes are consistent with the reasons for which the data were originally collected? 206 HIV/STI Surveillance for CAREC Member Countries Requirement 5, continued With regard to the first question, certain information containing patientidentifying data elements (including elements such as the patient's name, address, and social security number) may never be released for public distribution. Care must also be taken to ensure that information released cannot be linked with other databases containing additional information that can be used to identify someone. However, in developing a data release policy, state and local HIV surveillance programmes should be aware that several data elements that are not inherently identifying could be linked together to identify an individual. For example, when releasing data on a community with relatively few members of a racial/ethnic group (e.g., Carib Indians), a risk factor group (e.g., persons with haemophilia), or an age group (e.g., >50 years old or specifying the date of birth or death), surveillance staff should be careful that release of aggregate data on the distribution of HIV-infected individuals by these categories could not suggest the identity of an individual. Time periods also need to be considered when developing a data release policy. Output from cases reported cumulatively (since 1981) better hides any individual's identity than output from cases reported within the past 12 months. Therefore, care should be taken in deciding how both the numerator and the denominator are defined when developing a data release policy. Care should also be taken in graphic presentation of data. For example, geographic information systems (GIS) allow for relatively accurate dot mapping of observations. Care must be taken that graphic (like numeric) presentation of data cannot permit the identification of any individual by noting pinpoint observations of HIV cases at, for example, the county, district, parish or enumeration district level. Other considerations in developing data release policies include the need for national surveillance programmes to ensure that their data release policies are consistent with national confidentiality laws, and to include clear definitions of terms used in the data release policy (e.g., personal identifier, population size, and time period). For a complete discussion of this issue, refer to Unit 8, Analysis, Interpretation, and Dissemination of HIV Surveillance Data. The second issue that should guide the development of a data release policy is to consider the purpose for which the data were originally collected. No HIV surveillance information that could be used to identify an individual should be available to anyone for non-public-health purposes. Examples include the release of individual-level data to the public; to parties involved in civil, criminal, or administrative litigation; for commercial purposes; or to non-public health agencies of the national government. 207 HIV/STI Surveillance for CAREC Member Countries Requirement 5, continued Surveillance data are collected to monitor trends in the epidemic on a population-based level. However, some national surveillance programmes may choose to share individual case reports with prevention and care programmes to initiate referrals to services. Additionally, some surveillance programmes use surveillance data to initiate follow up for supplemental public health research. Programmes that choose to establish these linkages should do so without compromising the quality or security of the surveillance system and should establish principles and procedures for such practises in collaboration with providers and community partners. Programmes that receive surveillance information should be subject to the same penalties for unauthorised disclosure and must maintain the data in a secure and confidential manner consistent with these guidelines. Additionally, activities deemed to be research should get appropriate human subjects approvals consistent with the country’s Ministry of Health procedures. A discussion on using HIV surveillance data to initiate referrals to prevention or treatment services is available in the document Integrating HIV and AIDS Surveillance: A Resource Manual for Surveillance Co-ordinators - Toolkit 5, Using HIV Surveillance Data to Document Need and Initiate Referrals, found in Attachment G. Attachment G can be found as an annex to this unit (see Annex 7.4). Several other CDC resources and guidance documents are available online to inform local discussions, including HIV Partner Counseling and Referral Services: Guidance, HIV Prevention Case Management: Guidance, resources on evaluation of HIV prevention programmes, and more at: http://www.cdc.gov/hiv/pubs/guidelines.htm. Requirement 6 Policies must be readily accessible by any staff having access to confidential surveillance information or data at the central level and, if applicable, at non-central sites. (GP-2) As security questions arise in the course of surveillance activities, staff must have ready access to the written policies. In most circumstances, having a copy of the written policies located within the surveillance unit would satisfy this requirement. Computer access to an electronic version of the policies also may be acceptable. The key is for staff to have quick access to policies as security and confidentiality questions arise. Requirement 7 A policy must define the roles for all persons who are authorised to access specific information and, for those staff outside the surveillance unit, what standard procedures or methods will be used when access is determined to be necessary. (GP-2) 208 HIV/STI Surveillance for CAREC Member Countries Requirement 8 All authorised staff must annually sign a confidentiality statement. Newly hired staff must sign a confidentiality statement before access to surveillance data is authorised. The new employee or newly authorised staff must show the signed confidentiality statement to the grantor of passwords and keys before passwords and keys are assigned. This statement must indicate that the employee understands and agrees that surveillance information or data will not be released to any individual not granted access by the ORP. The original statement must be held in the employee's personnel file and a copy given to the employee. (GP-2) The policy should establish rules to ensure that only designated individuals, under specified conditions, can: access the information system (network logon, establish connection) activate specific system commands (execute specific programmes and procedures; create, view, or modify specific objects, programmes, information system parameters). The policy should include provisions for periodic review of access authorisations. The policy could limit access to sensitive data to specified hours and days of the week. It should also state types of access needed, which could be linked to roles defined for those with access. For example, epidemiologists may have access to data across programmes that do not include identifiers. Additionally, the policy should cover restrictions on access to the public internet or email applications while accessing surveillance information. Accidental transmission of data through either of these systems can be avoided if they are never accessed simultaneously. Similarly, intruders can be stymied in attempts to access information if it is not available while that connection is open. The policy should establish rules that ensure that group authenticators (administrators, super users, etc.) are used for information system access only when explicitly authorised and in conjunction with other authenticators as appropriate. The policy should express similar rules for individual users to ensure that access to identifiable data is allowed only when explicitly authorised and in conjunction with other authenticators as appropriate. The policy should document the process for assigning authorisation and identify those with approval authority. Information technology (IT) authorities granting access must obtain approval from the ORP or designee before adding users, and they should maintain logs documenting authorised users. The ORP or a designee should periodically review user logs. 209 HIV/STI Surveillance for CAREC Member Countries Requirement 9 A policy must outline procedures for handling incoming mail to and outgoing mail from the surveillance unit. The amount and sensitivity of information contained in any one piece of mail must be kept to a minimum. (GP-2) The local mailing system and private carrier services are commonly used for the movement of paper copies of information. There are many ways that project areas can protect the confidentiality of an HIV-infected individual when using the mail. For example, when surveillance staff and providers are mailing information (e.g., case report forms) to the central office, the policy could require that names and corresponding patient numbers be sent in one envelope, while the remaining information referenced by the corresponding patient number is sent in another envelope. In addition, the terms 'HIV' or 'AIDS' should not necessarily be included in either the mailing address or the return address. Mailing labels or pre-addressed, stamped envelopes may be supplied to field staff and providers to encourage this practise and to ensure the use of the correct mailing address. Whenever confidential information is mailed, double envelopes should be used, with the inside envelope clearly marked as confidential. Because of the potential number of entries on a given paper copy line list, programmes must exercise extreme caution if they find it necessary to mail a paper list. Procedures for mailing lists, including the amount and type of information permitted in any one mailing, must be clearly outlined in the local policy. Two methods that surveillance programmes currently employ to minimise risk when using the mail are: to generate lists containing names without references to HIV or AIDS to remove the names from the list and mail them separately from the other sensitive information. 210 HIV/STI Surveillance for CAREC Member Countries Responsibilities Requirement 10 The ORP must certify annually that all programme requirements are met. (GP-2) Requirement 11 Each member of the surveillance staff and all persons described in this document who are authorised to access case-specific information must be knowledgeable about the organisation's information security policies and procedures. (GP-3) Requirement 12 All staff who are authorised to access surveillance data must be responsible for challenging those who are not authorised to access surveillance data. (GP-3) Many programmes consider the area of personal responsibility as a potential area of concern because the actions of individuals within a surveillance system are much more difficult to prescribe than operational practises. This area represents one of the most important aspects of holding data in a secure and confidential fashion, but the development of objective criteria for assessing the degree of personal responsibility in individual staff members may be difficult. The programme requirements in this area may be evaluated objectively by using a series of questions supervisors pose during the annual review of security measures with staff. Input from staff can be obtained through such questions as: How often do you find the need to reference security policies or standards? Do you know who (by job position or name) should have access to the secure surveillance area? How would you approach someone who was entering the secured room if you believed that he or she was not authorised access? Have you had any occasion to challenge such a person? To whom should security irregularities be reported? What are some examples that would constitute an irregularity? What irregularities would not need to be reported, if any? Who else needs access to your computer for any reason? For example, do family members or other staff members ever need to use your workstation? Do you ever need to lend your key to a secured area to another member of the health department staff for after-hours access to the building? Who else knows your computer passwords? 211 HIV/STI Surveillance for CAREC Member Countries Requirement 13 All staff who are authorised to access surveillance data must be individually responsible for protecting their own workstations, laptops or other devices associated with confidential surveillance information or data. This responsibility includes protecting keys, passwords and codes that would allow access to confidential information or data. Staff must take care not to infect surveillance software with computer viruses and not to damage hardware through exposure to extreme heat or cold. (GP-3) Surveillance staff should avoid situations that might allow unauthorised persons to overhear or see confidential surveillance information. For example, staff should never discuss confidential surveillance information in the presence of persons who are not authorised to access the data. Staff working with personal identifiers should have a workspace that does not allow phone conversations to be overheard or paperwork and computer monitors to be observed by unauthorised personnel. Ideally, only staff with similar roles and authorisations would be permitted in a secure, restricted area. Training Requirement 14 Every individual with access to surveillance data must attend security training annually. The date of training must be documented in the employee's personnel file. IT staff and contractors who require access to data must undergo the same training as surveillance staff and sign the same agreements. This requirement applies to any staff with access to servers, workstations, backup devices, etc. (GP-3) Security training is required for all new staff and must be repeated annually thereafter, but the nature of this training may vary based on country circumstances. For example, in areas of low HIV prevalence where one surveillance person is on staff, if that person leaves before training a replacement, the policy should indicate that training for data security and confidentiality may be obtained in a neighbouring country with a similar system. In other areas, new staff may be trained by the surveillance co-ordinator one-on-one. In this instance, the policy should document what types of information must be covered in such a session, and provisions should be made to document that training was completed. In areas of high HIV prevalence with larger numbers of staff, periodic group training sessions may be more appropriate. 212 HIV/STI Surveillance for CAREC Member Countries Physical Security Requirement 15 All physical locations containing electronic or paper copies of surveillance data must be enclosed inside a locked, secured area with limited access. Workspace for individuals with access to surveillance information must also be within a secure locked area. (GP-1) Requirement 16 Paper copies of surveillance information containing identifying information must be housed inside locked file cabinets that are inside locked rooms. (GP-1) Requirement 17 Each member of the surveillance staff must shred documents containing confidential information before disposing of them. (GP-3) Maximum security practise dictates that HIV surveillance data be maintained on a dedicated file server at only one site in each project area where layers of security protections can be provided in a cost-effective manner. This would obviate the need to duplicate expensive security measures at multiple locations throughout the country. Remote sites that need access to the central surveillance server for surveillance activities could access the server through a secured method (e.g., virtual private network [VPN], or authentication server) set up for authorised users. Some countries may decide to maintain the reporting system in more than one site. If this is the case, every additional reporting system site in the country must meet the same minimum security measures outlined in all of the programme requirements. Because the surveillance system can potentially identify any number of persons with HIV infection within a country (or local jurisdiction if surveillance is decentralised), particular attention to the security of surveillance information is critical. The minimum security standard should be to enclose the surveillance information inside a locked room, regardless of the method used. Whether the reporting system resides on a server or workstation, the computer containing the electronic surveillance data must be enclosed inside a locked room. Only authorised surveillance personnel should have access to the locked room. However, depending on the numbers of HIV cases reported, the size and role of the surveillance staff, community interest, and department resources, the ORP may decide that other authorised health department staff need to work inside the surveillance room. 213 HIV/STI Surveillance for CAREC Member Countries Requirement 17, continued If the surveillance data reside on a server inside a locked room and not on the hard drive of any individual workstation within the department, the individual workstation (when logged off the network) does not pose a great security risk and would not necessarily have to be located behind a locked door to meet the minimum standard. LAN accounts with access to identifying information in the reporting system should be limited only to the workstations of those authorised. LAN accounts also should be limited by time of day. (See Requirement 7.) The use of cubicles in many office buildings can also present a challenge to creation of a secure area. Cubicles with low walls make it difficult, even within a secure area, to have a telephone conversation without others hearing parts of the conversation. Where necessary, higher cubicle walls with additional soundproofing can be used. When cubicles are part of the office structure, cubicles where sensitive information is viewed, discussed or is otherwise present should be separated from cubicles where staff without access to this information are located. When electronic surveillance data with personal identifiers are stored outside of a physically secure area (i.e., a locked room with limited access), or if limited local resources require that surveillance data with personal identifiers stored on a LAN be accessible to non-surveillance staff, real-time encryption software must be employed. The additional encryption software is designed to keep identifying information encrypted. Should an unauthorised individual gain access to the surveillance database, unencrypted identifying information cannot be viewed. Encryption requirements would also apply to backup storage media, which are frequently located off-site and could be managed by an outside vendor. Paper copy data stores must be maintained in locked cabinets and inside locked rooms. If a programme chooses to stop maintaining paper copies in locked file cabinets inside locked rooms (e.g., because of age or volume), the programme should destroy the completed forms after ensuring the data are entered into the reporting system and after they are no longer needed for follow-up. Before destroying the forms, a site may opt to digitally scan forms for future reference. Digitised forms should be secured the same as any other surveillance data. 214 HIV/STI Surveillance for CAREC Member Countries Requirement 17, continued Requirement 15 does not apply to sub-sets of case report forms, such as those that a surveillance staff member may hold in the course of an investigation, but does apply to paper copy line lists or logbooks that list a large number of reported cases by name in any one jurisdiction. Even if appropriate space is available to properly store all surveillance forms, programme staff should consider developing a records retention policy that would describe the record retention and the scheduling of records for destruction after a designated period. Older records offer only limited value, but continue to pose a security risk. Sites should carefully weigh the benefits and risks of retaining any paper copies of case report forms. Such a decision should be predicated on adherence to these security standards, national regulations, and local practise. Once a decision has been made to destroy a case report form, line list, notes or any other related paper surveillance document, the document must be destroyed in accordance with Requirement 17. Requirement 18 Rooms containing surveillance data must not be easily accessible by window. (GP-1) Window access, for the purposes of this document, is defined as having a window that could allow easy entry into a room containing surveillance data. This does not mean that the room cannot have windows; rather, windows need to be secure. If windows cannot be made secure, surveillance data must be moved to a secure location to meet this requirement. A window with access, for example, may be one that opens and is on the first floor. To secure such a window, a permanent seal or a security alarm may be installed on the window itself. Even if the window does not open, programme managers may decide to include extra precautions if, for example, the building does not have security patrols or if the building or neighbouring buildings have had breaches. If a project area has a concern about a current or planned physical location, staff can request advice from CAREC. 215 HIV/STI Surveillance for CAREC Member Countries Data Security For the purposes of this document, a remote site is defined as a site that remotely connects to and accesses a centralised electronic database to enter and store surveillance data even though paper forms may be stored locally. The central database is located in a different physical location than the remote site. A satellite location is defined as a site that collects and electronically enters surveillance data in a local database and then sends the electronic data file to a central location. If remote and satellite sites maintain case report forms or other surveillance information with personal identifiers, the central location should not be maintaining duplicate copies of the case report forms. Surveillance staff should discourage providers from maintaining duplicate copies of HIV case reports after they have been reported to the health department. The national HIV case database should be housed in only one location (excluding electronic backups and replication for disaster recovery); however, for countries with multiple database locations, the number of satellite locations should be kept to a minimum, thereby keeping the data collection and storage as centralised as possible. If the system is decentralised, each remote and satellite site should maintain only cases within that site's jurisdiction, and must meet the same physical security requirements discussed in the section on ‘Physical Security.’ If, after discussing a records retention schedule, programme staff decide to retain the hard copy case report form even after the record is entered into the reporting system, they should consider removing or striking out the name on the report before storage. The patient number or code would still provide linkage, when necessary, to the name in the reporting system, but record security would be improved. This practise would decrease: the number of places where names are stored the amount of time they are held the number of persons who may have access to them in the future. Security software that controls the storage, removal, and use of data maintained in the reporting system should be in place at all locations where the electronic surveillance data are maintained. Security software may include such protections as user identifications, passwords, boot protection, encryption algorithms, and digital signatures. Additionally, an area may maintain names outside of the reporting system and use a state ID number to link name and surveillance information when needed. 216 HIV/STI Surveillance for CAREC Member Countries Data Movement Requirement 19 Surveillance information must have personal identifiers removed (an analysis dataset) if taken out of the secured area or accessed from an unsecured area. (GP-1) Requirement 20 An analysis dataset must be held securely using protective software (i.e., software that controls the storage, removal and use of the data). (GP-1) Requirement 21 Data transfers and methods for data collection must be approved by the ORP and incorporate the use of access controls. Confidential surveillance data or information must be encrypted before electronic transfer. Ancillary databases or other electronic files used by surveillance also need to be encrypted when not in use. (GP-1) Electronic files stored for use by authorised surveillance staff should be encrypted until they are actually needed. If these files are needed outside of the secure area, real-time encryption or an equivalent method of protection is required. This requirement also applies in those situations where surveillance data are obtained electronically from external sources (clinical data management systems and laboratories) or as part of a separate collection system. Extracts from those systems need to be protected as if they were extracts from the surveillance data system. Additionally, those systems within other health facilities need to be held to the same standards as the HIV surveillance systems. External agencies are to be encouraged to review their procedures, and approved data transfer methods need to be used. Requirement 22 When case-specific information is electronically transmitted, any transmission that does not incorporate the use of an encryption package meeting national standards and approved by the ORP must not contain identifying information or use terms easily associated with HIV/AIDS. The terms HIV or AIDS, or specific behavioural information, must not appear anywhere in the context of the communication, including the sender and/or recipient address and label. (GP-2) The intent of this requirement is to eliminate the possibility that a third party may identify a person as being HIV-infected or a member of an HIV risk group. When trying to locate an HIV-infected person during an investigation or interview, do not send letters or leave business cards or voice messages at the person's residence if they include any terminology that could be associated with HIV, AIDS or the health department. 217 HIV/STI Surveillance for CAREC Member Countries Requirement 22, continued These precautions need to be taken in case a family member or friend discovers the letter or card or hears the voice message. Similarly, if a third party calls the telephone number listed on a card or letter, that party should not be able to determine by a phone greeting that it is an HIV surveillance unit (or the health department); nor should a third party be able to obtain that information by pretending to be the case patient. This may require the use of some confirmation mechanism to assure that the person calling is really the case patient and not someone pretending to be that person in order to discover confidential information. If secure fax or encrypted e-mail transmissions are used at all (a practise that is strongly discouraged), care must be taken to avoid linking HIV or risk factor status with identifiable information about a person. This may include ensuring that the terms HIV or AIDS do not appear in the fine print at the very top of a fax, indicating who sent it, and that these terms do not appear in more obvious locations in the letterhead and body of the fax. Other important steps include thinking about who else besides the intended recipient may have access to faxes on the receiving end, and the possibility of misdialling the fax number or using the incorrect e-mail address. Requirement 23 When identifying information is taken from secured areas and included on line lists or supporting notes in either electronic or hard copy format, these documents must contain only the minimum amount of information necessary for completing a given task and, where possible, must be coded to disguise any information that could easily be associated with HIV or AIDS. (GP-1) One purpose of this requirement is to make it difficult to link an individual's name on a line list with HIV/AIDS, should that line list fall into the hands of an unauthorised person. Terms that could be associated with HIV/AIDS include CD4 count or opportunistic infection (OI). Programmes should consider using less recognisable terms, codes, or abbreviations, such as T-lymphocyte count or OI. In some circumstances, just the word "count" may suffice. While risk factor information (e.g., injection drug use or sexual orientation) may not necessarily be associated with HIV/AIDS, it is, nevertheless, highly sensitive. Wherever possible, risk factor categories must be coded to help minimise the possibility of a breach. If a coding scheme for transmission category is already built into the reporting system, the codes should be used when there is a need to generate line lists with risk factor categories. When surveillance staff write notes, they should make it a habit to use these risk factor codes. For example, instead of using the phrase ‘injection drug user’ or the readily decipherable abbreviation IDU, a code could be substituted. 218 HIV/STI Surveillance for CAREC Member Countries Requirement 23, continued This requirement applies to information or data taken from secure areas. It does not refer to data collected from the field and taken to secure areas. While coding of terms associated with HIV/AIDS in the field is encouraged, there may be occasions when it cannot be done; for example, when uncoded terminology must be abstracted from a medical chart during the course of an investigation. Requirement 24 Surveillance information with personal identifiers must not be taken to private residences unless specific documented permission is received from the surveillance co-ordinator. (GP-1) Under exceptional circumstances, HIV surveillance information with personal identifiers may be taken to private residences without approval if an unforeseen situation arises that would make returning to the surveillance office impossible or unsafe. For example, if a worker carrying sensitive information were caught in a sudden heavy snowstorm, driving home instead of returning to the office would be permissible, provided the worker's supervisor is notified (or an attempt was made to notify the supervisor) of the need to return home with the sensitive information. Precautions should be taken at the worker's home to protect the information under such circumstances. All completed or partially completed paper case report forms should be transported in a locked satchel or briefcase. Managing field time effectively can be accomplished by using a variety of creative tactics. Field visits should be scheduled in the most efficient way possible. One option is to assign provider sites to workers by geographic area. For example, all providers in the east sector could be covered by the same worker to minimise travel time between sites. Another option might be to schedule visits so that sites located far from the office receive visits early in the day, with staff working their way back to the office by the end of the day. A flex-time schedule is another option that a site may wish to consider. If returning to the secured area creates significant inefficiencies in case surveillance investigations, alternative methods of securing sensitive surveillance information could be considered when developing the policy that satisfies this requirement. 219 HIV/STI Surveillance for CAREC Member Countries Requirement 24, continued Investigators could incorporate the use of pre-addressed, stamped envelopes and drop completed case report forms in the mail before returning home for the day. Tampering with the mail is a criminal offence, and case reports are considered better protected in the mail than at a private residence. This possibility should be accounted for when developing the mail policy discussed in Requirement 9. Some areas do not complete case report forms on-site, but take notes using shorthand that is not easily translated and does not contain HIV-related terms. Notes such as these could be stored in less secure areas because someone seeing the notes would not understand their meaning. When this method is used, blank case report forms or other HIV-related materials should not be stored at the same location as the notes. Staff using this technique may carry the notes around discreetly (e.g., in a purse or notebook) and then complete official forms when they return to the surveillance office. Other methods to disguise the data, de-identify it, or separate sensitive variables from it could be used to eliminate the need to return to the office at the close of business (i.e., if personal identifiers are removed using approved methods, the information is less sensitive and may be secured off-site). Whatever methods are used, the approved method must be described in the local security policy. Requirement 25 Prior approval must be obtained from the surveillance co-ordinator when planned business travel precludes the return of surveillance information with personal identifiers to the secured area by the close of business on the same day. (GP-1) Policies and procedures for gaining prior approval for not returning surveillance information with personal identifiers to the secured area at the close of each business day should be implemented. Refer to the discussion following Requirement 24 for additional considerations. Transferring data between sites In some instances, it may be necessary to transfer data between sites, e.g., between parish/district health departments. The sending and receiving sites must agree on the product that will be used for that purpose and identify the method of transfer. Transport by a designated officer should be done in such a manner as to minimise the risk of the information getting into unofficial hands, i.e., by direct non-stop transfer with handover to the designated person. There should be written records of the transfer and receipt of the documents. See Requirement 23 for electronic transfer of information and Requirement 9 for mailing of sensitive documents. 220 HIV/STI Surveillance for CAREC Member Countries Access Control Local Access Requirement 26 Access to any surveillance information containing names for research purposes (that is, for other than routine surveillance purposes) must be contingent on all of the following conditions being met: a demonstrated need for the names documentation of approval by the Institutional Review Board (IRB) of the country’s Ministry of Health (or designate) signing of a confidentiality statement regarding rules of access and final disposition of the information. Access to surveillance data or information without names for research purposes beyond routine surveillance may still require IRB approval depending on the numbers and types of variables requested in accordance with local data release policies. (GP-1) Most analyses of HIV surveillance data do not require IRB approval; in fact, most such analyses do not require the inclusion of identifying information in the data sets. Occasionally, investigators from other health department units or academia want to conduct supplemental studies using reported case patients as their study population. Additionally, clinic-based researchers may want to obtain additional information on their patients. 221 HIV/STI Surveillance for CAREC Member Countries Requirement 26, continued In these cases, the researcher should submit a request for the data set to the HIV surveillance co-ordinator. The surveillance co-ordinator should then refer to the local data release policy to determine if any of these types of data sets can be released. Data containing patients' names are not normally released for research purposes; furthermore, the data release policy should anticipate that even data not containing names could be used to breach an individual's confidentiality if data sets are created or can be created that could indirectly identify any individual (e.g., a data set of all Asian haemophiliacs with HIV infection in a county with a low Asian population and low morbidity). Under certain circumstances and in accordance with local data release policies, the surveillance co-ordinator should refer the researcher to the Chair of the IRB. If the Chair determines that an IRB should be convened, both the researcher and surveillance co-ordinator must abide by the ruling. The IRB may approve the release of an analysis data set. Before a researcher obtains access to a data set, the surveillance co-ordinator must obtain a signed statement from the researcher certifying that he or she will comply with standards outlined in the local security policy. Signing this statement should indicate that the researcher: understands the penalties for unauthorised disclosure assures that the data will be stored in a secured area agrees to sanitise or destroy any diskettes or other storage devices that contain the data set when the research project is completed. If the researcher is a member of the HIV surveillance unit and already has a signed confidentiality statement on file, there is no need to sign an additional statement. Analysis databases or data sets that are released to individuals who work outside the secured area must be held securely until the data are approved for release. For example, epidemiologists or statisticians who do not work in the secured area often use analysis databases for routine analysis. The computers used in these circumstances must have protective software (e.g., user ID and password protection) to maintain data securely. Other robust authentication methods also may be used since the examples described are only the minimum required. Encryption software is not required with analysis databases because they are considered much less sensitive than those that contain names or other personal identifiers. Analysis data are still considered sensitive, since it may be possible to identify individuals by using particular combinations of reporting system variables. 222 HIV/STI Surveillance for CAREC Member Countries Requirement 26, continued For that reason, analysis data should not be taken home, and all the results of all analyses performed by using reporting system variables must be approved for release as outlined in the surveillance unit's data release policy. Requirement 27 Access to any secured areas that either contain surveillance data or can be used to access surveillance data by unauthorised individuals can only be granted during times when authorised surveillance or IT personnel are available for escort or under conditions where the data are protected by security measures specified in a written policy and approved by the ORP. (GP-1) If unauthorised personnel (e.g., cleaning or maintenance crews) are allowed access to the secured area during times when surveillance staff are not present, then more stringent security measures must be employed inside the secured area to meet the programme requirements. Under such circumstances, computerised surveillance information and data stored on one or more stand-alone computers or accessible via a LAN-connected workstation must be held securely with access controls in place, such as boot-up passwords that prevent unauthorised access to the computer's hard drive by booting from a system disk; encryption software; or storing the data on removable devices that can be locked away before allowing unauthorised personnel access. If surveillance information is stored on a LAN server, accounts with authorised access should be restricted by time of day and day of week. See Requirement 7. Managing keys or keypad codes to a secure area is difficult when personnel who receive the keys or codes are not directly supervised by the surveillance unit. Because of staff turnover in cleaning crews, the number of people who may be given keys or codes to the secure area may multiply over time. The more people with keys and codes, the greater the risk to the system. While tracking who has a key or code in this scenario can be difficult, it is recommended that a method of tracking and logging the issuance of keys or codes be implemented. It is further recommended that if an accurate accounting of all keys or codes to a secure area cannot be made, that the lock or code to that area be changed and that new keys or codes be issued using the tracking and logging method developed. While many surveillance programmes do not routinely grant access to the secured area to cleaning crews or maintenance staff, programme requirements can be met even if cleaning crews are granted access without authorised escort, provided that added measures (as discussed previously) are employed. The added measures must be named and described in the local security policy. 223 HIV/STI Surveillance for CAREC Member Countries Requirement 27, continued For example, the policy might state that in lieu of escorting cleaning crews and other maintenance staff inside the secured area after hours, the surveillance unit will implement additional documented security measures to provide for enhanced data protection. Requirement 28 Access to confidential surveillance information and data by personnel outside the surveillance unit must be limited to those authorised based on an expressed and justifiable public health need, must not compromise or impede surveillance activities, must not affect the public perception of confidentiality of the surveillance system, and must be approved by the ORP. (GP-1) The primary function of HIV surveillance is the collection and dissemination of accurate and timely epidemiologic data. Areas that elect to establish linkages to other public health programmes for prevention or case management should develop policies and procedures for sharing and using reported data that ensure the quality and security of the surveillance system. These programmes should be developed in consultation with providers and community partners, such as their prevention planning groups. Recipients of surveillance information must be subject to the same training requirements and penalties for unauthorised disclosure as surveillance personnel. Before establishing any programme's linkage to confidential surveillance data, public health officials should define the public health objectives of the linkage, propose methods for the exchange of information, specify the type of surveillance data to be used, estimate the number of persons to be served by the linkage based on the availability of resources, outline security and confidentiality procedures, and compare the acceptability and effectiveness of basing the prevention programmes on individual HIV surveillance case reports to other strategies. The ORP must have the final approval of proposed linkages, since the ORP is ultimately responsible for any breach of confidentiality. Prevention programmes that use individual HIV surveillance case data should evaluate the effectiveness of this public health approach. On an ongoing basis, programmes also should assess confidentiality policies, security practises, and any breaches of confidentiality. Individual HIV case reports should not be shared with programmes that do not have welldefined public health objectives or with programmes that cannot guarantee confidentiality. 224 HIV/STI Surveillance for CAREC Member Countries Requirement 29 Access to surveillance information with identifiers by those who maintain other disease data stores must be limited to those for whom the ORP has weighed the benefits and risks of allowing access and can certify that the level of security established is equivalent to the standards described in this document. (GP-2) Security is compromised if other programmes that lack adequate standards to protect the security and confidentiality of the data are granted access to HIV surveillance data or information and use that access to add HIV data to their systems. Linking records from the surveillance data with records from other databases semi-annually or annually is encouraged to identify cases not previously reported, such as cases identified through TB surveillance or cancer surveillance. This provides a systematic means to evaluate the performance of health department surveillance and to take action to strengthen weaknesses in systems as they are identified. For example, programmes can plan site visits with those providers who do not comply with the country’s reporting laws to stimulate more timely and complete reporting. Before the linkage of surveillance data, protocols should be discussed and developed. The protocol should address how the linkage will be performed using methods that are secure, who will analyse the results, and how the information will be used to improve the selected surveillance systems. Requirement 30 Access to surveillance information or data for non-public health purposes, such as litigation, discovery or court order, must be granted only to the extent required by law. (GP-2) Some state laws mandate access to HIV surveillance information for purposes other than law enforcement or litigation activities. For example, some states in the US require school officials or prospective parents to be notified when they enrol or adopt HIV-infected children. However, the surveillance unit is not necessarily required to release the information just because it is requested by law enforcement or other officials. Access should be granted only to the extent required by law and not beyond any such requirement. Any request for surveillance information for law enforcement purposes should be reviewed by the ORP with the appropriate legal counsel to determine what specific information, if any, must be released from records maintained solely for epidemiologic purposes. 225 HIV/STI Surveillance for CAREC Member Countries Requirement 30, continued Medical information may be available to the courts from less convenient but more appropriate sources. When information is ordered released as part of a judicial proceeding, any release or discussion of information should occur in closed judicial proceedings, if possible. Central, Decentral, and Remote Access The most secure protection for HIV surveillance data is having only one centralised database in each country. Centralised data stores are those in which all electronic records of HIV cases are stored in only one location within each country. Centralisation of HIV surveillance data within a country has clear benefits. First, centralised data stores offer greater security. The advantages of having several HIV surveillance databases throughout a country may be outweighed by the risk of a security breach. Centralised data stores add efficiency by improving case matching. With a centralised database, remote surveillance staff may conduct matches against the parish/county/district database, thereby reducing local-level duplicates and minimising unnecessary field investigations of cases already reported elsewhere in the country. Centralised systems may cost less to maintain. Finally, a centralised platform may support parallel surveillance systems (e.g., TB and STI). In other words, the hardware used for centralised systems could enhance surveillance activities for other diseases, without increasing access to the HIV database or compromising existing database security in any way. Technologies such as browser-based applications, the internet, Wide-Area Networks (WANs), and advances in data encryption technology and firewalls have made centralisation of HIV surveillance data more feasible. New browser-based applications have numerous technical access controls, including authentication of the individual attempting access, assignment/restriction of access rights at the variable/field level, and assignment/restriction of access to functional components (role-based privileges). Use of a centralised database allows data entry and data analysis directly from the remote location while preventing access to nonauthorised uses. Further, the capacity exists to assign access rights and privileges to staff just as is done in a decentralised system. In addition to these access controls, centralised systems can be configured to limit access by allowing only those connections originating from an authorised person using an authorised workstation. 226 HIV/STI Surveillance for CAREC Member Countries Central, Decentral, and Remote Access, continued A centralised database can be accessed using a WAN or the internet, both of which have advantages and disadvantages. A WAN often uses transmission facilities provided by common carriers, such as telephone companies, to establish a dedicated, private and permanent point-to-point connection between satellite or remote offices and the central database, an option that may be cost-prohibitive for some countries. All communications between points must still be password-protected, and communications must be encrypted using methods that meet the data encryption standards set forth in this guidance. Use of the internet does not require dedicated phone lines and establishes temporary point-to-point connections over a public medium. This would be a less expensive alternative but, because the internet is a public medium, a Virtual Private Network (VPN) must be established to guard against intrusion during communications. In addition to establishing a VPN, these communications must also be encrypted using methods that meet the data encryption standards set forth in this guidance. Additionally, firewalls must be in place to prevent unauthorised access. When properly configured, a centralised system allows each local jurisdiction complete access to their HIV data while prohibiting access by outside jurisdictions. A local jurisdiction can conduct local-level data analyses directly from a central dataset, or they may download a de-identified dataset for analysis. If centralisation is not yet feasible, each satellite site should maintain only cases within their jurisdiction. For matching case notifications, sites may consider the utility of maintaining limited data on out-of-jurisdiction cases receiving care and/or reported in their jurisdiction. Security Breaches Requirement 31 All staff who are authorised to access surveillance data must be responsible for reporting suspected security breaches. Training of nonsurveillance staff must also include this directive. (GP-3) Requirement 32 A breach of confidentiality must be immediately investigated to assess causes and implement remedies. (GP-4) 227 HIV/STI Surveillance for CAREC Member Countries Requirement 33 A breach that results in the release of private information about one or more individuals (breach of confidentiality) should be reported immediately to the Chief Medical Officer of the Ministry of Health. In consultation with appropriate legal counsel, surveillance staff should determine whether a breach warrants reporting to law enforcement agencies. (GP-4) A breach may be attempted, in progress, done without negative outcome, or done with negative outcome. Attention should be paid to identifying a breach, responding to it, repairing damage, learning from the event, and if necessary, revising or enhancing policies and procedures, revising or instituting training, or enhancing physical or operational security. By keeping a log of breaches and lessons learned from investigating them, the surveillance unit will be able to detect patterns of breaches, track compliance, and incorporate improvements to the security system. The ORP should be notified of all breaches of confidentiality (i.e., those breaches that result in the unauthorised disclosure of private information with or without harm to one or more individuals). Laptops and Portable Devices Requirement 34 Laptops and other portable devices (e.g., personal digital assistants [PDAs], other hand-held devices, and tablet personal computers [PCs]) that receive or store surveillance information with personal identifiers must incorporate the use of encryption software. Surveillance information with identifiers must be encrypted and stored on an external storage device or on the laptop's removable hard drive. The external storage device or hard drive containing the data must be separated from the laptop and held securely when not in use. The decryption key must not be on the laptop. Other portable devices without removable or external storage components must employ the use of encryption software that meets federal standards. (GP-1) With current rate advances in technology, laptop computers, PDAs, and other hand-held or portable devices may common tools for HIV surveillance in the Caribbean and may be key components of centralised surveillance systems. Unfortunately, laptops are vulnerable to theft. Although the likely target of the theft would be the device rather than the data, extreme care must be taken if the device stores HIV surveillance data or information. 228 HIV/STI Surveillance for CAREC Member Countries Requirement 34, continued If surveillance data are stored on the device's hard drive, hard drives must be removable and stored separately when the device is being transported to and from the secured area. Alternatively, a security package that uses both software and hardware protection can be used. For example, an acceptable, though not as robust, level of protection can be achieved by using a smart disk procedure. This procedure prevents the device from booting up unless an encoded smart disk is inserted when the device is first turned on and a password is entered. Such a smart disk must not be stored with the device while in transit. The smart disk must be used in conjunction with an encryption package. Using this kind of protection scheme is critical, because the device is capable of containing large amounts of sensitive information (e.g., names, addresses, dates of birth). Therefore, if a device has sensitive data on either an external storage device or hard drive, it must be taken back to the secured area at the close of business (unless out-of-town business travel is approved). Contingency plans should be in place to outline protective steps to take in case returning to the secure surveillance area is not possible. See Requirement 24 and Requirement 25. A removable drive is worth using even if data are encrypted and the laptop employs several layers of security. Another option to consider when using laptops is to store encrypted data on an external storage device. If the device is lost or stolen, the data are protected. Unlike the laptop's hard drive, an external storage device lacks market value and is not as likely to be stolen or reused. Nonetheless, external storage devices containing patient identifiers must be encrypted when taken out of a secure area. For more information about removable and external storage devices, refer to section ‘Removable and External Storage Devices.’ With the inception of Wireless Fidelity (Wi-Fi) products, many devices can now connect wirelessly to the internet or a LAN. This functionality introduces risks regarding devices used to collect or store surveillance data. If these devices are not properly configured, data can be transmitted wirelessly over great distances without protection; this can result in the data being exposed to anyone with similar wireless products. Even if data are not being transmitted wirelessly, but the device is capable of a wireless connection to the internet, data stored on the device are susceptible to compromise by exposure to the internet. For example, surveillance data may be collected in the field and stored on a laptop with Wi-Fi capability. The person collecting the data stops by a store that has a "hot spot" in order to connect to the internet and check e-mail. The data stored on the laptop have the potential to be compromised. 229 HIV/STI Surveillance for CAREC Member Countries Requirement 34, continued Any use of Wi-Fi or similar evolving wireless technologies must be given serious consideration when developing local policies. It is strongly recommended that any local policy developed in response to Requirement 34 include explicit language regarding wireless technologies. Removable and External Storage Devices Requirement 35 All removable or external storage devices containing surveillance information that includes personal identifiers must: include only the minimum amount of information necessary to accomplish assigned tasks as determined by the surveillance coordinator be encrypted or stored under lock and key when not in use with the exception of devices used for backups, devices should be sanitised immediately following a given task. External storage devices include but are not limited to diskettes, CDROMs, USB port flash drives (memory sticks), zip disks, tapes, smart cards, and removable hard drives. Deleting electronic documents does not necessarily make them irretrievable. Documents thought to be deleted often are preserved in other locations on the computer's hard drive and on backup systems. Acceptable methods of sanitising diskettes and other storage devices that previously contained sensitive data include overwriting or degaussing (demagnetising) before reuse. Alternatively, the diskettes and other storage devices may be physically destroyed (e.g., by incineration). Such physical destruction would include the device, not just the plastic case around the device. 230 HIV/STI Surveillance for CAREC Member Countries Summary When conducting HIV surveillance, be mindful of patient confidentiality. Persons with HIV/AIDS are often subject to physical, legal and social harms. Also, try to take advantage of the potential benefits of surveillance, such as reducing stigma and guiding prevention and treatment programmes. Information on persons with HIV infection must be properly protected to prevent breaches of security that can result in disclosure of their HIV status. All policies developed and surveillance activities conducted should take into account the five guiding principals of data security. Countries should also work towards achieving the requirements described with regard to policies, training, physical security, data security and security breaches. 231 HIV/STI Surveillance for CAREC Member Countries Unit 7 Exercises Warm-up review Take a few minutes now to look back at your answers for the warm-up questions at the beginning of the unit. Make any changes you want. Small group discussion Get into small groups by country, region or province to discuss these questions. 1. What are the current regulations for surveillance among minors in your region? 2. Do you know of cases where violence or other problems have occurred when an individual was identified as HIV-infected? What happened in that case? 3. What high-risk groups have been identified in your district, region or country? What are some special considerations in dealing with highrisk populations? 232 HIV/STI Surveillance for CAREC Member Countries Apply what you’ve learned/ case study Try this case study. We will discuss the answers in class. You are the health officer in charge of HIV surveillance for Inyo Province in Cariba. You have been asked to design and implement a special seroprevalence survey among male patients with acute urethritis attending the STI clinic at the provincial referral hospital. You are weighing two choices: The first choice would entail a self-administered questionnaire and an additional blood test for HIV and syphilis. The second choice would entail a blinded survey of all patients who have blood drawn for syphilis serologies. Approximately 50% of patients who present with acute urethritis have serum samples drawn for syphilis; syphilis serologies are done at the clinician’s discretion, and there is no standard protocol for when to order these serologies. Now answer these questions. a. For which option would you need informed patient consent? b. How likely are the two options to yield an accurate estimate of the prevalence of HIV infection in this patient population? c. In which option would patient confidentiality be better protected? d. If you were to offer an incentive (for example, reimbursement for transportation) to participants in Option 1, would this be considered ethical? 233 HIV/STI Surveillance for CAREC Member Countries Annex 7.1. Additional Laptop Security Considerations Basic Security Choose a secure operating system and lock it down An operating system that is secure and offers a secure logon, file level security, and the ability to encrypt data should be used. A password is considered a single-factor authentication process, but for enhanced security, commercial products can be used that change the access to a two-factor authentication. This can be achieved, for example, by using a password and an external device that must be plugged into the USB port. Enable a strong BIOS password The basic input/output system (BIOS) can be password protected. Some laptop manufacturers have stronger BIOS protection schemes than others. In some models, the BIOS password locks the hard drive so it cannot be removed and reinstalled into a similar machine. Asset tag or engrave the laptop Permanently marking (or engraving) the outer case of the laptop with a contact name, address, and phone number may greatly increase the likelihood of it being returned if it is recovered by the authorities. A number of metal tamper-resistant commercial asset tags are also available that could help the police return the hardware if it is recovered. Clearly marking the laptops may deter casual thieves. Register the laptop with the manufacturer Registering the laptop with the manufacturer will flag it if a thief ever sends the laptop in for maintenance. The laptop's serial number should be stored in a safe place. In the event the laptop is recovered, the police can contact you if they can trace it back to your office. Physical Security Get a cable lock and use it Over 80% of the laptops on the market are equipped with a Universal Security Slot (USS) that allows them to be attached to a cable lock or laptop alarm. While this may not stop determined hotel thieves with bolt cutters, it will effectively deter casual thieves who may take advantage of users while their attention is diverted. Most of these devices cost between US$30 and US$50 and can be found at office supply stores or online. However, these locks only work if tethered properly to a strong, immovable, and unbreakable object. Use a docking station Many laptop thefts occur in the office. A docking station that is permanently affixed to the desktop and has a feature that locks the laptop securely in place can help prevent office theft. If a user is leaving the laptop overnight or for the weekend, a secure filing cabinet in a locked office is recommended. 234 HIV/STI Surveillance for CAREC Member Countries Lock up the PCMCIA NIC cards While locking the laptop to a desk with a cable lock may prevent laptop theft, a user can do little to keep someone from stealing the Personal Computer Memory Card International Association (PCMCIA) Network Interface Card (NIC) or modem that is inserted into the side of the machine. These cards can be removed from the laptop bay and locked in a secure location when not in use. Use a personal firewall on the laptop Once users connect to the web from home or a hotel room, their data are vulnerable to attack, as firewall protection provided in the office is no longer available. Personal firewalls are an effective and inexpensive layer of security that can be easily installed. It is recommended that a third-party personal firewall be used to secure workstations. Consider other devices based on needs Since laptop use has become common, as has laptop theft, a variety of security-enhancing devices are now available. Motion detectors and alarms are popular items, as are hard drive locks. Biometric identification systems are also being installed on some laptop models, which allow the fingerprint to be the login ID instead of a password. Cost, utility and risk need to be taken into account when considering additional devices. Preventing Laptop Theft No place is safe Precautions need to be taken with a laptop regardless of location, as no situation is entirely without risk. As discussed previously, the laptop should always be secured by using a cable lock or secure docking station. Use a nondescript carrying case Persons walking around a public place with a leather laptop case can be targets. A formfitting padded sleeve for the laptop carried in a backpack, courier bag, briefcase, or other common nondescript carrying case may be safer. If a person is travelling in airports and train stations, small locks on the zippers of the case (especially backpacks) can be used (when not passing through security checkpoints) to prevent a thief from reaching into the bag. Beware of distractions Business travellers often use cell or pay phones in airports, restaurants, and hotel lobbies. Care needs to be taken that a laptop set down on the floor or a nearby table is not stolen while someone is engrossed in a telephone conversation. When travelling by air Sophisticated criminals can prey on travellers. When carrying a laptop, travellers need to use caution to safeguard it. When a person sets a laptop bag down for a minute to attend to other things, there may be a risk of theft. Always be aware of your surroundings because a thief could be waiting for that moment of distraction to grab a laptop (or other valuables). 235 HIV/STI Surveillance for CAREC Member Countries When travelling by car When transporting a laptop, it is safer to rent a car with a locking trunk (not a hatchback/minivan/SUV). Regardless of vehicle type, laptops should never be visible from outside of the car. Even when the laptop is in the trunk, the cable lock can be used to secure the laptop to the trunk lid so it cannot be taken easily. While staying in a hotel The hazards of leaving valuables in hotel rooms are well documented, and professional thieves know that many business travellers have laptops that can be resold. If a user keeps the laptop in the hotel room, it can be securely anchored to a metal post or fixed object. Make security a habit People are the weakest link in the security chain. If a person cares about the laptop and the data, a constant awareness of potential risks will help keep it safe. The laptop should always be locked up when it is not being used or is in storage. (A cable lock takes less time to install than it does for the PC to boot.) Use common sense when travelling and maintain physical contact with the laptop at all times. If you are travelling with trusted friends or business associates, take advantage of the buddy system to watch each other's equipment. Protecting Sensitive Data Use the New Technology File System (NTFS) (proprietary to Windows operating systems) Assuming a user has Windows NT/2000/XP on the laptop, use the NTFS to protect the data from laptop thieves who may try to access the data. File Allocation Table (FAT) and FAT32 file systems do not support file-level security and provide hackers with an opening into the system. Disable the guest account Always double check to make sure the guest account is not enabled. For additional security, assign a complex password to the account and completely restrict login times. Some operating systems disable the guest account by default. Rename the administrator account Renaming the administrator account will stop some hackers and will at least slow down the more determined ones. If the account is renamed, the word 'Admin' should not be in the name. Use something innocuous that does not sound like it has rights to anything. Remember that some computer experts argue that renaming the account will not stop everyone, because some persons will use the Security Identifier (SID) to find the name of the account and hack into it. The SID is a machine-generated, non-readable binary string that uniquely identifies the user or group. 236 HIV/STI Surveillance for CAREC Member Countries Consider creating a dummy administrator account Another strategy is to create a local account named 'Administrator,' and give that account no privileges and a complicated 10+ digit complex password. If a dummy administrator account is created, enable auditing so a user knows when someone has tampered with it. Prevent the last logged-in user name from being displayed When a user presses CTRL+ALT+DEL, a login dialog box may appear that displays the name of the last user who logged into the computer. This can make it easier to discover a user name that can later be used in a password-guessing attack. This action can be disabled by using the security templates provided on the installation CD-ROM or via Group Policy snap-in. For more information, see Microsoft KB Article Q310125. Enable EFS (Encrypting File System) in Windows operating systems Some operating systems ship with a powerful encryption system that adds an extra layer of security for drives, folders or files. This will help prevent a hacker from accessing the files by physically mounting the hard drive on another PC and taking ownership of files. Be sure to enable encryption on folders, not just files. All files that are placed in that folder will automatically be encrypted. Disable the infrared port on a user laptop (if so equipped) Some laptops transmit data via the infrared port on the laptop. It is possible for a person to browse someone else's files by reading the output from the infrared port without the laptop user knowing it. Disable the infrared port via the BIOS, or, as a temporary solution, simply cover it up with a small piece of black electrical tape. Back up the data before a user leaves Many organisations have learned that the data on the computer is more valuable than the hardware. Always back up the data on the laptop before a user does any extended travelling that may put the data at risk. This step does not have to take a lot of time, and a user can use the built-in backup utilities that come with the operating system. If the network does not have the disk space to back up all of the travelling laptop user's data, consider personal backup solutions, including external hard drives (flash sticks), CD-Rs, and tape backup—all of which can also be encrypted. Consider using offline storage for transporting sensitive data Backing up the hard drive before users leave can help them retrieve the data when they return from a trip, but it does not provide an available backup of the data when they are out in the field. Several vendors offer inexpensive external storage solutions that can hold anywhere from 40 MB to 30 GB of data on a disk small enough to fit easily into the pocket. By having a backup of the files users need, they can work from another PC in the event that their laptop is damaged or missing. Most of these devices support password protection and data encryption, so the files will be safe even if a user misplaces the storage disk. When travelling, users should keep these devices with them, not in the laptop case or checked baggage. For additional security, lock or encrypt the files and have them sent by a courier service to the destination hotel or office. 237 HIV/STI Surveillance for CAREC Member Countries Annex 7.2. Additional Security and Policy Considerations Access and Storage Devices Establish and implement policies and procedures for using and transporting secure access devices (smart card, key FOB, etc.) and external storage devices (diskettes, USB flash drives, CD-ROM, etc.). Accountability Maintain a record of the movements of hardware and electronic media and any persons responsible for transporting these devices. Application and Data Criticality Analysis Assess the relative criticality of specific applications and data in support of other contingency plan components. Audit Controls and Logs Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use protected electronic health information. Establish and implement policies and procedures that regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports. Establish and implement policies and procedures for the backup, archiving, retention and destruction of audit logs. Automatic Logoff Establish and implement policies and procedures that terminate any electronic session after a predetermined period of inactivity. Browsers Establish and implement policies and procedures regarding browser configuration for browser-based applications and internet usage. Certificates Establish server and client digital certificate transportation, generation and use policies. Communications Letterhead stationery, business cards or dedicated phone lines are used among colleagues for professional purposes, and, in these cases, references to HIV/AIDS would not jeopardise the confidentiality of any case patient. In fact, such identification may be an important part of establishing credibility with providers who report cases. Addressing both purposes (protecting confidentiality and establishing credibility) will require careful organisation and perhaps some duplication of communication mechanisms by surveillance units (e.g., one card and phone line for investigation activities and another set for providers) or the use of more generic terminology (e.g., 'Epidemiology Unit' instead of 'HIV/AIDS Surveillance Unit'). 238 HIV/STI Surveillance for CAREC Member Countries Contingency of Operations and Disaster Recovery Establish and implement policies and procedures that allow facility access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency. A contingency planning policy and operations policy should address all critical aspects of contingency planning. Storage of data for backup and disaster recovery purposes should have the same (if not more stringent) accessibility, accountability and encryption security requirements as a production system. Along with the above, the following rules should be followed. They may be included in the policy or listed separately: Maintain list of all users and applications with access to the data. The list should include (per user or application) the day of week and the hours of the day that access will be needed. Access should be limited to these days and hours. The list should also identify those with access to identifiers. Conduct a monthly audit reflecting all successful/unsuccessful access. The report should include day, time of day and length of access. It should be verified against authorised users and access requirements. Define administrative privileges for IT personnel (should be very limited). IT personnel need to have programme approval before accessing the data. Identify some form of double authentication process for accessing the data. Keep systems containing the data in a secured area that is clearly labelled for authorised personnel only. Implement column and/or row level encryption of data. Create a data backup plan that includes procedures to create and maintain exact copies of protected electronic health information. Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity (time-outs). Emergency Access Procedures Establish and implement policies and procedures for obtaining necessary protected electronic health information during an emergency. Emergency Mode Operation Establish and implement policies and procedures to enable continuation of critical business processes for protecting the security of protected electronic health information while operating in emergency mode. Encryption and Decryption Implement a mechanism to encrypt and decrypt protected electronic health information. 239 HIV/STI Surveillance for CAREC Member Countries Integrity Controls Implement security measures to ensure that electronically transmitted protected electronic health information is not improperly modified without detection until disposed of. Ensure that any agent—including a contractor or sub-contractor to whom it provides such information—agrees to implement reasonable and appropriate safeguards to protect the information. Internet Connectivity If a modem (internal or external), DSL or cable is used on a workstation to provide access to the internet, ensure that passwords and login data used to access the internet are not stored on the workstation. Most communications software has the capacity to dial a service, connect a user and even to send a password down the line. To prevent this from happening, never programme a password into the workstation. Some modems have the capability to answer the telephone as well as to make calls. Make sure users know how to tell if their modem has been placed in answering mode and how to turn off that mode. External modems normally have an indicator light labelled AA that glows if Auto Answer mode is selected. Internal modems are harder to monitor, but small utility programmes are available that can help. Call-back modems actually call the user back at a prearranged number. External modems are recommended because the ease of turning them off offers programmes the greatest degree of control. It is highly recommended that workstations holding confidential and sensitive data that are connected to the internet should be disconnected from the internet except when the internet is being used for authorised activities. If the line is for data only, make sure that the telephone number of the line does not appear in the telephone directory and is not displayed on the telephone itself or on the wall socket. Intrusion Detection Establish and implement policies and procedures regarding intrusion detection and penetration vulnerabilities. Keyboard and Screen Locking Establish and implement policies and procedures for screen saving and keyboard locking. Logins and Monitoring Establish and implement policies and procedures for workstation logins, and designate who can request and authorise changes to a login. Establish and implement policies and procedures for monitoring login attempts and reporting discrepancies. Maintenance Records Establish and implement policies and procedures to document repairs and modifications to the physical components of a facility that are related to security (for example, hardware, walls, doors and locks). 240 HIV/STI Surveillance for CAREC Member Countries Media Disposal and Re-use Establish and implement policies and procedures to address the final disposition of protected electronic health information, and/or the hardware or electronic media on which it is stored. Establish and implement policies and procedures for removal of protected electronic health information from electronic media before the media are made available for re-use. Networks, LANs, and WANs Establish and implement policies and procedures governing all servers on the network. Establish and implement policies and procedures for the documentation of network configurations and architectures. Topics to include are: name and location of servers netware protocols users, groups and roles that access data and physical server authentication protocols e-mail hosting remote access web hosting data located on each server administrative safeguards. Computers used to maintain HIV surveillance information with personal identifiers should not be connected to other computers or computer systems that are located outside of the secure area until and unless the connection is deemed secure by adding multiple layers of protective measures—including encryption software, restricted access rights, and physical protections for the LAN equipment and wiring—and justifying a public health need to maintain highly sensitive data on a system that has multiple users and multiple locations. This system should operate under a certified LAN administrator, who will attest to the system's effectiveness and assume responsibility for any breach of security directly resulting from the system's failure to protect sensitive data. Internet access devices (e.g., modems and network interface cards) or cables should not be connected to any computer or computer system containing surveillance information and data unless authorised staff need internet access as a means to enhance surveillance activities. If internet connectivity is used for surveillance activities, specific rules of use should be provided in writing to authorised users, and they should sign a statement that they understand those rules. Password Management Establish and implement policies and procedures for creating, changing and safeguarding passwords. Patching and Service Packs Establish and implement policies and procedures for security patching and service pack control. 241 HIV/STI Surveillance for CAREC Member Countries Protection from Malicious Software Establish and implement policies and procedures for guarding against, detecting and reporting malicious software. Risk Analysis Establish and implement policies and procedures that require conducting a regular, accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of protected electronic health information held by the covered entity. Routers and Firewalls Establish and implement policies and procedures regarding router and firewall logs to capture packets that violate filter criteria. Establish and implement policies and procedures for firewall and router configuration. Software Inventory, Releases, Licensing, and Upgrades Establish and implement policies and procedures for the inventory of authorised software (including versions) that can be installed on development, training, testing, staging and production servers and workstations. Establish and implement policies and procedures for tracking and verifying software licenses. Establish and implement policies and procedures for pre-release and testing of software. Establish a methodology to deploy new or upgraded software to all appropriate workstations and servers (configuration management). Establish a method for tracking the software loaded on every workstation and server. Testing and Revision of Plans Establish and implement policies and procedures for periodic testing and revision of contingency plans. Transmission Security Implement technical security measures to guard against unauthorised access to protected electronic health information that is being transmitted over an electronic communications network. Workstation Use Establish and implement policies and procedures that specify the proper functions to be performed, the manner in which those functions are to be performed and the physical attributes of the surroundings of a specific workstation or class of workstation that can access protected electronic health information. 242 HIV/STI Surveillance for CAREC Member Countries Annex 7.3. Sample Employee Confidentiality Agreement/Oath <Insert Name of Agency Here> Confidentiality Agreement As an HIV/AIDS Programme employee, sub-contracted employee, student or visiting professional, I understand that I will be exposed to some very privileged patient information. Examples of such information are medical conditions, medical treatments, finances, living arrangements and sexual orientation. The patient's right to privacy is not only a policy of the HIV/AIDS Programme, but is specifically guaranteed by statute and by various governmental regulations. I understand that intentional or involuntary violation of the confidentiality policies is subject to appropriate disciplinary action(s), which could include being discharged from my position and/or being subject to other penalties. By initialing the following statements I further agree that: Initial below _____ I will never discuss patient information with any person outside of the programme who is not directly affiliated with the patient's care. _____ If in the course of my work I encounter facilities or programmes without strict confidentiality protocols, I will encourage the development of appropriate confidentiality policies and procedures. _____ I will handle confidential data as discreetly as possible and I will never leave confidential information in view of others unrelated to the specific activity. I will keep all confidential information in a locked cabinet when not in use. I will encrypt all computer files with personal identifiers when not in use. _____ I will shred any document to be disposed of that contains personal identifiers. Electronic files will be permanently deleted, in accordance with current HAP required procedures, when no longer needed. _____ I will maintain my computer protected by power on and screen saver passwords. I will not disclose my computer passwords to unauthorised persons. _____ I understand that I am responsible for preventing unauthorised access to or use of my keys, passwords and alarm codes. _____ I understand that I am bound by these policies, even upon resignation, termination or completion of my activities. I agree to abide by the HIV/AIDS Programme Confidentiality Policy. I have received, read, understand and agree to comply with these guidelines. Warning: Persons who reveal confidential information may be subject to legal action by the person about whom such information pertains. ___________________________________________________ __________ Signature Date ________________________________________________________ Printed Name ___________________________________________________ __________ Supervisor's Signature Date 243 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G: Using Surveillance Data to Document Need and Initiate Referrals 244 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 245 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 246 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 247 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 248 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 249 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 250 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 251 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 252 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 253 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 254 HIV/STI Surveillance for CAREC Member Countries Annex 7.4. Attachment G, continued 255 HIV/STI Surveillance for CAREC Member Countries Unit 8 Analysis, Interpretation, and Dissemination of HIV Surveillance Data Overview What this unit is about This unit describes the key stages in the HIV disease natural history that should be tracked by HIV surveillance activities and how the data are analysed and summarised. It describes the different analyses that can be preformed from HIV case surveillance data. Finally, it summarises the types of reports should be generated and disseminated. Warm-up questions 1. List three elements of an HIV surveillance report. a. b. c. 2. True or false? The conclusion section of an HIV surveillance report is an optional element. True False 3. True or false? Changes in reporting practises may result in a spurious increase or decrease in AIDS incidence. True False 4. When describing the HIV epidemic, why is it preferable to perform analysis based on date of diagnosis versus date of report? 256 HIV/STI Surveillance for CAREC Member Countries Warm-up questions, continued 5. True or false? Increases in the number of persons receiving ART can result in a decrease in AIDS incidence, regardless of the number of new HIV infections occurring. True False 6. Which of the following are potential target audiences for surveillance reports on HIV? a. people who contribute to collecting the surveillance data b. healthcare workers c. public health officials at the district, provincial, national and international levels d. all of the above 257 HIV/STI Surveillance for CAREC Member Countries Introduction What you will learn By the end of this unit, you should be able to: summarise data obtained from surveillance activities interpret HIV case surveillance data describe the basic elements of an annual HIV Surveillance Report describe the elements in an annual Epidemiologic Profile. Understanding the HIV epidemic In order to fully understand the HIV epidemic, several key stages in the disease should be monitored. These include: HIV incidence (that is, the number or rate of new HIV infections) HIV prevalence (that is, the number or rate of all persons living with HIV, regardless of how long they have been infected or whether or not they are aware of their infection) incidence of advanced HIV disease incidence of AIDS prevalence of advanced HIV disease prevalence of AIDS HIV-related deaths These target points for HIV surveillance are described in Unit 4. Background Decisions regarding public health are dependent on quality data. Accurate surveillance data are central to the effective monitoring of trends in HIV infection, identification of risk behaviours within populations, and the successful development and evaluation of HIV intervention and prevention programs. It is also important that surveillance data be presented in a manner that facilitates their use for public health action. Therefore, it is essential that HIV surveillance data meet certain criteria for quality before being analysed and disseminated. The following guidelines describe recommendations related to data quality, as well as the required and recommended HIV/AIDS analyses and reports. 258 HIV/STI Surveillance for CAREC Member Countries Using HIV case surveillance data The introduction of HIV case surveillance is necessary due to the increased availability of ART in developed countries, which has markedly altered the natural history of HIV infection. Without ART, it takes an average of eight to ten years for an HIVinfected person to develop AIDS. With ART, the progression to AIDS is delayed or possibly prevented. In this situation, relying just on AIDS case surveillance will miss many HIV-infected persons. The current method of estimating HIV prevalence in developing countries is to conduct unlinked anonymous HIV seroprevalence surveys in women attending antenatal clinics and/or high-risk populations. While these have been reasonable methods of estimating HIV prevalence, WHO encourages countries to conduct HIV case surveillance, as described in Unit 4: HIV Case Surveillance. Interpretation of HIV case surveillance data should begin only after HIV case surveillance has been in place for a long enough period of time for: all previously reported cases have been entered into the HIV case surveillance database case-finding for old unreported cases has been done and entered into the database assessment of the HIV case surveillance system shows that it is functional (see Unit 5: Monitoring Surveillance System Quality) This may take several years. This is to be sure that the data, especially trend data, are not misinterpreted. For example, in the first year of reporting, some of the newly diagnosed persons will be reported. In subsequent years, more infected people will be reported, but these reports may be from patients who were diagnosed in the past but not yet reported. Alternatively, these may be newly diagnosed persons. Once the people with long-standing HIV infection have been reported, data may be analysed in the same way that AIDS case data were analysed. Additionally, the WHO revised the surveillance case definitions to capture a broader spectrum of advanced disease and to link case surveillance to use of ART. Data collection in ART programmes should make HIV and advanced HIV case surveillance easier. WHO ART recommendations: call for considering use of ART for patients at HIV clinical stage 3 recommend use of ART for patients at HIV clinical stage 4. 259 HIV/STI Surveillance for CAREC Member Countries Using HIV case surveillance data, continued Countries that conducted AIDS case surveillance in the past that initiate HIV case surveillance (all clinical and immunologic stages) will be able to continue monitoring AIDS trends. It is critical to clearly define terms used in analysis of HIV case surveillance. Your audience may not be familiar with HIV case surveillance, how it is collected and how it should be interpreted. Also, use caution when interpreting data from HIV case surveillance, keeping in mind this is the number of persons who have been diagnosed with the disease and not all persons who are infected. We do not know what the true incidence or prevalence of HIV is in the population. Seroprevalence surveys are a way to measure this (See Unit 4), and HIV case surveillance data tells us the number of persons who know they are infected and therefore are likely to enter care and/or treatment programmes. Terms used in analysis of HIV case surveillance HIV incidence is the true number of new infections occurring in a population. See Unit 4 for methods to estimate HIV incidence. HIV prevalence is the true prevalence of people infected with HIV. See Unit 4 for methodologies to estimate HIV prevalence. New diagnoses of HIV includes persons with advanced HIV disease or AIDS. New diagnoses of advanced HIV disease includes persons with AIDS. The term ‘incidence’ may be used to describe the new cases diagnosed with advanced HIV disease. New diagnoses of AIDS includes only persons with clinical stage 4 or CD4 count less than 200. The term ‘incidence’ may be used to describe the new cases diagnosed with AIDS. Cumulative diagnoses of HIV includes persons with advanced HIV disease or AIDS. Cumulative diagnoses include all persons diagnosed with HIV infection since the beginning of the HIV epidemic. Cumulative diagnoses of advanced HIV disease includes persons with AIDS. Cumulative diagnoses include all persons diagnosed with advanced HIV disease (WHO clinical stage 3 or 4, or CD4 count <350 cells/uL) since the beginning of the HIV epidemic. 260 HIV/STI Surveillance for CAREC Member Countries Terms used in analysis of HIV case surveillance, continued Cumulative diagnoses of AIDS include all persons diagnosed with AIDS (WHO clinical stage 4 or CD4 count <200 cells/uL) since the beginning of the HIV epidemic. Deaths among persons with HIV may or may not be attributable to HIV disease. If your vital registration system includes cause of death, this is important information to present. Bear in mind that this may be an underrepresentation of the actual number of deaths due to HIV-related disease. HIV-related deaths. These are people who died from HIV-related conditions. The number of persons living with HIV is a critical number/analysis for planning purposes. To be able accurately count how many persons are diagnosed and living with HIV, subtract number of persons who have died (all causes of death) from all those diagnosed with HIV. Determining the number of persons living with advanced HIV disease is important for planning because it tells you how many people may need HIV care and treatment in the near future. According to WHO recommendations, these people should be receiving HIV treatment. This can also be referred to as prevalence of advanced HIV disease. Determining the number of persons living with AIDS is important because it tells you how many people currently need treatment. You can look at the number of PLWA and see how many people are on treatment and assess whether you are meeting your treatment needs. This can also be referred to as prevalence of AIDS. Interpreting HIV case data HIV, advanced HIV disease, and AIDS case data should be examined to answer the following questions: Are new diagnoses of HIV, advanced HIV disease and AIDS increasing, decreasing or remaining stable? Which parishes/regions/counties have the highest number of new diagnoses of HIV, advanced HIV disease, and AIDS? What are the differences between parishes/regions/counties where new diagnoses of HIV, advanced HIV disease and AIDS is low and those where it is relatively high? What are the differences between parishes/regions/counties where the new diagnoses of HIV, advanced HIV disease and AIDS is increasing and those where it is decreasing or not changing? 261 HIV/STI Surveillance for CAREC Member Countries Interpreting HIV case data, continued What proportion of persons with HIV, advanced HIV disease, and AIDS are receiving ART? Are there demographic differences between person receiving ART and those who are not, among those who need treatment? What are the most frequent HIV-related opportunistic illnesses and are these changing over time? This is applicable if data on OI are collected. Changes in HIV, advanced HIV disease and AIDS case reports may be due to factors other than a true decrease or increase in the number of infections and deaths occurring. Interpret surveillance data to understand factors that may produce spurious changes. These include: increases or decreases in the size of the risk population changes in risk behaviours; these would affect HIV transmission rates, and HIV, advanced HIV disease and AIDS incidence many years later. changes in HIV testing and/or other diagnostic procedures increase in VCT activities—that is, VCT campaigns or outreach programmes increases or decreases in the number of healthcare facilities or other access to care issues (institution of user fees resulting in decreased clinic attendance) increase in availability of ART impact of ART on the slowing of the progression of HIV disease to advanced HIV disease adoption of new case definitions changes in case surveillance practises (for instance, private providers reporting) duplicate case reports (that is, more than one report provided for an individual, leading to counting the person twice) A number of factors may affect the incidence of advanced HIV disease and AIDS, including: past HIV incidence (keeping in mind the time it takes to develop AIDS after HIV infection) HIV care provided to persons early in HIV infection may decrease progression to advanced HIV disease ART impact on delaying the progression of HIV to AIDS should decrease AIDS incidence Because AIDS represents late-stage HIV infection, AIDS incidence rates do not provide much information on HIV incidence. HIV incidence is the leading edge of the epidemic. 262 HIV/STI Surveillance for CAREC Member Countries Interpreting HIV case data, continued Factors that may affect the prevalence of advanced HIV disease and AIDS cases are: changes in incidence of AIDS due to increased availability of ART changes in advanced HIV disease and AIDS mortality—for example, a decrease in AIDS mortality from ART will increase the prevalence of advanced HIV disease. Figure 8.1. Reported HIV infections, AIDS cases, and AIDS deaths, Vietnam, by year of report, 1990 through 1999. Source: Quan VM, Chung A, Long HT, Dondero TH. HIV in Vietnam: the evolving epidemic and the prevention response, 1996 through 1999. J Acquir Immune Defic Syndr. 2000;25:311-7. Discussing the figure Look at Figure 8.1 and answer the following questions: a. What factors may explain the discrepancy in the number of HIV and AIDS cases between 1992 and 1994 (that is, high numbers of HIV cases but relatively low number of AIDS cases)? b. What would you expect to happen to the number of AIDS cases and deaths in the absence of ART in 2004? 263 HIV/STI Surveillance for CAREC Member Countries Data should meet minimum performance standards Before analysis, HIV surveillance data should meet the minimum quality standards for timeliness and completeness. Additionally, any report or presentation of the data should include discussion of the quality and limitations of the data. Data quality standards are listed Unit 5. For example, when looking at completeness of reporting, you should note that many Caribbean countries have had AIDS case surveillance from selected healthcare facilities. HIV-infected patients may be referred from public clinics to district-level clinics or specific private facilities for specialised care. This is particularly true for patients who are receiving ART. In this situation, it is not uncommon for reporting only to be completed from the public clinic, district and reference private facility. If cases are reported from a select number of sites, this should be mentioned in the report. Additionally, methods to estimate the proportion of missing cases should be considered. In general, limitations of the data should be mentioned in the report. Data should meet confidentiality requirements To reduce the risk of inadvertent identification of individuals, it is essential that data be presented in a way that preserves the confidentiality of persons in the HIV case surveillance database. Policies for data release should be guided by knowledge of the overall population characteristics and distribution, and of the HIV-infected population. Each area should have a written data release policy that has been reviewed and approved by the overall responsible party. In all circumstances, the primary consideration should be to maintain confidentiality in a manner consistent with making useful data available for local purposes. Data release policies should consider the purposes for which the data were originally collected, as well as the purpose of data presentation. Unit 7: Confidentiality and Data Security provides further details on the confidentiality requirements for HIV case surveillance data. 264 HIV/STI Surveillance for CAREC Member Countries Communicating HIV Data There are many uses for HIV surveillance data. The analysis, interpretation and dissemination of information will depend on the needs of the country for prevention and care and treatment programmes. In addition, the needs of the donors or scientific community may influence how the data are analysed and presented. Site-specific summaries should be provided to major reporting sources on a regular basis. HIV data can also be useful for presentations to policymakers, civic leaders, and legislators to help explain the need for services and funding of programmes. How data should be presented Data can be presented in graphical/tabular format and narrative format. There are important considerations for presenting data; below are some minimum standards for graphical/tabular formats. Standards for graphical/tabular data display All figures must include: clear titles, including the HIV diagnoses/disease stage and the time period labelled axes data source footnotes interpretation (including limitations of data). Additionally, when presenting HIV case surveillance data, you should follow local confidentiality procedures for displaying small cell sizes (< 5). Target audiences There are many consumers of HIV information, including: healthcare providers other units of the Ministry of Health National AIDS Programmes the scientific community community-based organisations community planning groups international donors policymakers the general public. 265 HIV/STI Surveillance for CAREC Member Countries Report styles Different audiences require different information and presentation styles, based on: their familiarity with the terminology and concepts of surveillance the action they will take based on the information, perhaps determined by their position in the HIV public health structure or elsewhere their interest in specific information, or their interest in comprehensive information their motivation to review the data critically their needs or expectations. The more organised the report, the more effective it will be in meeting the objectives. Formats for Disseminating HIV Data There are different formats for reporting data to the various audiences. It is critical that information be shared with those who provided input— particular, healthcare providers who report HIV cases. HIV surveillance report An HIV surveillance report should be published on a regular basis (annually at a minimum). The report should include observed trends of the HIV epidemic, the risk patterns observed, transmission categories, age and sex distributions, geographic distributions. Annual epidemiological report The Epi Profile uses strategic information available in the country to describe and inform on the HIV epidemic. The report provides data from all HIV/STI surveillance activities (HIV case surveillance, HIV seroprevalence surveys, STI surveillance, etc.) as well as related programme areas (such as VCT, PMTCT, care and treatment, TB control, etc.). Fact sheets Fact sheets are brief descriptions focused on a specific subject. They are written in simple language and are formatted to convey basic information on a single topic or subject area. In areas with populations of other languages, some fact sheets may need to be translated into other languages (such as Spanish, French and/or Creole). Fact sheets will often include contact information for follow-up if more in-depth information is desired. 266 HIV/STI Surveillance for CAREC Member Countries Fact sheets, continued Fact sheets can be tailored to address local populations of interest. Examples include: sex (men/women) risk category age groups (paediatric, adolescents, 50+) special interest populations (sex workers, homeless, migrant populations, etc.). Slide sets and presentations Visual presentations of surveillance data are an easy way to convey HIV surveillance data. Graphic presentations can add interest and impact to numeric data of comparisons, trends, etc. Slides prepared in PowerPoint (or a similar programme) can be used for electronic presentations, imbedded with text in printed reports, or printed as posters/displays. Slide sets can address similar topics as the fact sheets and should be updated annually. Examples include: summary data geographic distribution trends (5 or 10 years) proportions by demographic factors (sex, age, risk). Types of Analyses Below are some recommended analyses for HIV surveillance data. Analyses for HIV The term “HIV” refers to five categories of cases: 1. new diagnoses of HIV infection only 2. concurrent diagnoses of HIV infection and advanced HIV disease 3. new diagnoses of HIV infection with later diagnoses of advanced HIV disease 4. concurrent diagnoses of HIV infection and AIDS 5. new diagnoses of HIV infection with later diagnoses of AIDS. 267 HIV/STI Surveillance for CAREC Member Countries Analyses for HIV, continued It is recommended that data on HIV only be analysed and reported from areas that have had HIV reporting for long enough to allow for stabilisation of data collection and monitoring of trends. Analysis by year of diagnosis: To assess trends in HIV cases, deaths, or prevalence, it is preferable to analyse and present the data by year of diagnosis. Analyses by year of diagnosis will reflect what is currently happening with the epidemic, and eliminate artefacts of reporting in the surveillance system. Analysis by year of report: Analyses and presentation of data by year of report reflects reporting practises of the surveillance system. This does not reflect newly diagnosed cases or recent infections. By default, when analysing data by year of report, the data would not be adjusted. Analyses for advanced HIV disease The term “advanced HIV disease” refers to two categories of cases: 1. new diagnoses of advanced HIV disease 2. concurrent diagnoses of advanced HIV disease and AIDS. It is important to know the number of persons who have been diagnosed with advanced HIV disease, since this is the number of people who should receive care and treatment services. Analysis by year of diagnosis: To assess trends in advanced HIV disease cases, deaths, or prevalence, it is preferable to analyse and present the data by year of diagnosis. Analyses by year of diagnosis will reflect what is currently happening with the epidemic, and eliminate artefacts of reporting in the surveillance system. Analysis by year of report: Analyses and presentation of data by year of report reflects reporting practises of the surveillance system. This does not reflect newly diagnosed cases or recent infections. 268 HIV/STI Surveillance for CAREC Member Countries Analyses for AIDS AIDS represents the end stage of a disease spectrum, and for the reasons outlined above, is less representative of the current state of the HIV epidemic. However, it still has value to inform on potential differences in access to HIV testing and care services. Analysis by year of diagnosis: To assess trends in AIDS cases, deaths, or prevalence, it is preferable to present the data by year of diagnosis. Analyses by year of diagnosis will reflect what is currently happening with the epidemic, and eliminate artefacts of reporting in the surveillance system. Analysis by year of report: Analyses and presentation of data by year of report reflects reporting practises of the surveillance system. This does not reflect newly diagnosed cases or recent infections. Analyses of deaths among people with HIV The term “deaths among people with HIV” refers to two categories: 1. 2. HIV-related deaths deaths from all causes among persons with HIV infection. It is important to know the number of HIV-infected persons who have died. We need to be able to differentiate between those persons whose deaths were related to HIV disease and those who died from other causes. Data on HIV-related deaths can inform us about the access to and impact of care and treatment programmes. Data on all HIV-infected persons who have died is key to calculating the number of persons in the population currently living with the disease. Analysis by year of death: To assess trends in HIV-related deaths, it is preferable to present the data by year of death. Analyses by year of death will reflect what is currently happening with the epidemic, and eliminate artefacts of reporting in the surveillance system. Analysis by year of report: Analyses and presentation of data by year of report reflects reporting practises of the surveillance system. This does not reflect when people died. 269 HIV/STI Surveillance for CAREC Member Countries HIV Surveillance Report An HIV surveillance report should be published on a regular basis (annually at a minimum). In addition to the annual report, medium and high morbidity areas should also consider publishing summary data on a quarterly or semi-annual basis. Producing and distributing a routine report will decrease the number of individual requests for data. The report can be developed including the following components: Title or cover page A title or cover page is used to announce what is to follow. It extends an invitation to the reader to read the contents. The title should describe the content of the report, including the time period covered. Information on where the data come from should be included (for example, HIV case surveillance for Cariba and the office that produced the report). Executive summary An executive summary summarises the entire report in approximately a page. This is particularly useful for busy officials who may not have time to read the whole report. Include the salient points, especially recommendations. Acknowledgements An acknowledgements section lists the persons who contributed significantly to the report and the groups of healthcare providers who reported cases. Introduction The introduction includes a definition of the audience, dates and contents of previous reports, and statement of objectives/purpose of the report. Body of the report The body of the report includes the methodology of how the data were collected and managed, and the results. This includes: definitions of terms used in the surveillance report discussion of the quality and limitations of the data (such as timeliness and completeness) narrative interpreting each table and chart so that persons unfamiliar with the subject matter can interpret the data correctly. a logical sequence of presentation to ensure clarity for readers 270 HIV/STI Surveillance for CAREC Member Countries Body of the report, continued separate presentation of data for all HIV diagnoses, cases with advanced HIV disease, and cases with AIDS, deaths. The following analyses should be included in the report for HIV, advanced disease and/or AIDS): HIV cases, advanced HIV disease and/or AIDS cases diagnosed in most recent calendar year(s) number, percentage, and rates of HIV, advanced HIV disease and/or AIDS cases diagnosed in most recent calendar year by: o sex o age group number and percentage of HIV, advanced HIV disease and/or AIDS cases diagnosed most recent calendar year by: o age group and sex o risk factor and sex number and percentage of persons living with HIV (including all stages and CD4 counts) by: o age group and sex o risk factor and sex o race/ethnicity and sex (if applicable) number and percentage of persons living with advanced HIV disease: o age group and sex o risk factor and sex o race/ethnicity and sex (if applicable) number of persons living with AIDS: o age group and sex o race/ethnicity/sex (if applicable) o mode of exposure/sex number of HIV-related deaths by: o age group o sex trends in diagnoses of HIV, advanced HIV disease and/or AIDS stratified by age and sex and risk factor 271 HIV/STI Surveillance for CAREC Member Countries Discussion The discussion section interprets the data and explains the epidemic and how it has changed from previous years. It should also address any biases or limitations to the data. In particular, it should be noted if the data presented are not complete. Conclusion The conclusion reemphasises pertinent findings and integrates these findings into a comprehensive statement on the state of the epidemic. Annual HIV Epidemiologic Profile The Annual Epidemiologic Profile (Epi Profile) describes the HIV epidemic in various populations in a defined geographic area. It identifies characteristics of the general population, HIV-infected populations, and non-infected (and untested) persons whose behaviours place them at risk for HIV. It consists of information gathered to describe the HIV epidemic in terms of socio-demographic, geographic, behavioural, and clinical characteristics. Data sources for preparing the Epi Profile include vital registration; HIV case surveillance; sero-prevalence surveys; behavioural surveys; population-based surveys; health facility surveys; HIV programme data. The Epi Profile serves as a source of quantitative data from which HIV prevention, care and treatment needs are identified and priorities set for a given jurisdiction. An Epi Profile is designed to: provide a thorough description of the HIV epidemic among the various populations (overall, and sub-populations) in a geographic area identify characteristics of the general population and of populations who are living with, or are at high risk for, HIV in defined geographic areas, and who need prevention or care and treatment services describe the current status of the HIV epidemic in the geographic area and provide some understanding of how the epidemic may look in the future provide information required to conduct needs assessments and gap analyses. 272 HIV/STI Surveillance for CAREC Member Countries Recommended Analyses General population Demographics—number and percentage distribution of the population by: age group and sex race/ethnicity and sex (if applicable) age group and sex for geographic subunits (for example, parish, province, region), if applicable. HIV-infected population For the most recent available calendar year (analysis by HIV, advanced HIV disease and/or AIDS), important information includes: the number of cases diagnosed in that year the number, percentage, and rates of cases by sex and race/ethnicity (if applicable) the number and percentage of cases by: o age group and sex o risk factor/behaviour and sex. For geographic areas with large numbers of cases, you should determine: the number and percentage of cases by: o age group and sex o risk factor/behaviour and sex o geographic sub-unit. For mortality, determine: the number and rates of death, by age group and sex the number of deaths by underlying cause among persons age 25-44. For most recent five-year period, determine: the annual number of HIV diagnoses the annual advanced HIV disease diagnoses the annual number of AIDS diagnoses the prevalence of HIV cases the annual number of deaths among persons with HIV the annual number of HIV cases among perinatally exposed children annual number of HIV cases among perinatally infected children. 273 HIV/STI Surveillance for CAREC Member Countries At-risk populations Data sources for at-risk populations include: Behavioural Surveillance Surveys (BSS) Demographic Health Surveys (DHS) AIDS Indicator Surveys (AIS) Behavioural Risk Factor Surveillance Surveys (BRFSS) or Risk Factor Surveillance Surveys Sexually Transmitted Infections (STI) control programme Tuberculosis control programme Data on persons diagnosed with hepatitis infections Voluntary Counselling and Testing (VCT) programmes/sites HIV patient monitoring systems Maternal and Child Health Programmes. Direct and indirect measures of risk behaviour include: number and type of sex partners frequency of condom use pregnancies amongst young girls/women STI data, including: o syndromic surveillance data for the most recent calendar year o aetiologic surveillance data for the most recent calendar and trends TB data, including: o new diagnoses o concurrent HIV/TB diagnoses hepatitis data, including: o new diagnoses injection drug use and needle sharing HIV counselling and testing data, including: o total number of tests o number/percent positive o behavioural data (reason for test, etc.). 274 HIV/STI Surveillance for CAREC Member Countries Programme Monitoring Data Programmes for prevention of mother-to-child transmission of HIV (PMTCT) This section should present the number of pregnant women found to be HIV-infected and the number of HIV transmissions in children born to HIV-infected mothers. The report should describe what is being done (or the future plans) to prevent mother-to-child transmission of HIV in the public and private sector. It should also describe access to HIV testing in pregnant women during antenatal care, and use of antiretroviral drug therapy for infected mothers to prevent infection in their infants. Analyses should be stratified by age group and include: number of women offered HIV counselling and testing number of women who accepted HIV testing number of women who received their results number of women who tested positive for HIV number of women who were referred and put on treatment for HIV number of women administered NVP/AZT before and during delivery. HIV patient monitoring data Data collected by HIV patient monitoring systems should be included in reports. Analyses should include: cumulative number of persons who ever received HIV-related care, by age group, sex, and care site, and geographic unit annual trends in the number of persons who ever received HIV-related care, by age group, gender, and care site, district, or province number currently receiving HIV-related care, by age group, sex, and care site, and geographic unit cumulative number of persons ever started on ART, by age group, sex, and treatment site, and geographic unit annual trends in the number of persons who began ART, by age group, gender, and treatment site, district, or province number currently on ART, by age group, sex, and treatment site, and geographic unit. 275 HIV/STI Surveillance for CAREC Member Countries ART treatment cohort data The value of cohort data is to measure changes over time. Consequently, data from these cohorts should focus on annual changes in: functional status median CD4 counts or proportion of patients who had CD4 testing whose counts were > 200 cells/mm3 survival or number of deaths trends in the number of persons in the cohort living each year trends in the incidence of selected opportunistic illnesses Analyses should examine trends in these outcomes in aggregate and by selected demographic characteristics, such as age group, sex, and geographic unit. Persons not receiving HIV care and/or treatment Some HIV-infected people know their HIV status but are not receiving HIV care and/or treatment. HIV case surveillance data can help you estimate the unmet need for HV care and treatment. Comparison can be made using the number of persons diagnosed with advanced HIV disease and comparing them to the number of people receiving care and the number of people receiving treatment. If there are sizable discrepancies with the number of persons diagnosed with advance HIV disease and the number of persons on treatment, additional analyses can be undertaken to look at the characteristics of these persons. It is important to track this in order to determine the barriers to accessing/receiving treatment as well as to plan for provision of services. These data can then be used to try to identify ways to get them into treatment programmes. Health facility Surveys Health facility surveys (such as service provision assessment data) give information on the services provided by different health facilities, quality of service provided, and client perceptions of the quality of service received. 276 HIV/STI Surveillance for CAREC Member Countries Data from other Agencies Investigate whether confidential HIV reports can be collected from programmes that routinely test for HIV, such as the military, prisoners, insurance and visa applicants and drug rehabilitation programmes. Include recent estimates of prevalence of HIV/AIDS in your country and the region developed by CAREC, and briefly describe how such estimates were derived. 277 HIV/STI Surveillance for CAREC Member Countries Unit 8 Exercises Warm-up review Take a few minutes now to look back at your answers for the warm-up questions at the beginning of the unit. Make any changes you want. Small group discussion Get into small groups to discuss these questions. 1. Who is responsible for data analysis and reporting at each level, and what kinds of reports are generated? 2. What was the approximate AIDS incidence in your country in the last year? Is it increasing, decreasing or remaining stable? Are the trends the same among the various age groups? 3. Describe the types of reports that are routinely produced using surveillance data in your country. 4. What do you think will be the effect of HIV case surveillance on the existing trends for your country? Apply what you’ve learned/ case study Work on this case study independently. You work in the surveillance unit of Cariba and are responsible for developing the annual HIV surveillance report. You have data from AIDS case surveillance nationwide and from a single cohort of patients who received ART in a large urban clinic. Use this information to answer the following questions. 1. What data will you include in your report? Describe some of the ways you might display the data according to the source of the data. 278 HIV/STI Surveillance for CAREC Member Countries Apply what you’ve learned/case study, continued 2. The following table shows the AIDS case incidence rates over seven years. The rates are per 1 000 population. Use this information to develop a figure that will represent what you think are the most important aspects of these data. AIDS Incidence (per 1000), 1999-2005, Cariba. Age group (years) 15-19 20-24 >=25 60 150 103 75 160 118 20 29 18 90 155 120 60 162 125 50 140 120 30 88 100 Year 1999 2000 2001 2002 2003 2004 2005 3. What would you write in your report about these data? (That is, what is your interpretation of these data)? 4. The following table provides information from a clinic that has been providing ART to patients for a few years. Develop a figure that displays the data and provide explanatory text to accompany the figure. % on ART Men 2003 Women Men 2004 Women Men 2005 Women 25% 30% 35% 50% 35% 60% 279 Appendix A, References Appendix A, References CAREC/PAHO/WHO. Amendment to Caribbean Communicable Disease Surveillance Manual for Public Health Action. October 2002. CAREC/PAHO/WHO. Caribbean Communicable Disease Surveillance Manual for Public Health Action. October 1999. CAREC/PAHO/WHO. Clinical and Laboratory Guidelines for Dengue Fever and Dengue Haemorrhagic Fever/Dengue Shock Syndrome for Health Care Providers. February 1998. CAREC/PAHO/WHO. Guidelines for Upgrading of HIV/AIDS/STI Surveillance in the Caribbean. The Third Generation Surveillance of HIV/AIDS/STI Linking HIV, AIDS and Case-reporting, Behavioural and Care Surveillance. May 2002. CAREC/PAHO/WHO. Laboratory User Manual. June 2002. CAREC/PAHO/WHO. Managing Laboratories to Assure Quality – “A How-To Guide”: Module No. 4 - Operational Systems. 2002. CAREC/PAHO/WHO. Preparing the Annual HIV/AIDS Epidemiological Profile. A Template for CAREC-Member Countries. February 2005. CAREC/PAHO/WHO. Public Health Surveillance: A Caribbean Communicable Disease Surveillance Manual for Action. October 1999. CAREC/PAHO/WHO. Quality Assurance Workshop Training Manual. 1998. CAREC/PAHO/WHO. Regional Communicable Disease Surveillance System for CAREC Member Countries Interim Policy Guidelines. Feb 2005. CAREC/PAHO/WHO website: www.carec.org CCH Secretariat. Caribbean Cooperation in Health: Phase II. A New Vision for Caribbean Health. May 1999. Centers for Disease Control and Prevention and Council of State and Territorial Epidemiologists. Technical Guidelines for HIV/AIDS Surveillance Programs, Volume III: Security and Confidentiality Guidelines. Atlanta, Georgia: Centers for Disease Control and Prevention, 2006. This document is available at: http://www.cdc/gov/hiv/surveillance.htm. CDC Technical Guidelines for HIV/AIDS Surveillance Programs, Volume I: Policies and Procedures. A-1 Appendix A, References CDC/Morbidity and Mortality Weekly Report (MMWR), Guidelines for Evaluating Surveillance Systems, Douglas N. Klaucke, M.D., et al; and the Surveillance Coordination Group, May 6, 1988. Global HIV Prevention Working Group.Excerpt from the Executive Summary of New Approaches To HIV Prevention: Accelerating Research And Ensuring Future Access, 2006. www.gatesfoundation.org and www.kff.org. International Working Group For Disease Monitoring And Forecasting. CaptureRecapture and Multiple-Record Systems Evaluation I: History And Theoretical Development. Am J Epidemiol 1995;142:1047-58. International Working Group For Disease Monitoring And Forecasting. CaptureRecapture and Multiple-Record Systems Evaluation II: Applications In Human Diseases Am J Epidemiol 1995;142:1059-68. Multilateral Agreement for the Operation of the Caribbean Epidemiology Centre, January 2001-December 2005. Tilling K. Capture-Recapture Methods-Useful Or Misleading? Inter J Epidemiol 2001;30:12-14. WHO. Guidelines for Sexually Transmitted Infections Surveillance. WHO/CHS/HSI/99.2 WHO/CDS/CSR/EDC/99.3 WHO Recommended Surveillance Standards, Second Edition. (WHO/CDS/CSR/ISR/99.2) October 1999. WHO. Weekly Epidemiological Record No. 36: 322-326. September 3, 2004. Overview of the WHO Framework for Monitoring and Evaluating Surveillance and Response Systems for Communicable Diseases. WHO Proposals for the Revision of the International Health Regulations. (http://www.who.int/csr/ihr/en/) A-2 Appendix B, Abbreviations and Glossary Appendix B, Abbreviations and Glossary Abbreviations AIDS ARI ART BRFS BSS CAREC CARICOM CCH CDC CSF CSME CSR CSW DALY DHS EPI HIV ICT ILEP KAPB MSM MTCT PAHO PLWHA PMTCT PPT PYLL SAC SPSTI STI TB US VCT WHO Acquired Immune Deficiency Syndrome Acute Respiratory Infection Antiretroviral (Drug) Treatment Behavioural Risk Factor Survey Behavioural Surveillance Surveys Caribbean Epidemiology Centre Caribbean Community and Common Market Caribbean Cooperation in Health Centers for Disease Control and Prevention Cerebrospinal Fluid CARICOM Single Market and Economy CAREC Surveillance Report Commercial Sex Worker Disability-Adjusted Life Years Demographic Health Survey Expanded Programme on Immunization Human Immunodeficiency Virus Information and Communication Technology International Federation of Anti-Leprosy Associations Knowledge, Attitudes, Practises and Beliefs Men who Have Sex with Men Mother-to-Child Transmission Pan American Health Organization People Living With HIV or AIDS Prevention of Mother-to-Child Transmission Plasma Preparation Tube Person Years of Life Lost Scientific Advisory Council Special Programme on Sexually Transmitted Infections Sexually Transmitted Infection Tuberculosis United States of America Voluntary Counselling and Testing World Health Organization B-1 Appendix B, Abbreviations and Glossary Glossary Acquired immunodeficiency syndrome (AIDS): The late stage of HIV infection that includes development of one or more opportunistic illnesses (illnesses that occur because of low levels of CD4 lymphocytes, or immunodeficiency). Active infection: An infection that is currently producing symptoms (disease) or in which the organism that causes disease is reproducing. Active surveillance: A system in which health-authority personnel take the lead in identifying and reporting cases, as opposed to ‘passive surveillance.’ Adherence: The extent to which a patient takes his/her medication according to the prescribed schedule (also referred to as ‘compliance’). Aetiologic case reporting: A surveillance system in which a laboratory test has confirmed the presence of the pathogen. Aetiological: Refers to the causes of disease. Also known as ‘aetiologic.’ Agent: A factor, such as a micro-organism, chemical substance, or form of radiation, whose presence is essential for the occurrence of a disease. Aggregated data: Information, usually summary statistics, that is summed or presented together to prevent the identification of individuals. AIDS-defining illness: Any of a series of health conditions that are considered, in isolation, or in combination with others, to be indicative of the development of AIDS. These conditions result from low levels of CD4 lymphocytes that are destroyed by HIV. Algorithm: Step-by-step procedure for decision-making; a recipe for achieving a specific goal. Aliquot: A portion of a sample; for example, an aliquot of a 100 millilitre sample of blood might be a 5 millilitre portion of that sample. Anonymous: Having no known name or identity. For example, removing all personally identifying information from a sample that will be tested for HIV, in order to protect the patient’s identity. Anti-microbial resistance: The ability of an organism to avoid destruction or deactivation typically caused by drugs or chemicals designed to do so. Antibiotic medicines: Drugs that kill or inhibit the growth of bacteria. B-2 Appendix B, Abbreviations and Glossary Antibodies: Molecules in the blood or secretory fluids that tag, destroy, or neutralise bacteria, viruses, or other harmful toxins. Antimicrobial agents: An agent that kills or inhibits microbial growth. ‘See Antibiotic medicines’. Antiretroviral drugs: Drugs used to fight infections caused by retroviruses, such as HIV. Antiretroviral drug resistance: Resistance to one or more antiretroviral drugs. Antiretroviral drug resistance is one of the more common reasons for therapeutic failure in the treatment of HIV. Antiretroviral therapy (ART): Treatment with drugs that inhibit the ability of HIV to multiply in the body. Area map: A map used as a graph showing variables by geographic location. Artefact: An inaccurate observation, effect or result caused by experimental error. Asymptomatic: Without symptoms. B-lymphocytes: Also known as ‘B-cells.’ Blood cells of the immune system involved in the production of antibodies. In persons living with AIDS, the functional ability of both the B and the T lymphocytes is damaged, with the T lymphocytes being the principle site of infection by HIV. Bacterial vaginosis: A chronic inflammation of the vagina caused by the bacterium Gardnerella vaginalis. Bar graph: A visual display of the size of the different categories of a variable. Each category or value of the variable is represented by a bar (or column). The Y-axis represents frequency. The X-axis represents different classes. BED assay: A simple enzyme immunoassay (EIA) that can be used for detecting recent HIV-1 infection (within the last 160 days). It uses a branched peptide that includes sequences from HIV sub-types B, E and D, and allows detection of HIV-specific antibodies among various subtypes. Behavioural surveillance: Surveys of HIV-related behaviour that involve asking a sample of people about their risk behaviours, such as their sexual and drug-injecting behaviour. Bias: A systematic error in the collection or interpretation of data. B-3 Appendix B, Abbreviations and Glossary Body fluids: Any fluid produced by the human body, such as blood, urine, saliva, sputum, tears, semen, mother's milk, or vaginal secretions. Fluids that commonly transmit HIV are blood, semen, pre-ejaculate, vaginal fluids, and breast milk. Bridging populations: Persons in high-risk sub-populations who interact with people of lower risk in the general population, making it more likely that the HIV epidemic will shift from concentrated to generalised. Candida albicans: The fungal causative agent of vulvovaginitis in women and inflammation of the penis and foreskin in men. Carrier: A person or animal without apparent disease who harbours a specific infectious agent and is capable of transmitting the agent to others. Case: a condition, such as HIV infection (e.g., an HIV case) or AIDS (e.g., an AIDS case) diagnosed according to a standard case definition. Case-control study: A type of observational analytic study. Enrolment into the study is based on presence (‘case’) or absence (‘control’) of disease. Characteristics such as previous exposure are then compared between cases and controls. The purpose of case control studies is to identify factors that are associated with, or explain the occurrence of, the specific disease or condition being studied. Case definition: A set of standard criteria for deciding whether a person has a particular disease or health-related condition, by specifying clinical criteria and limitations on time, place and person. Case reporting: A surveillance system in which persons who are identified as meeting the case definition are reported to public health authorities. Catchement population: A geographic area that is to be examined or surveyed. Can refer to the population served by a given clinic. Categorical surveillance system: System that deals with reporting a single disease. Categorical variable: Refers to items that can be grouped into categories, such as marital status or occupation. Cause of disease: A factor (characteristic, behaviour, etc.) that directly influences the occurrence of disease. A reduction of the factor in the population should lead to a reduction in the occurrence of disease. CD4 count: A measure of the number of CD4 cells in a millilitre (mL) of blood. The CD4 count is one of the most useful indicators of the health of the immune system and a marker for the progression of HIV/AIDS. B-4 Appendix B, Abbreviations and Glossary CD4 receptors: Markers found on the surface of some body cells, including T-cells. These receptors are targets of HIV, and thus CD4+ cells are attacked by the virus. Centers for Disease Control and Prevention (CDC): The US Department for Health and Human Services agency with the mission to promote health and quality of life by preventing and controlling disease, injury, and disability. Chancroid: An acute, sexually transmitted, infectious disease of the genitalia caused by the bacteria Haemophilus ducreyi. The infection produces a genital ulcer that may facilitate the transmission of HIV. Chlamydia trachomatis: The most common sexually transmitted bacterial species of the genus Chlamydia that infects the reproductive system. Chlamydia infection causes infection of the cervix of women and the urethra of men and is frequently asymptomatic. If left untreated, it can cause sterility in women. Clustered bar chart: A bar chart in which the columns are presented as clusters of subgroups. Also known as ‘stacked bar charts.’ Code: A unique identification for a specimen. It may or may not be linked to any personal identifying information. Cohort: A well-defined group of people who have had a common experience or exposure, who are then followed up for the incidence of new diseases or events, as in a cohort or prospective study. Cohort analysis: Analysis that involves following groups of subjects over time. Completeness of data elements: The extent to which the information requested in the case report form is provided. Completeness of reporting: One of several attributes of a surveillance system. The term refers to the proportion of cases that were reported. Completeness of reporting is also referred to as the sensitivity of the surveillance system and is determined by using an alternative (and thorough) method of identifying cases of the disease and then dividing the number of cases reported by the total number of cases identified. Completeness is often reported as a percentage. Compulsory testing: Testing that is required of all individuals in a population to be surveyed. For example, requiring HIV tests to be done on all members of a prison population. Concentrated HIV epidemic: The epidemic state in which HIV has spread to a high level in a defined sub-population, but is not well-established in the general population. This epidemic state is characterised by an HIV prevalence that is consistently >5% in at least one defined sub-population, but <1% in pregnant women in urban areas. B-5 Appendix B, Abbreviations and Glossary Confidence interval: The compound interval with a given probability (for example, 95%) that the true value of a variable such as mean, proportion, or rate is contained within the limits. Also known as ‘confidence limits.’ Confidence limits: See ‘confidence interval.’ Confidentiality: Protecting information that concerns a study participant or patient from release to those who do not need to have the information. Consecutive sampling: This sampling method consists of sampling every patient that meets the inclusion criteria until the required sample size is obtained or the survey period is over. Contact: Exposure to a source of an infection, or a person so exposed. Contagious: The characteristic of an organism or person that renders it capable of being transmitted from one person to another by contact or close proximity. Continuous variable: Items that occur in a numerical order, such as height or age. Convenience sampling: The selection of entities from a population based on accessibility and availability. The advantage of convenience sampling is that it is easy to carry out. The weakness is that the findings may not be representative of the entire community. Core data elements: Information about a patient that must be collected during a survey. Cotrimoxazole preventative therapy (CPT): Administering cotrimoxazole prophylaxis to prevent opportunistic infections among HIV- infected patients. Cotrimoxazole prophylaxis: A combination of two anti-infection drugs, sulfamethoxazole and trimethoprim, used to prevent opportunistic infections in patients with HIV. Cross-sectional survey: A survey that is conducted at a given point in time, such as during one year, rather than studying a group over time. Cryolabel: Labels designed to adhere during freezer storage. Cryovial: A vial that is designed to be stored in a freezer. Cumulative cases: the total number of cases of a disease reported or diagnosed during a specified time. Cumulative cases can include cases in people who have died. Data dictionary: Electronic files that describe the basic organisation of a project or database. They contain all of the rules that guide data entry. B-6 Appendix B, Abbreviations and Glossary Data entry: The process of entering paper records into a computer database. Data entry screens: The forms on the computer screen into which a data entry clerk enters the data. Database: A computer program that stores the variables for each patient in the survey sample or surveillance system. Demographic information: The ‘person’ characteristics of epidemiology (usually collected with “place” and “time”)—age, sex, race and occupation—used to characterise the populations at risk. Denominator: The population (or population experience, as in person-years, etc.) at risk in the calculation of a proportion or rate. The denominator is the lower portion of a fraction used to calculate a rate or ratio. Dependent variable: In a statistical analysis, the outcome variable(s) or the variable(s) whose values are a function of other variable(s). Dichotomous variable: A special type of nominal variable that has only two categories, such as male/female. Direct transmission: The immediate transfer of an agent from a reservoir to a susceptible host by direct contact or droplet spread. Disaggregated data: Data that are divided up according to different variables, to provide a more detailed analysis. Disability-adjusted life years (DALYs): A measure of burden of disease in a population obtained by combining ‘years of life lost’ and ‘years lived with disability.’ Disease burden: The size of a health problem in an area, as measured by cost, mortality, morbidity or other indicators. Disease registry: The file of data that contains reported diseases. Disease reporting: The process by which notifiable diseases are reported to the health authority. Distribution: The frequency and pattern of health-related characteristics and events in a population. In statistics, the observed or theoretical frequency of values of a variable. Double-entered: Entered twice, to avoid mistakes by identifying and correcting discrepancies. B-7 Appendix B, Abbreviations and Glossary Dysuria: Painful, frequent or difficult urination. Endemic disease: The constant presence of a disease or infectious agent within a given geographic area or population group; may also refer to the usual prevalence of a given disease within such area or group. Enzyme-linked immunoassay (EIA): A type of test that identifies antibodies to an organism such as HIV. EIAs rely on a primary antigen-antibody interaction and can use whole viral lysate of HIV or one or more antigens from the virus. Enzyme-linked immunosorbent assay (ELISA): A type of enzyme immunoassay (EIA) to determine the presence of antibodies to an infectious agent such as HIV in the blood or oral fluids. Epidemic: The occurrence of a disease (or other health-related event) at a level of increase to a baseline. For example, the high prevalence of HIV found in many parts of the world today, including sub-Saharan Africa, Latin America and South and Southeast Asia. Epidemiologic profile: A document that describes the HIV/AIDS epidemic in various populations and identifies characteristics both of HIV-infected and HIV-negative persons in geographic areas. It is composed of information gathered to describe the effect of HIV/AIDS on an area in terms of socio-demographic, geographic, behavioural and clinical characteristics. The epi profile can serve as a basis from which prevention and care needs are identified. Epidemiology: The study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to the control of health problems. Epi Info™: A freely distributed epidemiological software available on the CDC website (www.cdc.gov/epiinfo). Exclusion criteria: Characteristics of patients who should be excluded from the sample, but who would otherwise be eligible. Experimental study: A study in which the investigator specifies the exposure category for each individual (clinical trial) or community (community trial), then follows the individuals or community to detect the effects of the exposure. Factor: An intrinsic factor (age, race, sex, behaviours, etc.) that influences an individual's exposure, susceptibility, or response to a causative agent. False positives: Test results that are positive when the patient does not actually have the disease that is being tested for. B-8 Appendix B, Abbreviations and Glossary False negatives: Test results that are negative when the patient actually has the disease that is being tested for. Filter paper: Porous paper on which samples can be placed. Generalised HIV epidemic: The epidemic state in which HIV is firmly established in the general population. This epidemic state is characterised by an HIV prevalence that is consistently >1% in pregnant women. Genital discharge syndrome: This syndrome includes infections due to N. gonorrhoea and C. trachomatis. Genital ulcer syndrome: Genital lesions due to T. pallidum, H. ducreyi, HSV, C. trachomatis or C. granulomatis. Glycoprotein (HIV): Proteins on the surface of the HIV virus that bind to CD4 receptors on target cells. Gonorrhoea: An infection caused by Neisseria gonorrhoeae bacteria. Although gonorrhoea is considered primarily a sexually transmitted infection, it can also be transmitted to newborns during the birth process. Gram-negative: Bacteria that do not absorb the stain during the process of Gram staining. Gram-positive: Bacteria that do absorb the stain during the process of Gram staining. Gram stain: A laboratory method of staining microscopic slides of organisms in order to identify and classify the various types of bacteria. Bacteria are classified as either Gramnegative (does not absorb the stain) or Gram-positive (absorbs the stain). Graph: A diagram that shows a series of one or more points, lines, line segments, curves or areas, representing variations of a variable in comparison with variations of one or more other variables. Haemophilus ducreyi: The causative agent of chancroid. See ‘Chancroid.’ Health indicator: A measure that reflects, or indicates, the state of health of persons in a defined population; for example, the infant mortality rate. Health information system: A combination of health statistics from various sources, used to derive information about health status, healthcare, provision and use of services, and impact on health. Health-seeking behaviour: The actions individuals or populations take to care for their health, for example, attending a clinic or district hospital when they feel ill. B-9 Appendix B, Abbreviations and Glossary Hepatitis B virus (HBV): The causative agent of hepatitis B. The virus is transmitted by sexual contact, the use of contaminated needles and instruments, and by contaminated serum in blood transfusion. The infection may be severe and result in prolonged illness, destruction of liver cells, cirrhosis or death. Hepatitis C virus (HCV): The causative agent of hepatitis C. This virus is transmitted largely by the use of contaminated needles and instruments and by blood transfusions. The disease progresses to chronic hepatitis in up to 50% of the patients acutely infected. Herpes viruses: A group of viruses that includes herpes simplex type 1 (HSV-1), herpes simplex type 2 (HSV-2), cytomegalovirus (CMV), Epstein-Barr virus (EBV), varicella zoster virus (VZV), human herpes virus type 6 (HHV-6), and HHV-8, a herpes virus associated with Kaposi's sarcoma. Herpes simplex virus 1 (HSV-1): A virus that causes cold sores or fever blisters on the mouth or around the eyes, and can be transmitted to the genital region. Herpes simplex virus 2 (HSV-2): A virus causing painful sores of the anus or genitals. While this is a sexually transmitted infection, it may be transmitted to a newborn child during birth from an infected mother. High-risk behaviours: Behaviours that increase the risk that a person will contract a disease. High-risk group: A group in the community with an elevated risk of disease, often because group members engage in some form of risky behaviour. Highly active antiretroviral therapy (HAART): The use of at least three ARV drugs in combination to suppress viral replication and progression of HIV disease by reducing the viral load to undetectable levels. Histogram: A graph that represents a frequency distribution by means of rectangles whose widths represent class intervals and whose heights represent corresponding frequencies. HIV-1: A type of HIV with slight genetic variations from HIV-2. More easily transmitted than HIV-2. HIV-2: A type of HIV with slight genetic variations from HIV-1. Less easily transmitted than HIV-1. HIV/AIDS case surveillance: The identification and reporting of persons meeting the HIV and AIDS case definitions to permit public health authorities to track the disease over time. Also known as ‘HIV/AIDS case reporting.’ B-10 Appendix B, Abbreviations and Glossary HIV-negative: Showing no evidence of infection with HIV (for example, absence of antibodies against HIV) in a blood or tissue test. HIV-positive: Showing indications of infection with HIV (for example, presence of antibodies against HIV) based on a test of blood or tissue. HIV sub-types: Distinct lineages of HIV that contain genetic differences. HIV viral suppression: Lowering the level of HIV RNA in plasma, below the threshold of detection. Human immunodeficiency virus (HIV): A retrovirus that causes AIDS by infecting Tcells of the immune system. Human papilloma virus (HPV): A causative agent of genital warts. Immune response: The activity of the immune system against foreign substances such as infectious agents, including bacteria and viruses. Immune system: The body's complicated natural defence against disruption caused by invading foreign agents (for example, microbes or viruses). Immunodeficient: A situation in which a patient’s health is compromised because his/her immune system is insufficient to ward off infections, thus making the person susceptible to certain diseases that they would not ordinarily develop. Immunology: The science of the system of the body that fights infections. Impact evaluation: An evaluation of a programme that determines what the impact of the programme is, as opposed to ‘process evaluation.’ Impact indicators: A standardised set of indicators developed by UNAIDS to help monitor HIV prevalence in particular populations. Incidence: A measure of the frequency with which an event, such as a new case of illness, occurs in a population over a period of time. The denominator is the population at risk; the numerator is the number of new cases occurring during a given time period. Inclusion criteria: Characteristics required in study participants, in order to be considered for the sample. Incubation period: A period of sub-clinical or unapparent pathologic changes following exposure, ending with the development of the infection. Independent variable: An exposure, risk factor, or other characteristic being observed or measured that is hypothesised to influence the outcome (that is, the dependent variable). B-11 Appendix B, Abbreviations and Glossary Indicators: Specific data that are gathered to measure how well a prevention or treatment programme is doing. Indicator mutations: Genotypic mutations that best predict resistance to a specific antiretroviral agent. Indirect transmission: The transmission of an agent carried from a reservoir to a susceptible host by suspended air particles or by animate (vector) or inanimate (vehicle) intermediaries. Infectiousness: The ability of an organism to cause infection. Infectivity: The proportion of persons exposed to a causative agent who become infected by an infectious disease. Informed consent: The permission granted by a patient or a participant in a research study after he or she has received comprehensive information about a research study or medical procedure. Informed consent protects the person’s freedom of choice and respects his or her autonomy with regard to decisions affecting his or her body and health. Integrated disease surveillance (IDS): An approach to surveillance in which communicable diseases are prioritised. Surveillance for all of the high-priority diseases is conducted in an integrated manner and is initiated at the district level. These diseases have a high potential for epidemic spread and can be controlled through public health measures. An example is chlamydia. Interval width: The range of certainty as to the true value of the calculated outcome value. For example, in the case of a 95% confidence interval, there is 95% certainty that the true outcome lies between the upper and lower bound of the interval. Statistically, this interval is equal to two standard deviations on either side of the calculated outcome value. Isolates: A population of bacteria or other cells that has been isolated and cultured. Isoniazid preventive therapy (IPT): Giving isoniazid to individuals with latent Mycobacterium tuberculosis infection, in order to prevent the progression to active disease. Klebsiella granulomatis: The bacterial causative agent of granuloma inguinale or donovanosis. Laboratory-based reporting: A surveillance system in which the reports of cases come from clinical laboratories. B-12 Appendix B, Abbreviations and Glossary Laryngeal TB: Tuberculosis involving the larynx, producing ulceration of the vocal cords and elsewhere on the mucosa, and commonly attended by hoarseness, cough, pain on swallowing, and hemoptysis. Latent period: A period of unapparent infection following exposure to a pathogen, ending with the onset of symptoms of chronic disease. Linked anonymous HIV testing: In linked anonymous testing, a person agrees to have an HIV test, but the specimen is labelled with a code without a name or identifiers that could reveal the person’s identity. This method is voluntary and requires obtaining informed consent and making the test results available (with appropriate counselling) to the person tested. Linked confidential HIV testing: In linked confidential testing, a person agrees to have an HIV test with the assurance that the test result will be kept confidential and only selected health-care providers may be informed. This method is voluntary and requires obtaining informed consent and discussing the test results with the person. Linked confidential testing also allows for the collection of more detailed demographic and riskbehaviour information. Linking: Refers to whether a tested individual’s names or identifying information is associated with his or her HIV test results. Low-level HIV epidemic: The epidemic state in which HIV has not reached significant levels in any sub-population, although HIV infection may have existed for many years. This epidemic state is characterised by an HIV prevalence that has not consistently exceeded 5% in any defined sub-population. This state suggests that networks of risk are rather diffuse or that the virus has only been recently introduced. Lymphocytes: A type of white blood cell that is involved with fighting infections in the body. The T lymphocyte is the cell that HIV infects and destroys. Macrophage cells: Tissue cell derived from monocytes that protect the body against infections. Mandatory testing: Testing that is required of a patient if he or she is to obtain certain services; for example, mandatory HIV testing of individuals who request marriage certificates. Margin of error: An estimation of the extent to which a survey’s reported percentages would vary if the same survey were taken multiple times. Mean: The measure of central location commonly called the average. It is calculated by adding together all the individual values in a group of measurements and dividing by the number of values in the group. B-13 Appendix B, Abbreviations and Glossary Microbe: A micro-organism, such as a bacteria or virus. Microbicide: A chemical or other agent that destroys microbes. Monitoring: Evaluating a programme’s performance over time. Monocyte: A type of white blood cell. Morbidity: Any departure, subjective or objective, from a state of physiological or psychological well-being. Mortality rate: A measure of the frequency of occurrence of death in a defined population during a specified interval of time. Mortality rate, infant: A ratio expressing the number of deaths among children under one year of age reported during a given time period, divided by the number of births reported during the same time period. Natural history of disease: The temporal course of disease. Negative controls: Specimens known to be negative and used to ensure that a laboratory reagent is working properly prior to testing specimens from patients. Negative predictive value: In HIV testing, the probability that a person with a negative test result is not infected. Also known as ‘predictive value negative.’ Neisseria gonnorrhoeae: The causative agent of gonorrhoea. Nominal variable: Variables that represent discrete categories without a natural order, such as marital status. Non-vesicular genital ulcer disease: An STI syndrome characterised by ulcers and the absence of vesicles. Notifiable disease: A disease for which law or regulation requires reporting to the health authority. Numerator: The upper portion of a fraction. In a rate, the numerator is usually the number of people infected. Opportunistic infections: Illnesses caused by various organisms infecting immunodepressed persons that usually do not cause disease in persons with healthy immune systems. Persons with advanced HIV infection (that is, AIDS) suffer opportunistic illnesses of the lungs, brain, eyes, and other organs. These illnesses are referred to as AIDS-defining illnesses or conditions. B-14 Appendix B, Abbreviations and Glossary Optical density: The intensity of colour, as measured by a machine in an EIA HIV antibody test, indicating whether the patient’s sample is HIV-positive. Ordinal variable: Variables that have a natural order, such as level of education. Over-sampling: Adding additional members of a sub-group during a survey, in order to have a sufficiently large sample to get stable estimates of prevalence. Pandemic: An epidemic occurring over a very wide geographic area (several countries or continents) and usually affecting a large proportion of the population. HIV is an example of a pandemic. Parenteral transmission: Transmission of an infectious agent through blood. Parenteral transmission of HIV can occur from the sharing of injection drug equipment, from transfusions with infected blood or blood products, or from needle stick injuries. Participation bias: Error in results from a study that is due to differences in characteristics between those who participate in a survey and those who do not. For example, persons who already know they are HIV-infected may find testing unnecessary; those who suspect they are HIV-infected may decline testing in order to avoid stigma. Passive surveillance: A system in which a healthcare provider or worker notifies the health authority of any cases of these diseases, as opposed to ‘active surveillance.’ Pathogen: A biological agent that causes disease or illness to its host (for example, bacteria or virus). Perinatal transmission: Transmission of an infectious agent, such as HIV, from mother to baby before, during, or after the birth process. Also known as ‘vertical transmission’ or ‘mother-to-child transmission.’ Period prevalence: The amount a particular disease that is present in a population over a specified period of time. Pie chart: A circular chart in which the size of each ‘slice’ is proportional to the frequency of each category of a variable. A pie chart compares sub-classes or categories to the whole class or category using different coloured slices. Point estimate: The amount of a particular disease present in a population at a single point in time. Also known as ‘point prevalence’ or ‘point incidence.’ Population: The total number of inhabitants of a given area or country. In sampling, the population may refer to the unit from which the sample is drawn, not necessarily the total population of people. B-15 Appendix B, Abbreviations and Glossary Population-based sero-survey: A type of sero-survey that uses a probability sample of a population defined by geographic boundaries, such as villages or provinces, in order to obtain a direct measure of HIV prevalence in a general population. Population sub-group: A group within a population that share certain characteristics or behaviours. Positive controls: Specimens known to be positive, as used in proficiency testing, for example. Positive predictive value: The probability that a person with a positive test result is infected; in surveillance this refers to the proportion of cases reported by a surveillance system or classified by a case definition which are true cases. Also known as ‘predictive value positive.’ Prevalence: The proportion of persons in a given population with a disease or condition at a given point in time. Prevalence assessment: Surveys that determine prevalence of a disease in a population. Prevalence monitoring: Monitoring prevalence repeatedly over time to track trends. Priority communicable disease: These are diseases that have the potential for epidemic spread and can be controlled through public health action. They are the diseases included in the Integrated Disease Surveillance form. Probability sampling: A sampling scheme that ensures that each entity in a population has a known, non-zero chance of being selected. Process evaluation: An evaluation of a programme that determines how well the programme is functioning, as opposed to ‘impact evaluation.’ Proficiency panel: A set of samples designed to judge the accuracy and precision of a laboratory. A necessary component of laboratory quality assurance. In the context of HIV testing, this may be a group that contains approximately six HIV-negative and HIVpositive (weak to strong) specimens representative of the HIV strains circulating in a country and of the different stages of HIV infection. The panel should be sent to participating laboratories once or twice each year for quality assurance testing. Proficiency testing: The act of sending a proficiency panel to a laboratory, designed to test the accuracy and precision of that laboratory. Prophylaxis: Treatment to prevent or suppress infection, often given before a person’s exposure to the pathogen. For example, the treatment given to mothers during childbirth in order to prevent infection of the newborn child. B-16 Appendix B, Abbreviations and Glossary Proportion: The relationship of a part to the whole, in which the numerator is included in the denominator; often depicted as a percent by multiplying by 100. Protocol: The detailed plan for conducting a research study or other activities in which specific steps are required, including surveillance activities. Quality assurance: The dynamic and ongoing process of monitoring a system for reproducibility and reliability of results that permits corrective action when established criteria are not met. Quality control: A laboratory’s internal processes for running specimens to ensure that the test equipment and reagents function properly. Random sample: A sample derived by selecting individuals such that each individual has the same probability of selection. Range: The difference between the largest and smallest values in a distribution. Rapid HIV test: An HIV antibody test that is simple, does not require any reagents or equipment other than what is contained in the kit and provides results in less than 20 minutes. Rapid plasma reagin test (RPR): A common serologic test for syphilis. Specifically, a non-treponemal test for anticardiolipin antibodies. Rate: An expression of the frequency with which an event occurs in a defined population. Ratio: The quantitative relationship between two or more things; the value obtained by dividing one quantity by another. Reference laboratory: A laboratory that functions as a recognised centre of expertise and standardisation of diagnostic techniques. Relative risk: A comparison of the risk of some health-related event, such as disease or death, in two groups. For example, an HIV-uninfected individual who has sexual intercourse with an HIV-infected person once a year may have a 5% chance of infection. But if the uninfected individual uses a condom every time, the relative risk when compared to condom non-use is 15%. Representative sample: A sample whose characteristics correspond to those of the original population or reference population. Representativeness: The extent to which the sample resembles the true population. B-17 Appendix B, Abbreviations and Glossary Resistance: The ability of an organism, such as HIV, to overcome the inhibitory effect of a drug. Retrovirus: A type of RNA virus that produces reverse transcriptase, which converts RNA into DNA. HIV is an example of a retrovirus. Reverse-transcription: The process by which HIV’s genetic material (RNA) is transformed into DNA, which allows it to fuse with the host’s genetic material (DNA). Risk: The probability that an event will occur; for example, that an individual will become ill within a stated period of time. Risk factor: An aspect of personal behaviour or lifestyle; an environmental exposure; an inborn, inherited, or demographic characteristic. Associated with an increased occurrence of disease or other health-related event or condition. For example, injection drug use is a risk factor for acquiring HIV. Sample: A selected sub-set of a population. There are specific types of samples used in surveillance and epidemiology such as convenience, systematic, population-based and random. Sample size: The number of subjects to be used in a given study. Sampling scheme: Procedure for choosing individuals to be included in a sample. Scale line graph: A graph that represents frequency distributions over time where the Yaxis represents frequency and the X-axis represents time. Second-generation surveillance: Built upon a country's existing data collection system, second-generation HIV surveillance systems are designed to be adapted and modified to meet the specific needs of differing epidemics. This form of surveillance aims to improve the quality and diversity of information sources by developing and implementing standard and rigorous study protocols, using appropriate methods and tools. Second generation surveillance refers to activities outside of those activities generally considered to be a part of routine case surveillance, such as case reporting and sentinel sero-surveys and uses additional sources of data to gain additional understanding of the epidemic. It includes biological surveillance of HIV and other STIs, as well as systematic surveillance of the behaviours that spreads them. Selection bias: A systematic error in the process respondent selection for a study or survey. Sensitivity: The proportion of persons with disease who are correctly identified by a screening test or case definition as having disease. Sentinel case reporting: Reporting cases of a disease from sentinel sites. B-18 Appendix B, Abbreviations and Glossary Sentinel populations: Populations that are subject to sentinel surveillance activities. They may not necessarily be representative of the general population, but rather they might be the first affected by HIV. Examples include sexually transmitted infection patients or truck drivers. Sentinel sites: Sites at which sentinel surveillance activities take place, including clinics attended by individuals who may or may not be representative of the general population but are likely to represent groups initially infected or at higher risk for infection than the general population. Sentinel surveillance: A surveillance system in which a pre-arranged sample of reporting sources at ‘watch post’ or ‘sentinel’ sites agrees to report all cases of one or more notifiable conditions. Often designed to provide an early indication of changes in the level of disease. Depending on the nature of the population surveyed, these data may be representative of the general population, or they may simply give more detailed information about the populations tested. Sero-conversion: The development of antibodies to a particular microbe. When people develop antibodies to HIV, they ‘sero-convert’ from HIV-negative to HIV-positive. Serologic test: A blood test that determines the presence of antibodies to particles such as viruses. For example, a blood test that detects the presence of antibodies to HIV. Sero-prevalence: The proportion of a population that is infected, as determined by testing blood for the appropriate antibody. For example, the proportion of a population that is infected with HIV, as determined by testing for HIV antibodies in blood samples. Sero-prevalence surveys: Surveys that estimate HIV prevalence by testing blood for HIV antibody. Sero-status: Refers to the presence/absence of antibodies in the blood. For example, the presence or absence of HIV. Sero-surveillance: Collecting blood samples for the purpose of surveillance. Latent, subclinical infections and carrier states can thus be detected, in addition to clinically overt cases. This is especially important in the case of HIV and other STIs, which often have a long latent period before symptoms are apparent. Sexual transmission: Transmission of an infectious agent, such as HIV, that occurs predominately through unprotected vaginal or anal intercourse, and less frequently through oral intercourse. Sexually transmitted infection (STI): Diseases that are spread by the transfer of organisms from person to person during sexual contact. B-19 Appendix B, Abbreviations and Glossary Simple random sampling: A sampling method that requires the use of a random number table or other method (for instance, computer-based) to generate random numbers that identify the patients to be included in the sample. Skewed: A distribution that is asymmetrical and does not follow a normal (bell-shaped) distribution. Specificity: The proportion of persons without disease who are correctly identified by a screening test or case definition as not having disease. Stakeholder group: Those with an interest in the results of surveillance activities. Includes public health practitioners, healthcare providers, data providers and users, representatives of affected communities; governments at the district, province and national levels; members of professional and private non-profit and donor organisations. Stigma: A mark of disgrace or shame. For example, in some societies, being infected with HIV causes a person to be stigmatised. Stratified sampling: Stratified sampling is generally used to obtain a representative sample when the population is heterogeneous, or dissimilar, where certain homogeneous, or similar, sub-populations can be isolated (strata). A stratified sample is obtained by taking samples from each stratum or sub-group of a population. Sub-population: See ‘population sub-group.’ Sufficient cause: A causal factor or collection of factors whose presence is always followed by the occurrence of the effect (of disease). Surveillance: The systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis, to gain knowledge of the pattern of disease occurrence and potential in a community, in order to control and prevent disease in the community. Surveillance sites: The places from which case reports are obtained. This includes sites in which universal reporting and sentinel reporting are done. These may be healthcare facilities or other locations in which sero-surveys are conducted. Survey protocol: A manual that describes all the steps and tasks involved in a serosurvey. Susceptible: Vulnerable or predisposed to a disease. Symptomatic: Exhibiting symptoms. Symptoms: Any perceptible, subjective change in the body or its functions that indicates disease or phases of disease, as reported by the patient. B-20 Appendix B, Abbreviations and Glossary Syndrome: A group of symptoms as reported by the patient and signs as detected in an examination that together are characteristic of a specific condition. Syndromic prevalence: The prevalence of a particular syndrome, or set of symptoms, in a given population. Usually calculated when testing equipment is not available to verify the presence of particular pathogen in a laboratory. Syndromic case reporting: A surveillance system in which a diagnosis of the infection is made through the presence of symptoms using a standard case definition. Frequently used for surveillance of sexually transmitted infections in countries in which access to laboratory testing may be limited. Syphilis: A sexually transmitted disease resulting from infection with the bacterium Treponema pallidum. Syphilis can also be acquired by newborns from their mothers during pregnancy. Systematic sampling: A sampling method that consists of randomly selecting the initial patient who meets the inclusion criteria and then selecting every ‘nth’ (for example, third or fifth) eligible patient thereafter until the predetermined sample size is reached or the survey period is over. Systemic: Concerning or affecting the body as a whole. T-helper lymphocyte: Also known as ‘T-cell.’ Immune cells that seek and attack invading organisms. HIV enters T-cells through their CD4 receptor proteins, making Tcells virtual HIV-factories. Table: A set of data arranged in rows and columns. Testing (HIV) strategy: The use of an appropriate HIV test or combination of HIV tests. The choice of testing strategy used is based on the objective of the test, the sensitivity and specificity of the test, and HIV prevalence in the population being tested. Timeliness of reporting: One of several attributes of a surveillance system. Timeliness may be defined as the time period between the diagnosis of the disease and the receipt of a case report form at the health district. Transmission: Any mode or mechanism by which an infectious agent is spread through the environment or to another person. Trend: A long-term movement or change in frequency, usually upwards or downwards. Treponema pallidum: The bacterial causative agent of syphilis. B-21 Appendix B, Abbreviations and Glossary Triangulation: The process of examining several different sets of data, which are measuring different things, to come up with a better understanding of how and where an epidemic is spreading. For example, the use of antenatal clinic data, census data, and registered deaths in order to create a more complete picture of the AIDS burden in a country. Trichomonas vaginalis: A sexually transmitted protozoan parasite that causes the vaginal infection Trichomoniasis, characterised by itching, burning and vaginal discharge. Reinfection is common if sexual partners are not treated simultaneously. True positives: Test results that are positive when the patient actually has the disease that is being tested for. True negatives: Test results that are negative when the patient actually does not have the disease that is being tested for. Universal case reporting: A surveillance system in which all persons who are identified as meeting the case definition for a particular disease are reported. For example, all persons with HIV who receive care at any healthcare facility are reported. This is in contrast to sentinel reporting, in which only selected sentinel sites report all persons who meet the case definition. Universal precautions: Recommendations issued by CDC to minimise the risk of transmission of bloodborne pathogens, particularly HIV and HBV, by healthcare and public safety workers. Barrier precautions are to be used to prevent exposure to blood and certain body fluids of all patients. Unlinked anonymous testing: In unlinked anonymous testing, a sample of blood originally collected for other purposes is tested for HIV after all information that could identify the source of the blood is eliminated from the sample. Urethritis: Inflammation of the urethra. Vaccine: When injected into an individual, a vaccine protects against subsequent infection by a particular organism or results in a less severe illness should infection occur. Currently there is no vaccine for HIV. Validity: The degree to which a measurement actually measures or detects what it is supposed to measure. Variable: Any characteristic or attribute that can be measured. Venereal Disease Research Laboratory test (VDRL): A common serologic test for syphilis. Specifically, a non-treponemal test for anticardiolipin antibodies. Vertical surveillance system: See ‘categorical surveillance system.’ B-22 Appendix B, Abbreviations and Glossary Vertical transmission: See ‘perinatal transmission.’ Vesicular: Pertaining to vesicles or blisters. Viral load: The amount of HIV in the circulating blood. Also known as ‘viral burden’ or ‘viral dose.’ Viral load test: Test that measures the quantity of HIV in the blood. Virulence: The relative capacity of an organism to overcome the body’s immune defences. Virus: Micro-organisms that typically contain a protein coat surrounding nucleic acid (RNA or DNA) that are capable of growth only within living cells. Vital records: Certificates of birth, death, marriage and divorce that are required by law. Voluntary counselling and testing (VCT): A program that provides both counselling and testing services to communities, allowing persons who are tested to obtain emotional and medical support before and after their HIV tests. Western blot: A type of HIV test, Western blot uses an electroblotting method in which proteins are transferred from a gel to a thin, rigid support and detected by binding of labelled antibody to HIV. Width: See ‘interval width.’ Years of potential life lost: A measure of the impact of premature mortality on a population, calculated as the sum of the differences between some predetermined minimum or desired life span and the age of death for individuals who died earlier than that predetermined age. B-23 Appendix B, Abbreviations and Glossary B-1 Appendix C, Useful Links Appendix C, Useful Links The Caribbean Epidemiological Centre www.carec.org CAREC is a public health information, service and consulting organisation dedicated to providing information that people need to improve and prevent disease in the Caribbean. The CAREC Reporting Tool http://carec.net/index.html The CAREC reporting tool is a query database that allows public access to AIDS surveillance data from CAREC member countries. Cochrane HIV/AIDS Group An affiliate of the International AIDS Society and the UCSF AIDS Research Institute, the Cochrane Collaborative Review Group on HIV Infection and AIDS is an international network of healthcare professionals, researchers and consumers working to prepare, maintain and disseminate systematic reviews on the prevention and treatment of HIV infection and AIDS. www.igh.org/Cochrane/ Centers for Disease Control and Prevention (CDC) CDC serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and education activities designed to improve the health of the people of the United States. www.cdc.gov Global AIDS Program (CDC) The Global AIDS Program (GAP) exists to help prevent HIV infection, improve care and support and build capacity to address the global HIV/AIDS pandemic. www.cdc.gov/nchstp/od/gap Division of AIDS and Health and Behavior Research of the National Institute of Mental Health The Division of AIDS and Health and Behavior Research (DAHBR) supports research and research training to: develop and disseminate behavioral interventions that prevent HIV/AIDS transmission, clarify the pathophysiology and alleviate the neuropsychiatric consequences of HIV/AIDS infection and use a public health model to reduce the burden of mental illness www.nimh.nih.gov/dahbr/dahbr.cfm Division of HIV/AIDS Prevention (CDC) The mission of the Division of HIV/AIDS Prevention is to prevent HIV infection and reduce the incidence of HIV-related illness and death, in collaboration with community, state, national and international partners. www.cdc.gov/hiv/dhap.htm C-1 Appendix C, Useful Links Division of STD Prevention (CDC) The Division of STD Prevention provides national leadership through research, policy development and support of effective services to prevent sexually transmitted diseases (including HIV infection) and their complications, such as enhanced HIV transmission, infertility, adverse outcomes of pregnancy and reproductive tract cancer. www.cdc.gov/std Epidemiological Fact Sheets on HIV/AIDS and Sexually Transmitted Infections In these fact sheets you can find country-specific information on numerous key indicators relevant to HIV. www.who.int/hiv/pub/epidemiology/pubfacts Epidemiological Information on HIV/AIDS from UNAIDS www.unaids.org/en/HIV_data/Epidemiology/default.asp Family Health International (FHI) Family Health International has pioneered ways to curtail the spread of HIV/AIDS. Many of the HIV prevention "best practises" in use today have emerged from FHI’s work in more than 60 countries. www.fhi.org/en/HIVAIDS Fogarty International Center The Fogarty International Center promotes and supports scientific research and training internationally to reduce disparities in global health. www.fic.nih.gov The Global Fund to Fight AIDS, Tuberculosis and Malaria The Global Fund was created to finance a dramatic turnaround in the fight against AIDS, tuberculosis, and malaria. These three diseases kill more than six million people a year. This massive scaling-up of resources is already supporting aggressive interventions against all three. www.theglobalfund.org HIV InSite HIV InSite is developed by the Center for HIV Information (CHI) at the University of California, San Francisco (UCSF). HIV InSite's mission is to be a source for comprehensive, in-depth HIV/AIDS information and knowledge. hivinsite.ucsf.edu National Center for HIV, STD, and TB Prevention (CDC) Umbrella organisation at the CDC for the divisions listed above. www.cdc.gov/nchstp/od/nchstp.html C-2 Appendix C, Useful Links National Institute of Allergy and Infectious Diseases (NIAID) News releases from the NIH's primary AIDS research institute, plus AIDS reagent programme catalogue and other information. www.niaid.nih.gov National Institutes of Health (NIH) National Institutes of Health is the federal focal point for medical research in the United States. The NIH, comprising 27 separate institutes and centres, is one of eight health agencies of the Public Health Service, which, in turn, is part of the U.S. Department of Health and Human Services. Simply described, the goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose and treat disease and disability. www.nih.gov National Library of Medicine (NLM) NLM provides a wide variety of resources related to the biomedical and health sciences. The website has information on how to access the various NLM databases, including how to establish an account for free access to its HIV/AIDS databases. www.nlm.nih.gov NIH Office of AIDS Research (OAR) NIH’s OAR is located within the Office of the Director of NIH and is responsible for the scientific, budgetary, legislative and policy elements of the NIH AIDS research programme. www.nih.gov/od/oar Sexually Transmitted Diseases Information from the NLM and NIH NLM provides a wide variety of resources related to the biomedical and health sciences. This web site provides a collection of information on STIs, including articles about prevention, diagnosis, research, and statistics. http://www.nlm.nih.gov/medlineplus/sexuallytransmitteddiseases.html Sexually Transmitted Diseases: Journal of the American Sexually Transmitted Disease Association Sexually Transmitted Diseases publishes original, peer-reviewed articles on clinical, laboratory, immunologic, epidemiologic, sociologic, and historical topics pertaining to sexually transmitted diseases and related fields. Reports from the CDC and NIH provide up-to-the-minute information. Included in each issue are studies and developments from around the world. www.stdjournal.com/ C-3 Appendix C, Useful Links International Society for Sexually Transmitted Diseases Research (ISSTDR) The ISSTDR promotes research related to all aspects of sexually transmitted diseases. The aim of the ISSTDR 2005 is to provide a forum for investigators and policymakers and to discuss recent advances in research and control of all STIs, including HIV. The 16th biennial meeting of the ISSTDR was held July 10–13, 2005 in Amsterdam, the Netherlands. The meeting was organised jointly by Dutch and Belgian STD researchers. www.isstdr.org/ Sexually Transmitted Infections information from Planned Parenthood This website, maintained by the United States branch of the International Planned Parenthood Federation, provides basic information about common STIs. The materials presented are suitable for younger audiences, and include fact sheets and guidelines to safer sex. www.plannedparenthood.org/sti/ International Union Against Sexually Transmitted Infections (IUSTI) IUSTI is the oldest international organisation in the field whose object is the achievement of international cooperation in the control of sexually transmitted diseases, including HIV infection. IUSTI is especially concerned not only with the medical aspects but the social and epidemiological aspects of the control of sexually transmitted diseases and increasingly HIV/AIDS. www.iusti.org/ Sexually Transmitted Infections Information From the WHO This page, maintained by the World Health Organization, provides links to descriptions of activities, reports, news and events, as well as contacts and cooperating partners in the various WHO programmes and offices working on this topic. Also included are links to related web sites and topics. www.who.int/topics/sexually_transmitted_infections/en/ UNAIDS (Joint United Nations Programme on HIV/AIDS) As the main advocate for global action on HIV/AIDS, UNAIDS leads, strengthens and supports an expanded response aimed at preventing the transmission of HIV, providing care and support, reducing the vulnerability of individuals and communities to HIV/AIDS and alleviating the impact of the epidemic. www.unaids.org UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance Global surveillance of HIV/AIDS and STIs is a joint effort of the WHO and UNAIDS. The UNAIDS/WHO working group on global HIV/AIDS and STI surveillance, initiated in November 1996, is the co-ordination and implementation mechanism for UNAIDS and WHO to compile and improve the quality of data needed for informed decision-making and planning at national, regional and global levels. www.unaids.org/en/HIV_data/Epidemiology/epiworkinggrp.asp C-4 Appendix C, Useful Links United States Agency for International Development USAID is an independent federal government agency that receives overall foreign policy guidance from the Secretary of State. The agency works to support long-term and equitable economic growth and to advance U.S. foreign policy objectives by supporting: economic growth, agricultural and trade, global health, democracy, conflict prevention and humanitarian assistance. www.usaid.gov United States Department of Commerce, U.S. Census Bureau’s International Programs Center The International Programs Center, part of the Population Division of the U.S. Bureau of the Census, conducts demographic and socio-economic studies and strengthens statistical development around the world through technical assistance, training, and software products. The IPS maintains an HIV/AIDS Surveillance database, the Monitoring the AIDS Pandemic (MAP) Network, and a series of HIV/AIDS country profiles. http://www.census.gov/ipc/www Veterans Health Administration: Public Health Strategic Health Care Group, AIDS Information Center Provides a variety of educational links related to HIV/AIDS care, treatment, policy and research. Detailed information is also provided on blood exposure and needle stick safety in healthcare settings as well as treatment guidelines and recommendations. www.hiv.va.gov/vahiv?page=pt-home World Bank, The Global HIV/AIDS Program The Global HIV/AIDS Program was created in 2002 to support the World Bank’s efforts to address the HIV/AIDS pandemic from a cross-sectoral perspective. The program offers global learning and knowledge sharing on approaches and best practises to addressing HIV/AIDS. http://www1.worldbank.org/hiv_aids/globalprogram.asp World Health Organization (WHO) The World Health Organization is the United Nations specialised agency for health. WHO's objective, as set out in its Constitution, is the attainment by all peoples of the highest possible level of health. WHO is governed by 192 Member States through the World Health Assembly. The Health Assembly is composed of representatives from WHO's Member States. www.who.int WHO: Department of HIV/AIDS The HIV/AIDS Department co-ordinates a strategic, organisation-wide response to the HIV/AIDS epidemic and enables WHO to provide enhanced technical support in HIV/AIDS to countries and regional offices. www.who.int/hiv/en C-5 Appendix C, Useful Links WHO HIV/AIDS Programme WHO and its HIV/AIDS department work within the family of UNAIDS co-sponsors to facilitate multi-sectoral efforts to respond to the HIV/AIDS epidemic. WHO specifically serves as the convening agency within the United Nations system for HIV/AIDS treatment, care and support, as well as for preventing the mother-to-child transmission of HIV. www.who.int/hiv WHO HIV/AIDS Surveillance A good selection of key HIV/AIDS surveillance reports and documents, including the following: New strategies for HIV/AIDS surveillance in resource-constrained countries Ethical issues to be considered in second generation surveillance Guidelines for conducting HIV sentinel serosurveys among pregnant women and other groups HIV/AIDS Epidemiological Surveillance Update for the WHO African Region 2002 Guidelines for Second-Generation HIV Surveillance www.who.int/hiv/pub/surveillance C-6 Appendix D, Answers to Warm-Up Questions and Case Studies Appendix D, Answers to Warm-Up Questions and Case Studies Answers are provided in italics for each unit’s warm-up questions and case study. Answers to the questions within the unit are not included. Unit questions are designed to stimulate small group discussion among participants in the workshop or class. Unit 1 Answers Warm-up questions 1. True or false? Almost 40 million people worldwide are infected with HIV. True. UNAIDS estimates that 39.4 million adults and children were living with HIV/AIDS in 2004. 2. What region of the world has been most affected by HIV/AIDS, with an infection prevalence of over 30% in some countries? Sub-Saharan Africa. According to UNAIDS, the region is home to 64% of people living with HIV/AIDS worldwide. 3. Which region of the world has the second-highest HIV prevalence? The Caribbean is the second-most affected region in the world. In the Caribbean, AIDS is the leading cause of death among adults (15–44 years) and claimed an estimated 27 000 [18 000–37 000] lives in 2005. 4. What region in the Caribbean has been most affected by HIV/AIDS? Hispaniola Island, which includes Haiti and the Dominican Republic, is the epicentre of the HIV epidemic in the Americas. 5. The major factor that accounts for the prevalence rates of HIV/AIDS in the Caribbean is: a. injection drug use c. homosexual transmission d. heterosexual transmission e. blood exposure from unsafe medical practises f. all of the above In the Caribbean, the primary mode of sexual transmission has changed from being predominantly homosexual to being a mosaic of homo/bi and heterosexual epidemics. Heterosexual transmission accounts for the majority of HIV/AIDS cases in the Caribbean. Injecting drug use is responsible for a minority of HIV infections and only contributes significantly to the spread of HIV in Bermuda. D-1 Appendix D, Answers to Warm-Up Questions and Case Studies Case study Cariba is a Caribbean nation that had its earliest cases of AIDS recognised in 1986. Data below are based on estimates of HIV prevalence by parish. HIV prevalence (%) by parish, Cariba, 1995-2002. Parish St. Mary Kingstown Arima St. James Yotown 1995 1998 .2 0.5 1.0 0.1 0.4 2000 0.5 0.7 2.0 0.7 0.9 2002 1.0 0.9 2.7 2.8 1.3 1.1 0.8 2.9 3.8 1.2 a. What parish has historically had the greatest proportion of its population infected with HIV? Arima. b. What are prominent recent trends? Prominent recent trends are: continued slow growth in St. Mary and Arima, levelling off or decrease in Kingstown and Yotown and rapid growth in St. James. c. In 2002, which parish had the highest prevalence? Is the epidemic increasing or decreasing in this parish? St. James. The epidemic is increasing rapidly. D-2 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 2 Answers Warm-up questions 1. Which body cells does HIV infect? b. respiratory cells c. skin cells d. red blood cells e. white blood cells HIV infects white blood cells, which are involved with protecting the body against infection as part of the immune system. These include lymphocytes and macrophages. 2. How many major strains of HIV exist? Two: HIV-1 and HIV-2. 3. Which of the following is not a method of HIV transmission? a. sexual intercourse b. casual physical contact c. blood exchange d. mother-to-foetus transmission HIV transmission is transmitted through body fluids, not through casual physical contact. 4. What type of infectious agent is HIV? a. bacterium b. virus c. prion d. none of the above HIV is a virus. HIV stands for ‘human immunodeficiency virus.’ 5. True or false? HIV infection and the onset of AIDS occur simultaneously. True False False. AIDS is characterised by the clinical appearance of symptoms. It can occur years after the initial HIV infection. 6. Which region of the world has the greatest diversity of HIV sub-types, making the development of one unique treatment or vaccine difficult? Sub-Saharan Africa has the greatest diversity of HIV sub-types. This region has not only the highest HIV prevalence levels, but also the greatest diversity of sub-types, making treatment especially difficult. D-3 Appendix D, Answers to Warm-Up Questions and Case Studies Warm-up questions, continued 7. Which of the following is associated with increased risk of sexual transmission of HIV? a. failure to use a male or female condom b. a greater number of sexual partners c. a high viral load in an infected partner d. all of the above The failure to use a condom allows the virus to pass more easily from an infected to an uninfected person. The more sexual partners an individual has, the higher the risk that the one of them is infected with HIV. A greater amount of virus in the bodily fluids increases the chances that the virus will be transmitted to the uninfected partner. 8. True or false? The presence of existing sexually transmitted infections (STIs) increases the risk of acquiring HIV during sexual intercourse. True False True. The inflammation and ulceration caused by existing STIs makes it easier for HIV to enter the body. 9. List the three main types of antiretroviral drugs used to treat HIV infection. a. nucleoside reverse transcriptase inhibitors (NRTIs) b. non-nucleoside reverse transcriptase inhibitors (nNRTIs) c. protease inhibitors (PIs) 10. Which of the following fatal opportunistic infections commonly occur(s) in AIDS patients? a. herpes zoster b. fungal infections c. tuberculosis (TB) d. all of the above AIDS patients have weaker immune systems, making it easier for the patients to acquire these opportunistic infections. 11. True or false? A vaccine for the prevention of HIV infection is currently available. True False False. While vaccines are being researched and may be available many years in the future, currently there is no HIV vaccine. 12. True or false? Some STIs, such as chlamydia, are biologically more easily acquired by young women, making them more susceptible to HIV infection. True False D-4 Appendix D, Answers to Warm-Up Questions and Case Studies Warm-up questions, continued True. Because of their more fragile vaginal walls, young women are more likely to be infected. 13. Prophylaxis is the term used to describe the treatment to prevent or suppress infection. Prophylaxis helps to prevent opportunistic infections from developing in patients with HIV infection. Case study Cariba has experienced rapid expansion of the HIV epidemic. Prevention programmes to date have focused primarily on prevention of mother-tochild transmission. Examine the data and answer the questions. Incidence of various STIs over time, Cariba. 2000 Gonorrhoea* Syphilis* Reported cases of urethritis from STI clinic HIV incidence (estimated) 2001 2002 5.0 2.1 2 987 12.8 4.5 3 452 23.5 16.4 6 784 2.0% 4.3% 5.0% * Cases per 1000, population 15-49 years a. Do you think that sexually transmitted infections (STIs) may be playing an important role in the spread of HIV infection? Why? Yes, it is likely that STIs are playing a major role in the spread of sexually transmitted HIV in Cariba. It’s likely that STIs are important in HIV transmission because: rates of STIs are high and increasing prevalence of HIV is relatively low and incidence is rising. This is a classic exponential growth phase and similar to the situation in Mwanza, Tanzania, where STI control was able to show an effect on HIV incidence. b. Would an STI prevention programme be an important part of the country’s HIV control efforts? Yes, these data suggest that a situation similar to that in Mwanza, Tanzania exists in Cariba. An enhanced STI control programme may be critical to decreasing HIV incidence. D-5 Appendix D, Answers to Warm-Up Questions and Case Studies Warm-up questions, continued c. Given the HIV incidence in Cariba, what do you think will happen to tuberculosis rates in the next several years, and why? Tuberculosis (TB) rates will likely increase as the HIV epidemic spreads. TB cases will involve both the appearance of active tuberculosis among persons already infected with TB, and transmission of TB from HIV-infected persons to those with and without HIV infection. D-6 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 3 Answers Warm-up questions 1. Which of the following terms indicates the number or proportion of persons in a population who have a disease at a given point in time? a. sensitivity b. prevalence c. negative predictive value d. none of the above Prevalence is a measure of disease burden in a given population, while sensitivity and negative predictive value are terms used to describe the validity of case definitions. 2. True or false? One-time cross-sectional surveys are valid methods of HIV/AIDS surveillance. True False False. Surveillance systems involve ongoing collection and analysis of data, not a one-time survey. 3. Match the following terms with their definitions: _a_ laboratory-based reporting _b_ case definition a. surveillance system in which the reports of cases come from clinical laboratories, as opposed to healthcare practitioners or hospitals b. the clinical and laboratory characteristics that a patient must have to be counted as a case for surveillance purposes 4. Which of the following terms indicates the number of persons who develop a disease within a specified time period? a. specificity b. positive predictive value c. incidence d. none of the above Incidence is the rate at which disease burden is increasing in a particular population, while specificity and positive predictive value are terms used to describe case definitions. D-7 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 4 Answers 4.1 Warm-up questions 1. What are the key differences between HIV sero-surveillance and HIV case reporting? HIV sero-surveillance refers to the component of second-generation HIV surveillance that measures HIV prevalence. HIV serosurveillance measures HIV prevalence in specific populations on a regular basis using sero-surveys. HIV case reporting refers to the process of reporting the names or codes of persons with confirmed HIV positive status to surveillance staff. 2. True or false? HIV testing of women coming in for antenatal care is a component of HIV case reporting. True False True. HIV testing of women attending antenatal clinics has been the most frequently used data for prevalence estimates. 3. Which of the following is NOT a purpose of advanced HIV disease/AIDS case reporting? a. to determine the burden of disease attributable to advanced HIV disease/AIDS in the region b. to assess trends in advanced HIV disease/AIDS cases c. to provide information on the opportunistic infections associated with cases of advanced HIV disease d. to measure HIV incidence AIDS has a long latent period before symptoms are clinically apparent. Advanced HIV disease/AIDS case reporting does not measure incidence of HIV infection. 4. List five key measures that target points for HIV surveillance. 1. HIV incidence (that is, the number or rate of new HIV infections) 2. HIV prevalence (that is, the number or rate of all persons living with HIV, regardless of how long they have been infected and whether or not they are aware of their infection) 3. The incidence of advanced HIV disease (or AIDS) 4. The prevalence of advanced HIV disease (or AIDS) 5. Deaths from advanced HIV disease (or AIDS) D-8 Appendix D, Answers to Warm-Up Questions and Case Studies 4.1 Warm-up questions, continued 5. To capture the leading edge of the epidemic 1. To provide a complete count or estimate of the number of persons with HIV infection, because AIDS case reporting does not include asymptomatic HIV-infected persons 2. As a way to measure the effectiveness of treatment programmes and other interventions. 6. Which stage in the life cycle of HIV requires use of special (not routine) laboratory tests to measure? Special laboratory tests are required to detect HIV incidence. The BED assay is a promising technique to measure HIV incidence in a single blood specimen. The BED assay identifies persons who were infected in the last 160 days (or nearly six months.) 4.1 Case study 1. You are the parish surveillance officer in Cariba, which is estimated to have one of the highest prevalence rates of HIV in the region. The national AIDS control programme is interested in expanding and improving its surveillance programme, and the national surveillance officer is conducting site visits to various parishes to discuss ways of improving surveillance. During your meeting with the national surveillance officer, you are asked to suggest additional surveillance activities in your parish that you believe could be implemented successfully. Describe the activities you would suggest. Additional surveillance activities that could be successfully implemented to expand the AIDS control programme surveillance system include: using data from HIV testing and prevention of motherto-child programmes to count asymptomatic HIV cases; using data from treatment and care programmes to supplement HIV case surveillance data. 2. The national surveillance officer has indicated that there is interest in using data collected from care programmes, including HIV care programmes, for HIV case reporting. What programmes would you suggest using? Antiretroviral treatment programme data can provide patient monitoring data. Data from ART programmes can also be used to measure the effectiveness of treatment programmes and other interventions. For efficient use of time and resources, those programmes that serve the largest number of HIV-infected persons should be targeted for assisting with case reporting. D-9 Appendix D, Answers to Warm-Up Questions and Case Studies 4.2 Warm-up questions 3. True or false? In the revised (2006) adult and paediatric WHO HIV clinical staging systems, there are four clinical stages. True False True. The revised (2006) adult and paediatric WHO HIV clinical staging systems both include four clinical stages, with stage 1 representing early disease and stage 4 representing late-stage disease (AIDS). For surveillance purposes, stages 3 and 4 meet the criteria for reporting. 4. True or false? The revised (2006) WHO case definition for advanced HIV disease is the same for adults and infants. True False False. Adults and infants may have different clinical manifestations of advanced HIV disease. Also, serologic evidence of immunosuppression differs between adults and infants. Brief case definitions of advanced HIV disease are provided below. For adults, the case definition for advanced HIV disease is: A positive HIV antibody test AND EITHER Any clinical stage 3 or stage 4 disease OR Where CD4 testing is available, any clinical stage and CD4 count < 350 cells/mm3. For infants, the case definition for advanced HIV disease is: The presence of HIV infection AND EITHER Any clinical stage 3 or stage 4 disease OR Where CD4 testing is available, any clinical stage with CD4 <20% TLC in children aged 12-59 months. 5. List the three options for HIV reporting that WHO recommends. WHO recommends that countries standardise their reporting practises. Countries may: report all HIV cases (clinical stages 1-4) report advanced HIV disease (clinical stages 3 and 4) report AIDS cases (clinical stage 4). D-10 Appendix D, Answers to Warm-Up Questions and Case Studies 4.2 Warm-up questions, continued 6. True or false? The clinical criteria included in the revised (2006) WHO advanced HIV infection surveillance case definition only include definitive diagnoses of clinical events. True False The revised case definitions include both presumptive clinical diagnoses that can be made in the absence of sophisticated laboratory tests and definitive clinical criteria that require confirmatory laboratory tests. 7. List four reasons why HIV clinical staging systems were developed. 1. to provide uniformity for clinical evaluation of persons with HIV infection 2. to provide an indicator of prognosis 3. to guide clinical management of patients 4. to help study the natural history of HIV infection. 8. True or false? Previous surveillance case definitions in developing countries focused only on stage 4 (AIDS). True False True. Prior to 1994, the WHO had not developed a surveillance case definition for HIV disease alone (that is, persons who have HIV infection but who do not meet the surveillance case definition of AIDS). Unit 4.2 Case study 1. As an HIV surveillance officer for Cariba, you are charged with standardising the country’s HIV reporting practises. What processes would you implement to ensure that HIV case-based reporting is standardised? Processes to ensure that HIV surveillance is standardised include: standardising HIV case definitions for surveillance purposes using a standardised case report form defining the minimum set of information required to report/count a case educating providers regarding reporting requirements, including laws and regulations, case definitions, specific data elements, case report forms, laboratory reports and timeliness of reporting. 2. Cariba recently began providing free antiretroviral therapy to HIVinfected individuals. The country uses the WHO antiretroviral treatment recommendations to determine the best time to begin antiretroviral therapy. D-11 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 4.2 Case study, continued a. In St. James Parish, CD4 testing is available. What are the WHO recommendations for when adults and adolescents should begin ART? If CD4 testing is available, ART can begin at WHO clinical stage 4 (AIDS) regardless of the CD4 count, at WHO clinical stage 3 in patients whose CD4 count is <350 cells/mm3 or in patients with WHO clinical stages 1 or 2 when the CD4 count is < 200 cells/mm3. b. In St. Mary Parish CD4 testing is not available. What are the WHO recommendations for when adults and adolescents should begin ART? If CD4 testing is not available, a total lymphocyte count ≤1200 cells/ mm3 can be used as an indication of immunodeficiency that is severe enough to begin ART. Unit 4 Final case study You are the new HIV programme director in Cariba. Cariba has conducted antenatal sero-surveillance for many years and the results from those surveys have been used to estimate the HIV prevalence in the country. The prevalence in young adults in Cariba is estimated to be 3% in urban areas. HIV case reporting has been recommended, but only a few facilities have reported HIV cases. Because of the high HIV prevalence, it is assumed that the prevalence of AIDS is also very high. Cariba has received additional resources that are to be used for providing HIV-infected patients with ART. Because of its high prevalence, Yotown County, which has a large urban area, has been selected as a site to offer ART. The provision of ART to HIV-infected patients is co-ordinated by your colleague (Dr. MB) at the Ministry of Health in Cariba. To begin planning for treating patients you set up a meeting with Dr. MB. Together you decide that the initial focus should be on conducting reporting of persons with advanced HIV disease. How would you go about doing this? In order to determine the number of patients who will need ART, you will need to know the number of patients with advanced HIV disease. (HIV clinical stages 3 and 4.) The clinical/immunological criteria for diagnosing a person with advanced HIV disease are as follows: D-12 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 4 Final case study, continued Category Advanced HIV in infants, children, adults and adolescents with documented HIV infection Children > 6 years, adolescents and adults with documented HIV infection Children < 6 years with documented HIV infection Clinical/immunological criteria Presumptive or definitive diagnosis of any one stage 3 or 4 condition (as defined in annex 2.3 and 2.4). CD4 count less than 350/ mm3. %CD4 < 30 in those less than 11 months of age %CD4 < 25 in those aged 12–35 months %CD4 < 20 in those aged 35–59 months. Reporting should be done at the time the person is initially diagnosed with advanced HIV disease. You and Dr. MB must make decisions regarding how ART should be provided in Yotown Parish. You both agree to follow the WHO treatment guidelines. What are the WHO criteria for initiating ART? The best time to begin antiretroviral treatment can be determined using clinical staging and, if available, CD4 counts/percents. The WHO antiretroviral treatment recommendations for adults and adolescents are as follows: If CD4 testing is: Available Not available WHO ART recommendation for adults and adolescents WHO clinical stage 4 (AIDS) regardless of the CD4 count WHO clinical stage 3 when the CD4 count is <350 cells/mm3 WHO clinical stages 1 or 2 when the CD4 count is < 200 cells/mm3 D-13 WHO clinical stage 4 (AIDS), regardless of total lymphocyte count WHO clinical stage 3, regardless of total lymphocyte count WHO clinical stages 2 with a total lymphocyte count < 1200 cells/mm3 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 4 Final case study, continued You and Dr. MB decide to offer ART at three clinics and at the medical college in Yotown Parish. How will this affect your plans for advanced HIV disease case reporting? The link between staging, ART use and case reporting is useful for surveillance purposes. HIV case reporting is generally done by healthcare providers, usually from hospitals and clinics that provide ART. Therefore, patients who are receiving care at these facilities will have their clinical stage determined. The clinical/immunological criteria for diagnosing advanced HIV disease correspond to the clinical/immunological criteria for initiating ART. What are some initial steps that should be taken prior to offering ART? Prior to offering ART, treatment protocols should be developed; methods to record patient treatment information should be determined; and staff should be trained. Use of WHO methods is recommended. What are the outcomes that you think should be monitored in order to evaluate the impact that ART is having on patients with HIV? In order to determine how well the programme is working, you will need to monitor how many patients initiate ART, what regimens they are receiving, and adherence. To measure the impact that treatment is having, it is best to monitor the development of new opportunistic illnesses and death. Effective treatment programmes should result in declines in both of these. What methods can be used to measure the impact of ART on mortality? Ideally, there would be existing mortality data that could be used. If these are not available, then it is worthwhile to develop methods of obtaining census data, deaths, and causes of death using verbal autopsy methods. D-14 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 5 Answers Warm-up questions 1. List three aspects of a disease under surveillance that an effective surveillance system should monitor. In order to describe the condition under surveillance, the surveillance system must be able to describe the condition by the following attributes: person, place and time. 2. List two methods to measure completeness of case reporting. a. Expand surveillance activities to find (and report) any missed cases. b. Estimate the proportion of all cases that were reported in a specified time period using a capture-recapture methodology. 3. List two methods to report the timeliness of case reporting. To report the timeliness of case reporting you can use: a. the median time between diagnosis of HIV or AIDS and receipt of the case report form b. the proportion of cases that are received within a specified time period from diagnosis to receipt of report. Case study St. James Parish is in the coastal area of Cariba and has the country’s major port city. A British university has been conducting studies of commercial sex workers in the port city for nearly a decade. For the last five years, they have been conducting serial sero-prevalence surveys for HIV and syphilis. You are the National Surveillance Officer for St. James Parish. You are asked by the Ministry to evaluate these special studies to determine if the Ministry should take over sponsorship of the studies and include them in the provincial sentinel surveillance system. Now answer the questions below. Look back in the unit for more information if you wish. a. How would you start your evaluation? The first step in evaluating these special studies would be to meet with study staff members and Ministry of Health personnel. The people conducting the special studies and/or the Ministry of Health may want to define the questions to be addressed by the D-15 Appendix D, Answers to Warm-Up Questions and Case Studies Case study, continued surveillance system evaluation. They may also want to decide how to use the findings from the evaluation. b. On what would you focus in your evaluation? As the Ministry of Health is deciding whether or not to take over sponsorship of the studies and include them in the provincial sentinel surveillance system, a possible focus of the evaluation would be to assess how the system can detect and report HIV and syphilis among sex workers and to assess the quality of the epidemiologic information produced. c. What criteria would you use to assess the performance of the system? In a comprehensive evaluation, the simplicity, flexibility, data quality, acceptability, sensitivity, positive predictive value, representativeness, timeliness and stability of the surveillance system should be assessed. CAREC recommends that member countries evaluate the completeness (sensitivity), timeliness and validity of surveillance systems on an annual basis. d. What would you recommend? Although specific recommendations depend on the findings of the assessment, recommendations following an assessment would include: developing strategies for communicating the findings from the evaluation, tailoring the recommendations to relevant audiences, and distributing the results to all partners and sites involved. D-16 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 6 Answers Warm-up questions 1. True or false? Some elements of an STI surveillance system are more important for HIV surveillance activities. Others are more important for STI control programme activities. True False True. For example, combined STI/HIV behavioural surveillance surveys are important for HIV surveillance, while anti-microbial resistance monitoring is more important for STI control programmes. 2. True or false? STI surveillance data can serve as an indicator of trends in HIV risk behaviours. True False True. Because STIs and sexually transmitted HIV are transmitted the same way, trends in STI data may reflect similar trends in HIV transmission. 3. True or false? Aetiologic reporting of syphilis (by stage), gonorrhoea and chlamydia is considered a basic surveillance activity in the Caribbean. True False False. Aetiologic reporting is only possible where well-developed systems of laboratory diagnosis exist. In some countries of the Caribbean, the use of laboratory services for diagnosis is frequently not available for routine care. 4. Which of the following is not a component of an STI surveillance system? a. STI universal case reporting b. STI sentinel surveillance systems c. STI testing and treatment d. STI prevalence assessment and monitoring While important to controlling the spread of STIs and HIV, treatment of STIs is not a component of STI surveillance activities. 5. True or false? In generalised HIV epidemics, surveillance activities should include monitoring gonorrhoea and chlamydia. True False True. These conditions suggest recent high-risk behaviours. 6. True or false? An STI surveillance system includes conditions that are newly acquired, as well as those that represent past infections. D-17 Appendix D, Answers to Warm-Up Questions and Case Studies Warm-up questions , continued True False True. This will help to accurately calculate prevalence and incidence. 7. In aetiologic reporting, STI cases are reported by the specific microbial organism that caused the STI, while in syndromic reporting, STI cases are reported by the clinical syndrome with which the patient presents. Aetiologic testing involves a well-developed laboratory system. Therefore, it is less common in the Caribbean region. Case study You are the national STI surveillance officer for the Cariba. You rely primarily on syndromic surveillance using a universal reporting system. You have noticed an increase in the number of reported cases of male nonvesicular genital ulcer disease in St. James Parish, one of five parishes in the country. Number of reported cases of male non-vesicular genital ulcer disease by parish and year, Cariba. Parish Year 1998 1999 2000 2001 2002 2003 40 42 38 54 45 38 St. Mary 60 70 72 84 65 58 Kingstown 47 50 42 40 41 39 Arima 53 87 76 95 107 197 St. James 49 49 36 72 65 48 Yotown a. What are some possible causes of this increase? improved surveillance artefact increase in health-seeking behaviour by local population increase in high-risk behaviour immigration Arima and Yotown, the parishes that border with St. James, are primarily rural areas, whereas St. James has an urban centre with a recently refurbished and expanded health centre. b. Could these differences between the parishes account for the increase in STI cases in St. James? Yes. Because of the refurbished and expanded health centre in St. James, there could be increased health-seeking behaviour in St. D-18 Appendix D, Answers to Warm-Up Questions and Case Studies Case study, continued James. Additionally, people from Arima and Yotown could be travelling to St. James to receive care. c. How would you investigate this? When analysing the data, stratify analysis by region or geographical area to show if there are significant differences between places. You examine all syphilis tests done at the clinic for one month. Because this is a sentinel site for syphilis screening as well, demographic data, including parish of residence, are available. The table below shows your findings: Results of sentinel syphilis screening by parish of residence, Cariba. Parish of residence Arima St. James Yotown Positive syphilis tests 10 25 3 Total tested 60 150 80 Percentage positive 16.7 16.7 3.8 d. Calculate the prevalence by parish of residence. How could these data be used for STI control? For HIV control? Potential uses of these STI data include: estimating the quantity and types of drugs required for treatment of current and future STI cases advocating for resources for STI care developing focused interventions for STIs, including HIV D-19 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 7 Answers Warm-up questions 1. True or false? Because of the urgent need to treat and prevent HIV infection, issues such as confidentiality and informed consent do not need to be addressed. True False False. Because of the stigma associated with HIV and related behaviours, infected individuals are vulnerable to social, physical and legal harms. They need to have their privacy protected through measures such as confidentiality and informed consent. 2. The principle of ‘beneficence’ refers to minimising risk to individuals in the areas of: a. physical risk b. psychological harm c. stigmatisation d. all of the above Beneficence refers to balancing the benefits and risks to individuals. This includes not only physical dangers, but psychological harm and stigmatisation, as well. 3. True or false? Providing large monetary or in-kind incentives is an ethical way to ensure that more participants agree to give informed consent. True False False. With excessive incentives, individuals may decide to participate for purely economic reasons. This might create bias, since the sample might then include a larger number of people with high infection rates who are in greater need of money or healthcare. 4. True or false? In low-level epidemics, information about HIV infection in high-risk or marginalised groups should be widely publicised to prevent further spread of the disease. True False False. In the early stages of a low-level epidemic, the general public may react to information about HIV infection in high-risk groups by calling for restrictive and prohibitive measures, driving these groups further underground. Be careful when designing public awareness programmes during this epidemic state. D-20 Appendix D, Answers to Warm-Up Questions and Case Studies Warm-up questions, continued 5. The process by which potential threats to confidentiality are discussed with subjects before they decide to participate is known as informed consent. Giving subjects full information about the study and its potential risks and benefits helps them to make a more informed decision about whether to participate. 6. List three potential risks to participants in a behavioural surveillance study. Potential risks include identification as a member of a high-risk group, disclosure of HIV status, identification as HIV-positive, isolation, loss of employment, prosecution, etc. 7. True or false? Surveillance is an academic exercise. Investigators should not become involved as advocates in the communities in which they work. True False False. Investigators can become advocates for the communities they study, promoting additional treatment and prevention services. 8. List two types of programmes or services that can be developed as a result of surveillance activities. Potential services include STI clinics, voluntary testing and counselling centres, HIV prevention programmes, public awareness campaigns, etc. 9. If confidentiality about HIV infection is violated, subjects may suffer discrimination and stigmatisation. They may even be subject to criminal charges. Maintaining confidentiality requires protecting the personal information of study participants, including their infection status. If this is violated, they may suffer physical, social or legal harms because of stigma associated with HIV. 10. True or false? In unlinked anonymous testing, informed consent is not obtained. Some information identifying the sample with the patient remains. True False False. Informed consent does not need to be obtained because the survey is anonymous. That is, none of the patient’s personal identifying information remains on the sample. D-21 Appendix D, Answers to Warm-Up Questions and Case Studies Case study You are the health officer in charge of HIV surveillance for St. James Parish in Cariba. You have been asked to design and implement a special sero-prevalence survey among male patients with acute urethritis attending the STI clinic at the provincial referral hospital. You are weighing two choices: The first would entail a self-administered questionnaire and an additional blood test for HIV and syphilis. The second would entail a blinded survey of all patients who have blood drawn for syphilis serologies. Approximately 50% of patients who present with acute urethritis have serum samples drawn for syphilis; syphilis serologies are done at the clinician’s discretion, and there is no standard protocol for when to order these serologies. Now answer these questions. a. For which option would you need informed patient consent? You would need informed patient consent for Choice 1, because this involves procedures that would not be routinely conducted (interview and separate blood draw). If you wanted to administer a questionnaire to patients in Choice 2 and link it to their HIV results, you would need an informed consent for this as well. b. How likely are the two options to yield an accurate estimate of the prevalence of HIV infection in this patient population? It would depend on the participation rate. If you could get most patients to participate in Choice 1, that would be preferable. Because syphilis serologies, which are the basis for HIV testing in Choice 2, are only drawn for 50% of the patients and are drawn at the discretion of the clinician, they are unlikely to represent a true random sample of the clinic population. c. In which option would patient confidentiality be better protected? Patient confidentiality would be better protected in Choice 2, because the patients’ names would not be linked to their HIV results. On the other hand, patients found to be HIV-infected in Choice 2 would not necessarily have the opportunity to seek care for HIV. d. If you were to offer an incentive (for example, reimbursement for transportation) to participants in Choice 1, would this be considered ethical? Incentives must be modest in order to be ethical. Reimbursing participants for out-of-pocket expenses incurred in getting to the study site is a reasonable incentive. Buying them a cow or a chicken is not. D-22 Appendix D, Answers to Warm-Up Questions and Case Studies Unit 8 Answers Warm-up questions 1. List three elements of an HIV surveillance report. Any of the following: a. executive summary b. introduction c. body of the report d. discussion e. conclusion 2. True or false? The conclusion section of an HIV surveillance report is an optional element. True False False. The conclusion must be included in order to re-emphasize pertinent findings and integrate these findings into a comprehensive statement on the state of the epidemic. 3. True or false? Changes in reporting practises may result in a spurious increase or decrease in AIDS incidence. True False True. Changes in reporting practises can change the number of cases reported, but this change is an artefact of reporting and not an indication of a true change in the epidemic. For this reason, it is important to pay attention to reporting practises and to investigate any change in the number of reported cases that seems unlikely to be true. 4. When describing the HIV epidemic, why is it preferable to perform analysis based on the date of diagnosis rather than the date of report? Analyses by year of diagnosis will reflect what is currently going on with the epidemic, and eliminate artefacts of reporting in the surveillance system. 5. True or false? Increases in the number of persons receiving ART can result in a decrease in AIDS incidence, regardless of the number of new HIV infections occurring. True False True. ART can delay the clinical progression of HIV disease, which means that HIV-infected persons on ART may not develop AIDS, or if they do, it may take longer than if they were not treated. D-23 Appendix D, Answers to Warm-Up Questions and Case Studies Warm-up questions, continued 6. Which of the following are potential target audiences for surveillance reports on HIV? a. people who contribute to collecting the surveillance data b. healthcare workers c. public health officials at the district, provincial, national and international levels d. all of the above Surveillance reports can be used by the above groups to target or prioritise services for HIV prevention and patient care; and to help explain the need for services and funding to policy makers, civic leaders, and legislators. Case study You work in the surveillance unit of Cariba and are responsible for developing the annual HIV surveillance report. You have data from HIV case reporting nationwide and from a single cohort of patients who received ART in a large urban clinic. Use this information to answer the following questions. 1. What data will you include in your report? Describe some of the ways you might display the data according to the source of the data. In the annual HIV surveillance report you should include data on: HIV, advanced HIV disease and/or AIDS cases diagnosed in most recent calendar year(s); number and percentage of HIV, advanced HIV disease and/or AIDS cases diagnosed most recent calendar year (by age group and sex, transmission category and sex, and transmission category for each sex group); number, percentage, and rates of HIV, advanced HIV disease and/or AIDS cases diagnosed by race/ethnicity in most recent calendar year (if applicable); number and percentage of persons living with HIV (by age group and sex, transmission category and sex, and transmission category for each sex group); number and percentage of persons living with advanced HIV disease (by age group and sex, transmission category and sex, and transmission category for each sex group); number of persons living with AIDS (by age group and sex, transmission category and sex, and transmission category for each sex group). You should also provide information on trends in new diagnoses of HIV, advanced HIV disease and/or AIDS stratified by age and sex and transmission mode. When presenting data from the cohort of patients receiving ART, you should focus on annual changes in: functional status D-24 Appendix D, Answers to Warm-Up Questions and Case Studies Case study, continued median CD4 counts or proportion of patients who had CD4 testing whose counts were > 200 cells/mm3 survival or number of deaths trends in the number of persons in the cohort living each year trends in the incidence of selected opportunistic illnesses Analyses should examine trends in these outcomes in aggregate and by selected demographic characteristics, such as age group, sex, and district or province. To assess trends in HIV cases, deaths, or prevalence, it is preferable to analyse and present the data by year of diagnosis. Analyses by year of diagnosis will reflect what is currently going on with the epidemic, and eliminate artefacts of reporting in the surveillance system. Analyses and presentation of data by year of report reflects reporting practises of the surveillance system. This is not reflective of newly diagnosed cases or recent infections. By default, when analysing data by year of report the data would not be adjusted. D-25 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries Introduction To begin the process of operationalising case-based HIV surveillance and basic STI surveillance, you will need to: develop country-specific operational guides for HIV/AIDS/STI surveillance develop country-specific implementation work-plans organise your country’s approach to case reporting and regional reporting. What is an action plan? A well-developed action plan allows you to: establish clear goals and objectives present your ideas to achieve consensus among all persons involved establish a realistic budget ensure that the appropriate staff in each facility are trained on surveillance determine activities determine responsible persons establish a timeline for completion of activities. Instructions Over the next couple of days, you will be developing a draft action plan and will discuss your action plan with the group. You will use the Worksheet for Developing an National Plan (Worksheet 1) Your country Action Plan and presentation, 30 minutes. E-1 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries National Action Plan Worksheet Instructions If you are not doing so already, move now to sit with all the participants from your country. As a team, take some time to discuss and fill out the questions on the National Action Plan Worksheet, next page (facilitator will hand out a clean version of this form). This worksheet will help you determine the activities needed to implement your country surveillance activities. This worksheet will also help us in determining each country’s plans and schedules, as we will be providing technical assistance where needed. We understand that you may not know all the final answers to the questions in the National Action Plan Worksheet. Please fill in the information as completely and accurately as possible. If you have questions, facilitators will be available to discuss the worksheet process with you. Timing Choose a scribe to keep track of your team’s comments on each area of the worksheet. Spend about 30 minutes on this worksheet. E-2 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries WORKSHEET FOR DEVELOPING ACTION PLAN (WORKSHEET 1) 1. What is the name of your country? 2. Who are the stakeholders who will review your plan? Please provide names, if possible. MOH: CAREC: NGOs: Donors: Other: 3. List key persons who will be working to complete the actions in the Action Plan and their position. Develop contact list with name, address, phone number, fax number, e-mail address and role of each person. Finalise operational procedures manual: Finalise test forms: Co-ordinate training (logistics, materials): Instructors: 4. List facilities in need of training. 5. List staff that in need of training at each facility (community health nurses, family welfare educators, data manager, data entry clerks, others?) 6. What is the estimated number of people in need of training? (multiply the number of facilities by the estimated number of persons at each facility in need of training). E-3 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries 7. What are the best dates to conduct trainings? List conflicting meetings/holidays during which the trainings cannot be held. 8. Are you aware of any sites where training can be conducted? If yes, please list the name and type of facility and how many people it can accommodate at one time. 9. Challenges in implementing your action plans can include: few or no designated trainers lack of or conflicting policies lack of needed materials schedule conflicts lack of money turnover/attrition of staff List your possible challenges to the right. 10. List resources that you may be missing. 11. How can CAREC and partner organisations help you to implement your plan? Discuss your worksheet with a facilitator or go on to the next part of the action planning process. E-4 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries Action Plan Development Now use the information from your national worksheet to develop an action plan. An action plan helps you keep track of all activities and helps you review your progress. We have provided an action plan template for your use. Instructions Remain in your country group. Address the key elements listed below. Add additional elements if you wish. Work together to develop a PowerPoint presentation that goes with your action plan. You will need a calendar for this activity. Take 30 minutes for this activity. Timing Activities While completing your action plan, please address the key elements listed below (these activities and general timeframe have been added to the action plan template next page): Identify stakeholders; debrief MOH and NAP (within one month). Finalise operational procedures manual (within two months). Finalise forms (test forms) (within two months). Conduct training of providers and labs (go through case report forms. and data flow, roles and responsibilities within one month of finalising forms and operational manual). Talk with statistics office to obtain death records (within two months). Check national database to make sure it is set up appropriately. Train data entry persons (identify back-up). E-5 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries Activities, continued You will want to consider other important areas and may add any of these to your action plan: determining budget determining final training dates selecting the appropriate audience for training adapting the training curriculum from existing materials organising the training(s) (facility, audiovisual equipment, supplies) evaluating the training conducting follow-up activities and site visits after the training to reinforce learning. If you have other details you would like to add, please go ahead. Due dates Adding due dates to an action plan helps you establish a realistic schedule. Here’s the sequence of events: list your activities put the activities in the order you (or your team) will do them add due dates. Why have due dates? Having due dates: provides the overall picture for planning your programme helps keep your project on schedule avoids assigning too many things to one person helps you to meet your program goals and objectives helps you to remember critical steps so nothing is forgotten in the planning process. E-6 Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries How to choose due dates When you are developing due dates, think about: the order of activities which activities are dependent on earlier activities the overall timeframe for completing the entire activity what factors might cause someone to miss a due date, such as existing schedules, commitments, holidays, vacation schedules or any other sources of delay. It is important to remember to include the people who will be involved and who will be responsible for meeting the due dates. If they are involved in the decision-making about key issues, especially deadlines, the team involved will be more likely to meet those deadlines. Everyone involved should receive a copy of the agreed to action plan. Action plan template An action plan template is provided on the next page. You may use the template or any other format you desire. Use the notes and discussion you had when you filled out your worksheet. Change the order of the activities or add additional activities. Check your calendar to assign realistic due dates for each activity. Some ‘suggested’ timeframes have been added to the activities. You may change those if you wish. Your presentation Develop your presentation as you complete the action plan or after it is done. Choose a member of your team to present the action plan presentation to the group. The facilitators have a slide master, or you may use one of your own. E-7 National Action Plan: (Your Country and Title of the Plan) (Worksheet 2) Activities 1. Debrief MOH and NAP (within one month) 2. Finalise operational procedures manual (within two months) 3. Finalise test forms (within one months) 4. Conduct training of providers and labs (within one month of finalising forms and operational manual) 5. Talk with Statistics office to obtain death records (within two months) 6. Check national database to make sure it is set up appropriately 7. Train data entry persons and back-up staff. Responsible Person Resources Needed Challenges/ Solutions Target Due Date Actual Completion Date Appendix E, Action Plan for Strengthening Surveillance in Caribbean Countries 8. 9. 10. 11. 12. 13. 14. 15. 16. Appendix F, Regional Surveillance Indicators and Data Appendix F, Regional Surveillance Indicators and Data Indicators Proportion of reporting sites and countries that submit weekly syndromic reports Number of reporting sites reporting on time / Total number of reporting sites Number of countries reporting on time / Total number of countries Number of countries reporting / Total number of countries Proportion of reporting sites and countries that submit four weekly disease reports Number of reporting sites reporting on time / Total number of reporting sites Number of countries reporting on time / Total number of countries Number of countries reporting / Total number of countries Proportion of countries that submit HIV, AIDS and STIs reports annually Number of countries reporting on time / Total number of countries Number of countries reporting / Total number of countries Proportion of countries that submit leprosy reports annually Number of countries reporting on time / Total number of countries Number of countries reporting / Total number of countries Proportion of countries that submit TB reports quarterly Number of countries reporting on time / Total number of countries Number of countries reporting / Total number of countries Data Number of cases reported by syndrome by country weekly Number of positive communicable disease tests by syndrome and pathogen weekly Number of age and sex specific cases reported by disease by country every quarter Analysis of cases reported by specific diseases (e.g. HIV, AIDS, STIs, leprosy) by country annually Number of outbreaks investigated and reported annually INDICATOR GOALS: >90% of countries reporting on time and completely by January 2008. As systems are being revised, the interim goals are: > 65% of countries reporting on time and completely by January 2006 > 80% of countries reporting on time and completely by January 2007 F-1 Appendix G, Regional Reporting Requirements HIV/AIDS and STI Appendix G, Regional Reporting Requirements HIV/AIDS and STI HIV, AIDS and selected STIs shall be reported to CAREC on a quarterly basis using CAREC forms. CAREC has provided case definitions for HIV, AIDS and the STIs. Transmit reports to CAREC no later than one month after the end of each quarter. Complete an annual HIV/AIDS report using the CAREC standard report template. Submit it by the end of the first quarter of the following year. G-1