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1. 2. Republic of Namibia MINISTRY OF HEALTH AND SOCIAL SERVICES GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV i Guidelines for PMTCT in Namibia Republic of Namibia MINISTRY OF HEALTH AND SOCIAL SERVICES GUIDELINES FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV Directorates: Primary Health Care and Special Programmes Divisions: Family Health and Health Sector Private Bag 13198 Windhoek Tel 061 203 2272/2731 Fax 061 224 155 First Edition December 2004 ii Guidelines for PMTCT in Namibia PREFACE HIV/AIDS poses the greatest threat to individual and family survival. HIV can be silently transmitted from HIV-positive pregnant women to their babies during pregnancy, labour and delivery, or through breastfeeding. Approximately 90% of HIV infection among children is acquired through this mode of transmission. According to several epidemiological studies which were carried out in Africa, close to 20% of children born to HIV positive mothers acquire the infection vertically. The World Health Organization estimates that the rates of transmission ranges from 13 to 32% in developed countries and between 25 to 48% in developing countries. Most of these children eventually die during infancy and early childhood. The Declaration of Commitment adopted by the United Nations General Assembly Special Session on HIV/AIDS commits Member States to reduce the proportion of infants infected with HIV and to provide information, counselling and other prevention services to pregnant women during antenatal visits. Administration of antiretroviral medicines during pregnancy is associated with a marked reduction in HIV transmission from the mother to her baby. The Government of the Republic of Namibia has introduced a national programme for the prevention of mother to child transmission of HIV. Out of more than 500 babies who were born to HIV positive mothers at Katutura and Oshakati hospitals and who received Nevirapine according to schedule, only 4 babies tested HIV positive after 18 months of follow up, which represents 0.8% prevalence ratio. The cornerstone of a successful PMTCT programme is a high rate of HIV testing among pregnant women in order to identify those who are positive and at risk of transmitting the virus to their babies. HIV testing should be routinely provided at the first antenatal visit or at any other opportunity to all pregnant women who accept it. Health care workers should strongly promote routine counselling and testing for pregnant women and their partners. Family members should support the expectant mother to receive counselling and testing in order to protect the unborn child. Studies elsewhere, and experiences in some regions in Namibia, have shown that most women actually desire testing in order to protect their babies, but unfortunately they often fear the stigma and rejection if they were to test positive. Quality counselling and support is essential and the Ministry is working with its partners to introduce community counsellors to assist health care workers with meeting the large demand. The Ministry is also working with the laboratory services to introduce same-day HIV testing results to reduce the waiting time and to increase the proportion of pregnant women who receive their results. As indicated in these guidelines, wherever possible, HIV-positive pregnant women who have a CD4 count ≤ 300/mm3 or have a WHO stage III or IV disease should receive a combination of three antiretroviral medicines as care for them in the long term. Otherwise, the HIV-positive pregnant women will receive a single dose of Nevirapine at the onset of labour and a single dose to the baby after birth. Safe obstetrical practices as outlined in these guidelines should also be followed. All health professionals caring for pregnant women should undergo the Ministry’s established PMTCT training to be able to implement these guidelines in a competent manner. iii Guidelines for PMTCT in Namibia Infant nutrition is also a critical component of PMTCT. All pregnant women should be counselled on infant feeding regardless of their HIV status. Breastfeeding is still the best feeding option for mothers who test HIV-negative, or for those who do not know their HIV status. Feeding options for HIV-positive mothers are described in the guidelines. The development of these comprehensive PMTCT Guidelines required the collaboration of individuals, agencies, and organisations. The Ministry of Health and Social Services wishes to recognise the contributions of the Department of Obstetrics and Gynaecology and the Department of Paediatrics at Katutura Hospital, the Directorates of Primary Health Care and Special Programmes, DED, GTZ, the Franco-Namibia Co-operation, UNICEF, USAID/FHI and the Centres for Disease Control. Guidelines developed by other agencies and African countries served as useful reference materials. These guidelines are for both the public and private sectors and I urge all doctors, nurses, and other health professionals to familiarise themselves with the content of these guidelines to be able to assist their clients. Dr. K. Shangula Permanent Secretary iv Guidelines for PMTCT in Namibia TABLE OF CONTENTS PREFACE ........................................................................................................................................... III Table of Contents ................................................................................................................................ v List of Tables ...................................................................................................................................... vi List of Figures ..................................................................................................................................... vi List of Abbreviations ...........................................................................................................................vii CHAPTER 1: BACKGROUND ............................................................................................................ 1 1.1 Introduction .................................................................................................................................... 1 1.2 Magnitude of HIV Infection during Pregnancy in Namibia ............................................................. 2 1.3 Risk of Mother-to-Child Transmission of HIV ................................................................................ 3 1.4 The Benefits of the PMTCT .......................................................................................................... 5 1.5 Interventions to Prevent Mother-To-Child Transmission of HIV .................................................... 5 CHAPTER 2: PREVENTION OF HIV INFECTION AND UNINTENDED PREGNANCIES ................ 6 2.1 Prevention of STIs / HIV ................................................................................................................ 6 2.2. Prevention of Unintended Pregnancies ........................................................................................ 6 CHAPTER 3: ROUTINE COUNSELLING AND TESTING (RCT) ...................................................... 8 3.1 Benefits of Counselling and Testing for HIV .................................................................................. 8 3.2 Counselling .................................................................................................................................... 9 3.3 Testing for HIV Infection in Pregnancy ........................................................................................ 11 CHAPTER 4: MODIFICATION OF ROUTINE CARE DURING PREGNANCY, LABOUR, DELIVERY AND THE POSTNATAL PERIOD FOR HIV-POSITIVE WOMEN. .................................................... 13 4.1 Management of the Known HIV-positive Woman during Pregnancy .......................................... 13 4.2 Management of the HIV-positive Woman during Labour and Delivery ...................................... 16 4.4 Care of HIV-positive Women After Delivery ................................................................................ 19 CHAPTER 5 : MANAGEMENT OF THE HIV-EXPOSED NEW-BORN ............................................ 20 5.1 Management of the Newborn in the Early Postnatal Period ....................................................... 20 5.2 Infant Feeding Options ................................................................................................................ 20 5.3 Management of Breastfeeding .................................................................................................... 24 5.4 Introducing Complementary Feeding 6 – 12 months ................................................................. 24 5.5 Clinical Management of the HIV exposed Newborn .................................................................... 25 5.6 Diagnosis of HIV Infection in Children ......................................................................................... 25 CHAPTER 6: MANAGEMENT OF ANTIRETROVIRAL DRUGS DURING PREGNANCY, INTRAPARTUM AND POSTPARTUM .............................................................................................. 27 6.1 Overview of Antiretroviral (ARV) Drug Use for PMTCT............................................................... 27 6.2 Management of ARV Drugs in Pregnancy According to Clinical Scenarios ............................... 29 6.3 Monitoring of Pregnant Women Placed on HAART .................................................................... 31 v Guidelines for PMTCT in Namibia CHAPTER 7: PROGRAMME MANAGEMENT OF PMTCT .............................................................. 34 7.1 Promotion of PMTCT through Communication Strategies .......................................................... 34 7.2 Organisation and Administration ................................................................................................. 34 7.3 Monitoring, Evaluation and Reporting ......................................................................................... 36 REFERENCES .................................................................................................................................. 39 LIST OF APPENDICES APPENDIX I. TREND IN HIV PREVALENCE AMONG PREGNANT WOMEN BY BY SENTINEL SITES 1992-2004 .................................................................................................. 41 APPENDIX II. HIV PREVALENCE IN PREGNANT WOMEN BY AGE GROUP………………….41 APPENDIX III. TESTING FOR HIV INFECTION IN PREGNANCY… .................... ……………….42 APPENDIX IV WHO STAGING SYSTEM FOR HIV INFECTION AND DISEASE IN ADULTS AND ADOLESCENTS……………………………………….................................... 44 APPENDIX V. ORAL ARV SHORT COURSE REGIMENS FOR PMTCT ………………………...45 APPENDIX VI. CONSENT / RELEASE FORM……………………………….…..............................46 APPENDIX VIII. CONSENT/RELEASE FORM TO BE TESTED AND TO PROVIDE NEVIRAPINE TO A NEW BORN ................................................................................................. 47 List of tables TABLE 1. TABLE 2. TABLE 3. TABLE 4. TABLE 5. TABLE 6. TABLE 7. TABLE 8. TABLE 9. ESTIMATED NUMBER OF INFANTS INFECTED WITH HIV PER YEAR (MOHSS). ... 3 TRANSMISSION PATTERNS IN BREASTFEEDING AND NON-BREASTFEEDING POPULATIONS IN THE ABSENCE OF ANTI-RETROVIRAL (ARV) DRUG INTERVENTION ............................................................................................................. 4 FACTORS INCREASING OR AFFECTING MOTHER-TO-CHILD TRANSMISSION OF HIV .................................................................................................................................. 4 EFFICACY OF VARIOUS PMTCT INTERVENTIONS……………………......................5 REQUIREMENTS AND COSTS OF INFANT FORMULA FOR THE FIRST SIX MONTHS………………………………………………………………………………………23 BABY’S MINIMUM REQUIREMENTS WHILE USING MODIFIED COW’S AND GOAT’S MILK ............................................................................................................... 24 DOSAGES OF NEVIRAPINE SUSPENSION ............................................................... 25 RECOMMENDED DOSES OF CO-TRIMOXAZOLE FOR PCP PROPHYLAXIS ........ 25 RECOMMENDATION FOR ARV THERAPY IN HIV-POSITIVE PREGNANT WOMEN WITH TUBERCULOSIS ............................................................................................. 32 List of figures FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 FIGURE 5 TREND IN HIV PREVALENCE AMONG PREGNANT WOMEN IN NAMIBIA, 19922004……………………………................................................................................ …….2 RISK OF OF MOTHER-TO-CHILD TRANSMISSION DURING DIFFERENT STAGES OF PREGNANCY .......................................................................................................... 3 DIAGNOSIS OF HIV INFECTION IN INFANT ............................................................. 26 ALGORITHM FOR USE OF ARV DRUGS FOR HAART OR PMTCT IN PREGNANT WOMEN ....................................................................................................................... 28 PMTCT RECORD-KEEPING AND REPORTING SYSTEM ........................................ 38 vi Guidelines for PMTCT in Namibia LIST OF ABBREVIATIONS AIDS Acquired immunodeficiency virus ALT Alanine amino transferase ANC Antenatal care AROM Artificial rupture of membranes ART Anti-retroviral therapy ARV Anti-retroviral CDC Communicable Disease Clinic CMV Cytomegalovirus DNA Deoxyribonucleic acid ECV External cephalic version EFV Efavirenz ELISA Enzyme Linked Immunosorbent Assay FBC Full blood count HAART Highly active anti-retroviral therapy Hb Haemoglobin HBsAg Hepatitis B surface antigen HBV Hepatitis B virus HIS Health Information System HIV Human Immuno Deficiency Virus HW Health worker ICU Intensive care unit IM Intramuscular IMCI Integrated Management of Childhood Illnesses IMR Infant Mortality Rate IPT Isoniazid Preventive Therapy IUCD Intrauterine contraceptive device IV Intravenous KJ Kilo Joule NGO Non Governmental Organisation NIP Namibian Institute of Pathology NRTI Nucleoside reverse transcriptase inhibitor NNRTI Non-nucleoside reverse transcriptase inhibitor PCP Pneumocystis carinii pneumonia PCR Polymerase chain reaction PI Protease Inhibitor PLWHA People living with HIV/AIDS PML Progressive multifocal leukoencephalopathy PMTCT Prevention of Mother-to-Child Transmission PNC Post natal care PO By mouth QID Four times per day RCT Routine Counselling and Testing RNA Ribonucleic acid ROM Rupture of membranes RPR Rapid Plasma reagin STD Sexually Transmitted Disease vii Guidelines for PMTCT in Namibia STIs TB TBA TDS TOT ULN UNAIDS VCT VDRL WBC WHO Sexually Transmitted Infections Tuberculosis Traditional Birth Attendant Three times per day Trainer of Trainers Upper limit of normal Joint United Nations Programme on AIDS Voluntary Counselling and Testing Venereal Disease Research Laboratory White blood count World Health Organisation Acronym of drugs 3TC ABC AZT D4T ddC DdI DMPA IDV IDV/r LPV LPV/r NFV NVP RTV SQV (hgc) SQV (sgc) SQV/r TDF ZDV Lamivudine Abacavir Zidovudine Stavudine Zalcitabine Didanosine Depo-Medroxyprogesterone Acetate Indinavir Indinavir + Ritonavir Lopinavir Lopinavir + Ritonavir Nelfinavir Nevirapine Ritonavir Saquinavir, hard gel Saquinavir, soft gel Saquinavir + Ritonavir Tenofovir Zidovudine viii Guidelines for PMTCT in Namibia CHAPTER 1 BACKGROUND 1.1. Introduction During 2002, UNAIDS estimates that approximately 800,000 children acquired HIV infection world-wide through mother-to-child transmission, including 720,000 in subSaharan Africa. This translates into approximately 2,200 new infections in children per day. As of 2002, UNAIDS estimated that 3.2 million children under 15 years of age were living with HIV/AIDS, and 2.4 million of these resided in Sub-Saharan Africa. An estimated 610,000 children died world-wide in 2002 from AIDS alone. The situation with respect to mother-to-child transmission of HIV clearly poses a global public health emergency, particularly in Sub-Saharan Africa. The most common mode of HIV transmission in children is vertical infection from an HIV positive woman to her child during pregnancy, labour and delivery, or through breastfeeding. It has been established that the use of antiretroviral medicines reduces the proportion of children who become infected vertically to 3% and below. It should however be noted that in children born to HIV positive mothers, the maternally acquired HIV antibodies may persist for up to 18 months. Therefore a positive HIV antibody test in a baby younger than 18 months may represent exposure to maternal infection rather than infection of the baby. Prevention of Mother to Child Transmission of HIV includes four main strategies: i. Primary prevention of HIV in women of reproductive age; ii. Prevention of unintended pregnancy in HIV-infected women; iii. Prevention of mother-to-child transmission through the use of antiretroviral (ARV) drugs and other practices; iv. Provision of comprehensive care to HIV infected women, partners, and children. In spite of the increasing availability and feasibility of using ARV drugs, numerous challenges must be addressed in order for PMTCT services to be effective. They include: i. Capacity to provide routine HIV counselling and testing to all pregnant women early in antenatal care. ii. Making counselling services available in antenatal clinic for pre, post and on going counselling. iii. Providing the most appropriate and the most effective ARV drug regimen to qualifying pregnant women. iv. Promoting breastfeeding in the general population and supporting infant feeding options for HIV positive mothers to reduce transmission through breastfeeding. v. Training a large number of health professionals in order to sustain PMTCT services. The purpose of these PMTCT guidelines is to: i. Provide the basis for a national standard of care to prevent mother-to-child transmission in all health facilities. ii. Sensitise health service providers and other stakeholders involved in PMTCT to issues that are important to the success of the programme. iii. Promote the importance of PMTCT services and networking amongst all those involved in the care of pregnant women and family members. 1 Guidelines for PMTCT in Namibia iv. v. Equip health workers with essential knowledge and information on counselling, infant feeding, obstetric care, laboratory services, ARV drugs, programme management, and monitoring and evaluation process of the programme. Mobilise community support, and active participation for the successful implementation of the programme. Therefore, appropriate information needs to be disseminated for the public to understand the benefits of the PMTCT. These guidelines are complemented by other MOHSS documents, which health workers should consult for more in-depth information and guidance, they include: i. The National Strategic Plan on HIV/AIDS, Medium Term Plan III, 2004-2009. ii. The Namibian Reproductive Health Policy, 2002. iii. Guidelines for Counselling of HIV/AIDS and Sexually Transmitted Diseases, 2001. iv. Clinical Management of HIV/AIDS, 2001. v. Guidelines for ARV Therapy, 2003. vi. Guidelines in confidentiality, testing and notification, 2001. vii. National VCT Guidelines, 2004. viii. Infant and Young Child Feeding, National Guidelines for Health Professionals, (Draft). ix. National Policy on Infant and Young Child Feeding, 2003. x. Food and Nutrition Guidelines for Namibia, 2000. xi. Nutritional Management in HIV/AIDS; A Resource Guide for Health Workers, 2003. xii. TB Guidelines, 2004. xiii. National policy and guidelines for malaria control, 1995. 1.2. Prevalence of HIV infection in pregnancy in Namibia In 2004, the national HIV prevalence ratio amongst pregnant women was 19.8%, ranging from 9% in Opuwo to 43% in Katima Mulilo across the 24 sentinel sites. Figure 1. Trend in HIV prevalence ratio among pregnant women, 1992 – 2004 HIV Prevalance (%) 25 17.4 20 19.3 22 19.8 15.4 15 8.4 10 4.2 5 0 1992 1994 1996 1998 2000 2002 2004 Year Figure 1 shows the trend over time in the proportion of pregnant women who tested HIVpositive in Namibia from 1992 to 2004. HIV surveillance has been conducted every two years amongst pregnant women in Namibia since 1992 using the same standardised methodology. 2 Guidelines for PMTCT in Namibia 1.3. Risk of Mother-to-Child Transmission of HIV In the absence of antiretroviral medicines and with breastfeeding, published estimated ratio of mother-to-child transmission (MTCT) of HIV range from 21% to 43% in various African settings. An estimate of the magnitude of transmission to newborns in Namibia per year is summarised in Table 1. Each year an estimated 4,620 newborns acquire HIV infection as a result of mother-to-child transmission. Table 1. Estimated number of infants infected with HIV per year (MOHSS) Population (Census 2001) 1.8 million Births per annum, 2002 (estimated HIS 2001) 70,000 HIV prevalence in mothers, 2002 22% Total number of births to HIV-positive mothers at risk of MTCT, assuming no multiple pregnancy 15,400 Number of new-born infected with HIV during 2002 in Namibia, assuming a 30% risk of transmission and no intervention provided 4620 As depicted in Figure 2 most transmission takes place during labour and delivery, followed by transmission in the uterus and through breastfeeding, depending on duration. The greater risk of transmission around labour and delivery is due to the increased exposure of the new-born to HIV-contaminated blood and body fluids. Also, the longer the child is breastfed, the greater the risk of HIV transmission. Figure 2. Risk of mother-to-child transmission during the stages of pregnancy Risk of MTCT, if the mother is breastfeeding and not receiving ARV Antenatal Labour and Delivery Early Postpartum, 0-6 months Late Postpartum, 6-24 months Risk of Transmission: 5-10% 10-20% 5-20% Source: Adapted from Guidelines for Anti-Retroviral Therapy, MOHSS, 2003 The estimated risk of HIV transmission to exposed new-borns, assuming no intervention is as follow: 5-10% during pregnancy, 10-20% during labour and delivery, and 5-20% from breastfeeding depending on the duration. 3 Guidelines for PMTCT in Namibia Without any PMTCT intervention, for every 300 children born to HIV-infected women, about 100 will become infected. Of those 100 children infected about 16 would have acquired HIV during pregnancy, 50 during labour and delivery and 34 after delivery through prolonged breastfeeding. In the absence of ARV medicines intervention, transmission patterns and risks vary between breastfeeding infants, depending on duration of breastfeeding, and non-breastfeeding infants as shown in Table 2. Table 2. Transmission patterns in breastfeeding and non-breastfeeding populations in the absence of anti-retroviral (ARV) medicines intervention Transmission ratio % HIV transmission by stages No Breastfeeding Breastfeeding breastfeeding for 6 months for 18-24 months During pregnancy 5-10% 5-10% 5-10% During labour 10-20% 10-20% 10-20% Early (first 2 months) 5-10% 5-10% Late (after 2 months) 1-5% 5-10% 25-35% 30-45% Through breastfeeding Overall 15-30% Source: de Cock K.M. et al (2000) Though transmission can occur at any stage, the main factors that increase the risk of mother-to-child transmission are summarised in Table 3 below. Table 3. Factors increasing or affecting mother-to-child transmission of HIV Obstetrical Maternal Foetus/New-born Viral Episiotomy High viral load Prematurity Viral resistance? Invasive monitoring Low CD4 count Multiple births Viral subtype? Mode of delivery Advanced disease Breastfeeding ROM > 4 hours Poor nutrition Mixed feeding Intrapartum Breast condition or Immature gastro haemorrhage disease intestinal tract Instrumental delivery STIs Genetic factors Chorio-amniocentesis New HIV infection Immature immune Illicit substance abuse Vit A deficiency 4 system Guidelines for PMTCT in Namibia 1.4. Benefits of the PMTCT PMTCT provides several benefits at the societal, household, and individual levels: i. Reduces suffering from HIV/AIDS in children and those affected. ii. Decreases the burden on the household and health system, by decreasing the number of HIV infected children. iii. Provides a linkage to early and comprehensive HIV/AIDS care for the mother, partner, and child, including ARV therapy. iv. Counselling, testing, access to ARV therapy and community sensitisation can also contribute to reduce stigma in society. v. Promotes behaviour change, e.g., use of dual methods of family planning, improved attendance for antenatal care, improved infant feeding practices. vi. Provides opportunity to plan for the future, for example infant feeding options. vii. Gives an opportunity to improve, expand health services and to strengthen health infrastructure. 1.5. Interventions to prevent mother-to-child transmission of HIV Table 4. Efficacy of various PMTCT interventions Intervention No intervention No breastfeeding Short-course with one ARV, but breastfeeding Short-course with one ARV, but no breastfeeding Short course with 2 ARV, but no breastfeeding 3 ARV drugs, no breastfeeding 3 ARV drugs but breastfeeding Risk of Transmission 30 to 45% 20 to 25% 15 to 25% 5 to 15% 5% 1% Unknown A number of clinical trials in Sub-Saharan Africa have demonstrated the efficacy of various short-course ARV drug regimens for PMTCT. Generally speaking, the more ARV drugs are given to the pregnant woman and her HIV exposed newborn, the lower the risk of transmission. However, simplicity of use, potential toxicity, and cost are also important considerations in selecting drug regimens, which is why single-dose Nevirapine (SD-NVP) serves as the standard for PMTCT in Namibia. The advantages of single-dose Nevirapine to the mother and exposed new-born include: It is simple to administer, making it a more feasible option in resource-limited settings. Nevirapine is rapidly absorbed by the gastrointestinal tract and is readily transferred across the placenta to provide protection to the baby. A single dose of Nevirapine results in a rapid decline in maternal viral load and is long-acting. There are virtually no side effects from single-dose Nevirapine to the mother and exposed newborn, and its safety is now well-demonstrated. 5 Guidelines for PMTCT in Namibia CHAPTER 2 PREVENTION OF HIV INFECTION AND UNINTENDED PREGNANCIES 2.1. Prevention of sexually transmitted infections (STIs) including HIV 2.1.1. Behavioural change communication. Preventing HIV infection in women will contribute significantly to the prevention of HIV transmission to infants and young children. HIV prevention programmes will need to be directed to all women and their partners. Behavioural change communication towards the ABC (abstinence, be faithful and use condoms) should make particular efforts to reach young people, the future parents. 2.1.2. Voluntary counselling and testing (VCT) services. VCT plays an important role in HIV prevention through detection of HIV, risk reduction, and counselling of couples. Providing accessible VCT services is therefore an effective strategy to decrease primary HIV infection. 2.1.3. Treatment of Sexually Transmitted Infections. Human immunodeficiency virus is passed from one person to another more easily when one or both people are infected with another STI. The STIs that are particularly important in this interaction are chancroid, chlamydia, gonorrhoea, syphilis, trichomoniasis, genital herpes and granuloma inguinale. Depending on which infection it is, these STIs can make it two to nine times more likely that someone will be infected with HIV when exposed to the virus. Rapid treatment of STIs reduces the risk of acquiring additional infections and infecting other people. Referral of sexual partners for treatment is essential for the interruption of re-infection. The Syndromic Approach adapted by the Namibian Government is well suited for primary health care services and for rural clinics because it does not require laboratory services. People with STIs can get care right in their own community. Appropriate counselling and treatment of STIs also improves the use of condoms, changing risky sexual behaviour, accepting HIV testing and convincing their partner to seek treatment. 2.2. Prevention of Unintended Pregnancies 2.2.1 Family planning services Family planning programmes in Namibia have made significant progress in the provision of contraception to reduce unintended pregnancies. Most HIV-infected women in resource-limited countries are unaware of their sero-status. Being HIV infected can influence a woman’s and partner’s choices about pregnancy. Therefore, family planning services need to be strengthened so that all women, including those infected, can receive support and services to prevent unintended pregnancies. Sexually transmitted infections, including HIV, remain a matter of concern to the MOHSS. Therefore, prevention of these infections must be reinforced in the context of comprehensive reproductive health, including family planning and sexual health. The concept of “dual protection” against STIs/HIV and unintended pregnancy should be actively promoted. To promote dual protection, health workers should provide information on methods to prevent unintended pregnancies as well as on STIs and HIV. 6 Guidelines for PMTCT in Namibia “Dual protection” is defined as the simultaneous prevention of STI/HIV infection and unintended pregnancy through the use of condoms. Informed choice on contraception must include the recognition and acknowledgement that many methods are effective against pregnancy, yet offer no protection against STIs or HIV infection. Informed choice must include information that correct and consistent condom use prevents HIV and STIs, but is also a highly effective contraceptive. Condom use combined with another contraceptive method further helps to prevent pregnancy. Dual protection is particularly important for anyone who is sexually active and is not planning a pregnancy with a partner of unknown HIV status, or with anyone who is in an HIV discordant relationship. The operationalization of dual protection requires a number of actions, including: i. maximising the integration of family planning and STI/HIV prevention services; ii. ensuring widespread availability of male and female condoms at service delivery points, and other outlets; iii. development of adolescent friendly reproductive health services; iv. male involvement in reproductive health; v. appropriate introduction of female condoms into reproductive health programmes; vi. Promotion of dual protection in antenatal and postnatal services. 2.2.2. Contraceptive considerations when female patients are on ARV therapy Women known to be infected with HIV should receive essential care and support services, including family planning and other reproductive health services, so that they can make informed decisions about their future reproductive lives. For all male and female patients receiving ARV therapy, the use of barrier methods is recommended to reduce the risk of transmission of HIV and other sexually transmitted infections. Most ARV drugs lower blood concentration of estrogens. Therefore, women on ARV therapy should not use oral contraceptives. Suitable contraceptive methods for women on ARV therapy are: Inject able Progestagen Barrier methods (female and male condoms) Emergency contraception Sterilization Contraceptive implants A short course ARV regimen for PMTCT will not have an effect on the woman’s postpartum contraceptive options. 7 Guidelines for PMTCT in Namibia CHAPTER 3 ROUTINE COUNSELLING AND TESTING (RCT) 3.1. Benefits of counselling and testing for HIV In Namibia HIV infection has emerged as the most important factor contributing to adult and child morbidity and mortality. According to the 2004 sentinel sero-survey, 1 in 5 pregnant women is infected with HIV. Life-saving interventions are now available to prevent mother-to-child transmission and prolong survival of people living with HIV/AIDS. Therefore, all pregnant women should be routinely counselled and tested for HIV infection at their first ANC visit, and their sexual partner(s) should be encouraged to be tested as well. Most pregnant woman will test HIV negative, which offers an opportunity to counsel them on risk reduction for the prevention of HIV infection. Knowing the HIV status of the partner is also critical. HIV-negative women with an HIV-positive partner are at high risk for HIV infection. Conversely, if the woman is HIV-positive, the partner may be HIV negative. These two are examples of discordant couples. Discordant couples have unique and complex needs in terms of on-going counselling and support. RCT has become increasingly important in national and international prevention and care efforts. Knowledge of HIV status can be a motivating force for HIV-positive and negative people alike to adopt safer sexual behaviour, which enables sero-positive people to prevent their sexual partners from getting infected, and those who test negative to remain negative. Counsellors could be midwives, doctors, nurses, religious workers, community members, friends, family, members of AIDS organisations and people living with HIV/AIDS. Guidelines for counselling exist; refer to them for the definition, the objectives, the process of counselling, training and the skills required. RCT is the cornerstone of all interventions to reduce mother-to-child transmission (MTCT) of HIV. In the PMTCT programme, pre-test, post-test, and on-going counselling are offered to all pregnant women and postpartum women and their partners and families. Routine counselling and testing in the antenatal clinic is different from VCT in several aspects: In VCT the client seeks the service for the specific purpose of learning their HIV serostatus and to receive counselling regarding the results as well as other information about HIV infection and AIDS. This testing is done anonymously, or the names of the clients are known but kept confidential. In the ANC the pregnant woman is seeking medical care to ensure the health of her baby and herself. HIV testing and counselling is at best a secondary purpose for seeking care. Therefore, routine counselling and testing in the antenatal clinic should be provided by the health worker to all pregnant mothers as part of a routine comprehensive package of care. It is the responsibility of the staff at the antenatal clinics at all levels to provide information and support to pregnant women regarding their HIV status. This has the effect of de-stigmatizing HIV testing, which indirectly, reduces stigma of HIV in the health care setting. The benefits of HIV routine counselling and testing in the ANC are described below: 8 Guidelines for PMTCT in Namibia Benefits of routine counselling and voluntary testing for HIV in ANC services Box 1. Making counselling and testing a routine ANC service (offered to every ANC client) can help reduce the stigma associated with both VCT and HIV infection. Counselling and testing offered at ANC clinics may be more acceptable to pregnant women compared to VCT centres that serve both men and women. Counselling and testing services based in antenatal clinics can reach a high percentage of pregnant women. When women come for follow-up visits to antenatal clinics, they can be given answers to different HIV-related questions at various stages of the pregnancy. Offering counselling and testing within the clinic/health centre will help to integrate HIV/AIDS programmes with other forms of health care, such as treatment of STIs and other infections, nutrition support, and family planning. For women who are found to be HIV-positive, counselling and testing at the health centre can help to ensure that they are referred for other interventions (treatment of STIs, TB and opportunistic infection prophylaxis, ARV prophylaxis, infant feeding counselling). For women who are found to be HIV-negative, safe sexual behaviour (or primary prevention of HIV) can be reinforced. Adapted from Preble and Piwoz, 2001 3.2. Counselling 3.2.1. Pre-test counselling for all pregnant women. For all pregnant women, education and counselling about health and health risks is an essential part of quality care. The following topics can be covered in group or individual counselling: Personal hygiene Maternal nutrition Family planning Prevention and treatment of STIs Prevention and treatment of TB and other opportunistic diseases Information on HIV transmission and prevention Routine counselling and voluntary testing for HIV Sharing results with partners ARV medicines for PMTCT and for therapy Baby care and infant feeding options No pregnant woman who refuses HIV testing should be tested. All the pregnant women who accept to be tested will sign a Consent Form, while those who refuse will sign a Release Form. 9 Guidelines for PMTCT in Namibia 3.2.2. Post-test counselling if HIV-negative Women should understand the meaning of a negative test and the window period. Those who wish to have a repeat test should be given this opportunity. Discuss risks of couples having discordant HIV results and review disclosure plans; counsel couple or partner if not tested together. Provide counselling on primary prevention of HIV infection and the importance of remaining negative. Counsel the client on the development of an individual risk reduction plan to remain negative. HIV-negative women should be advised to breastfeed in order to promote good health and nutrition for her infant. Review other aspects of pregnancy care and self-care (nutrition, hygiene, malaria, immunisations, etc.). Schedule next visit. 3.2.3. Post-test counselling if HIV-positive Counselling of mothers who are informed for the first time that they are HIV-infected may require more than one session. It is important to establish rapport that will encourage the client to feel comfortable at return visits, ideally seeing the same nurse or counsellor. At each visit check if the information on HIV/AIDS is well understood and promote safer sex. The following topics are important on which to counsel HIV-infected women. A. B. The meaning of positive results (having HIV infection) Coping with feelings of shock, loss. Difference between HIV and AIDS. Infection prevention and care. PMTCT through ongoing care and ARV medicines for the mother and baby. Living positively. Sharing results with partner Discuss whom to tell the result. Nearly all people who learn their HIV results disclose these results to someone else. Discuss couple discordance and the importance of having partner(s) tested. Since HIV is a sexually transmitted disease, it is especially important for their partners also to be counselled and tested, since the partner may or may not be infected. Discuss support systems at home and in the community. Discuss return visit or referral for couple or partner to VCT. Discuss safer sex: abstinence, being faithful to partner of known HIV status and condom use to prevent re-infection and protect partner(s). C. PMTCT interventions General information should be given about PMCT interventions at each visit: Explain the need for additional clinical evaluation and laboratory tests to check if she is eligible for HAART, co-trimoxazole prophylaxis and/or isoniazid preventive therapy. Explain the regime of Nevirapine for mother and baby. Give the mother Nevirapine to take home at 32 weeks, in case the mother is delayed in travelling to the hospital or in case she delivers at home. For Nevirapine, emphasize the importance of taking the tablet at the onset of labour. 10 Guidelines for PMTCT in Namibia D. Instruct the mother to bring the baby to the clinic immediately if she has delivered at home. Nutrition for mother and infant Healthy food for the mother. Benefits of breastfeeding and the risk of MTCT. Risks and benefits of replacement feeding for HIV-exposed infants. Acceptability, feasibility, safety and affordability of replacement feeding. Exclusive breastfeeding for four months and abrupt stopping. Issues on Family Planning Information about making decisions on future fertility. Information on contraceptive options. Drug interactions between antiretroviral drugs and contraceptives. E. F. Support groups Link the women and family members to local AIDS support groups (NGOs, community based organisations, church organisations, home based care groups), including support groups of other people living with HIV/AIDS. Health institutions should collaborate with AIDS support groups and utilise their services including peer counselling. Linking HIVpositive women and family members to these groups is important for: Reducing fear, ignorance and stigma surrounding HIV. Reducing the potential for domestic violence. Stimulating a community response in those living positively with HIV/AIDS. Contributing to an environment supportive of safer sexual behaviour. G. Planning for the future Living with uncertainty due to a chronic illness and planning for the future. Be aware of the need for ongoing HIV care, opportunistic infection prevention and treatment. Be aware of the life long increased risk of tuberculosis and the importance of early diagnosis and treatment. The criteria for the start of the ARV therapy, benefits and risks involved. Importance of drug adherence. Referral to the closest Communicable Disease Clinic. 3.3. Testing for HIV infection in pregnancy The only way to know whether or not a person is infected with HIV is to take an HIV test. The role of HIV testing in this programme is that of determining the sero-status of pregnant women, their partners, and babies born to HIV-infected mothers. It is important to note that results are needed in a timely manner in order to intervene. For women who give consent, HIV testing should be performed routinely like the other tests performed at the ANC (Rhesus, full blood count, haemoglobin, syphilis test). 3.3.1. Types of HIV tests related to the management of HIV/AIDS. HIV antibody tests ELISA tests Simple/rapid HIV Rapid HIV tests are accurate, simple to perform and provide results immediately. 11 Guidelines for PMTCT in Namibia For a pregnant woman arriving late in pregnancy, early in labour or immediately post partum, the rapid test is the only option to get a HIV result in time to intervene effectively for PMTCT. 3.3.2. Rapid HIV Testing According to the NIP, two different rapid HIV tests should be performed concurrently on a finger-stick blood sample and results reported as follows: If both tests are positive – report positive. If both tests are negative – report negative. If the tests are discordant (1 positive and 1 negative), or if the results cannot be interpreted, then perform a third test as tie breaker or send a specimen to the NIP for ELISA testing. Only trained health professionals or trained community counsellors should perform these tests in the context of a quality control assurance programme. 3.3.3 Blood sample collection It is important to remember universal body fluid precautions to prevent blood-borne transmission of HIV and other pathogens. Precautionary measures include the following: Wear gloves. Cover your sores with a plaster. Wash your hands with soap or disinfectant in case of contact with blood. Wash your hands after taking the blood. Be careful when you manipulate used needles or sharp instruments. Never re-cap used needles! Put the used needle in the disposal box. Keep the work environment clean and disinfected before and after the work. Collect the appropriate amount of blood for ELISA or rapid tests, CD4 count and any other laboratory examination to be done (refer to NIP guidelines for the amounts needed). Seal the blood containers well and label them before forwarding them to the testing site. 12 Guidelines for PMTCT in Namibia CHAPTER 4 MODIFICATION OF ROUTINE CARE DURING PREGNANCY, LABOUR, DELIVERY AND POST-NATAL PERIOD FOR HIV-POSITIVE WOMEN 4.1 Management of known HIV-positive woman during pregnancy 4.1.1. Nutrition for an HIV-positive pregnant mother. The health of a woman influences her fertility as well the health of the baby. A wellnourished mother will ensure a well-nourished foetus and newborn infant, and improve breast milk production. All HIV-infected patients need information on a healthy diet and nutritional support. During pregnancy every woman has an altered immune system. It is even more important for pregnant women who have HIV to eat a balanced healthy diet. Balanced diet during pregnancy Eating a variety of foods ensures that the body gets all the nutrients that it needs. A healthy diet for the pregnant women will ensure appropriate foetal growth and organ development. In later pregnancy when women have difficulties eating a full meal at one time, frequent eating of smaller portions and healthy snacks are good options. Energy is the capacity of a body to do work. All of a person’s energy is derived from the plant and animal food they eat. The energy value depends mainly on the carbohydrates, proteins and fats contained in food. The daily Kilo Joule (KJ) required in pregnancy are 9000-10500. Carbohydrates are the main source of energy for the body. The most common forms of carbohydrates are starches such as maize, mahangu, rice and wheat and starchy roots such as potatoes and sweet potatoes. They are cheap, easy to find and should form the base of every diet. Unrefined cereals are rich in micro nutriments, which help strengthen the immune system. Proteins play an important role in enhancing the body’s defence system. Nuts, meats and legumes should be taken in combination with cereals. Fats are a concentrated source of energy and are therefore needed in smaller amounts. Besides providing energy for the body, fats are needed for building cells and absorbing and using vitamins. Vitamins and Minerals become increasingly important when the immune system is weakened. They can be found in dark green leafy vegetables, yellow and orange fruits, sweet potatoes, pumpkins, carrots, avocados and tomatoes. Nutritional guidance for all pregnant women Box 2. Every day, the pregnant women should consume the following food: Milk products e.g. yoghurt, omaere, fresh milk and omootekwa (different names in indigenous languages applicable as well). Meat, fish, eggs, or/and beans interchangeably and at regular daily intervals. Fruit and vegetables, e.g. orange, spinach, pumpkins, and apples. Bread and cereals, interchangeably and at regular daily intervals. Lots of liquid, e.g. water, oshikundu, and fresh juice. Alcohol intake is prohibited. Other types of food and liquid may be consumed in line with cultural preferences and practice. 13 Guidelines for PMTCT in Namibia Precautions to prevent or minimise food or waterborne diseases, recommended for pregnant women living with HIV/AIDS. Eat food that is well cooked and not contaminated. Never leave raw or cooked meat, poultry, fish and shellfish outside a refrigerator for more than 1 hour. Uncooked meat should not be in contact with other foodstuff. Knives and all the instruments should be washed after contact with uncooked foodstuff. Raw food should be stored separately from cooked food. A person living with HIV/AIDS should not drink water directly from lakes, ponds, and rivers, due to the risk of acquiring various water-borne diseases, for example cryptosporidiosis, giardiasis and others. 4.1.2. Routine antenatal care When a woman who is known to be HIV-positive becomes pregnant, or is diagnosed as being HIV-positive during pregnancy, her obstetric and medical care will need to be strengthened and modified. All routine ANC supplies and vaccinations for example iron, multivitamin, folic acid, tetanus toxoid should be provided. Sexually transmitted infections should be treated following MOHSS syndromic management guidelines. The schedule for follow up of the HIV-positive women is the same as in routine ANC. From 0 to 28 weeks: follow-up visit monthly From 28 to 36 weeks: follow-up visit every 2 weeks From 36 weeks: follow-up visit every week Additional visits will not be required for obstetric reasons, although the HIV positive pregnant woman may need to attend further counselling sessions or for complications related to her HIV status. When possible procedures, such as chorionic villus sampling, amniocentesis or cordocentesis and external cephalic version (ECV), should be avoided because they may carry a risk of HIV transmission to the foetus. Medical evaluation for opportunistic infections At the initial and at subsequent visits, a review of HIV-related symptoms and determination of WHO staging should be done with focus on the following HIV-related signs and symptoms. Persistent diarrhoea; Fever; Respiratory infections; Signs of TB; Oral and vaginal candidiasis; Lymphadenopathy; Herpes zoster; Other skin conditions can be common in HIV-infected persons; Other sexually transmitted infections; Poor weight gain, weight loss, or wasting in pregnancy are a poor prognostic sign of HIV infection. 14 Guidelines for PMTCT in Namibia TB and bacterial respiratory infections are common in HIV-positive individuals. All HIVinfected pregnant women should be screened for active TB and further evaluated if they have any of the following signs and symptoms. Cough, Fever, Weight loss, Night sweats. In case of illness, the nurse should refer the pregnant women to the medical officer for further evaluation. Laboratory investigations for HIV-positive pregnant women All HIV positive pregnant women should have the normal routine tests. In addition, CD4 count and the Hepatitis B surface antigen should be performed if not done previously as a baseline. Prophylactic treatment Prophylaxis in HIV-positive pregnant women may include: Pregamal Multivitamin supplementation Tetanus toxoid immunisation Intermittent Preventive Treatment (IPT) during first and second pregnancies for women living in malarious areas. Sulphadoxine-pyrimethamine should be given in two doses. The first dose should be given after quickening and the second one at least four weeks apart up to 36 weeks of pregnancy. Cotrimoxazole prophylaxis after the first trimester if her CD4 count is below 300. Pregnant women should be encouraged to sleep under impregnated mosquito nets. Isoniazid Preventive Therapy (IPT) to treat latent TB infection is recommended for HIV-infected pregnant women as long as there is no evidence of active TB and they have not received IPT before. Who should get IPT Who should not get IPT Pregnant women HIV infected with none Any HIV infected pregnant woman of the following signs or symptoms of TB. with any of the following signs or symptoms. No fever Loss of weight No cough Fever No night sweats Cough No significant lymphadenopathy Night sweats No active liver disease (jaundice) Lymphadenopathy Has not received IPT before or TB Liver disease (jaundice) treatment in the previous year TB treatment in the previous year NB: Isoniazid is safe to administer during pregnancy and breastfeeding. 15 Guidelines for PMTCT in Namibia HIV related illnesses in pregnant women HIV related illnesses in pregnant women are treated in the same way as in non-pregnant women. The patient should be referred to a doctor familiar with HIV care and pregnancy. Tuberculosis is the most significant common disease and should be managed and treated in accordance with TB treatment protocols. However, the management of TB and ARV treatment in pregnant women is complex. HIV-positive women may have other sexually transmitted infections that will require treatment. Urinary tract infection and respiratory infections are more common in HIV-positive women and may require antibiotic therapy. Vaginal candidiasis may be recurrent and should be treated with local antifungal preparations. Oral and/or oesophageal candidiasis should be treated with fluconazole and/or local anti-fungal preparations. Antiretroviral therapy for the mother If the pregnant woman meets the criteria for antiretroviral therapy, she should be put on treatment. In order to prevent the transmission of HIV to the unborn baby, a single dose of Nevirapine 200mg should be given to the mother to take home in last trimester (32 weeks) for self-administration at the onset of labour. Partner involvement Counselling, testing and, if indicated, treatment is advocated for all partners of HIVpositive pregnant women. When possible the HIV follow-up of the pregnant woman and her partner should be done simultaneously. Repeated counselling sessions will support the family in the feeding option chosen. Counselling for lifestyle and behaviour change Unprotected sex in the presence of STIs during pregnancy may be associated with an increased risk of HIV transmission to the baby. Women and their partners should be encouraged to reduce risk of transmission to the child and partner by using condoms. Smoking, alcohol and drug use should be discouraged. Follow-up for HIV-positive pregnant women HIV-infected pregnant women with CD4 more than 300/mm3 and asymptomatic need to be followed-up routinely at their ANC appointments. They should be monitored for symptoms of disease progression. CD4 count should be repeated every 6 months. Pregnant women with CD4 less than 300/ mm3 or WHO stage III or IV should be referred to the Communicable Disease Clinic for ARV therapy where they will receive monthly follow up. Prevention and treatment of opportunistic diseases and infections are important priorities for care at all stages of HIV disease. 4.2. Management of the HIV-positive woman during labour and delivery 4.2.1. Universal precautions Women with HIV infection should not be isolated from other women in labour. Universal precautions should be used by health workers on all women in labour irrespective of their HIV status. 16 Guidelines for PMTCT in Namibia Remember to follow universal precautions in all women. Box 3. • Reduce needle stick injuries, do not recap needles. • Wash hands with soap and water after contact with blood and body fluids. • Wear gloves during operations and delivery or any invasive procedures. • Cover your own broken skin or open wounds. • Wear impermeable plastic apron when conducting delivery. • Wear eye shields/goggles during operations and deliveries. 4.2.2. Specific intrapartum interventions Management of labour in all known HIV positive women i. Midwives should confirm the HIV status of all women who are admitted to the labour ward by checking the records and/or by asking the mother whether she has been tested for HIV infection. The management of those who are HIV-positive is discussed below. ii. Labour management should follow normal obstetric guidelines in most respects. Analgesia should be given in labour, if required and epidural analgesia is not contraindicated. iii. Proper and consistent use of the partogramme in the monitoring progress of labour will improve the management and reduce the risk of prolonged labour in all women. iv. Emotional support during labour is important for all women, and may be even more necessary for an HIV-positive woman who is concerned about her condition and the risk of transmission to the child. This may be made worse by her fear of stigmatisation and discrimination by medical staff, her partner or family members. v. Whenever possible, during labour, HIV-positive women should have the option to have a companion of their choice present who knows their HIV status and who can provide supportive companionship. vi. Labour ward staff should be sensitive to the fears and concerns of the HIV-positive mother about her HIV status. Management of normal vaginal deliveries Vaginal cleansing with Hibitane (chlorhexidine 0.25%) solution reduces the risk of puerperal and neonatal sepsis. It may also have some effect on HIV transmission where membranes are ruptured for more than 4 hours. After every vaginal examination, the birth canal is wiped with gauze or cotton wool, soaked in Hibitane solution. The number of vaginal examinations should be kept to minimum required. Where induction of labour is indicated, membranes should be left intact for as long as possible because prolonged rupture of membranes is associated with increased risk of transmission. Artificial Rupture of Membranes (AROM) of more than four (4) hours duration is associated with an increased risk of HIV transmission. Therefore, it should be reserved for women with foetal distress or abnormal progress. Episiotomies should be used only for specific obstetric indications. Delivery should be conducted using standard practice while avoiding unnecessary trauma or prolongation of the second stage. 17 Guidelines for PMTCT in Namibia Management of deliveries by Caesarean Section (CS). Caesarean Sections can reduce the risk of MTCT compared to vaginal delivery. However, it carries the risk of surgical complications, such as infections and slow healing of wound. Caesarean Sections should only be performed for standard obstetric indications. Activities to consider when performing a safe delivery Box 4. Perform vaginal cleansing with Hibitane (chlorhexidine 0.25%). Avoid episiotomies unless absolutely necessary. If assisted delivery is required it should involve as little trauma as possible. Clamp cord immediately after baby is delivered and avoid milking the cord. Cut cord under cover of a lightly wrapped gauze swab to avoid blood spurting. 4.2.3. Management of ARV medicines for HIV-positive women in labour. ARV medicines are effective in reducing transmission of HIV from the mother to the baby when used appropriately. In Chapter 6, the different clinical scenarios and recommendations for use of ARV drugs are described. If the pregnant woman does not qualify for ART she, should be given single-dose Nevirapine (SD-NVP) to reduce the risk of transmission to the baby. During the last trimester (32 weeks), the mother should receive 1 tablet of Nevirapine (200 mg each) to take home and to be taken at the onset of labour and report to the nearest health facility. If more than 48 hours have past since the first Nevirapine dose and she is in labour, then Nevirapine single-dose should be repeated. SD-NVP is most effective when given at the onset of labour. Upon admission to the labour ward, the midwife should ask whether the HIV-positive pregnant woman received a dose of Nevirapine during antenatal care and whether she took it before admission. If she did not take Nevirapine prior to admission and is in labour, a stat single-dose of Nevirapine 200 mg orally should be given immediately. In the case of elective Caesarean Section, a single-dose should be given 2 to 6 hours prior to the procedure. If the mother is HIV-negative with an HIV-positive partner, neither she nor the new-born are to receive Nevirapine. Mother to child transmission of HIV can only occur if the mother is HIV-infected. 4.3. Management of women with unknown HIV status when in delivery or postpartum. It is common for women with unknown status, such as unbooked cases, to present to the health facility in active labour. In such cases the health worker should counsel the mother about the need to know her HIV status. The benefit of Nevirapine to prevent the HIV transmission from the possible HIV infected mother to the child should be explained, and the possibility to reduce transmission by providing Nevirapine to the new born, should also be explained. If she agrees to be tested she should sign a consent form for 18 Guidelines for PMTCT in Namibia HIV testing and giving NVP to the baby. When the test results are known she should be counselled accordingly. 4.4. Care of HIV-positive women after delivery The postnatal period remains without complications in the majority of cases. However, HIV positive women are prone to infection in the postnatal period. Once infection is suspected intervention should be promptly instituted. Information on possible complications should be given before discharge. Decision on infant feeding is best made before delivery. Infant feeding options should be reviewed and support should be provided on the choice made. Information on contraception options should be given and services provided. The use of barrier methods (male or female condom) is recommended to reduce the risk of transmission of HIV and other sexually transmitted infections. An additional highly effective contraceptive method is recommended to minimise the risk of unintended pregnancies. Women whose HIV status is not known should be offered counselling and testing in the immediate postnatal period once the patient has been stabilised. The patient needs to be reviewed 6 weeks after delivery for a PAP smear and possible referral to the relevant unit for ongoing clinical and laboratory evaluation and monitoring. Further counselling and support will be needed. Women and their partners should be referred to community-based organisations or other support groups available. 19 Guidelines for PMTCT in Namibia CHAPTER 5 MANAGEMENT OF THE HIV-EXPOSED NEWBORN 5.1. Management of the Newborn in the Early Postnatal Period 5.1.1. All babies should be handled with gloves and wiped with towel or surgical cloth and washed with water and gentle soap. 5.1.2. Avoid suction in most newborns. If suction is required do it gently and use a mechanical suction unit (at a pressure below 100mmHg) or a bulb suction and not a mouth-suctioning device. 5.1.3. Cut the cord under the cover of lightly wrapped gauze. 5.1.4. All babies, irrespective of their HIV status should be kept warm after delivery. 5.1.5. Assessment of the newborn including the determination of the birth weight, length, head circumference and eye care are done as usual. 5.1.6. Vitamin K, BCG, polio immunisation should be given according to the recommendations for all newborns. Injections should be given only after bathing. 5.1.7. Infant should receive 1% tetracycline eye ointment or 1% silver nitrate eye drop as prophylaxis against ophthalmia neonatorum. 5.1.8. Skin to skin contact with the mother should be established in all babies, even if the mother is not intending to breastfeed. 5.1.9. Breastfeeding should commence at once if the mother has decided to breastfeed. 5.1.10. Solid waste e.g. dressings and placenta, should be properly disposed of. 5.2. Infant Feeding Options The objective of health services should be to prevent HIV transmission through breastfeeding and optimize nutrition for the HIV exposed newborn while continuing to protect, promote and support breastfeeding as the best choice of infant feeding for women who are HIV negative and women who do not know their HIV status. Meeting this objective requires: Organising counselling services, Strengthening ANC services, Providing infant feeding counselling for all pregnant women during ANC and mothers post partum, Facilitating access to replacement feeding1 where appropriate, Preventing any “spill over “ effect of replacement feeding to those who are HIVnegative and of unknown status, Preventing commercial pressures of artificial feeding and, Providing appropriate follow-up care and support for HIV-positive women and their children, particularly up to the age of two years. 1 Replacement feeding is defined as the process of feeding a child who is not receiving any breast milk with a diet that provides all the nutrients the child needs. During the first six months this should be with a suitable breast milk substitute-commercial formula or fresh cows or goats milk with vitamins and minerals supplements. After six months it should preferably be with a suitable breast milk substitute, and complementarily prepared and nutrient – enriched family foods, given three times a day. If suitable breast milk substitutes are not available, appropriately prepared family foods be further enriched and given five times a day. 20 Guidelines for PMTCT in Namibia 5.2.1 Feeding recommendations for HIV negative women Exclusive and sustained breastfeeding means breastfeeding with no any other feeding for the first four months of life for the baby, which is followed by the introduction of complementary foods at six months with continued breastfeeding up to 2 years and beyond. This feeding pattern is recommended for all mothers who are HIV negative and those who do not know their sero-status. Health workers are required to assist mothers with appropriate breastfeeding techniques and management of breastfeeding problems. Exclusive and sustained breastfeeding is recommended for all children of women whose HIV-status is negative or unknown. 5.2.2. Feeding recommendations for HIV-positive women Breastfeeding is normally the best way to feed an infant. However, if a mother is infected with HIV, it is preferable to replace breast milk to reduce the risk of HIV transmission to her infant. Breastfeeding is a preventable mode of HIV transmission to infants and there is an urgent need to educate, counsel and support women and families so that they can make decisions about how best to feed infants in the context of HIV. Mothers who are HIV-positive but choose to breastfeed can reduce the risk of transmission to their infants by modifying breastfeeding. HIV infection is an acceptable medical reason for feeding milk other than breast milk. Health workers and counsellors should help HIV infected pregnant and lactating women who choose not to breastfeed to identify safe, affordable, sustainable, feasible and acceptable alternatives to breast milk. The risk of replacement feeding should be less than the potential risk of HIV transmission through infected breast milk, so that infant illness and death from other causes do not increase; otherwise there is no advantage in replacement feeding. Replacement feeding in the case of HIV is applied to mothers known to be HIV positive and is not a violation of the “baby and mother friendly initiative” guidelines or the Code of Marketing of breast milk substitutes. A. Exclusive breastfeeding from birth to four months and abrupt stopping An HIV positive mother may choose to breastfeed her baby if she considers it to be the best way of feeding. If the mother chooses this method of feeding, she requires support and encouragement. The baby should be breastfed on demand at least 8 to 12 times in 24 hours including night feeds. Exclusive breastfeeding provides the best infant nutrition for growth and development. Giving the baby any drinks, water or foods other than breast milk and use of pacifiers or dummies or artificial teats interferes with exclusive breastfeeding. In addition, it may cause gut infection and irritation that will the baby more susceptible to HIV transmission. How to achieve exclusive breastfeeding Teach the mother the importance of exclusive breastfeeding during antenatal care. Initiate breastfeeding within ½ an hour of birth with skin-to-skin contact. Show mothers how to correctly position and attach their babies to the breast. Teach the importance of breastfeeding on demand, rooming-in and night feeds. Teach and show mothers how to express and feed breast milk. Teach mothers about the dangers of using bottles, artificial teats, dummies and cups with spouts. 21 Guidelines for PMTCT in Namibia How to help mothers to achieve early and abrupt stopping Stopping breastfeeding early reduces the risk of transmission of HIV by reducing the length of time the infant is exposed to the virus in breast milk. Before a mother stops breastfeeding abruptly, she needs counselling about replacement feeding and support for her decision. This counselling should begin in the post partum period. It should include the following points: Finding a regular supply of another kind of milk. It is important that she does not mix formula and breast milk as this might increase the risk of HIV transmission. Milking her breasts to dry up without engorgement. Ensuring continuing physical contact with her baby without giving in to the pressure to breastfeed How to cup feed her baby. B. Replacement feeding (infant formula, cows and goats milk) Replacement feeding can be an option of choice provided it is acceptable, affordable, sustainable, feasible and safe. Commercial infant formula is already modified but cow's and goat's milk for the first 6 months needs to be modified. The baby on exclusive replacement feeding needs water. How to achieve exclusive replacement feeding Exclusive replacement feeding is more difficult than exclusive breastfeeding. Therefore mothers should be taught: the dangers of mixed feeding; how to prepare infant formula; How to correctly and safely modify cow’s or goat’s milk. Commercial Infant formula Safe formula feeding is expensive. This option should be considered by the HIV-positive mother when: Formula feeding is acceptable and affordable in the social context. The family has reliable access to a sufficient supply of commercial infant formula for at least 6 months. The cost given in Table 5 does not include the cost of utensils and fuel needed for the preparation. The family has resources, including clean water, fuel for food preparation, utensils, skills and time to prepare commercial infant formula accurately and hygienically. The mother should be educated about the dangers of diarrhoea and how to treat dehydration with ORS. The family has access to an optimal environment, including sanitation and safe water. Table 5: Requirements and costs of infant formula for the first six months. Age (Months) Quantity First month Second month Third month onwards TOTAL 2.5 kg (5 tins) 3.0 kg (6 tins) 4.0 kg (8 tins) 22 Cost N$ (500 gm tins at 30 N$) 30 x 5 = 150.00 30 x 6 = 180.00 30 x 8 = 240.00 570.00 Guidelines for PMTCT in Namibia Preparation of Infant Formula Mothers should be advised to follow all the instructions given for preparation and mixing of the formula: Wash hands with clean water and soap before preparation. Use clean utensils washed in soap and water and kept covered. Boil water for 5 minutes and cool to room temperature before mixing. Make sure the water and the powder is correctly measured. Mix powder and water well. Prepare only one feed at a time. Use a cup to feed the baby, hold the baby close to foster bonding. Discard left over feed. The mother should be advised on the following: Not store prepared feed in a thermos, because this will help bacteria to multiply. Always check the expiry date on the tin. Store infant formula in cool and dry place. Follow the manufacturer’s instructions on the infant formula label in order to ensure safe preparation of formula. This option requires a lot of support. Preparation of modified cow’s and goat’s milk Modified animal milk is another option for infant feeding but in Namibia fresh cow’s and goat’s milk may not be available all year round. The only milk reliably available is “Long Life” milk, which is more expensive in comparison to fresh cow’s milk. In addition, modification of animal milk is more complicated than preparation of infant formula, which is already modified. Furthermore, there is a need to provide supplements in the form of vitamins and minerals. After six months the baby can be given full strength milk. Animal milk contains twice as much protein and about six times as much mineral salts than human milk. In addition, it has less carbohydrate content than breast milk. It is therefore difficult for an infant’s immature kidney to excrete the extra waste. Unmodified milk may lead to illness including convulsions. To make it safer for the baby less than 6 months it should be modified by diluting it with water to reduce protein and minerals and boiled to make the protein more digestible. Sugar should be added to increase the energy content. The baby should also be given multi-vitamin supplements to prevent micronutrient deficiency. Follow the following steps to prepare the milk feeds: Wash hands with clean water and soap before preparation. Use clean utensils washed in soap and warm water and kept covered. Boil water for 5 minutes and cool to room temperature before mixing. Boil milk to the boiling point and cool it to room temperature Measure the correct amount of water, milk and sugar. Mix well. Use a cup and a spoon to feed the baby. Hold the baby while feeding. Discard left over milk. 23 Guidelines for PMTCT in Namibia Table 6: Baby’s minimum requirements while using modified cow’s and goat’s milk. 150 ml/kg of body weight per day Average weight st 1 month 3 kg 2nd month 4 kg rd 3 month 5 kg th 4 month 5 kg 5th month 6 kg th 6 month 6 kg Age (months) Dilution: 100ml milk +50ml water + (2 teaspoons) sugar = 150 ml Milk 320 ml 420 ml 480 ml 480 ml 600 ml 600 ml Water 160 ml 210 ml 240 ml 240 ml 300 ml 300 ml Sugar 32 g 42 g 48 g 48 g 60 g 60 g Total volume/day Approximate number of feeds 480 ml 640 ml 720 ml 720 ml 900 ml 900 ml 8 x 60 ml 7 x 90 ml 6 x 120 ml 6 x 120 ml 6 x 150 ml 6 x 150 ml The baby requires about 92 litres for the first six months as the actual intake. The cost is ± N$7.00 per litre x 92 = N$644. Like in the case of infant formula, this cost does not include the cost of utensils and fuel for preparation. After six months the baby can be given full strength milk. Offer the baby clean water to drink 2-3 times a day to avoid constipation. 5.3. Management of Breastfeeding For breastfeeding to be successful the following issues should be explained and/or shown to mothers. It is ideal to do this during antenatal period and reinforce after delivery. Correct positioning and attachment. Importance of early initiation of breastfeeding immediately after birth. Frequency and duration of breastfeeding 8 to 12 times including night feeds. Importance of exclusive breastfeeding. The importance of breastfeeding on demand and rooming in. Dangers of mixed feeding. 5.4. Introducing complementary feeding 6-12 months It is recommended that solids be introduced at 6 months for both breastfed and replacement fed babies. The first food to be introduced is the household staple energy food. The consistency and frequency of solid food is very important: Answering the following questions will assist health workers in advising the mother to do the right thing: When? From 6 months. What? Household staple energy food. How? Gradually by spoon. How often + How much? Once a day on the first day, increase amount and frequency gradually up to 2 times a day until 9 months. What consistence? Soft and smooth, but not watery. When and How? At 9 months, gradually introduce well-mashed fruits and vegetable one spoon of one food at a time Increase as the child is becoming used to the food. Add other food e.g. soft meat, fish, chicken, egg (only yellow). Enrich staple food with oil, fats and sugar. Increase the amount, consistency and frequency up to 5 times per day at 1 year,. 24 Guidelines for PMTCT in Namibia 5.5. Clinical Management of the HIV-exposed Newborn The child should be monitored closely and in case of clinical signs of HIV infection referred to Communicable Disease Clinic (CDC). 5.5.1 Management of ARV medicines. The newborn of an HIV-infected mother should receive single-dose of Nevirapine 2 mg/kg between 12-72 hours after delivery if the mother has received Nevirapine at least 2 hours before delivery. If an HIV-infected mother has not received Nevirapine during labour and presents with her new-born baby, the following is recommended: Table 7. Weight <1.5 kg <2kg 2-3kg 3-4 >4kg Dosages of Nevirapine suspension Nevirapine (mg) Nevirapine suspension (10 mg/ml) Adjust the dose according to 2mg/kg 4 mg 0,4 ml 6 mg 0,6 ml 8 mg 0,8 ml 10 mg 1,0 ml 5.5.2. Prophylaxis for Opportunistic Infections Pneumocystis carinii pneumonia (PCP) is the leading cause of HIV related mortality in infants, therefore PCP prophylaxis is recommended for all HIV-exposed infants beginning at the age of 6 weeks. Indications for stopping PCP prophylaxis are: i. HIV infection excluded; ii. HIV infected children, over 1 year, on ARV drugs, with CD4>20% for 3 to 6 months. Table 8. Recommended doses of co-trimoxazole for PCP prophylaxis Age Co-trimoxazole dosage Six weeks to five months 2.5 ml once daily on Mondays, Wednesdays and Fridays. Six months to six years 5 ml once daily on Mondays, Wednesdays and Fridays. All HIV exposed contacts under 5 years who are exposed to a TB patient having a positive AFB sputum smear are eligible for Isoniazid Preventive Therapy (IPT). The infant should be seen at the first scheduled immunisation visit at 6 weeks, followed by monthly visits until 6 months of age. 5.6. Diagnosis of HIV Infection in Children Maternal HIV antibodies pass through the placenta during pregnancy. Therefore children born to HIV-positive mothers may have a positive HIV antibody test. Passively transferred maternal HIV antibody may persist for up to 18 months. The current minimum standard in Namibia is to use an HIV antibody test to diagnose HIV infection in HIV exposed children. All babies born to HIV infected mothers should be tested regularly for HIV in accordance with the Protocol for PMTCT. Polymerase Chain Reaction (PCR) tests, which detect viral RNA or DNA rather than maternal antibodies can be used when become available. PCR should be performed after the end of the breastfeeding, or if clinically indicated according to the flow chart below. 25 Guidelines for PMTCT in Namibia Diagnosis of HIV infection in infants Infant No Yes Breastfed? 1 ELISA or 2 rapid (1) HIV tests at 18 months (2) 1 ELISA or 2 rapid (1) HIV tests at 9 and 12 months 2 Positives tests 1 positive test and 1 negative 2 negatives tests Positive eee Negative The child is HIV Positive The child is HIV negative e test Antibody test at 18 months HIV result Positive The child is HIV Negative HIV result Negative The child is HIV Positive. 26 Guidelines for PMTCT in Namibia CHAPTER 6 MANAGEMENT OF ANTIRETROVIRAL INTRAPARTUM, AND POSTPARTUM 6.1. MEDICINES DURING PREGNANCY, Overview of Antiretroviral Drug Use for PMTCT There are essentially three types of ARV medicines used in Namibia. Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) These medicines inhibit the transcription of viral RNA into DNA, which is necessary for reproduction of the virus. They include zidovidine (AZT) and lamivudine (3TC); the best studied and most widely used NRTIs for PMTCT. Stavudine (d4T) and didanosine (ddI) are also commonly used NRTIs in long term ARV therapy, but not in short course for PMTCT. Non-Nucleoside Analogue Transcriptase Inhibitors (NNRTIs) These are of a chemically different class than NRTIs but also inhibit transcription of viral RNA into DNA. They include nevirapine (NVP) and efavirenz (EFV). Nevirapine is widely used and well studied for PMTCT, but efavirenz should not be given to pregnant women due to potential teratogenicity. Protease inhibitors (PIs) They act on the viral enzyme that cuts long chains of amino acids into smaller proteins. Protease inhibitors are used for long-term ARV therapy, not as a component of shortcourse ARV drug regimens for PMTCT. ARV medicines should be administered to HIV-positive pregnant women for purposes of PMTCT and/or therapy under the following clinical scenarios. Scenario 1 Continuation of Highly Active Antiretroviral Therapy (HAART) during pregnancy. Scenario 2 Initiation of HAART during pregnancy for women who have WHO stage III or IV disease or CD4 below 300/mm3, but have not yet been started on antiretroviral therapy. Scenario 3 HIV-infected pregnant women who do not qualify for ART and their exposed newborn should receive a recommended short course of antiretroviral medicine regimen for PMTCT. Scenario 4 ARV drug prophylaxis for the HIV-exposed newborn, when the mother did not receive any antiretroviral drug. 27 Guidelines for PMTCT in Namibia Fig. 4. Algorithm for use of ARV Drugs for HAART or PMTCT in Pregnant Women First ANC Visit HIV routine counselling and voluntary testing YES Known HIV positive NO NO HIV Result HIV Negative YES Receiving HAART YES HIV Positive Counsel on HIV prevention and ` promote breastfeeding Home delivery and mother did not take NVP Counselling, clinical and laboratory assessment,included. CD4 NO WHO clinical stage III / IV or CD4<300 cells/mm3 Scenario 1 Continue HAART, but discontinue or switch if On EFV , or On ddI/d4T, or Severe toxicity or side effects (vomiting) YES Assess for medical contraindications. Scenario 4 Scenario 3 Scenario 2 NVP 2 mg/kg to new-born STAT Second dose after 48-72 hours NVP 200 mg at onset of labour and 2 mg/kg to newborn at 12-72 h Start therapy with NVP+AZT+3TC Or if Hb<7 NVP+d4T+3TC (1) Regular follow-up counselling and clinical follow-up of mother and infant (1) - For those on TB treatment, special regimen is required, see Section 6.3.2 EFV=efavirenz ddI=didanosine d4T=stavudine NVP=nevirapine AZT=zidovudine 3TC=lamivudine 28 Guidelines for PMTCT in Namibia 6.2 Management of ARV Drugs in Pregnancy According to Clinical Scenarios 6.2.1. Scenario 1 HIV infected pregnant women already on HAART during current pregnancy HAART regimens in pregnant women achieve efficacy for PMTCT through significant reductions in maternal viral load. For women already receiving HAART and who become pregnant, continuation of HAART with a recommended regimen for pregnant women is the best option for mother and child. Not all HAART regimens, however, are safe or recommended in pregnant women. All recommended regimens consist of two nucleosides and a potent third drug to complement it. Because some patients will not tolerate the recommended first line therapy, clinicians providing HAART should be familiar with the various regimens. The most widely used ARV therapy regimens in pregnant women include zidovudinelamividine (AZT/3TC), in combination with nevirapine (NVP), or nelfinavir, or lopinavir/ritonavir (LPV/R), or saquinavir/ritonavir. These combinations are recommended by WHO. The combination of stavudine-didanosine (d4T/ddl) should not be used in pregnant women due to the increased risk of lactic acidosis. Efavirenz (EFV) should not be used in pregnant women due to the potential teratogenic effects on the foetus. Pregnant women who lopinavir/ritonavir (LPV/r). cannot tolerate nevirapine (NVP) should be given Women on HAART should be counselled about potential risks and benefits of continuing therapy during the first trimester. If therapy is discontinued during the first trimester, stop all medicines at once and restart all the same medicines simultaneously in the second trimester as long as the medicines are not contraindicated in pregnancy. If the pregnancy is identified during the second trimester, continue with treatment. Consult a specialist physician if HAART in a pregnant woman needs to be switched or interrupted. 6.2.2. Scenario 2 HIV-positive pregnant women who have not received prior antiretroviral therapy but needs it for their own health For HIV-positive pregnant women who have not received ARV therapy, follow Figure 4 to determine if she qualifies for ARV therapy. The use of ARV therapy during pregnancy, when indicated, will improve the health of the mother and substantially decrease the risk of transmission of HIV to the infant. If she does not qualify for ARV therapy, she should receive a short course ARV regiment for PMTCT. Pregnant women should be started on ARV therapy if they meet the following criteria: 29 Guidelines for PMTCT in Namibia WHO stage III or IV HIV disease irrespective of CD4 cell count; WHO stages I or II, with a CD4 cell count below 300/mm³, Social criteria,which include the following: ~ Lived in a stable residence for the past 3 months; ~ Are not acutely abusing alcohol or other substances; ~ Have access to the Communicable Disease Clinic for follow-up; ~ Patient is committed to long-term ARV therapy, adherence to treatment, practising safer sex, and allowing home visits if indicated; ~Patient has identified someone at home, in the community, or at the workplace to serve as a therapy supporter. The first-line regimen for HIV-positive pregnant women who do not have active TB and meet the eligibility criteria for HAART is zidovudine-lamivudine-nevirapine (AZT-3TC-NVP). The dosages for the first-line HAART regimen in pregnant women are: i. Zidovudine (AZT) 300 mg twice daily. Monitor haemoglobin levels. ii. Lamivudine (3TC) 150 mg twice daily. iii. Nevirapine (NVP) 200 mg daily x 14 days, then twice daily. Monitor alanine amino transferase (ALT). HAART should be started in the second trimester unless the patient is severely ill, in which case therapy should be started as soon as possible. Prior to initiation of therapy, assessment for medical contraindications to regimen must be done. ARV drugs should be continued as usual during labour and the post partum period. Women who are put on HAART should be observed for evidence of ARV medicine toxicity, in particular Nevirapine-related liver toxicity and skin rash. Zidovudine (AZT) should not be used in women with Hb≤7 g/l. They should receive stavudine (d4T/20mg) twice daily as well as appropriate management of underlying causes of anaemia. 6.2.3 Scenario 3 HIV infected pregnant women who do not qualify for ARV therapy or HIV-infected pregnant women in labour who have received no ARV medicines drugs during pregnancy HIV positive pregnant women, who are not yet eligible for ARV therapy on the basis of their disease status should be offered a short course ARV regimen for PMTCT. HIV-positive pregnant women, who do not meet the eligibility criteria for ARV therapy or are in labour and have received no ARV therapy before, should receive SD-NVP at the onset of labour. The baby should receive a SD-NVP. 30 Guidelines for PMTCT in Namibia 6.2.4 Scenario 4 Infants born to HIV infected mothers who received no ARV medicines during pregnancy or labour If an HIV infected mother, for some reasons, has not received Nevirapine during labour and presents with her new-born baby, the following is recommended: * Newborns who present less than 24 hrs of age should receive a dose of Nevirapine syrup and a second dose at 48-72 hrs. * New-borns who present more than 24 hrs of age but less than 72 hours of age should receive a single dose of NVP syrup. * New-borns who present more than 72 hours of age do not benefit from PMTCT prophylaxis and should not receive Nevirapine. 6.3 Monitoring of pregnant women placed on HAART 6.3.1. Clinical monitoring for pregnant women placed on HAART Baseline clinical assessment The baseline medical history should include essential demographic characteristics; the past medical history including major illnesses, hospitalisations and surgeries, the length of time since the diagnosis of HIV infection, current medications and review of symptoms. The baseline physical examination should include vital signs, weight, and detailing of any abnormalities of the eyes, oropharynx, lymph nodes, lungs, heart, abdomen, extremities, nervous system and genital tract. Once ART has commenced, a reasonable schedule for clinical monitoring includes follow-up visits at two, four, and six weeks after initiation and a minimum of every two months thereafter for clinical and laboratory monitoring. Monthly visits to trained staff, which can be combined with drug dispensing, are encouraged so as to monitor and reinforce adherence and identify problems requiring referral. At each visit, inquiries regarding adherence to treatment, any new symptoms that may be related to drug side effects, HIV disease progression or opportunistic infections should be made. Clinical monitoring for toxicities and effectiveness of ARV medicines in pregnant women Patients should be informed about the symptoms of ARV medicines side effects/toxicities and should be educated regarding the need to seek care. Clinical evaluation of the effectiveness of ART is important. The basic parameters examined and documented should include: ~ the patient’s perception of how he/she is doing on therapy; ~ changes in body weight over the course of therapy; ~ signs of immune reconstitution syndromes. ~ HIV-related disease progression. ~ signs of drug toxicities. ~ decrease in symptoms of HIV disease and an improved quality of life. 31 Guidelines for PMTCT in Namibia Baseline laboratory assessment Baseline laboratory assessment for HIV-infected pregnant women prior to starting ARV therapy: HIV CD4 count FBC RPR HBs Ag (Hepatitis B surface Antigen) ALT Creatinine Blood glucose 6.3.2 Management of pregnant HIV-positive women with concurrent diseases. Tuberculosis It is preferable that pregnant women with TB disease complete their TB therapy prior to beginning ARV medicines for therapy or PMTCT. However, they will need to be started while still on TB treatment if they are in the last trimester of pregnancy because there is high risk of HIV disease progression and death during the period of TB treatment. Normally, in cases where a person needs TB and HIV therapy concurrently, first line therapy options include efavirenz (EFV) plus zidovudine-lamivudine (AZT/3TC) or stavudine/lamivudine (d4T/3TC). However, efavirenz (EFV) should not be used during the first trimester of pregnancy. Except for SQV/r, PIs are also not recommended during TB treatment with rifampicin due to their interactions with the latter drug. Therefore, the regimen of choice for pregnant women with AIDS and TB is AZT-3TC saquinavir/ritonavir (SQR/R) or abacavir (ABC), or efavirenz. Nevirapine (NVP) should only be use if there is no alternative, considering the hepatotoxicity of Nevirapine and the effect of rifampicin on reducing serum levels of NVP. Table 9: Recommendation for ARV therapy in HIV-positive pregnant women with Tuberculosis Situation Pulmonary >200mm³ Recommendations for PMTCT and HAART TB and CD4 Treat TB. Monitor CD4 counts. Give only short-course regimen for PMTCT. Start TB treatment. Start ART after 2 months of TB therapy and if in 2nd trimester of Pulmonary TB and CD4 50pregnancy use zidovudine-lamivudine 200/mm³ (AZT/3TC) plus saquinavir/ritonavir (SQV/R) or efavirenz. Start TB therapy. Evaluation at 2 weeks, and Pulmonary TB and CD4 start HAART as soon as TB therapy is <50/mm² tolerated using AZT-3TC-SQV/r or efavirenz if Or extra pulmonary TB in 2nd trimester. Hepatitis B Virus (HBV) Limited studies have shown that there is a high prevalence of HBV among Namibians with HIV. Among patients with effective HAART, liver disease is one of the most common complications due to hepatotoxicity of many HAART regimens as well as accelerated liver damage following immune reconstitution. Two ARV drugs for HIV have 32 Guidelines for PMTCT in Namibia also shown antiviral effect on HBV. These drugs are lamivudine and tenofovir. The combination of these drugs reduces the development of viral resistance of HBV. Among the NNRTIs, efavirenz is the best tolerated and nelfinavir is the best tolerated PI. All ARV drugs are potentially hepatotoxic. Ritonavir and nevirapine should especially be avoided in patients with chronic active hepatitis B. Renal Failure In patients with renal failure dosages need to be adjusted for some medicines on the basis of creatinine clearance. Consult with a specialist physician before starting HAART in a patient with renal failure or when renal failure develops in a patient on HAART. Tenofovir can cause franconi’s Syndrome. This is asymptomatic and can be monitored by checking for proteinuria and elevated creatinine. In the following circumstance, consult a specialist. Failure of first line therapy; Discordant couples considering having children; Combined pathologies (hepatitis, renal failure, diabetes, neoplasia, etc) ; Severe drug toxicities; Pregnant women receiving any other treatment than the recommended regimens. 33 Guidelines for PMTCT in Namibia CHAPTER 7 PROGRAMME MANAGEMENT OF PMTCT 7.1. Promotion of PMTCT through communication strategies Communication is a key component to empower individuals and communities to support behaviour change including the utilization of PMTCT services. Communication plays a vital role in changing knowledge in mother to child transmission (MTCT) of HIV as well as influencing values, social norms and correct understanding of MTCT. There is therefore a need to provide adequate information to women/families on safe pregnancy, delivery and newborn/infant care and to promote access to key services. There is also need to address beliefs and harmful community practices which place women at risk, and affect their access to information, services, and support. Communication operates through three main strategies: Programme communication (behaviour change communication) for changes in knowledge, attitude and practices of specific key social groups. Activities focus on strengthening programmes for women, their male partners, families and peers by developing their skills, confidence and to challenge harmful norms. Health workers should use interpersonal communication and counselling skills to support women and their male partners. PMTCT and HIV messages could be disseminated through Maternal and child health services, including, Family Planning, ANC, PNC, and Under Fives. Social mobilisation for wider participation and ownership of community leaders and groups of people. Activities include raising awareness through campaigns or establishing support groups or strengthening links between groups. It is done through the use of community networks to encourage community support and action. Advocacy is to raise political will and social leadership commitment. Activities focus on developing new policies or laws to protect vulnerable individuals or increase their access to services. It may also include sourcing support from politicians and policy makers. 7.2. Organisation and Administration 7.2.1. Infrastructure. It is useful to consider the issue of systems and health care infrastructure in terms of three dimensions: Human resources Physical infrastructure Management infrastructure Human Resource The presence and availability of adequate human resource is the most important ingredient of a successful PMTCT programme. The term “human resource” incorporates staffing levels, staffing mix and staff competencies and motivation. 34 Guidelines for PMTCT in Namibia Staffing levels Services that run with inadequate staff do not run well. In all health facilities, the PMTCT programme entails an increase in workload and clinical responsibilities. If this additional workload is not compensated by additional staff, this can result in stress and possibly deterioration in the overall quality of care provided. In Namibia it was therefore decided to strengthen the introduction of the PMTCT programme by the recruitment of community counsellors to assist with the counselling. PMTCT is integrated into routine ANC care and should be provided by all nurses, not specialized staff. The minimum staffing levels for PMTCT counselling should be based on the following norms: Initial pre- and post-test counselling – an average of 60 minutes total per client; follow up counselling and support - an average of 30 minutes per visit on two separate occasions for HIV-positive women; a maximum of 8 clients seen per day for pre and post-test counselling per counsellor. Staff mix It is important to note that a comprehensive PMTCT programme requires a mix of clinic nurses, midwives, counsellors, obstetric and paediatric staff and doctors playing complementary roles. Community counsellors are a critical element of the PMTCT programme. They need to work in close collaboration with professional staff. Operational links between PMTCT services with welfare and nutrition staff is important to provide post-partum care and support of mothers with HIV and their children. Staff competencies, morale and motivation Training and human capacity development is critical for the development of adequate staff competencies, morale and motivation. A pool of experts and trainers with the commitment and time to provide training is needed in each region. In terms of training content, there is a need to balance the focus on HIV counselling and testing with more training on infant feeding and child health. Off-site, formal classroombased training needs to be complemented with more on-site, in-service training with a focus on skills development, local problem solving and on changing attitudes towards HIV. A strategy, to ensure that HIV counselling, PMTCT and infant feeding is taught thoroughly and effectively in all under-graduate nurse and medical training institutions, must be developed and implemented immediately. Management infrastructure Good management and a functional Regional Management Team (RMT) in collaboration with the Regional AIDS Co-ordination Committee (RACOC) is a key factor determining the success, efficiency, effectiveness and sustainability of the PMTCT programme. Senior managers and effective multi-sectoral committees are important for integrating the programme horizontally across the departments and creating an enabling environment for programmatic staff. Strong technical capacity and the presence of experienced clinicians with a commitment to HIV within the regional PMTCT management structures are also important components of regional capacity. At the local level, effective and integrated management is required at district level. The active involvement of the DCC, local medical staff, HIS managers, hospital matrons and PHC supervisors are equally important. 35 Guidelines for PMTCT in Namibia NGOs are important potential role-players in the recruitment, training, remuneration, support and supervision of community counsellors. A more pro-active development of new NGOs and PLWHA support groups is suggested. It is necessary to improve the capacity to work with NGOs efficiently, effectively and in the spirit of partnership. Physical infrastructure The importance of physical infrastructure is reflected in two ways. First of all, an inadequate physical space and privacy hampers the ability of facilities to provide adequate counselling and HIV testing services. It may therefore be necessary to expand or renovate facilities. In many of the rural sites, the difficulties and expense of simply getting to health facilities that provide antenatal, delivery and post-natal care remain a major barrier to adequate coverage of health services including PMTCT services as well as to adequate continuity of care. Improvements in access to care will improve PMTCT coverage. 7.2.2. Integration of PMTCT into routine services HIV-positive pregnant women should be followed up at the antenatal clinic. Women who are not eligible for ARV therapy should receive Nevirapine from the antenatal clinic to take home during the third trimester. Pregnant women who are eligible for ART should be referred to the Communicable Disease Clinic (CDC) for the assessment, follow-up and counselling. Where CDC has not yet been established the client must be referred the nearest CDC. Counsellors should be available at the ANC to ensure the HIV counselling and the regular follow up of the pregnant woman and her partner. Nevirapine will be dispensed from the antenatal clinic for purposes of PMTCT. 7.3. Monitoring, Evaluation and Reporting 7.3.1 Supportive supervision Without regular support and supervision of front-line staff, the positive impact of training is not sustained. Support and supervision, as well as organising peer support groups, is required to help prevent staff burn-out. Providing effective and appropriate support and supervision to front-line staff is a highly skilled job that should be part of a human resource development plan. 7.3.2. Monitoring and Evaluation (M&E) Monitoring means tracking the key elements of programme performance on a regular basis (inputs, activities, results). Evaluation is the periodic assessment of the change in targeted results that can be attributed to the programme intervention, or the analysis of inputs and activities to determine their contribution to results. Monitoring and evaluation helps programme implementers to: Determine the extent to which the programme is on track and to make any needed corrections accordingly; Make informed decisions regarding operations management and service delivery; Ensure the most effective and efficient use of resources; and Evaluate the extent to which the programme/project is having or has had the desired impact. Effective M&E is based on a clear, logical pathway of results, in which results at one level are expected to flow towards results at the next level, leading to the achievement of the overall goal. If there are gaps in the logic, the pathway will not flow towards the required results. The major levels are inputs, outputs outcomes and impacts 36 Guidelines for PMTCT in Namibia 7.3.3. Indicators The indicators in the UNGASS M&E and the National Strategic Plan on HIV//AIDS in Namibia framework will help in monitoring progress. While the aim is not to measure progress at every step, the proposed indicators constitute parameters for the monitoring of progress at all levels. Since it is not realistic to develop indicators for all possible areas of action and programming, indicators have been developed for those areas where particular emphasis is called for, and where progress needs to be measured: No. of health facilities providing PMTCT No. of health workers trained in PMTCT No. of TOTs for PMTCT No. of pregnant women starting ANC % pregnant women pre-test counselled % pregnant women post-test counselled % pregnant women tested for HIV % pregnant women tested HIV-positive % women who have received Nevirapine % babies who have received Nevirapine % HIV-infected infants born to HIV-infected mothers % pregnant women receiving a complete course of antiretroviral prophylaxis to reduce the risk of MTCT. % of HIV+ women who choose to exclusively breastfeed for 4 months % HIV+ women who choose replacement feeding 7.3.4 PMTCT record-keeping and reporting Prevention of mother-to-child transmission (PMTCT) of HIV is an integral part of the existing Maternal and Child Health service. In addition to preventing HIV infection from HIV-positive mothers to their newborns, it also aims at improving ANC services in general. Monitoring of the intervention is indeed not intended to introduce a new system of recording and reporting. Instead, it intends to improve the existing recording and reporting system through addition of some new components/variables to be recorded and providing for means of data storage and analysis in the hospitals delivering the service. The PMTCT record-keeping and reporting system consists of the following elements: The Antenatal Clinic Register and the Maternity Register have been updated to include HIV status and PMTCT information. The 2 facility-based Monthly Report Forms which are aggregated from the antenatal and maternity registers and submitted to the HIS office. The computerised PMTCT database at the district, regional, and national level. 37 Guidelines for PMTCT in Namibia Figure 5. PMTCT record keeping and reporting system Data Collection and Reporting Procedure Health Facility ANC Register Maternity (L&D) Register ANC Monthly Summary Form Maternity (L&D) Monthly Summary Form District / Regional Office Feedback National Office Data Processing Analysis Forward flow: Feedback Feedback: The following steps assist programme managers in optimizing the use of data: collect good-quality data by completing ANC and labour and delivery registers accurately Compile monthly summary reports: Form 1 for ANC statistics and Form 2 for labour and delivery statistics. Identify the different end-users, and present and package the data according to their needs. Setup mechanisms for an efficient data analysis and utilization at each level. Provide feedback to clinics and health centres, DCCs, RMTs as well as ART/PMTCT management committees. Results of the analysis of routinely collected data will help the hospital management and health staff to identify, in a timely manner, the problems occurring in their health facility regarding the above three dimensions of the intervention, namely availability of essential resources, utilisation of services and adherence. When problems are identified, managers and the health staff will rationally conduct analysis of the identified problems with stakeholders and plan for possible solutions. 38 Guidelines for PMTCT in Namibia References 1. Government of the Republic of Namibia, Guidelines for the Use of Anti-retroviral Therapy. Ministry of Health and Social Services, May 2003. 2. Government of the Republic of Namibia, National Guidelines on Clinical Management of HIV Disease ad AIDS. Ministry of Health and Social Services, Namibia, July 2001 3. MOHSS, 2004: Preliminary results of 2004 Sentinel Sero Survey. 4. 2001 USPHS/IDSA Guidelines for the Prevention of Opportunistic Infections in Persons Infected with Human Immunodeficiency Virus. November 28, 2001. Available at http://www.aids-ed.org and http://cdc.gov/mmwr. 5. Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1 Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States. The Living Document: February 4, 2002. Available at http://www.aids-ed.org and http://hivatis.org. 6. World Health Organization, Prevention Of Mother-To-Child Transmission Of HIV: Selection And Use Of Nevirapine; Technical Notes; Geneva 2001 WHO/HIV_AIDS/2001.3, WHO/RHR/01.21 7. WHO; Exploring common ground: STI and FP activities; Ref. WHO/RHR/01.20; http://www.who.int/reproductive-health/publications/RHR_01_20/abstract.en.html 8. WHO; Prevention of HIV in Infants and Young Children; Review of Evidence and WHO’s Activities; WHO/HIV/2002.08 9. Health Systems Trust for the national Department of Health, Interim Findings on the national PMTCT Pilot Sites - Lessons and Recommendations; South Africa, June 2002; http://www.hst.org.za 10. Family Health International, Institute for HIV/AIDS, Baseline Assessment Tools For Preventing Mother-To-Child Transmission (PMTCT) of HIV; August 2003; www.fhi.org 11. WHO: Increasing Access to HIV testing and Counselling, report of a WHO consultation. 19 – 21 November 2002. 12. Republic of Kenya, National Guidelines for Prevention of Mother to Child HIV/AIDS Transmission 13. WHO: (draft) Antiretroviral drugs and the prevention of mother-to-child transmission of HIV infection in resource-constrained settings, recommendations for use, 2004 Revision. 39 Guidelines for PMTCT in Namibia Appendix I Table 1.Trend in HIV prevalence ratio among pregnant women by sentinel site, 1992-2004 Sentinel site Katima Mulilo Oshakati Grootfontein Onandjokwe Katutura Hospital Oshikuku Walvis Bay Tsumeb Otjiwarongo Uutapi Rundu Nyangana Andara Engela Nankudu Keetmanshoop Swakopmund Gobabis Mariental Rehoboth Opuwo Windhoek C.H. Luderitz Outjo Overall 1992 14% 4% 4% 2% 1994 25% 14% 9% 8% 7% 1996 24% 22% 1998 29% 34% 2000 33% 28% 17% 16% 21% 23% 29% 23% 31% 21% 28% 16% 18% 14% 10% 16% 17% 13% 7% 15% 9% 2002 43% 30% 30% 28% 27% 27% 25% 25% 25% 23% 22% 22% 21% 19% 16% 16% 16% 13% 12% 10% 9% 22.0% 9% 7% 6% 2% 7% 8% 5% 11% 18% 8% 7% 17% 3% 3% 1% 4% 6% 14% 16% 15% 23% 18% 17% 22% 9% 10% 9% 7% 4.2% 8.4% 15.4% 17.4% 19.3% 3% 35 15 2004 43% 25% 28% 22% 24% 27% 26% 16% 17% 17% 21% 15% 18% 18% 19% 16% 28% 14% 11% 14% 9% 10% 22% 12% 19.8% Sourse: MOHSS. This table shows the trend over time in the proportion of pregnant women who tested HIV-positive by sentinel survey site. HIV surveillance has been conducted in alternate years amongst pregnant women in Namibia since 1992 using the same standardized methodology. The number of sentinel sites was increased from 18 to 21 in 2002 to improve survey quality. Appendix II Table 2. HIV prevalence ratio in pregnant women by age-group Age group (years) 13 - 19 20 – 24 25 – 29 30 – 34 35 – 39 40 – 44 45+ Overall Source: MOHSS Negative. 677 1092 771 536 293 114 20 3503 Positive. 74 251 269 163 93 14 3 867 40 Total 751 1343 1040 699 386 128 23 4370 Prevalence 9.9% 18.7% 25.9% 23.3% 24.1% 10.9% 13.0% 19.8% 95% CI 7.9 – 12.3 16.7 – 20.9 23.2 – 28.7 20.3 – 26.7 20.0 – 28.7 6.1 – 17.7 2.8 – 33.6 18.7 – 21.1 Guidelines for PMTCT in Namibia Appendix III TESTING FOR HIV INFECTION IN PREGNANCY Types of HIV tests Related to HIV Management: 1. HIV antibody tests: Most commonly available HIV tests detect antibodies against HIV. They do not detect the virus itself. Detectable antibodies against the HIV take from 1-3 months to develop after HIV infection occurs. This time period is known as the window period. HIV antibody tests are sometimes false positive, therefore, the laboratory routinely confirms with a second antibody test. 2. ELISA tests (Enzyme-Linked Immuno abSorbent Assay): These are the most efficient tests for testing large numbers per day, but require laboratory facilities with expensive equipment, maintenance, staff and a reliable power supply. In Namibia, they are used for blood safety and diagnosis because they are very sensitive (false negative tests are rare). A positive ELISA test result needs to be confirmed with a second ELISA test using a different test kit, in order to diagnose HIV infection conclusively. ELISA tests are also used to run quality assurance programmes for rapid HIV tests. 3. Simple/rapid HIV tests: These tests utilise serum or a small whole blood sample from a finger prick. Like ELISA, the rapid test determines whether there are HIV antibodies in a person’s blood. It gives only two results, positive or negative. This simplifies interpretation by the provider. They are a type of ELISA test built into an absorbent strip where the serum passes over a test and control line. They do not require special equipment or highly trained staff and they are as accurate as the routine ELISA tests. Simple/rapid tests will usually give results in less than 30 minutes and are easy to perform. Quality control for rapid testing As with any laboratory test, quality control is also important to establish and maintain for rapid HIV testing. Such a programme will help to detect any substandard tests as a result of manufacturing errors, poor storage conditions, or user error. It is recommended that each facility performing rapid testing should: ~ Ensure that any staff performing rapid HIV testing has been trained and certified by the NIP to perform the test. ~ Maintain a log book of rapid test results which lists date of the test, results for test 1 and test 2, any tie-breaker test results, any ELISA results if performed, comments, and signature of the person who performed the test. ~ On 1-2 days per month, collect an additional specimen for ELISA testing in addition to rapid testing and submit to the NIP. 4. HIV antigen and viral test: These tests measure components of the virus itself and often quantify the amount of the virus in the blood stream. These tests are useful for: ~ Diagnosing HIV infection in the window period, before HIV antibodies have formed. ~ Diagnosing HIV infection in infants. All infants have maternal antibodies present and so will test positive for HIV antibodies. Only those infected with HIV will have the virus itself found. DNA PCR could be used for HIV1. 41 Guidelines for PMTCT in Namibia ~ Monitoring efficacy of ARV treatment: if effective, the viral amount/quantity of virus in the blood) should drop when on treatment. load (or 5. HIV RNA by PCR: This is a good tool for measuring disease progression and response to therapy. The level of plasma HIV-1 RNA is clearly a useful indicator of the response to ART in individual patients. A baseline viral load is not required for initiating therapy, but it serves as a useful baseline marker for response to therapy. In fully adherent patients, viral load is likely to reach undetectable levels in 70-80% of the patients after 4 to 6 months. This is therefore an appropriate time to assess therapy effectiveness. The viral load test detects levels between 400-750,000 copies/ml. Depending on resources this test can be regularly repeated or when treatment failure is suspected. However, due to its high cost and limited availability in resource constrained settings, it is not presently recommended in these guidelines as a required monitoring tool for managing ARV therapy. In the absence of viral load monitoring treatment failure will need to be assessed immunologically and clinically, rather than virologically. 6. CD4+ lymphocyte cell count: HIV targets lymphocytes having a receptor on their surface known as “CD4”, destroys them, and thereby creates immunodeficiency. As the CD4 count progressively declines, immunodeficiency becomes progressively worse and opportunistic disease occurs. A CD4 count is only performed on patients with HIV infection. Available in Namibia, the “CD4 count” is the best measure of immune function in a patient with HIV infection and is measured using flow cytometer equipment in the laboratory. CD4+ lymphocyte counts are one of the most useful and reliable ways of assessing whether an HIV-positive patient should start ART and they are also extremely important in the assessment of the effectiveness of ART. An increase of >100 CD4 cells/mm3 in the first 6-12 months is typically seen in an ART adherent patient. Higher elevations can be seen and the response often continues in subsequent years in individuals who are maximally virologically suppressed. Immunologic failure on therapy can also be assessed by CD4+ cell counts. 42 Guidelines for PMTCT in Namibia Appendix IV WHO STAGING SYSTEM FOR HIV INFECTION AND DISEASE IN ADULTS AND ADOLESCENTS Clinical Stage I: Asymptomatic Persistent generalized lymphadenopathy (PGL). Performance scale 1: Asymptomatic, normal activity. Clinical Stage II: Weight loss, < 10 % of body weight. Minor mucocutaneous manifestations (seborrheic dermatitis, prurigo, fungal nail infections. Recurrent oral ulcerations, angular cheilitis. Herpes Zoster, within the last 5 years. Recurrent upper respiratory tract infections (i.e., bacterial sinusitis). And/or Performance scale 2: symptomatic, normal activity. Clinical Stage III: Weight loss, > 10 % of body weight. Unexplained chronic diarrhoea, > 1 month. Unexplained prolonged fever (intermittent or constant), > 1 month. Oral candidiasis (thrush). Oral hairy leukoplakia. Pulmonary tuberculosis, within the past year. Severe bacterial infections (i.e., pneumonia, pyomyositis). And/or Performance scale 3: bed-ridden, < 50% of the day during the last month. Clinical Stage IV: HIV wasting syndrome, as defined by CDC1. Pneumocystis carinii pneumonia. Toxoplasmosis of the brain. Cryptosporidiosis with diarrhoea, > 1 month. Cryptococcosis, extrapulmonary. Cytomegalovirus (CMV) disease of an organ other than liver, spleen or lymph nodes. Herpes simplex virus (HSV) infection, mucocutaneous > 1 month, or visceral any duration. Progressive multifocal leukoencephalopathy (PML). Any disseminated endemic mycosis (i.e. histoplasmosis, coccidioidomycosis). Candidiasis of the oesophagus, trachea, bronchi or lungs. Atypical mycobacteriosis, disseminated. Non-typhoid Salmonella septicaemia. Extrapulmonary tuberculosis. Lymphoma. Kaposi’s sarcoma (KS). HIV encephalopathy, as defined by CDC2. And/or Performance scale 4: bed-ridden, > 50 % of the day during the last month. 43 Guidelines for PMTCT in Namibia Appendix V ORAL ARV SHORT-COURSE REGIMENS FOR PMTCT Alternative regimens (not for use in the public sector) For use in public health facilities. Drug For the mother Pregnancy Labour 200 mg onset Nevirapine (NVP) None Zidovudine 300mg Q12h at 28- 300mg Q3h 36 wks Postpartum Neonatal at None 2mg/kg at 12-72 hrs (e.g., a 3 kg new-born should receive 0.6 ml of a 10 mg/ml suspension) 300mg Q12 4mg/kg Q12h x 7 days x 7 days AZT 4mg/kg Q12h x 7 days AZT 300mg AZT 300mg Zidovudine Q12h at 28 Q3h NVP200 None Nevirapine -35 wks mg at onset (AZT + NVP) AZT 300mg Zidovudine – 300/150mg Q3h Lamivudine Q12h at 36 3TC 150mg (AZT + 3TC) weeks Q12h at 32 weeks AZT 300 Zidovudine – bd Continue all Lamivudine - 3TC150mg medications, Nevirapine bd change AZT AZT+3TC+NV NVP 200mg Q3h P od for 2 wks then bd NVP 2mg/kg at 12-72 hrs (e.g., a 3 kg new-born should receive 0.6 ml of a 10 mg/ml suspension) 300/150mg AZT4mg/kg, Q12h x 3TC 2mg/kg Q12h x 7days 7days Continue entire SD-NVP 2mg/kg at 12regimen for 72 hours 3 days postpartum AZT dose adjustment for IV dosage (1.5mg/kg/12 hours) and premature infants (2mg/kg/12hours) 44 Guidelines for PMTCT in Namibia Appendix VI CONSENT / RELEASE FORM FOR PREGNANT WOMEN IN ANC Name: _________________________________________________ Physical address _________________________________________________ Phone _______________________ Hereby confirm that 1. I have been counselled 2. I understand the implications of the tests 3. I want to be tested for HIV 4. I refuse to be tested for HIV before my delivery Signed at _________________________ Date _________________________ Signature of the pregnant women: _____________________________ Signature of the counsellor: _____________________________ 45 Guidelines for PMTCT in Namibia Appendix VII Consent / release form to be tested and to provide Nevirapine to a new born CONSENT / RELEASE FORM FOR PREGNANT WOMEN IN ANC Name: ________________________________________________ Physical address _________________________________________________ Phone: _________________________________________________ Hereby confirm that: 1. I have been counselled 2. I understand the implications of the tests 3. I want to be tested for HIV 4. I refuse to be tested for HIV before my delivery 5. I want my baby receive 1 or 2 doses of nevirapine according to the medical indication Signed at _________________ Date _________________ Signature of the pregnant women: __________________________________ Signature of the nurse: __________________________________ 46 Guidelines for PMTCT in Namibia Printed with support from the US Presidential Emergency Plan for AIDS Relief 47