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Author: K. Mona Moore, PA-C, MA, AAHIVS Acknowledgements: The development of this clinical standard operating procedure (SOP) template was led by Nicole Buono, Project HEART Director and Elizabeth Flanagan, Senior Technical Officer as an activity of the Elizabeth Glaser Pediatric AIDS Foundation’s (EGPAF’s) Project HEART (Cooperative Agreement U62/CCU123541) in cooperation with EGPAF’s Technical Advisory Group (TAG) focused on supporting countries in the adaptation and implementation of the World Health Organization’s revised 2010 guidelines for HIV prevention, care and treatment. The clinical SOP template provided in this document was conceptualized based on feedback and review by technical directors, field-based clinical staff, and other senior staff. During the process, members of a technical review team proposed, agreed upon, and worked with the author to develop the template for SOPs for HIV prevention, care and treatment to meet the needs of country teams. The efforts of numerous individuals should be recognized. We would like to thank the following individuals for their contributions and assistance in the review and finalization of this SOP template: EGPAF Senior Technical Reviewer: RJ Simonds, Vice President of Program Innovation and Policy EGPAF Technical Review Team: Serge Agbo, Stephen Lee, Mary Morris, Appolinaire Tiam, Sue Willard François-Xavier Bagnoud Center at the School of Nursing, University of Medicine and Dentistry of New Jersey for support with editing, proofreading, and formatting: Virginia Allread, Deborah Hunte, Karen Forgash, and Mary Jo Hoyt EGPAF Cover Design: Katherine Warminsky This publication was supported by the Centers for Disease Control and Prevention (CDC) through Cooperative Agreement U62/CCU123541. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention. We also acknowledge the efforts of the author, technical review team, and editorial staff to ensure the quality of the publication. Finally, we would like to acknowledge the tireless efforts of our partners and staff around the world to eliminate pediatric AIDS, and the women, children and families in the countries where we work. Table of Contents Acronyms and abbreviations ............................................................................................................................................. 5 Introduction ................................................................................................................................................................................... 7 Enrollment into care and ARV initiation, if eligible ............................. 12 SOP 1: Registration and enrollment............................................................................................................................16 SOP 2: Initial assessment visit to determine eligibility....................................................................................18 SOP 3: Clinical visit — clients not eligible for ART .............................................................................................24 SOP 4: Clinical visit — clients eligible for ART ......................................................................................................27 SOP 5: Treatment readiness and adherence counseling................................................................................34 SOP 6: ART regimen selection .......................................................................................................................................40 SOP 7: Conduct routine laboratory monitoring ...................................................................................................52 Ongoing Care and Management, Including Treatment Failure .......... 55 SOP 8: Provide CTX prophylaxis....................................................................................................................................58 SOP 9: Provide INH preventive therapy .....................................................................................................................63 SOP 10: Management of common symptoms and complications of HIV .............................................68 SOP 11: Management of common HIV-associated coinfections ................................................................75 SOP 12: Recognition of adverse events and ART toxicity .............................................................................79 SOP 13: Recognition of treatment failure and when to switch ART regimens ..................................89 SOP 14: Switching to second-line ART regimens................................................................................................94 SOP 15: Switching to third-line ART regimens...................................................................................................101 Integrated Sexual and Reproductive Health ...................................... 105 SOP 16: Contraception ......................................................................................................................................................108 SOP 17: STI screening for adults and adolescents..........................................................................................112 SOP 18: Cervical screening ............................................................................................................................................118 SOP 19: ART and HIV-related treatment for WRA.............................................................................................122 SOP 20: Counseling and support for adults and adolescents living with HIV ................................127 SOP 21: HIV prevention for people living with HIV ...........................................................................................129 Nutrition ................................................................................................ 132 SOP 22: Nutritional assessment ..................................................................................................................................134 SOP 23: Determine level of nutritional support needed ................................................................................139 SOP 24: Develop nutrition care plan .........................................................................................................................141 Mental Health ........................................................................................ 143 SOP 25: Conduct mental health assessment ......................................................................................................145 SOP 26: Conduct mental status examinations ...................................................................................................148 SOP 27: Develop mental health care plan..............................................................................................................156 SOP 28: Provide links to additional care sites ....................................................................................................159 Appendices ........................................................................................... 162 Appendix A: Patient adherence record form .......................................................................................................162 Appendix B: Clinical algorithms ..................................................................................................................................173 Appendix C: How to do a 24-hour dietary recall ................................................................................................186 Appendix D: Patient nutrition management form (adult)..............................................................................188 Appendix E: Nutritional assessment tool for PLWHIV ...................................................................................190 Illustrative examples of national adaptations ......................................................................................................191 List of tables and figures ..................................................................... 192 References and resources .................................................................. 196 4 Acronyms and abbreviations >, < /r 3TC ABC AFB AIDS ALT ANC ART ARV ASCUS AST ATV AZT AV BMI BP CD4 CDC CMV CNS CSF CT CTX CTC CXR d4T ddI DHHS DLV DRV DNA DNA PCR EFV ETR ETV FP FPV FTC GFR HBV HCV HIV HSV Greater than, less than Ritonavir (see also “RTV”) Lamivudine Abacavir Acid-fast bacilli Acquired immune deficiency syndrome Alanine amino transferase Antenatal care Antiretroviral therapy Antiretroviral or antiretroviral drug Atypical cells of undetermined significance Aspartate aminotransferase Atazanavir Zidovudine (also known as ZDV) Arteriovenous or atrioventricular Body mass index Blood pressure Cluster of differentiation 4 U.S. Centers for Disease Control and Prevention Cytomegalovirus Central nervous system Cerebrospinal fluid Computerized tomography Cotrimoxazole Care and treatment center/clinic Chest X-ray Stavudine Didanosine Department of Health and Human Services Delavirdine Darunavir Deoxyribonucleic acid DNA polymerase chain reaction Efavirenz Etravirine Etravirine Family planning Fos-amprenavir Emtricitabine Glomerular filtration rate Hepatitis B virus Hepatitis C virus Human immunodeficiency virus type 1 (HIV-1) Herpes simplex virus 5 INH IRIS IUD IV KS L LPV LSIL MRI mL mmol MVC NASCOP NFV NNRTI NVP OD PCP PCR PI PIT PLHIV PMTCT PO RAL RNA RPR RTV sd-NVP SJS SOP SQV SRH STI TB TDF TPV VAS VDRL VI WBC WHO WRA Isoniazid Immune reconstitution inflammatory syndrome Intrauterine device Intravenous Kaposi’s sarcoma Microliter (cubic millimeter, mm3) Lopinavir Low grade squamous intraepithelial lesion Magnetic resonance imaging Milliliter Millimole Maraviroc National AIDS and STI Control Programme (Kenya) Nelfinavir Non-nucleoside reverse transcriptase inhibitor Nevirapine Once daily Pneumocystis carinii (now jiroveci) pneumonia Polymerase chain reaction Protease inhibitor Pill Identification Test People living with HIV Prevention of mother-to-child transmission By mouth, orally Raltegravir Ribonucleic acid Rapid plasma reagent syphilis test Ritonavir Single-dose nevirapine Stevens-Johnson syndrome Standard operating procedure Saquinavir Sexual and reproductive health Sexually transmitted infection Tuberculosis Tenofovir Tipranavir Visual Analogue Scale Venereal Disease Research Laboratory Visual inspection (of uterine cervix) White blood cell World Health Organization Women of reproductive age 6 Introduction Who should use the templates for SOPs? The template is intended as a resource to support clinical and other staff engaged in national, program, district and facility-level planning for implementing HIV care and treatment programs in low-resource settings for adults. What is the purpose of these templates? SOPs provide a comprehensive framework of operational guidelines to assist in the translation of recommended adult HIV treatment guidelines and adult service delivery approaches into steps in the actual delivery of services and care. SOPs help to define and promote best practices, and maintain consistency, quality, and effectiveness of service delivery. SOPs support evidence-based service delivery practices to improve outcomes for clients and their families by promoting consistent approaches in service delivery, information provision and service management. SOPs are useful to: Facilitate comprehension of technical information related to HIV care and treatment and maintain consistency in its application to daily practice Increase health team’s capacity to deliver integrated HIV services and care Assist health team to deliver integrated adult HIV services that comply with national guidelines, policies and protocols Provide a facility-specific record of standards of service delivery adhered to Provide managerial and clinical staff with step-by-step operational information to organize and deliver HIV services Promote safe and effective patient care. Increase consistency of service provision Improve communication and referral pathways Reduce provider mistakes and omissions that may harm patients SOPs can also: Assist staff to perform tasks in a way that optimizes patient safety, positive care outcomes, and efficient service delivery Introduce new elements of care Prepare new staff for service delivery Reinforce standards and processes for existing staff Provide a mechanism to evaluate service delivery, serve as checklist for supervisors to monitor job performance, and provide a framework for supportive supervision. Provide guidance to quality improvement initiatives. Guide the referral and follow up process to assure that patients still get the care they need when services are not within the capacity of a health facility or level of care 7 SOPs are “working documents” that should be revised and updated regularly to assure compliance with new treatment regimens and approaches to care How were the templates developed and reviewed? The draft SOPs were prepared by consultants working closely with EGPAF technical staff in Washington DC. The final version was prepared following additional review of the draft for completeness and technical accuracy in Washington D.C. and by EGPAF staff in country offices throughout Africa and other countries where the Foundation is working. The SOPs were developed following extensive review of many excellent global, and country-specific adult HIV treatment guidelines, adult HIV SOPs and other related documents. A complete list of the references reviewed to inform the development of these SOPs is provided at the end of this document. When tables or charts appear in this document originated from source documents reviewed, the source document is acknowledged. How should the templates be used? In many countries, national guidelines have been or are now being revised to incorporate 2010 WHO recommendations that define standards of HIV care and service delivery approaches and provide evidence-based clinical protocols and treatment regimens. The purpose of this SOP template is to provide guidance on how to operationalize global and national guidelines and develop standardized steps for day-today implementation of clinical, counseling and care services required to provide integrated adult HIV interventions. In many countries, adult HIV services are provided in a wide range of settings with varying levels of human, material, and financial resources. This SOP template was developed to be adapted and utilized at national and local levels to reduce time spent locally developing SOPs. As new treatment recommendations and service delivery approaches evolve, SOPs can help to develop, standardize and implement realistic local approaches to the delivery of new or expanded services. Their use can facilitate seamless, uninterrupted adult HIV service delivery even when the continuum of care is provided by multiple care sources. What is the audience for the adult HIV SOP template? Audience for the Adult HIV SOPs includes: Physicians, medical officers, clinical officers, nurse-midwives, nurses, counselors, peer educators Laboratory and pharmacy staff Health facility managers and District Health Team members These SOPs are aimed at HIV service sites that refer to care and treatment clinics (CTCs) that provide more extensive tertiary care. They cover basic HIV treatment; care and support that can be delivered at health center level, and suggest referral to the next upward level of care where complicated cases can be handled. Adaptation of these SOPs at country level will need to consider national policy for task sharing of HIV 8 treatment-related tasks and responsibilities, and national guidelines for second and third line treatment regimens when required. What are the objectives of the adult HIV SOP template? This set of SOPs on adult HIV addresses both HIV service delivery and treatment objectives. Service delivery objectives include the following global health priorities: Provide a comprehensive continuum of HIV treatment and care Integrate service delivery for HIV, tuberculosis (TB), maternal child health, sexual and reproductive health (SRH) Decentralize service delivery to health facilities Enable health facilities to effectively initiate, monitor, manage or refer HIV care and treatment, and Facilitate implementation of task shifting, or nurse-initiated HIV treatment according to national guidelines Treatment objectives include: Emphasis on earlier HIV diagnosis, assessment of antiretroviral therapy (ART) eligibility and treatment initiation for HIV Prevent progression of HIV disease and avert AIDS-related deaths Increase use of less toxic ART regimens Early recognition of side effects and adverse events and timely, appropriate treatment modification Increase retention of patients and adherence with lifelong therapy Prevent new infections and re-infection Routine clinical assessment after initiating ART 9 Table 1: WHO recommendations at a glance When to start All adolescents and adults including pregnant women with HIV infection and CD4 counts of ≤350 cells/mm3, should start ART, regardless of the presence or absence of clinical symptoms. Those with severe or advanced clinical disease (WHO clinical stage 3 or 4) should start ART irrespective of their CD4 cell count. What to use in first-line therapy First-line therapy should consist of an NNRTI + two NRTIs, one of which should be zidovudine (AZT) or tenofovir (TDF). Countries should take steps to progressively reduce the use of stavudine (d4T) in first-line regimens because of its wellrecognized toxicities. What to use in secondline therapy Second-line ART should consist of a ritonavir-boosted protease inhibitor (PI) plus two NRTIs, one of which should be AZT or TDF, based on what was used in first-line therapy. Ritonavirboosted atazanavir (ATV/r) or lopinavir/ritonavir (LPV/r) are the preferred PIs. Laboratory monitoring All patients should have access to CD4 cell count testing to optimize pre-ART care and ART management. HIVRNA (viral load) testing is recommended to confirm suspected treatment failure. Drug toxicity monitoring should be symptom directed. HIV/TB coinfection Irrespective of CD4 cell counts, patients coinfected with HIV and TB should be started on ART as soon as possible after starting TB treatment. HIV/HBV coinfection Irrespective of CD4 cell counts or WHO clinical stage, patients who require treatment for HBV infection should start ART. Firstline and second-line regimens for these individuals should contain TDF and either emtricitabine (FTC) or lamivudine (3TC). From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 10 Table 2: Summary of changes in 2010 WHO recommendations On the basis of the available evidence the panel recommended ART initiation for all PLHIV with a CD4 count of ≤350 cells/mm3 Earlier initiation of ART and, if CD4 testing is not available, for those with WHO clinical stage 3 or 4. Simplified, less toxic ARV drugs for use in first-line and secondline therapy While current options have permitted rapid ART scale-up, the cost in terms of side effects has been considerable. There is a clear demand both from PLHIV and health-care providers to phase in less toxic ARVs while maintaining simplified fixed-dose combinations. Available evidence indicates that initial ART should contain an NNRTI (either NVP or EFV) plus two NRTIs, one of which should be 3TC or FTC and the other AZT or TDF. Countries are advised to choose one second-line regimen for individuals with first-line failure. Promoting the initiation of ART for all those with HIV/TB co infection While recognizing that this recommendation will be challenging for many countries with a significant HIV and TB burden, the panel placed high value on reducing the impact of TB on societies and on the data demonstrating a reduction in all-cause mortality among individuals provided with TB therapy and ART. Promoting improved HBV diagnosis and more effective treatment of HIV/HBV co infection Evidence supports the initiation of ART, irrespective of WHO disease stage or CD4 cell count, for all those with HIV/HBV coinfection and chronic active hepatitis B when treatment is indicated for hepatitis B. However, there is no agreed definition of chronic active hepatitis in resource-limited settings. Despite this, the panel felt that it was necessary to include the principles of optimum care for those with HIV/HBV coinfection and bring these into alignment with recommendations in well-resourced settings. There is an urgent need to develop diagnostic criteria to identify individuals with HIV/HBV coinfection who need treatment in situations where HBV DNA and liver biopsy are not routinely available. More strategic monitoring for ARV efficacy and toxicity While laboratory monitoring should not be a barrier to initiating ART, the newly recommended ARV regimens may require more laboratory monitoring than current regimens, especially in individuals at higher risk for adverse events. A phased-in approach to the use of viral load testing, if feasible, will improve the identification of treatment failure. From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 11 Enrollment into care and ARV initiation, if eligible Background A key component of a package of comprehensive HIV care is early assessment for ART eligibility, by clinical assessment and CD4 testing when feasible, to increase early treatment initiation and effective management of HIV. It is expected that clients will have already received HIV diagnosis before presenting for further assessment or enrollment in care. Previous HIV testing and referral for enrollment in care may have taken place at any of the following where integrated HIV testing now occurs: HIV testing and counseling/VCT services, ANC/PMTCT, labor and delivery services, postnatal care, outpatient clinic, family planning/SRH clinics, STI services, TB service, inpatient hospital services either prior to or after discharge, PLWHIV or other community support groups, home-based care program, or self-referral. Patients who self-identify as HIV positive should be retested so that HIV status is confirmed for the patient record. The first visit (SOPs 1 and 2) provides an opportunity to offer preventive and supportive care and introduce or reinforce information about the progression of HIV disease, prophylactic treatment, and ART. Regular routine care (SOPs 3 and 4) beginning as soon as possible after HIV diagnosis can maintain health and delay progression of HIVrelated complications and conditions. The first clinical visit provides an opportunity to provide preventive and supportive care and introduce or reinforce information about the progression of HIV disease, prophylactic therapy, and ART. Each country program will have nationally-recommended visit schedules, visit content and treatment regimens and these SOPs for ART and ART-associated care and treatment will need to be modified accordingly. Adherence (SOP 5) Adherence to ART is essential for successful treatment and sustained viral control. As evidence accumulates around the benefits of early HIV treatment in preventing HIV transmission, adherence to ART is of greater significance for HIV transmission prevention. Clients who do not adhere to their regimens are more likely to develop drug resistance, become ill, and require 2nd line — even 3rd line — ART. Adherence levels of 95% or greater have been shown to maximize effectiveness of ART and minimize the development of drug resistance. Adherence to a lifelong HIV treatment regimen and effectively incorporating the many associated changes in lifestyle into regular daily life are challenges that are facilitated by the support of partners, family, and community. Compassionate and comprehensive counseling on treatment readiness and adherence from counseling and clinical staff is the cornerstone of successful family-based ART programs. 12 Adherence to other HIV-associated treatment regimens, such as cotrimoxazole (CTX) prophylaxis, and to clinic visit schedules and referrals are also an important element of successful outcome of HIV treatment programs. The goals of treatment readiness assessment and adherence counseling include: To educate HIV positive patients eligible for ART about ART as part of comprehensive care to improve health and prolong life To assess patient readiness to start and maintain a lifelong ART regimen To identify and address barriers to adherence, adherence problems and underlying factors negatively influencing adherence To identify the need for additional resources and adherence support Treatment readiness counseling or pre-ART counseling is usually conducted on an individual basis. Routine adherence monitoring can be individual or in treatment adherence support groups if available and acceptable to the patient, partner and family. Adherence messages should be standardized in terms of general content, but individually tailored to reflect the needs of each client and family. ARV selection and monitoring (SOP 6) Appropriate selection of initial ART regimen (SOP 6); quality clinical, laboratory (SOP 7) and adherence monitoring; timely changes in therapy when indicated; and rational sequencing of replacement ARVs when initial regimens fail improves quality of life for the patient and helps to preserve future treatment options. Definitions Immunological staging: The WHO immunologic staging system helps to assess the degree of damage to the immune system cause by HIV disease. Immunological staging, where available, is used with WHO clinical staging to plan treatment and care options. Clinical staging: The clinical stages identify a progression sequence from least to most severe (numbers 1 through 4) — the higher clinical stage, the poorer the prognosis. For classification purposes, once a stage 4 clinical condition has occurred, the individual continues to be classified as clinical stage 4, even in the context of improvements in health related to ART. Clinical staging events can also be used to identify the response to ART if there is no access to viral load or CD4 testing. CD4: CD4 cells are a type of white blood cell that coordinates the immune system’s response to certain microorganisms and viruses. They are the cells infected by HIV. CD4 test results are used to determine immunological staging. Staging helps in the determination for starting and managing ART and prophylaxis for opportunistic infections. Viral load: Viral load is a laboratory test (HIVRNA) that measures how much virus is 13 in the blood of an infected person. It can be used to diagnose HIV (a positive virological test indicates infection) but it is more commonly used to measure viral activity and the effectiveness of ART. An effective ART regimen should reduce viral load, preferably below the level of detection (e.g. less than 50 copies/ml). Antiretroviral (ARV) prophylaxis: Short-term use of ARV medications to reduce the risk of MTCT. Prophylaxis for opportunistic infections (OIs): Medication or treatment used to prevent illness. In HIV-exposed infants, HIV-infected infants, children and adults, CTX prophylaxis is used to prevent many infections. Likewise, isoniazid (INH) preventive therapy is used in eligible patients to prevent TB. Adherence to treatment: Adherence means that the adult takes ART exactly as prescribed, every day, without missing doses. Adherence is required for ART to be effective; poor adherence usually results in the development of drug-resistant virus and disease progression. The standard clinical definition of adherence has been taking at least 95% of medications the right way, at the right time. Over time, this definition has been broadened to include more factors related to continuous care, such as following a care plan, attending scheduled clinic appointments, picking up medicines on time, and getting regular CD4 tests. Immune reconstitution inflammatory syndrome (IRIS) is a spectrum of clinical signs and symptoms associated with immune recovery brought about by a response to ART. This is the result of either the unmasking of latent or subclinical infection or the reactivation of previously diagnosed, and often treated, conditions (infectious or non-infectious). Policy 1. Patients should be referred to other health services or community services as needed. Care should be coordinated as much as possible in order to reduce the burden of visits on the individual. 2. A chronic care model should be utilized so that individuals with HIV are seen regularly and routinely for monitoring and health promotion activities as well as seen for episodic care in the event of acute illness. 3. A multidisciplinary team approach should be utilized for the care of men and women living with HIV. Teams may include a nurse, prescribing clinician, pharmacist, counselor, social worker or others. Responsibility at health facility A single individual should be assigned at each health facility to establish and supervise HIV care and treatment; ensure all services meet or exceed national policies, practices and guidelines; and to conduct quality assurance measures. A nurse or prescribing clinician should serve as the team leader in managing the care of each PLHIV and his or her family. ART, CTX prophylaxis and other drugs should be prescribed by a physician, medical or clinical officer or a nurse with training in care of the HIV exposed child. Where 14 possible this individual should have the support of a multidisciplinary team that includes health workers that provide counseling and support (which may be a nurse, counselor, social worker, peer educator, or another trained professional) and pharmacist who is responsible for dispensing medications. In health facilities staffed by a single professional, that individual should be trained in HIV and able to fill all roles. 15 SOP 1: Registration and enrollment Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To conduct initial assessment, triage to identify appropriate level of enrollment in care as part of comprehensive care, treatment and support to adults with HIV. Responsibility Triage nurse, registration and intake staff Auxiliary nurse Supplies 1. Space: appropriate intake/registration area with adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 3. Intake forms and appointment follow-up cards 4. Unique ART identification card 5. Laboratory test referral request form if required Procedure Confirm HIV diagnosis and register/enroll in care Greet client and introduce yourself. Explain what to expect at this visit. Assure client and partner/family (if present) that confidentiality will be maintained, and that information about the client will only be shared with health workers and case managers who are directly involved in their care. Request medical records that document HIV status and/or referral forms. Review patient records for documentation of HIV status or determine need for HIV testing to establish diagnosis. Provide or refer for counseling, as appropriate Conduct patient history to assess: Patient reported signs and symptoms of HIV disease, patient understanding of progression, and current status of HIV disease Hospitalizations Previous laboratory testing and results, including CD4 cell count 16 Current and previous HIV and non-HIV medications: what they were prescribed for, where they were prescribed Medication allergies Determine any immediate HIV-related medical needs; refer to HIV clinician for acute management of problems, if required. Assess for other pre-existing medical conditions such as TB, diabetes mellitus, hypertension, chronic liver disease. Assess for social issues such as client or family alcohol abuse, psychological or mental health problems, family violence, joblessness or other issues. Conduct mental health assessment. Explain process of enrollment, determination of eligibility for ART, and other elements of HIV care that will take place. Explain the clinic operations, including what to do if the patient is sick and how to change or request an appointment. Review: Disclosure status Family and social support Perceived barriers to enrollment in care Retention in care Adherence to medications Prepare a realistic and mutually agreeable visit plan based on initial assessment. If patient records include CD4 levels from within the past 6–12 weeks, make appointment for next clinical visit OR Order CD4 testing and other required laboratory tests, set appointment to review CD4 results Initiate enrollment in care by creating an enrollment number and a unique identification number as per national guidelines. Schedule next visit; record appointment in follow-up register. Document: Create individual client record using HIV chronic care card based on WHO model or national guidelines; record all findings Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 17 SOP 2: Initial assessment visit to determine eligibility Date of creation or revision: Prepared by: Reviewed by: Approved by: Purpose To assess progression of HIV and determine ART eligibility on all newly enrolled patients as part of comprehensive care, treatment and support. The first clinical visit may take place on the same day as the registration/enrollment visit if HIV diagnosis is confirmed and clinic schedule allows, or if the patient is very ill. Responsibility Triage nurse, registration and intake staff, auxiliary nurse Physician or clinical officer Nurse trained in HIV care and treatment Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 3. Intake forms and appointment follow-up cards 4. TB screening form 5. Laboratory test referral request form if required Procedure The first visit provides an opportunity to provide preventive and supportive care and introduce or reinforce information about the progression of HIV disease, prophylactic treatment, and ART. Greet client and introduce yourself. Explain what to expect at this visit. Review records from registration/enrollment visit (see SOP 1), confirm unique patient identification number. If more than a week has passed since registration/enrollment visit, review with patient: Patient status since last visit New laboratory results, if any Review process of enrollment in care, including planned content of today’s visit. 18 Assess client familiarity with: Concept of positive living Knowledge of HIV and ART Determine, in consultation with client, if additional HIV counseling is required; provide or refer for counseling if necessary. See SOPs 25–28 for guidance on the mental health assessment. Explain to client the criteria for ART eligibility, and that regardless of need for initiation of ART, an individualized program of HIV care will be established during today’s visit. Review medical history in depth. Conduct directed medical history focused on: Experience with ART and other HIV medications since last visit Any HIV medications taken previously Medication allergies Patient-perceived changes in health status Symptoms of possible side effects or toxicities Adherence (if applicable) Review use of all current medications — HIV, non-HIV and traditional — and reinforce potential interactions between western medicines and traditional medicines. Confirm initial intake information and discuss with HIV clinician before initiating therapy if required. Document vital signs and other physical findings. Perform comprehensive physical examination to assess general health and identify signs of HIV-related conditions, including opportunistic infections (OIs), TB, and STIs. Identify symptoms of HIV disease and document. Conduct symptomatic screening for TB using national TB screening checklist; and order TB laboratory confirmation if TB disease suspected. Review CD4 result and other laboratory results available in patient record. Order additional laboratory tests if required to complete assessment of eligibility for ART. Determine and document WHO HIV staging according to findings from medical history and physical examination. Review results of history, exam, lab results and WHO staging, determine eligibility for ART. Discuss and document ART eligibility findings with client and proceed with visit 19 according to eligibility. Inquire about partner, children and other family HIV status and reinforce the concept of family centered care. Review importance of adherence to: Clinic visit schedule Agencies to which the client has been referred Treatment, including ART and preventive treatment (CTX, INH), once initiated Assess for social issues such as client or family alcohol abuse, psychological or mental health problems, family violence, joblessness or other possible factors that could negatively influence adherence. Provide counseling and take-home leaflets (if available) on prevention for people living with HIV as part of every visit (see SOP 21). Schedule routine follow-up: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Create individual client record using HIV chronic care card based on WHO model or national guidelines; record all findings Assign enrollment number or unique identification number Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 20 Figure 1: Recommendations at a glance Adolescent or adult living with HIV CD4 testing / WHO clinical staging of all patients Eligible for ART: CD4 count ≤350 cells/mm3 and/or WHO stage 3 or 4 Ineligible for ART or unknown eligibility: CD4 count >350 cells/mm3 OR WHO stage 1 or 2 Screen for OIs including TB and HBV Screen for opportunistic infections Provision of counseling on positive (OIs) including TB and HBV infections Preparation for ART, including history of previous exposure to ARVs Revised recommended ART regimens for eligible adults and adolescents living with HIV: AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC/FTC + EFV TDF + 3TC/FTC + NVP living Regular follow up appointments, including WHO clinical staging, in accordance with national guidelines Repeat CD4 testing every six months WHO clinical staging at every visit CTX and INH preventive therapy as indicated according to national guidelines From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner. 21 Table 3: Criteria for ART initiation in specific populations Target population Clinical condition Recommendation Asymptomatic individuals (including pregnant women) WHO clinical stage 1 Start ART if CD4 ≤350 WHO clinical stage 2 Start ART if CD4 ≤350 WHO clinical stage 3 or 4 Start ART irrespective of CD4 cell count Active TB disease Start ART irrespective of CD4 cell count HBV infection requiring treatment* Start ART irrespective of CD4 cell count Symptomatic individuals (including pregnant women) TB and hepatitis B co infections From: WHO Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach 2010 revision. Table 4: WHO clinical staging of HIV disease in adults and adolescents Clinical stage 1 Asymptomatic Persistent generalized lymphadenopathy Clinical stage 2 Moderate unexplained weight loss (under 10% of presumed or measured body weight) Recurrent respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis) Herpes zoster Angular cheilitis Recurrent oral ulcerations Papular pruritic eruptions Seborrhoeic dermatitis Fungal nail infections Clinical stage 3 Unexplained severe weight loss (over 10% of presumed or measured body weight) Unexplained chronic diarrhea for longer than 1 month Unexplained persistent fever (intermittent or constant for longer than 1 month) Persistent oral candidiasis Oral hairy leukoplakia Pulmonary TB Severe bacterial infections (e.g. pneumonia, empyema, meningitis, pyomyositis, bone or joint infection, bacteraemia, severe pelvic inflammatory disease) Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis 22 Unexplained anemia (below 8 g/dl), neutropenia (below 0.5 x 109/l) and/or chronic thrombocytopenia (below 50 x 109/l) Clinical stage 4 HIV wasting syndrome Pneumocystis jiroveci pneumonia Recurrent severe bacterial pneumonia Chronic herpes simplex infection (orolabial, genital or anorectal of more than 1 month’s duration or visceral at any site) Esophageal candidiasis (or candidiasis of trachea, bronchi or lungs) Extrapulmonary TB Kaposi sarcoma Cytomegalovirus disease (retinitis or infection of other organs, excluding liver, spleen and lymph nodes) Central nervous system toxoplasmosis HIV encephalopathy Extrapulmonary cryptococcosis including meningitis Disseminated nontuberculous mycobacteria infection Progressive multifocal leukoencephalopathy Chronic cryptosporidiosis Chronic isosporiasis Disseminated mycosis (histoplasmosis, coccidiomycosis) Recurrent septicaemia (including nontyphoidal Salmonella) Lymphoma (cerebral or B cell non-Hodgkin) Invasive cervical carcinoma Atypical disseminated leishmaniasis Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 23 SOP 3: Clinical visit — clients not eligible for ART Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To conduct the initial assessment as part of a package of comprehensive HIV care, treatment and support to newly enrolled patients. Much of the first clinical visit may take place on the same day as the registration/enrollment visit if HIV diagnosis is confirmed and clinic schedule allows. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 1. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 3. CTX, multivitamins 4. Counseling materials as teaching aids and for distribution to patients 5. TB screening form 6. Laboratory test referral request form if required Procedure Once clinical and laboratory assessment, staging of HIV disease, and determination of eligibility for ART have taken place, continue with initial visit as follows for patient categorized as not yet eligible for ART. This SOP is a direct follow-on to SOP 2: Initial assessment visit to determine eligibility if patient is determined to be non-eligible (SOP 2 content is not duplicated here). 24 Greet client and re-emphasize confidentiality of HIV services. Provide pre-ART counseling: Discuss the reasons for determination of non-eligibility for ART at this time Explain that once ART is prescribed, it is for life Discuss the importance of attending all routine clinic appointments Discuss the importance of excellent adherence to preventive treatment (CTX, INH) and ART, once initiated Explain that starting ART before an individual is ready may impact future treatment options Briefly review concept of regular routine HIV monitoring, and explain types, rationale and schedule for HIV care that will be provided until patient becomes ART eligible. Discuss importance of adherence to clinic visit schedule for physical exam, lab updates, especially CD4 testing, and preventive treatment and care. Conduct comprehensive physical examination to assess for signs of HIV-related conditions, complications, and other medical conditions: Female patients: conduct pelvic exam to screen for STIs (include RPR/VDRL lab screening for syphilis) including genital/anal warts; screen for cervical cancer by visual inspection once yearly if in accordance with national guidelines or defer until second clinical visit, see SOPs 17 and 18 Male patients: conduct a genital exam to assess for presence of circumcision, STIs (include RPR/VDRL lab screening for syphilis), genital/anal warts, see SOP 17 Order or conduct laboratory testing (or wait until ART eligibility is confirmed before ordering laboratory profile), if consistent with national guidelines: Urinalysis Complete blood count blood chemistries including liver function test Conduct symptomatic screening for TB using national TB screening checklist; and order TB laboratory confirmation if TB disease suspected. Assess immunization status and provide immunizations required according to national guidelines. Initiate CTX prophylaxis in all HIV positive clients according to national guidelines (see SOP 8). Provide mental health assessments (see SOPs 25, 26 and 27): Assess general mental status, including adjustment to HIV diagnosis, reaction to non-eligibility for ART Screen for social issues such as client or family alcohol abuse, psychological or mental health problems, family violence, joblessness or other possible factors that 25 could negatively influence adherence Provide mental health and support group referrals, as appropriate Review reproductive history: Discuss reproductive intentions Explain contraceptive options; provide or refer for additional contraceptive method, if desired (see SOP 16) If planning a family, discuss safe conception Discuss safer sex, dispense condoms Conduct or refer for nutritional assessment and counseling (See SOP 22 nutritional assessment). Recommend or dispense multivitamins, if available. Provide or refer for counseling to review elements of “positive living”: Avoidance of HIV transmission or re-infection by practicing safer sex and partner notification and testing Personal hygiene (washing hands after using toilet or before preparing/eating food, bathing daily, brushing teeth, etc) Nutrition and good food hygiene Provide counseling and take-home leaflets (if available) on prevention for people living with HIV as part of every visit (see SOP 21). Explain concept of family centered HIV care and treatment and offer HIV testing for family members and support for partner/family discussions. Schedule routine three-monthly follow-up: Schedule earlier appointment if required for follow-up of problems identified during the visit If initial assessment was conducted before laboratory tests were returned, and the laboratory work subsequently reveals that the client is eligible for ART; contact him or her for immediate follow up, even if it is not yet time for the follow-up appointment Record appointment in follow-up register Document: Record all findings and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 26 SOP 4: Clinical visit — clients eligible for ART Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To conduct the initial assessment as part of a package of comprehensive HIV care, treatment and support to newly enrolled patients. The first clinical visit may take place on the same day as the registration/enrollment visit if HIV diagnosis is confirmed and clinic schedule allows. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. CTX, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. TB screening form 7. Laboratory test referral request form if required Procedure Once clinical and laboratory assessment, staging of HIV disease, and determination of eligibility for ART have taken place, continue with initial visit as follows for patient categorized as eligible for ART. Eligibility for ART and readiness to begin ART are not the same. This SOP is a direct follow-on to SOP 2: Initial assessment visit to determine eligibility if and when a patient is 27 determined to be eligible (SOP 2 content is not duplicated here). 4.1 Confirm eligibility for ART initiation Review patient records and confirm ART eligibility by physical examination, WHO staging and laboratory criteria (CD4 count) according to national guidelines. Discuss with appropriate members of HIV team (counselors, social workers) to determine if patient also meets social criteria for initiation of ART. Social criteria may include: Residence in district where health facility is located An understanding of the importance of excellent adherence and risks of poor adherence (see SOP 5) Expressed willingness to comply with visit schedule and treatment schedule Prior disclosure of HIV status to partner/family and availability of family/social support to accompany client to clinic visits and/or assist with adherence to ART Prior experience with good adherence to CTX prophylaxis or other HIV-related treatment if applicable Make final determination of treatment readiness and appropriateness of ART initiation and document in patient record. 4.2 Provide routine HIV care for ART-eligible HIV patients in accordance with National Guidelines Greet patient and reemphasize confidentiality of HIV services. Provide ART counseling: Explain reasons for determination of eligibility and treatment readiness Briefly review concept of regular routine HIV monitoring, and explain types, rationale and schedule for HIV care that will be provided in addition to ART Explain need for more frequent clinic visits during first several months of ART to check for side effects, drug toxicities, and to monitor adherence, according to national protocol Re-emphasize importance of excellent adherence to ART and preventive treatment (CTX, INH); provide or refer to counselor for additional ART adherence counseling if required (See SOP 5) Discuss importance of adherence to clinic visit schedule for physical exam, lab updates, especially CD4 testing, adherence checks, medication refills, and preventive treatment and care. This is particularly important now that client is about to begin treatment. Emphasize the importance of following up on referrals, where made Conduct directed medical history to determine progression of disease and care provided since HIV diagnosis received. 28 Conduct directed physical examination: Document vital signs, body mass index (BMI), and to assess for signs of HIVrelated conditions and complications, confirm previous WHO staging Screen both male and female patients for STIs (include rapid syphilis test to screen for syphilis) Female patients: conduct pelvic exam to screen for STIs including genital/anal warts; screen for cervical cancer by visual inspection once yearly if in accordance with national guidelines or defer until second clinical visit Male patients: conduct a genital exam to assess for presence of circumcision, STIs (include RPR/VDRL lab screening for syphilis), genital/anal warts Female patients: rule out pregnancy by history, pregnancy test and/or exam Provide treatment for conditions detected, according to national guidelines. Order or conduct laboratory testing, according to national guidelines, and document in patient chart: Urinalysis Renal function Complete blood count blood chemistries including liver function test CD4 cell testing, if not conducted in the past three months; compare CD4 to previous CD4 count(s) to gain an understanding of disease status Where available, baseline viral load Conduct symptomatic screening for TB using national TB screening checklist; and order TB laboratory confirmation if TB disease suspected. Assess immunization status and provide immunizations required according to national guidelines. Initiate CTX prophylaxis in HIV positive clients according to national guidelines (see SOP 8). Provide mental health assessments (see SOPs 25, 26, and 27): Assess general mental status, including adjustment to HIV diagnosis, reaction to eligibility for ART, likelihood of successful adherence and perceived barriers to adherence Screen for social issues such as client or family alcohol abuse, psychological or mental health problems, family violence, joblessness or other possible factors that could negatively influence adherence Provide mental health and support group referrals, as appropriate Review reproductive history: Discuss reproductive intentions 29 Explain contraceptive options; provide or refer for additional contraceptive method, if desired (see SOP 16) If planning a family, discuss safe conception Discuss safer sex, dispense condoms Conduct or refer for nutritional assessment and counseling (see SOP 22 nutritional assessment). Recommend or dispense multivitamins, if available. Write prescription and/or dispense initial ART medications (or defer ART in light of contraindications, concurrent conditions or other factors encountered during initial visit, in accordance with national guidelines), see SOP 6 for guidance on ART regimen selection. If acute brain syndrome — secondary to HIV-associated encephalopathy, Stage 4 — or pregnancy, “Fast-track” to receive ART within 2 weeks–1 month of clinical staging or as soon as possible If TB disease confirmed, initiate ART as soon as possible, preferably within 8 weeks of starting TB treatment Temporarily defer initiation of ART if: Poor level of understanding of ART and ART adherence Patient refusal to begin therapy Current alcohol or drug abuse severe enough to affect adherence All other patients should receive ART as soon as possible after clinical staging or CD4 measurement that qualified them for ART initiation Describe and discuss potential side effects of ART and drug-drug interactions, how to recognize, what to do if these occur. Notify clinic manager if not possible to initiate ART as above, to develop an appropriate alternative. Provide or refer for counseling to review elements of “positive living”: Avoidance of HIV transmission or re-infection by practicing safer sex and partner notification and testing Personal hygiene (washing hands after using toilet or before preparing/eating food, bathing daily, brushing teeth, etc) Nutrition and good food hygiene Provide counseling and take-home leaflets (if available) on prevention for people living with HIV as part of every visit (see SOP 21). Explain concept of family centered HIV care and treatment and offer HIV testing for family members and support for partner/family discussions. 30 Schedule routine three or six monthly follow-up Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 31 Table 5: When to start ART Target population HIV+ asymptomatic ARV-naive individuals 2010 ART guideline CD4 ≤350 cells/mm3 2006 ART guideline CD4 ≤200 cells/mm3 WHO stage 2 or 3 and CD4 ≤200 cells/mm3 WHO clinical stage 2 if CD4 ≤350 cells/mm3 HIV+ symptomatic ARV-naive individuals OR WHO clinical stage 3 or 4 irrespective of CD4 cell count CD4 ≤350 cells/mm3 irrespective of clinical symptoms HIV+ pregnant women OR WHO clinical stage 3 or 4 irrespective of CD4 cell count HIV/TB co infection ARV-naive individuals WHO stage 4 irrespective of CD4 cell count Consider treatment for WHO clinical stage 3 and CD4 cell count between 200 and 350 cells/mm3 WHO stage 1 or 2 and CD4 ≤200 cells/mm3 WHO stage 3 and CD4 ≤350 cells/ mm3 WHO stage 4 irrespective of CD4 count Presence of active TB disease and CD4 ≤350 cells/mm3 ART Initiation can be delayed if CD4 ≥200 cells/mm3 No specific recommendation Individuals who require treatment for their HBV infection*, irrespective of CD4 cell count The current diagnosis of chronic active hepatitis in well-resourced settings is based on histological parameters obtained by liver biopsy and/or the availability of HBV DNA testing, neither of which is usually available in resource-limited settings. A global definition of chronic active hepatitis in the context of resource-limited settings based on clinical signs and simpler laboratory parameters is under discussion. HIV/HBV co infection ARV-naive individuals * Presence of active TB disease, irrespective of CD4 cell count WHO stage 3 if CD4 not available From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 32 Table 6: What ART to start Target population 2010 ART guideline 2006 ART guideline No change, but in settings where d4T HIV+ ARVnaive adults and adolescents HIV+ pregnant women HIV/TB co infection HIV/HBV co infection regimens are used as the principal option for starting ART a progressive plan to move towards AZT-based or TDF-based first-line regimens should be developed, based on an assessment of cost and feasibility AZT preferred but TDF acceptable EFV included as a NNRTI option (but do not initiate EFV during first trimester) Benefits of NVP outweigh risks where CD4 count is 250−350 cells/mm3 In HIV+ women with prior exposure to MTCT regimens No change ART should be initiated as soon as possible in all HIV/TB-co infected patients with active TB (within 8 weeks after the start of TB treatment) NNRTI regimens that contain both TDF + 3TC (or FTC) are required AZT or TDF + 3TC (or FTC) + EFV or NVP AZT + 3TC + NVP AZT or TDF + 3TC (or FTC) + EFV TDF + 3TC (or FTC) + EFV From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 33 SOP 5: Treatment readiness and adherence counseling Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To determine ART treatment readiness and provide adherence counseling to adults with HIV, as part of an integrated HIV service package. Introduction: Adherence levels of 95% or greater have been shown to maximize effectiveness of ART and minimize the development of drug resistance. Treatment readiness or pre-ART counseling requires 2–3 visits at least one week apart to allow time to adjust to the reality of lifelong treatment and time to assess coping with diagnosis and treatment realities. This also provides time for the patient to build a relationship with their health-care team. Routine adherence monitoring visits after initiation of ART should be scheduled at 5– 7 days after initiation, every two weeks for the first two months, and every month thereafter, coordinated with regular clinic visit whenever possible to improve attendance. All members of the health-care team should be encouraged to ask about adherence at every point of contact. Responsibility Adherence counselors Triage nurses All levels of clinical staff Peer counselors, patient advocates, community support workers Supplies 1. Counseling area that offers adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, adherence register, peer educator registers, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Adherence counseling monitoring forms and checklists b. Adherence counseling materials for patients and family c. Rapid Adherence Assessment for triage nurse if applicable 34 d. Pill boxes, adherence calendars, Procedure Using adherence counseling skills and adherence counseling content that is consistent with national guidelines: 5.1 Provide treatment readiness (pre-ART) counseling to assess readiness to begin and maintain ART Greet client and introduce yourself. Explain the purpose of treatment readiness assessment(s). Review patient self-assessment of health status in presence of HIV diagnosis. Assess patient willingness to begin and continue lifelong ART. Assess knowledge and provide information: Assess patient overall knowledge of HIV disease Determine patient understanding of rationale and criteria for ART initiation Assess patient’s basic understanding of mechanism of action of ARVs Explain rationale and criteria for other prophylactic treatment such CTX and INH Discuss side effects/drug interactions: Describe and discuss possible side effects Explain the importance of early recognition of signs and symptoms of ART side effects, adverse reactions and drug toxicities Explain possible interactions between ARVs and other HIV-related medications patient is taking or may need to take Discuss non-HIV medications and beliefs in traditional cures for HIV, and explain potential problems with use of certain non-HIV and traditional medicines while on ART (potential interactions) Explain how to recognize signs/symptoms of drug-drug interactions Discuss adherence: Explain importance of taking all required actions to assure that the first ART treatment regimen selected is effective for as long as possible to avoid development of infections associated with immunosuppression, complications of more complex treatment regimens, drug resistance Explain importance of continuing to take ARVs even when physical condition improves Discuss the link between adherence, resistance, and future treatment options 35 Explain that clients who adhere to their ARV regimen are much less likely to transmit HIV to their sexual partners (but continue to strongly encourage and support use of condoms) Explain the need to avoid erratic or interrupted ARV dosing Discuss drug-related factors influencing treatment adherence: pill burden, complexity of dosage regimen, unpleasant tastes or other medication-associated factors Explain the risks of discontinuing therapy and caution against it Discuss the risks of sharing medications and caution against it Assess ability and willingness to self-monitor and report adherence, with clinic or family assistance if required Conduct assessment of well-being: Determine level of coping with HIV diagnosis and “comfort level” with need to initiate treatment Discuss disclosure and social support: identify to whom patient has disclosed HIV status Discuss stigma and discrimination, either perceived or actual, that patient fears or has encountered Explain importance of “treatment adherence partner”; determine availability of family and social support, identify specific individuals who might become “treatment adherence partners” (see Table 7, below) Assess patient’s use of and reasons for traditional and non-HIV medications or treatments, alcohol and other mood altering drugs Identify presence of specific factors known to be associated with poor adherence: Competing priorities — changes in social circumstances/employment Stress/depression New partners/non-disclosure Men living alone Alcohol use/abuse Develop an ART plan: Show patient the actual drugs in his/her ART regimen, review names of each ARV and explain which medications to take at which times; ask patient to repeat demonstration to you several times Agree on times that the patient will take their medication daily, and what reminders will be used to assist with adherence Assess ability and willingness to fit medication schedule into daily life 36 Assess ability to store medications safely and correctly Assess ability to adhere to visit schedule: Assess willingness and ability to maintain regular clinic visit schedule Identify potential difficulties with transportation for medication refill visits and/or clinic visits and identify realistic solutions Assure method of regular communication between clinic visits, home visits and ability to contact patient in case of default or loss to follow up Connect patient with any community resources that are available. 5.2 Once client has begun ART: assess and monitor adherence to ART regimen Review and update patient record and registration information. Discuss patient experience with ARV medications since last visit. Discuss any illnesses experienced since last visit. Identify any drug-associated problems such as side effects, adverse events. Reassure about availability of medications to address side effects and make referral to clinical staff if required. Identify any use of traditional therapies or other medicines. Assess and discuss adherence: Assess level of adherence by 7-day patient self-report and compare with information from adherence partner if available Verify patient-assessed adherence using one or more of several methods: Visual Analogue Scale (VAS) Pill Identification Test (PIT), pill count, provide estimate, pharmacy refill data, self-report (information on conducting the VAS, PIT, and pill count can be found in Appendix A) Explore barriers to adherence, including alcohol and mood altering drugs and discuss possible solutions Identify food and nutrition related factors to adherence (no food to take with ARVs as prescribed) Discuss use of adherence tools: patient adherence diary, reminder cards or calendars, pill boxes Identify mental health, depression, denial issues and plan referral for clinical assessment if required. Compare clinical and laboratory status at last visit and at current visit to assess likely signs of non-adherence (new infections, weight loss, significant change in lab values). Emphasize importance of behaviors to prevent risk of transmission and minimize risk 37 of re-exposure or reinfection even while on ART and regardless of improved physical health: safer sex, partner reduction, condom use, universal precautions and personal hygiene. Special adherence support may be needed for: Initial weeks of combined TB- ART treatment Second-line ART regimens Patients experiencing adverse effects of treatment Co-morbidities or complex medical problems Difficult family or social situations Patients who live far away from the health facility Alcohol or drug use Psychiatric or neurolologic conditions Confer with social worker or triage nurse if indicated to coordinate treatment adherence plan. Discuss with clinical staff or triage nurse if any significant clinical manifestations of ART-related problems are identified. Schedule next treatment readiness/ adherence counseling appointment preferably on same day as next medical appointment to facilitate attendance: If patient adherence verified, schedule next regular adherence visit according to counseling protocol If patient non-adherent, but wants to continue ART, schedule visit within 48 hours to reinforce today’s counseling content and request treatment adherence partner also attend if possible Record appointment in follow-up register Document: Record all findings and discussions in patient record Complete adherence checklists, if available Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 38 Table 7: Treatment adherence partners Support the use of treatment adherence partners Definition A treatment adherence partner (“adherence buddy”) can be a partner, parent, son/daughter, someone from support group, friend, neighbor, teacher, religious advisor, etc. who is: Chosen by the patient Accepted the patient’s HIV-positive status Committed to support the patient with ART for a long time Available to participate in training sessions to be educated on HIV, ART, TB and other opportunistic infections Available twice daily especially in the first months of therapy and after that as necessary to support adherence Somebody who will maintain confidentiality Prepare the treatment adherence partner Meet with the proposed adherence partner to explain requirements. Discuss primary responsibilities of an adherence partner: Remind client to take the medicine (and to work out with the patient how best to do so) Attend all follow-up clinic appointments Attend appointments at agencies to which the client has been referred Discuss the need to provide the client with psychosocial support, help coping with stigma and related issues in the community. Explain the concept and responsibility of confidentiality. Discuss “burn-out” and prepare for potential emotional needs of the treatment adherence partner, him/herself. Explain how to reach the clinical team if urgent problems with the patient arise. 39 SOP 6: ART regimen selection Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide guidance on ART regimen selection and monitoring as part of an integrated HIV service package. (Laboratory monitoring appears in SOP 7.) Introduction There is wide variation in treatment protocols among countries, based on available resources and local expert advice. Basic principles of treatment and monitoring can be adapted by country programs to adhere to national treatment and monitoring guidelines. (See also the section entitled “Illustrative examples of national adaptations”.) Responsibility Physician or clinical officer Nurse trained in HIV care and treatment HIV specialist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. CTX, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required 40 Procedure 6.1 Review patient profile Assess patient profile and select recommended initial ART regimen considering contraindications: Review all pertinent clinical information to assure accuracy, completeness and ART eligibility Review counseling notes and assessment of ability to adhere to ART regimen once initiated Review and update targeted history, physical findings and laboratory results (including anemia, renal or hepatic function, reproductive status, see SOP 7) Review patient profile in light of global technical treatment recommendations (see Table 8) 6.2 Start ART in eligible patients, according to national guidelines The best time to start ART, if possible, is before patients become sick or present with an opportunistic infection. Start ART in all adolescents and adults, including pregnant women, with HIV who: Have CD4 count less than 350 cells/mm, whether or not clinical signs and symptoms are present (i.e., even if they are in WHO Stage 1 or Stage 2) or Are in WHO Clinical Stage 3 or Stage 4 at ANY CD4 count, or if no CD4 is yet available 6.3 Select appropriate initial regimen for ART-naïve patients Treatment-naïve patients should be started on ART as per country treatment guidelines. It is typical to initiate ART using one non-nucleoside reverse transcriptase inhibitor (NNRTI) in combination with two nucleoside reverse transcriptase inhibitors (NRTI). Use fixed-dose combinations, if available, to reduce complexity of regimen and maximize patient adherence. Do not use EFV during first trimester of pregnancy to avoid possible neural tube defects. EFV can more safely be used after first trimester to replace NVP if required due to NVP intolerance or contraindication. Treatment guidelines in Tables 9–13 (below) describe the most recent treatment recommendations from both WHO and DHHS, but may suggest drugs that are not yet available in some countries. 6.4 Monitor patients on ART 41 Provide clinical monitoring for all ART patients according to national guidelines. Beginning with initiation of first-line ART (Day 0), usual schedule for ART clinical revisits includes: Revisit at 2 weeks, 4–6 weeks, 8–10 weeks, 12–14 weeks, every 3 months for the first two years of ART After Year 2, visits can take place every 6 months, more frequently if complications occur Adolescent patients should continue with visits every 3 months until age 18–20 years, depending on national protocol See SOP 15 for second- or third-line ART clinical re-visit schedule Every follow up clinical visit includes: Adherence assessment by an adherence care team. Clinical staff are informed if adherence is determined to be less than 90%. Adherence assessment includes determination of presence of specific factors known to be associated with poor adherence (see SOP 5 Adherence) CTX prophylaxis, identification and treatment of OIs or other conditions, drug toxicities, TB screening, INH preventive therapy if indicated, STI screening, pap smear, pregnancy testing and family planning method review, immunization update (see SOP 4 for full schedule and content of routine clinical visits) Review with patient, partner and family, if possible, the importance of adherence to clinic visit schedule and drug regimens (ART, TB, and preventive treatments such as CTX and INH, if initiated) Counseling on positive living 6.5 Recognize and manage interruption or discontinuation of ART Interruption or discontinuation of ART, whether required to manage medical problems, intentional by patient, or unintentional due to supply outages, can negatively affect treatment outcome as well as contribute to development of resistant strains. Timely management according to national guidelines is key. Recognize and manage required therapeutic interruption of ART: Review patient records to determine cause of required therapeutic treatment interruption. These can include: Life-threatening drug toxicity such as Stevens-Johnson Syndrome or acute fulminant hepatitis Inability to take medications orally due to acute illness Severe immune reconstitution syndrome (IRIS) 42 TB coinfection causing drug intolerance interactions When possible, adjust rather than discontinue ART, since ART discontinuation may result in: Rapid increase in HIV viral load Rapid decrease in CD4 cell count Increased risk of rapid clinical progression of HIV-related complications and progression to AIDS Consider long half-life of EFV and NVP, and with exception of life-threatening toxicity, stop EFV/NVP two weeks prior to discontinuing other medications. If NVP treatment is interrupted for longer than 2 weeks, when reintroducing, begin with NVP 200 mg once daily and increase to NVP twice daily if single daily dose is well tolerated. Consult senior clinician or HIV Specialist if available, to develop ART interruption treatment plan. Recognize and manage discontinuation of ART: Thoroughly review patient records and interview patient, partner, family to determine possible causes of ART discontinuation. These can include: Patient or family-centered adherence issues (see SOP 5) Access issues: cost, distance, transport Necessary medical decisions such as intolerable side effects or toxicities with no appropriate alternative regimen available, patient or family wishes to discontinue therapy, or end stage HIV-related illness and can no longer comply with therapy If patient deliberately discontinued ART, request patient agreement to continue to monitor clinically for OIs. Prior to re-initiation in same patient, conduct new baseline clinical and laboratory assessment and new treatment readiness assessment. As with any routine and non-routine visit: provide counseling and take-home leaflets in response to emerging needs (see SOP 21); inquire about partner, children and other family members; review importance of clinic visit schedule and set date/time for next appointment. At all visits Schedule routine follow-up Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: 43 Record all findings and discussions in patient record ART enrollment form and record book Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable Table 8: Global technical treatment recommendations Key 2010 technical treatment recommendations Revised WHO guidelines suggest progressive phase-out of stavudine (d4T) as part of first-line regimen, using less toxic AZT or TDF instead. Do not use EFV during first trimester of pregnancy to avoid possible neural tube defects. EFV can more safely be used after first trimester to replace NVP if required due to NVP intolerance or contraindication. Avoid starting CTX prophylaxis and ART at the same time. Rash may occur with use of either drug, so starting CTX prophylaxis before ART makes identification of cause of rash easier. In TB-HIV coinfection, start anti TB drugs first, then ART as soon as possible within 8 weeks. Consider pharmacologic selection criteria: Therapeutic efficacy, cost, availability Minimal or manageable side effects Pill burden and ease of use Ease of storage (refrigeration etc) for facility and patient Requirement to take medication with food Drug/drug interactions, i.e. TB treatment, oral contraceptives Fertility plans 44 Table 9: Preferred first-line ART in treatment-naïve adults and adolescents Target population Preferred options Adults and adolescents AZT or TDF + 3TC or FTC + EFV or NVP Pregnant women AZT + 3TC + EFV or NVP HIV/TB co infection AZT or TDF + 3TC or FTC + EFV HIV/HBV co infection TDF + 3TC or FTC + EFV or NVP Comments Select the preferred regimens applicable to the majority of PLHIV. Use fixed-dose combinations. Do not initiate EFV during first trimester. TDF acceptable option. In HIV women with prior exposure to PMTCT regimens, see “Table 30: ART regimens recommended for women with prior exposure to PMTCT regimen”. Initiate ART as soon as possible (within the first 8 weeks) after starting TB treatment. NVP or triple NRTIs are acceptable options if EFV cannot be used. Consider HBsAg screening before starting ART, especially when TDF is not the preferred firstline NRTI. Use of two ARVs with anti-HBV activity required. From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 45 Table 10: Dosages of recommended ARVs Generic name Dose Nucleoside reverse transcriptase inhibitors (NRTIs) Abacavir (ABC) 300 mg twice daily or 600 mg once daily Didanosine (ddI) 400 mg once daily (>60 kg) 250 mg once daily (≤60 kg) Emtricitabine (FTC) 200 mg once daily Lamivudine (3TC) 150 mg twice daily or 300 mg once daily Stavudine (d4T) 30 mg twice daily Zidovudine (AZT) 250−300 mg twice daily Nucleotide reverse transcriptase inhibitors (NtRTIs) Tenofovir 300 mg once daily1 Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz (EFV) 600 mg once daily Etravirine (ETV) 200 mg twice daily Nevirapine (NVP) 200 mg once daily for 14 days, followed by 200 mg twice daily2 Protease inhibitors (PIs) Atazanavir + ritonavir (ATV/r) 300 mg + 100 mg once daily Darunavir + ritonavir (DRV/r) 600 mg + 100 mg twice daily Fos-amprenavir + ritonavir (FPV/r) 700 mg + 100 mg twice daily Indinavir + ritonavir (IDV/r) 800 mg + 100 mg twice daily Fixed Dose Combination tablets (LPV 200 mg / RTV 50 mg) Two tablets (400 mg/200 mg) twice daily3 Considerations for individuals on TB therapy In the presence of rifabutin, no dose adjustment required In the Lopinavir/ritonavir (LPV/r) presence of rifampicin; use ritonavir super boosting (LPV 400 mg + RTV 400 mg twice daily) or LPV 800 mg + RTV 200 mg twice daily, with close clinical and hepatic enzyme monitoring 1 TDF dosage adjustment for individual with altered creatinine clearance can be considered (using Cockcroft-Gault formula). Creatinine clearance ≥50 ml/min, 300 mg once daily. Creatinine clearance 30−49 ml/min, 300 mg every 48 hours. Creatinine clearance ≥10−29ml/min (or dialysis), 300 mg once every 72−96 hours. Cockcroft-Gault formula: GFR = (140-age) x (Wt in kg) x (0.85 if female) / (72 x Cr) 46 2 3 In the presence of rifampicin, or when patients switch from EFV to NVP, no need for lead-in dose of NVP. LPV/r can be administered as 4 tablets once daily ( i.e. LPV 800 mg + RTV 200 mg once daily) in patients with less than three LPV resistance-associated mutations on genotypic testing. Once-daily dosing is not recommended in pregnant women or patients with more than three LPV resistance-associated mutations. From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. Table 11: Acceptable ARV regimens for treatment-naïve patients Acceptable Regimens (CI): Regimens that may be selected for some patients but are less satisfactory than preferred or alternative regimens, and Regimens that may be Acceptable but more definitive data are needed (CIII). NNRTI-Based Regimen EFV + ddI + (3TC or FTC) (CI) PI-Based Regimens ATV + (ABC or AZT)/3TC1 (CI) DRV/r + (ABC or AZT)/3TC1 (CIII) INSTI-Based Regimen RAL + (ABC or AZT)/3TC1 (CIII) Comments EFV + ddI + (FTC or 3TC) has only been studied in small clinical trials. ATV/r is generally preferred over ATV. Unboosted ATV may be used when RTV boosting is not possible. MVC: Tropism testing should be performed before initiation of therapy; CCR5 Antagonist-Based Regimens MVC + AZT/3TC1 (CI) MVC + TDF/FTC1 or ABC/3TC1 (CIII) Regimens that may be acceptable but should be used with caution: Regimens that have demonstrated virologic efficacy in some studies but have safety, resistance, or efficacy concerns (see comments below). NNRTI-Based Regimens NVP + ABC/3TC1 (CIII) NVP + TDF/FTC1 (CIII) PI-Based Regimens FPV + [(ABC or AZT)/3TC1 or TDF/FTC1] (CIII) SQV/r + TDF/FTC1 (CI) SQV/r + (ABC or AZT)/3TC1 (CIII) Comments Use NVP and ABC together with caution because both can cause HSRs within first few weeks after initiation of therapy. Early virologic failure with high rates of resistance has been reported in some patients receiving NVP + TDF + (3TC or FTC). Larger clinical trials are currently in progress. FPV/r is generally preferred over unboosted FPV. Virologic failure with unboosted FPV-based regimen may select mutations that confer cross-resistance to DRV. SQV/r •QV/r was associated with PR and QT prolongation in a healthy volunteer study. 47 Baseline ECG is recommended before initiation of SQV/r. SQV/r is not recommended in patients with any of the following: pretreatment QT interval >450 msec refractory hypokalemia or hypomagnesemia concomitant therapy with other drugs that prolong QT interval complete AV block without implanted pacemaker risk of complete AV block 1 3TC may be substituted with FTC or vice versa. From: Panel on Antiretroviral Guidelines for adults and Adolescents. Guidelines for the use of ARV agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS). January 10, 2011; 1-166. 48 Table 12: ARV components not recommended as initial therapy ARV Drugs or Components (in alphabetical order) ABC/3TC/AZT (coformulated) as triple-NRTI combination regimen (BI) Reasons for NOT recommending as initial therapy Inferior virologic efficacy ABC + 3TC + AZT + TDF as quadruple-NRTI combination (BI) Inferior virologic efficacy ABC + ddI (BIII) Insufficient data in ART-naïve patients ABC + TDF (BIII) Insufficient data in ART-naïve patients DRV (unboosted) Use without RTV has not been studied DLV (BII) Inferior virologic efficacy Inconvenient (three times daily) dosing ddI + TDF (BII) T-20 (BIII) No clinical trial experience in ART-naïve patients Requires twice-daily subcutaneous injections ETR (BIII) Insufficient data in ART-naïve patients IDV (unboosted) (BIII) Inconvenient dosing (three times daily with meal restrictions) Fluid requirement IDV (RTV-boosted) (BIII) High incidence of nephrolithiasis NFV (BI) Inferior virologic efficacy High incidence of diarrhea RTV as sole PI (BIII) High pill burden Gastrointestinal intolerance SQV (unboosted) (BI) Inferior virologic efficacy High rate of early virologic failure Rapid selection of resistance mutations Potential for immunologic nonresponse/CD4 T-cell decline Increased ddI drug exposure and toxicities Significant toxicities including lipoatrophy; peripheral d4T + 3TC (BI) TPV (ritonavir-boosted) (BI) neuropathy; and hyperlactatemia, including symptomatic and life-threatening lactic acidosis, hepatic steatosis, and pancreatitis Inferior virologic efficacy From: Panel on Antiretroviral Guidelines for adults and Adolescents. Guidelines for the use of ARV agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS). January 10, 2011; 1-166. 49 Table 13: ARV regimens or components that should not be offered at any time Rationale Exception ARV regimens not recommended Rapid development of resistance Monotherapy with Inferior ARV activity when No exception NRTI (AII) compared with combination of three or more ARV agents Dual-NRTI regimens (AI) Rapid development of resistance Inferior ARV activity when No exception compared with combination of three or more ARV agents High rate of early virologic nonresponse seen when tripleABC/AZT/3TC (BI) and NRTI combinations, including Triple-NRTI regimens possibly TDF + ABC/TDF/3TC and (AI) except for AZT/3TC (BII) in TDF/ddI/3TC, were used as ABC/AZT/3TC (BI) or patients in whom other initial regimen in ART-naïve possibly TDF + combinations are not patients. AZT/3TC (BII) desirable Other triple-NRTI regimens have not been evaluated. ARV components not recommended as part of an ARV regimen Potential additive ATV + IDV (AIII) No exception hyperbilirubinemia ddI + d4T (AII) High incidence of toxicities: peripheral neuropathy, pancreatitis, and hyperlactatemia Reports of serious, even fatal, cases of lactic acidosis with hepatic steatosis with or without pancreatitis in pregnant women When no other ARV options are available and potential benefits outweigh the risks (BIII) ddI + TDF (AII) Increased ddI concentrations and serious ddI-associated toxicities Potential for immunologic nonresponse and/or CD4 cell count decline High rate of early virologic failure Rapid selection of resistance mutations at failure Clinicians caring for patients who are clinically stable on regimens containing TDF + ddI should consider altering the NRTIs to avoid this combination. 2-NNRTI combination (AI) When EFV combined with NVP, higher incidence of clinical No exception 50 adverse events seen when compared with either EFV- or NVP-based regimen. Both EFV and NVP may induce metabolism and may lead to reductions in ETR exposure; thus, they should not be used in combination with ETR. EFV in first trimester Teratogenic in nonhuman of pregnancy or in primates women with significant childbearing potential (AIII) Similar resistance profiles FTC + 3TC (AIII) No potential benefit When no other ARV options are available and potential benefits outweigh the risks (BIII) No exception ETR + unboosted PI (AII) ETR may induce metabolism of these PIs; appropriate doses not yet established No exception ETR + RTV-boosted ATV or FPV (AII) ETR may alter the concentrations of these PIs; appropriate doses not yet established No exception ETR + RTV-boosted TPV (AII) ETR concentration may be significantly reduced by RTVboosted TPV No exception NVP in ARV-naïve women with: CD4 count >250 cells/mm3 or men with CD4 count >400 cells/mm3 (BI) High incidence of symptomatic hepatotoxicity If no other ARV option available; if used, patient should be closely monitored d4T + AZT (AII) Unboosted DRV, SQV, or TPV (AII) Antagonistic effect on HIV-1 No exception Inadequate bioavailability No exception From: Panel on Antiretroviral Guidelines for adults and Adolescents. Guidelines for the use of ARV agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS). January 10, 2011; 1-166. 51 SOP 7: Conduct routine laboratory monitoring Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To conduct routine laboratory monitoring to support timely initiation and monitoring of ART and HIV disease, as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment HIV specialist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers as per national guidelines 3. Laboratory test referral request form if required Procedure Routine laboratory testing facilitates optimum therapeutic effect, rapid identification/confirmation of significant or potentially life threatening side effects and toxicities. However, ART can be initiated and continued without extensive laboratory monitoring if no other options are available. Routine laboratory monitoring should be integrated into routine clinical visits (see SOP 3, 4 and 6). Ensure that each clinical visit includes a routine review of laboratory results received since the last visit and integration of these results into the decision-making process. Routine lab monitoring of immunologic and virologic status of patients on first-line ART is presented in Table 14. Additional lab monitoring to consider include the following: Initial CD4 and at 3 and 6 months, 1 year and 6 monthly thereafter at minimum to monitor immunologic response to ART Viral load, if available at initiation, 6 months, 1 year and then yearly to monitor virologic response to ART If available, order genotyping at baseline and as indicated by national guidelines Hemoglobin at 1 month, 3 months and 4–6 months if on AZT to rule out AZT52 related severe anemia; full blood count if symptoms/signs/labs indicate AST/ALT: If on NVP — at 2, 4 and 12 weeks and if rash or hepatic signs/symptoms develop to identify NVP-related hepatic toxicity If on EFV — at 4 and 12 weeks Creatinine clearance test for all patients, if available, at: Baseline 1 months, every 3–6 months Yearly Conduct creatinine clearance test for all patients on TDF-containing regimen to screen for TDF-related renal toxicity Fasting total cholesterol and triglycerides at baseline and: If baseline is normal: repeat annually If baseline is abnormal: repeat every 6 months If on LPV/r: consider repeating every months Fasting blood glucose at baseline and: If baseline is normal: repeat every 6 months If baseline is abnormal: repeat every 3–6 months If patient is on a PI: repeat every 3–6 months 53 Table 14: Laboratory monitoring before, during and after initiating ART Phase of HIV management Recommended test At HIV diagnosis CD4 Pre-ART CD4 Desirable test HBsAg CD4 Hb for AZT1 Creatinine clearance for TDF2 ALT for NVP3 On ART CD4 Hb for AZT1 Creatinine clearance for TDF2 ALT for NVP3 At clinical failure CD4 Viral load At immunological failure Viral load Women exposed to PMTCT interventions with sd-NVP with a tail within 12 months and without a tail within 6 months of initiating ART Viral load 6 months after initiation of ART At start of ART 1 2 3 Recommended test in patients with high risk of adverse events associated with AZT (low CD4 or low BMI). Recommended test in patients with high risk of adverse events associated with TDF (underlying renal disease, older age group, low BMI, diabetes, hypertension and concomitant use of a boosted PI or nephrotoxic drugs). Recommended test in patients with high risk of adverse events associated with NVP (ART-naive HIV+ women with CD4 of >250 cells/mm 3, HCV coinfection). Patients who are not yet eligible for ART should have CD4 count measurement every six months and more frequently as they approach the threshold to initiate ART. If feasible, HBsAg should be performed in order to identify people with HIV/HBV coinfection and who, therefore, should initiate TDF-containing ART. From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 54 Ongoing Care and Management, Including Treatment Failure Background Chemoprophylaxis CTX prophylaxis (SOP 8) is a well-tolerated, cost-effective and lifesaving intervention for PLHIV. Similarly, INH preventive therapy (SOP 9) is an important intervention for preventing and reducing active TB in communities affected by HIV. INH preventive therapy is safe in people taking ART — safer, in fact, than four-drug TB therapy. INH preventive therapy and CTX prophylaxis should be part of the package of care delivered by HIV service providers for people living with HIV and their families. Management of common symptoms and coinfections (SOPs 10 and 11) Minor signs and symptoms of opportunistic infections are often the first indication of worsening immunologic status, especially in settings where CD4 testing is not available. Patient visits for common HIV-related symptoms create an opportunity to provide symptomatic relief, reassurance and patient education, and help improve quality of life while living with HIV. Increased clinical vigilance to recognize early signs of OIs and initiate timely treatment can prolong life and help improve quality of life in patients with HIV. Recognition of adverse events (SOP 12 and 13) ARV medications can be responsible for a wide range of toxicities. Differentiating between complications of HIV disease and ART toxicity (also known as adverse reactions) is sometimes difficult. Alternative explanations for an observed toxicity could include a concurrent infectious process (e.g. hepatitis A or malaria) or a reaction to medications other than ARVs (e.g. INH-induced hepatitis in a client on treatment for TB or a rash induced by CTX). Drug-related adverse reactions while on ART can occur immediately (soon after the drug has been administered), early (within the first days or weeks of treatment) or late (after months or more of treatment). Adverse reactions can vary in severity from mild to severe to life-threatening and may be specific to the drug or generic to the class of drugs in use. The decision to substitute a new ARV or a new regimen depends on the severity of the adverse reaction. Toxicity can be monitored clinically and can also be assessed by a limited number of laboratory tests — the specific tests depend on the ART regimen in use. Routine monitoring is desirable, but not essential to treatment eligibility. Switching regimens (SOPs 14 and 15) Poor adherence, inadequate drug levels or prior existing drug resistance can all 55 contribute to ART failure. Always assess and address adherence issues, treat any intercurrent infection, and exclude IRIS before switching therapies. Use clinical criteria supported by immunological or virological confirmation, where possible, to identify treatment failure. If CD4 testing is not available, decision-making on switching to a second-line regimen is based on clinical criteria (new stage 3 or stage 4 events). When treatment failure is confirmed, it is necessary to switch to a second-line regimen. This should not be confused with substitution of a single drug because of toxicity. Definitions Prophylaxis for opportunistic infections (OIs): Medication or treatment used to prevent illness. For example, CTX is used to prevent many infections, including PCP. Likewise, INH preventive therapy is used in eligible patients to prevent TB. TB exposure: An individual comes into close contact with an infectious TB patient. The individual may have a positive tuberculin skin test, but a positive tuberculin skin test is not necessary to prove exposure. TB infection: The individual inhales the aerosol droplet containing the TB organism. TB infection is usually indicated by a positive tuberculin skin test; however, there are limitations to the test. Clients with M. tuberculosis infection, but without active disease, are not ill and do not have symptoms suspicious of TB. Treatment failure, failure to suppress viral replication with development of viral resistance, can be clinical, immunologic or virologic. WHO defines treatment failure as: Clinical failure: New or recurrent WHO stage 4 condition Certain WHO clinical stage 3 infections (e.g. pulmonary TB, severe bacterial infection) after differentiating from IRIS Immunologic failure: Fall of CD4 count to baseline or below 50% fall from on-treatment peak value Persistent CD4 levels below 100 cells/mm Virologic failure: Plasma viral load above 5000 copies/ml (repeated) after 6 months on ART First line therapy: The ARV combination given at the beginning of treatment to an individual who has never been treated previously for HIV. Second line therapy: This refers to the combination of ARVs prescribed for a person after the first line therapy fails (clinical and/or immunological progression of disease despite good adherence to an effective ARV regimen. Second line therapy will ideally include a minimum of three new drugs, with at least one from a new class, 56 in order to increase the likelihood of treatment success. Policy 1. Individuals and families should be referred to other health services or community services as needed. Care should be coordinated as much as possible in order to reduce the burden of visits. 2. A chronic care model should be utilized so that patients and their families are seen regularly and routinely for monitoring and health promotion activities as well as seen for episodic care in the event of acute illness. 3. A multidisciplinary team approach should be utilized for the care of clients with HIV. Teams may include a nurse, prescribing clinician, pharmacist, counselor, social worker or others Responsibility at health facility A single individual should be assigned at each health facility to establish and supervise HIV care and treatment, including prescribing of ARVs and CTX; ensure all services meet or exceed national policies, practices and guidelines; and to conduct quality assurance measures. ART, CTX prophylaxis and other drugs should be prescribed by a physician, medical or clinical officer or a nurse with training in HIV. Where possible this individual should have the support of a multidisciplinary team that includes health workers that provide counseling and support (which may be a nurse, counselor, social worker, peer educator, or another trained professional) and pharmacist who is responsible for dispensing medications. In health facilities staffed by a single professional, that individual should be trained in HIV and able to fill all roles. 57 SOP 8: Provide CTX prophylaxis Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To decrease morbidity and mortality from common opportunistic diseases by providing adults with CTX prophylaxis as part of an integrated HIV service package. Introduction CTX is effective in preventing bacterial pneumonia, salmonella bacteremia, pneumocystis jiroveci pneumonia (PCP), diarrhea (salmonella, cyclospora, isospora), toxoplasmosis, and malaria. Evidence from resource-limited settings has shown that CTX can reduce hospitalization, morbidity and mortality among people living with HIV, regardless of whether or not they are on ART. CTX prophylaxis should be initiated as soon as possible if CD4 count is less than 350 cells/mm; or if patient is in WHO Stage 2, Stage 3, Stage 4 disease (regardless of CD4 count); or at first adherence visit. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Pharmacist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. CTX, ARV medications, multivitamins 58 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure Review and update medical history including current HIV, non-HIV and traditional medications, previous use of sulfa drugs, kidney or liver disease, previous reaction to sulfa drugs. Determine if there is a documented past allergic reaction to sulfa drugs, including Fansidar and CTX (CTX is also referred to as trimethoprim and sulfamethoxazole, Septra, and Bactrim). Review lab results including most recent CD4 level. Order complete blood count as baseline. Conduct directed physical examination to identify signs of OIs or other HIV-related infections; provide or refer for treatment, if required. Review or explain concept of opportunistic infections and benefits of CTX prophylaxis to patient. Review signs and symptoms of sulfa allergy (maculopapular rash or severe skin sloughing (Stevens Johnson Syndrome), anemia, fever, hepatitis. Explain importance of discontinuing or interrupting CTX if allergic response occurs. If no history of sulfa allergy or other contraindications, start CTX 160/800 mg once daily (two single strength or one double strength tablet) at first adherence visit or as soon as possible following HIV diagnosis in: All HIV positive adults with CD4 count below 350 (or as per national guidelines) All symptomatic HIV positive adults, that is patients with WHO Stage 2, Stage 3, Stage 4 disease, regardless of CD4 count Patients with HIV/TB coinfection regardless of CD4 count, at least for duration of TB treatment All pregnant women with HIV unless CD4 is greater than 350 and asymptomatic Do not give both CTX as prophylaxis and sulfadoxine-pyrimethamine (Fansidar) malaria prophylaxis simultaneously If sulfa allergy is confirmed, substitute Dapsone 100 mg daily if available and according to national protocol. Discontinue CTX prophylaxis if: ART therapy is initiated and CD4 level rises above 350 and remains high for 2 consecutive visits at least 6 months apart Serious side effects or signs of sulfa allergy occur If concurrent ART causes severe hepatic or renal insufficiency 59 Grade 4 hypersensitivity reaction See Table 16 Schedule routine three or six monthly follow-up: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable Table 15: Initiation of CTX prophylaxis among adults and adolescents living with HIV Based on who clinical staging criteria alone (when CD4 count is not available) WHO clinical stage 2, 3 or 4 [A-I] Based on who clinical staging and CD4cellcount criteria Any WHO clinical stage and CD4< 350 cells per mm3 b [A-III] OR WHO clinical stage 3 or 4 irrespective of CD4 level [A-I] Universal option: Countries may choose to adopt universal CTX for everyone living with HIV and any CD4 count or clinical stage. This strategy may be considered in settings with high prevalence of HIV and limited health infrastructure [C-III]. From: World Health Organization, Department of HIV/AIDS. Guidelines on Co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. Geneva 2006. 60 Table 16: Summary of recommendations for discontinuing primary CTX among adults and adolescents Target population Recommendations Do not discontinue CTX prophylaxis, particularly in settings where bacterial infections and malaria are common HIVrelated events [A-IV] CD4 testing not available (clinical assessment only) Adults and adolescents living with HIV Consider discontinuing CTX prophylaxis among people with evidence of good clinical response to ART (absence of clinical symptoms after at least one year of therapy), good adherence and secure access to ART [C-IV] In countries where CTX prophylaxis is recommended only for preventing PCP and toxoplasmosis, it can be discontinued among those with evidence of immune recovery in response to ART (CD4 >200 cells per mm3 CD4 testing available (clinical after at least six months of ART) [B-I] and immunological In countries with a high incidence of bacterial assessment) infections and malaria, discontinue CTX prophylaxis among people with evidence of immune recovery related to ART (CD4 >350 cells per mm3 after at least six months of ART) [C-IV] From: World Health Organization, Department of HIV/AIDS. Guidelines on Co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. Geneva 2006. When adapting these SOPs, this table should be replaced by a similar table from the national guidelines. 61 Table 17: CTX toxicity grading scale for adults and adolescents Toxicity Clinical description Recommendation Erythema Continue CTX prophylaxis with careful and repeated observation and follow-up. Provide symptomatic treatment, such as antihistamines, if available Diffuse maculopapular rash, dry desquamation Continue CTX prophylaxis with careful and repeated observation and follow-up. Provide symptomatic treatment, such as antihistamines, if available GRADE 3 Vesiculation, mucosal ulceration CTX should be discontinued until the adverse effect has completely resolved (usually two weeks), and then reintroduction or desensitization can be considered GRADE 4 Exfoliative dermatitis, StevensJohnson syndrome or erythema multiforme, moist desquamation CTX should be permanently discontinued GRADE 1 GRADE 2 From: World Health Organization, Department of HIV/AIDS. Guidelines on Co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. Geneva 2006. 62 SOP 9: Provide INH preventive therapy Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To decrease morbidity and mortality from TB by providing adults with INH preventive therapy as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Pharmacist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (INH, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. INH, pyridoxine, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure 9.1 All HIV-infected clients are eligible for INH preventive therapy unless contraindicated. Screen all HIV positive clients for active TB disease or INH preventive therapy eligibility at every clinic visit Rule out active TB disease according to national TB/HIV protocol. If active TB disease diagnosed, refer on-site or to closest source of TB treatment, 63 document referral. See Figure 2, below. Note: All healthcare facilities must have in place infection control measures to prevent transmission of TB in the healthcare setting (See Table 19). 9.2 If there is no indication of active TB, determine INH preventive therapy eligibility and dispense Order baseline lab tests including full blood count, LFTs (bilirubin, ALT/AST) if available. Review benefits of INH preventive therapy with patient and reinforce need for adherence. Discuss side effects of INH including anorexia, nausea, abdominal or joint pain. Suggest taking INH at night to minimize side effects. Explain need to stop taking INH and return to clinic promptly if serious side effects occur (severe itching or skin rash, dizziness, confusion, convulsions, vomiting, jaundice, dark color urine, or icterus). Advise patients who drink alcohol to stop or reduce intake while on INH preventive therapy and provide rationale. Dispense or prescribe: INH 300 mg daily for 6–9 months either self-administered or DOT according to HIV/TB national protocol Pyridoxine 50 mg daily to avert peripheral neuropathy often associated with INH treatment; increase to 100 mg daily if neuropathy persists Use caution and routinely monitor if administering INH with d4T or ddI due to increased risk of peripheral neuropathy. Schedule monthly monitoring and medication resupply visit. Refer for additional adherence counseling or community follow up if indicated. See Figure 3, below. 9.3 Complete INH preventive therapy treatment course (6–9 months) Congratulate patient on successful adherence and INH preventive therapy completion. Continue to screen for active TB disease at every clinic visit. If active TB disease diagnosed, refer on-site or to closest source of TB treatment; document referral. Conduct routine clinical visit as per SOP 3 or SOP 4. 64 At all TB-related visits: Schedule routine follow-up (monthly if still on INH preventive therapy): Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings and discussions in patient record, including date INH was started Enter date INH was started in adherence follow-up book Complete all relevant as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 65 Figure 2: Algorithm for diagnosis of TB in ambulatory HIV-positive patient Ambulatory patient with cough 2–3 weeks and no danger signs st 1 Visit AFB HIV test HIV+ or status unknown AFB-positive AFB-negative 2 nd Visit Treat for TB CPT HIV assessment TB likely CXR Sputnum AFB and culture Clinical assessment TB unlikely rd 3 Visit Treat for PCP HIV assessment th 4 Visit Response Treat for bacterial infection HIV assessment CPT No or partial response TB unlikely Reassess for TB From: Phase 1 Toolkit: Understanding the Revised WHO Recommendations and Supporting Their Adaptation into National Guidelines Elizabeth Glaser Pediatric AIDS foundation (EGPAF). Washington, DC (May 2010). 66 Figure 3: Algorithm for TB screening in adults and adolescents living with HIV in HIV-prevalent and resource-constrained settings Adults and adolescents living with HIV* Screen for TB with any one of the following symptoms:** Current cough Fever Weight loss Night sweats NO Assess for contraindications to INH preventive therapy*** NO Give INH preventive therapy YES Defer INH preventive therapy YES Investigate for TB and other diseases**** Other diagnosis Not TB TB Treat and consider INH preventive therapy Follow up and consider INH preventive therapy Treat for TB Screen for TB regularly at each encounter with a health worker or visit to a health facility Footnotes * Every adult and adolescent should be evaluated for eligibility to receive ART. Infection control measures should be prioritized to reduce M. tuberculosis transmission in all settings that provide care. ** Chest radiography can be done if available, but is not required to classify patients into TB and nonTB groups. In high HIV-prevalence settings with a high TB prevalence among people living with HIV (e.g. greater than 10%), strong consideration must be given to adding other sensitive investigations. *** Contraindications include: active hepatitis (acute or chronic), regular and heavy alcohol consumption, and symptoms of peripheral neuropathy. Past history of TB and current pregnancy should not be contraindications for starting INH preventive therapy. Although not a requirement for initiating INH preventive therapy, tuberculin skin test may be done as a part of eligibility screening in some settings. **** Investigations for TB should be done in accordance with existing national guidelines. From : WHO, Dept of HIV/AIDS. Guidelines for intensified tuberculosis case finding and isoniazid preventive therapy for people living with HIV in resource constrained settings. World Health Organization. 2011 67 SOP 10: Management of common symptoms and complications of HIV Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To manage the common symptoms and complications of HIV and AIDS experienced by adults with HIV, as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. Essential medications to treat HIV-related illnesses according to national formulary, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure Review patient records and progression of clinical and laboratory findings since HIV diagnosis. Conduct directed medical history focused on patient-perceived changes in health status, and signs and symptoms of possible HIV-related illnesses. Common signs and symptoms of possible HIV-related illnesses include: 68 Weight loss/wasting, fever, persistent generalized lymphadenopathy, persistent cough, anemia, diarrhea, rash, dermatitis, pruritis, lesions, white exudates either oral, pharyngeal, esophageal or vaginal, headache or other persistent pain, neuropathy, altered mental status, anorexia, depression Discuss with patient any possible medication side effects or toxicities. See SOP 12. Determine or update WHO Stage of HIV disease. Based on history and exam, conduct or order appropriate laboratory tests to assist in identification of HIV-related illnesses including: Complete blood count and hemoglobin, blood glucose, serum creatinine, ALT/AST, TB and STI screen, sputum for AFB, stool culture or blood culture, microscopy or culture to identify fungal organisms Treat symptomatically or with appropriate medication according to national protocol. Explain diagnosis and treatment regimen to patient and family, if present. Reassure about probable resolution of symptoms with treatment. Consult with team members either in the clinic or at a distance if difficult diagnostic profile. As with any routine and non-routine visit: re-assess for social issues that could negatively influence adherence; provide counseling and take-home leaflets in response to emerging needs (see SOP 21); inquire about partner, children and other family members; review importance of clinic visit schedule and set date/time for next appointment. Annual physical examination In addition to the directed physical exam at every follow-up visit (to identify/confirm signs and symptoms of possible HIV-related illnesses), all patients should be provided with a complete physical examination yearly. Schedule next clinic visit to assess resolution of symptoms: Advise sooner return to clinic if signs and symptoms do not resolve or reoccur Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable For additional information: See Table 18. The large number of signs and symptoms of complications according to WHO clinical staging and the details involved in recognizing and 69 managing them, make it easier to present the information in tables rather than narrative text. Country-specific modifications in treatment recommendations will be required to reflect individual national guidelines Appendices Appendix B: Clinical algorithms Table 18: Diagnostic criteria for staging of HIV-related clinical events Clinical event Clinical stage 1 Clinical diagnosis Definitive diagnosis Asymptomatic No HIV-related symptoms reported and no signs on examination Not applicable Persistent generalized lymphadenopathy Painless enlarged lymph nodes >1 cm, in two or more noncontiguous sites (excluding inguinal), in absence of known cause and persisting for 3 months or longer Histology Clinical stage 2 Moderate unexplained weight loss (under 10% of body weight) Reported unexplained weight loss. In pregnancy, failure to gain weight Documented weight loss (under 10% of body weight) Recurrent bacterial upper respiratory tract infections (current event plus one or more in last 6 months) Symptoms complex, e.g. unilateral face pain with nasal discharge (sinusitis), painful inflamed eardrum (otitis media), or tonsillopharyngitis without features of viral infection (e.g. coryza, cough) Laboratory studies if available, e.g. culture of suitable body fluid Herpes zoster Painful vesicular rash in dermatomal distribution of a nerve supply does not cross midline Clinical diagnosis Angular cheilitis Splits or cracks at the angle of the mouth not attributable to iron or vitamin deficiency, and usually responding to antifungal treatment Clinical diagnosis Recurrent oral ulcerations (two or more episodes in last 6 months) Aphthous ulceration, typically painful with a halo of inflammation and a yellow-grey pseudo membrane Clinical diagnosis Papular pruritic eruption Papular pruritic lesions, often with marked post inflammatory pigmentation Clinical diagnosis Seborrhoeic dermatitis Itchy scaly skin condition, particularly affecting hairy areas (scalp, axillae, upper trunk and groin) Clinical diagnosis Fungal nail infections Paronychia (painful red and swollen nail bed) or onycholysis (separation of nail from Fungal culture of nail / nail plate material 70 Clinical event Clinical diagnosis nail bed) of the fingernails (white discoloration, especially involving proximal part of nail plate, with thickening and separation of nail from nail bed) Definitive diagnosis Clinical stage 3 Severe unexplained weight loss (more than 10% of body weight) Unexplained chronic diarrhea for longer than 1 month Unexplained persistent fever (intermittent or constant and lasting for longer than 1 month) Reported unexplained weight loss (over 10% of body weight) and visible thinning of face, waist and extremities with obvious wasting or body mass index below 18.5. In pregnancy, weight loss may be masked. Documented loss of more than 10% of body weight Chronic diarrhea (loose or watery stools three or more times daily) reported for longer than 1 month Not required but confirmed if three or more stools observed and documented as unformed, and two or more stool tests reveal no pathogens Reports of fever or night sweats for more than 1 month, either intermittent or constant with reported lack of response to antibiotics or anti malarials, without other obvious foci of disease reported or found on examination. Malaria must be excluded in malarious areas. Documented fever exceeding 37.6oC with negative blood culture, negative Ziehl-Nielsen stain, negative malaria slide, normal or unchanged CXR and no other obvious focus of infection Oral candidiasis Persistent or recurring creamy white curdlike plaques which can be scraped off (pseudo membranous), or red patches on tongue, palate or lining of mouth, usually painful or tender (erythematous form) Clinical diagnosis Oral hairy leukoplakia Fine white small linear or corrugated lesions on lateral borders of the tongue, which do not scrape off Clinical diagnosis Pulmonary TB Chronic symptoms (lasting at least 2 to 3 weeks): cough, haemoptysis, shortness of breath, chest pain, weight loss, fever, night sweats, plus EITHER positive sputum smear OR negative sputum smear AND compatible chest radiograph (including but not restricted to upper lobe infiltrates, cavitation, pulmonary fibrosis and shrinkage). No evidence of extra pulmonary disease. Isolation of M. tuberculosis on sputum culture or histology of lung biopsy (together with compatible symptoms) Severe bacterial infection (e.g. Fever accompanied by specific symptoms or signs that localize infection, and Isolation of bacteria from appropriate clinical 71 Clinical event pneumonia, meningitis, empyema, pyomyositis, bone or joint infection, bacteraemia, severe pelvic inflammatory disease) Clinical diagnosis response to appropriate antibiotic Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis Severe pain, ulcerated gingival papillae, loosening of teeth, spontaneous bleeding, bad odor, rapid loss of bone and/or soft tissue Clinical diagnosis No presumptive clinical diagnosis Diagnosed on laboratory testing and not explained by other non-HIV conditions. Not responding to standard therapy with haematinics, anti malarials or anthelmintics as outlined in relevant national treatment guidelines, WHO IMCI guidelines or other relevant guidelines. Unexplained anaemia (below 8g/dl), neutropenia (below 0.5 x 109/l) and/or chronic (more than 1 month) thrombocytopenia (under 50 x 109/l) Definitive diagnosis specimens (usually sterile sites) Clinical stage 4 HIV wasting syndrome Reported unexplained weight loss (over 10% of body weight) with obvious wasting or body mass index below 18.5, plus EITHER unexplained chronic diarrhea (loose or watery stools three or more times daily) reported for longer than 1 month OR reports of fever or night sweats for more than 1 month without other cause and lack of response to antibiotics or anti malarials. Malaria must be excluded in malarious areas. Documented weight loss (over 10% of body weight) plus two or more unformed stools negative for pathogens OR documented temperature exceeding 37.6°C with no other cause of disease, negative blood culture, negative malaria slide and normal or unchanged CXR Pneumocystis pneumonia Dyspnoea on exertion or nonproductive cough of recent onset (within the past 3 months), tachypnoea and fever; AND CXR evidence of diffuse bilateral interstitial infiltrates, AND no evidence of bacterial pneumonia. Bilateral crepitations on auscultation with or without reduced air entry. Cytology or immunofluorescent microscopy of induced sputum or bronchoalveolar lavage (BAL), or histology of lung tissue Recurrent bacterial Current episode plus one or more episodes Positive culture or 72 Clinical event pneumonia (this episode plus one or more episodes in last 6 months) Clinical diagnosis in last 6 months. Acute onset (under 2 weeks) of symptoms (e.g. fever, cough, dyspnoea, and chest pain) PLUS new consolidation on clinical examination or CXR. Response to antibiotics. Definitive diagnosis antigen test of a compatible organism Chronic herpes simplex virus (HSV) infection (orolabial, genital or anorectal) of more than 1 month, or visceral at any site or any duration Painful, progressive anogenital or orolabial ulceration; lesions caused by recurrent HSV infection and reported for more than one month. History of previous episodes. Visceral HSV requires definitive diagnosis. Positive culture or DNA (by PCR) of HSV or compatible cytology/histology Oesophageal candidiasis Recent onset of retrosternal pain or difficulty in swallowing (food and fluids) together with oral candidiasis Macroscopic appearance at endoscopy or bronchoscopy, or by microscopy/histology Extra pulmonary TB Systemic illness (e.g. fever, night sweats, weakness and weight loss). Other evidence for extra pulmonary or disseminated TB varies by site: pleural, pericardial, peritoneal involvement, meningitis, mediastinal or abdominal lymphadenopathy, osteitis. Miliary TB: diffuse uniformly distributed small miliary shadows or micro nodules on CXR. Discrete cervical lymph node M. TB infection is usually considered a less severe form of extra pulmonary TB. M. tuberculosis isolation or compatible histology from appropriate site, together with compatible symptoms/ signs (if culture/ histology is from respiratory specimen there must be other evidence of extra pulmonary disease) Typical appearance in skin or oropharynx of persistent, initially flat patches with a pink or blood-bruise color, skin lesions that usually develop into violaceous plaques or nodules Macroscopic appearance at endoscopy or bronchoscopy, or by histology Cytomegalovirus disease (retinitis or infection of other organs, excluding liver, spleen and lymph nodes) Retinitis only: may be diagnosed by experienced clinicians. Typical eye lesions on fundoscopic examination: discrete patches of retinal whitening with distinct borders, spreading centrifugally, often following blood vessels, associated with retinal vasculitis, haemorrhage and necrosis. Compatible histology or CMV demonstrated in CSF by culture or DNA (by PCR) CNS toxoplasmosis Recent onset of a focal neurological abnormality or reduced level of consciousness AND response within 10 days to specific therapy. Positive serum toxoplasma antibody AND (if available) single/multiple Kaposi sarcoma 73 Clinical event Clinical diagnosis Definitive diagnosis intracranial mass lesion on neuroimaging (CT or MRI) HIV encephalopathy Clinical finding of disabling cognitive and/or motor dysfunction interfering with activities of daily living, progressing over weeks or months in the absence of a concurrent illness or condition, other than HIV infection, which might explain the findings Diagnosis of exclusion, and, if available, neuroimaging (CT or MRI) Extra pulmonary cryptococcosis (including meningitis) Meningitis: usually sub-acute, fever with increasingly severe headache, meningism, confusion, behavioral changes that respond to cryptococcal therapy Isolation of Cryptococcus neoformans from extra pulmonary site or positive cryptococcal antigen test on CSF/blood From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 74 SOP 11: Management of common HIV-associated coinfections Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To manage common HIV-associated opportunistic infections and coinfections experienced by adults with HIV, as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment HIV Specialist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. Essential medications to treat opportunistic infections and coinfections according to national formulary, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure 11.1 Overview of procedure for most HIV-associated opportunistic infections and coinfections Review patient records and progression of clinical and laboratory findings since HIV diagnosis to identify previous coinfections. 75 Conduct directed medical history focused on patient-perceived changes in health status, and signs and symptoms of possible coinfections. Conduct directed physical exam to identify/confirm signs and symptoms of possible coinfections. Determine or update WHO Stage of HIV disease. Based on history and exam, conduct or order appropriate laboratory tests to assist in identification of coinfection including: Complete blood count and hemoglobin, liver function and renal function blood tests, CXR, sputum for AFB and culture, TB screen Treat with appropriate medication according to national protocol, or refer if required. For Hepatitis see 10.2, below; for TB, see 10.3, below. Explain diagnosis and treatment regimen to patient and family, if present. Reassure about probable resolution with treatment. Consult with additional clinical staff if difficult diagnostic profile. As with any routine and non-routine visit: re-assess for social issues that could negatively influence adherence; provide counseling and take-home leaflets in response to emerging needs (see SOP 21); inquire about partner, children and other family members; review importance of clinic visit schedule and set date/time for next appointment. Two of the most common coinfections are TB/HIV and Hepatitis B/HIV. 11.2 Hepatitis B/HIV coinfection If patient has Hepatitis B/HIV coinfection and requires treatment for their Hepatitis B regardless of CD4 cell count or WHO HIV clinical stage, s/he should be initiated on a regimen containing both Tenofovir (TDF) and lamivudine (3TC) except in case of severe side effects. TDF 300 mg QD + 3TC 150 mg twice a day + EFV 600 mg QD Monitor AST/ALT closely — TDF has been associated with life-threatening flare-ups of hepatitis. 11.3 TB/HIV coinfection Among people living with HIV, TB is the most frequent life-threatening opportunistic infection and a leading cause of death. At every clinical encounter, implement the three I's strategy to prevent, detect and treat TB/HIV confection: INH preventive therapy where indicated Intensified case finding (ICF) for active TB TB infection control: TB infection control for facilities is summarized in Table 19, 76 below Refer for household and contact tracing for TB (assess family members, neighbors, household). All visits Schedule next clinic visit: Advise sooner return to clinic if signs and symptoms do not resolve or reoccur Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable Appendices Appendix B: Clinical algorithms 77 Table 19: Measures for facility-level TB infection control Facility-level measures 1. Implement the set of facility-level managerial activities: a) Identify and strengthen local coordinating bodies for TB infection control, and develop a facility plan (including human resources, and policies and procedures to ensure proper implementation of the controls listed below) for implementation. b) Rethink the use of available spaces and consider renovation of existing facilities or construction of new ones to optimize implementation of controls. c) Conduct on-site surveillance of TB disease among health workers and assess the facility. d) Address advocacy, communication and social mobilization for health workers, patients and visitors. e) Monitor and evaluate the set of TB infection control measures. f) Participate in research efforts. Administrative controlsa 2. Promptly identify people with TB symptoms (triage), separate infectious patients, control the spread of pathogens (cough etiquette and respiratory hygiene) and minimize time spent in health-care facilities. 3. Provide a package of prevention and care interventions for health workers, including HIV prevention, ART and INH preventive therapy for HIV-positive health workers. Environmental controls 4. Use ventilation systems. 5. Use ultraviolet germicidal irradiation (UVGI) fixtures, at least when adequate ventilation cannot be achieved. Personal protective equipment 6. Use particulate respirators. a Administrative controls include (in addition to the items listed above) reduction of diagnostic delays, use of rapid diagnostic tests, reduction of turnaround time for sputum testing and culture, and prompt initiation of treatment. From: WHO policy on TB infection control in health-care facilities, congregate settings and households, 2009 78 SOP 12: Recognition of adverse events and ART toxicity Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To recognize early and manage side effects, adverse events and ART toxicity in adults with HIV as part of pharmacologic vigilance in an integrated HIV service package. Introduction Pharmacovigilance — a key element of ART monitoring — is to prevent, identify, address and report adverse events or other possible drug-related problems to maximize adherence, patient safety and health outcomes (WHO 2010). Extreme watchfulness is important during the first six months of ART, especially in patients started on ART when already seriously immuno-compromised. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Pharmacist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (adverse event register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. CTX, INH, pyridoxine, medications for symptomatic management of drug side effects, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required 79 Procedure 12.1 Recognize early and manage side effects, adverse events and ART toxicity Review patient records and progression of clinical and laboratory findings since HIV since HIV diagnosis. Conduct directed medical history focused on experience with ART and other HIV, non-HIV and traditional medications since last visit, patient-perceived changes in health status, symptoms of possible side effects or toxicities, and adherence. Discuss patient concerns about treatment, health status or other events since last visit. Conduct directed physical exam to identify/confirm signs and symptoms of possible side effects or toxicities, and adherence. Identify physical signs of lipodystrophy. Based on history and exam, conduct or order appropriate laboratory tests to confirm suspicion of medication side effect, adverse event or toxicity. If HIV medication-related problem confirmed, classify severity of side effect, adverse event or toxicity. If symptoms are mild Grade 1: headache, mild gastric upset, appetite or sleep changes, fatigue: Reassure patient, provide medications for symptomatic relief, suggest return visit within 1–2 weeks to reassess symptoms Do not discontinue medications If symptoms are moderate to severe, Grade 2: nausea and vomiting, severe headache, mild peripheral neuropathy: Treat with appropriate medications (antiemetics, antidiarrheals, analgesics, neuroleptics) as per national protocol or refer for appropriate care if required, suggest reasonable return visit date to reassess symptoms Do not discontinue medications If symptoms are severe Grade 3–4: severe anemia, dehydration due to severe vomiting, lactic acidosis, serious skin eruptions, severe headaches, severe hepatic or renal changes, pancreatitis, lipodystrophy, insulin resistance: Review drug regimen, discontinue current medication(s) as indicated and determine drug regimen change required according to national protocol and availability, in consultation with HIV specialist if appropriate If ARVs are being discontinued, discontinue all medications in regimen to avoid resistance related to single-drug interruption with the exception of NNRTIs Refer for additional treatment and care if required See Tables 20, 21, 22 and 23, below. 80 Severe anemia and lactic acidosis require drug modification/discontinuation and hospital admission. Review with patient — and family, if present — any therapeutic changes made, changes in dosage or timing of administration. Provide or refer for additional adherence or other counseling if required. As with any routine and non-routine visit: re-assess for social issues that could negatively influence adherence; provide counseling and take-home leaflets in response to emerging needs (see SOP 21); inquire about partner, children and other family members; review importance of clinic visit schedule and set date/time for next appointment. Schedule repeat visit within 1–2 weeks to reassess effect of medical intervention or regimen change: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings and discussions in patient record Complete all relevant registers (HIV client register, ARV, follow-up/default register, etc) as per national guidelines If appropriate, complete ART adverse event register and national forms for upward adverse event reporting (see 11.2, below) Complete paperwork for laboratory tests or other referrals, if applicable 12.2 Record adverse events in a central register Record in an adverse event register (or other clinic record) individual patient events severe enough to result in: Change in therapy Cessation of ART Significant disability or death Include in the register: Age and sex of patient Drug history including date drug was started and the date adverse events started Drug suspected of causing toxicity Type and severity of adverse reaction 81 And outcome of treatment change(s) instituted Report and discuss with ministry of health officials at next supervisory visit, or according to national protocol. Modify clinic procedures if required. If a HIV Specialist Review Committee is available, report confirmed severe adverse events and drug toxicities and clinical management to the Review Committee and upward authorities according to national protocol. Ensure that reporting of adverse events is included as part of supportive supervision or other clinic performance improvement activities. Table 20: Grading of selected clinical and laboratory toxicities Mild Grade 1 Estimating Severity Grade Clinical adverse Symptoms causing event NOT identified no or minimal elsewhere in the interference with table usual social and functional activities Haemoglobin Absolute neutrophil count Platelets Hyperglycaemia (nonfasting and no prior diabetes) Triglycerides Creatinine AST (SGOT) ALT (SGPT) Severe Grade 3 Potentially LifeThreatening Grade 4 Symptoms causing greater than minimal interference with usual social and functional activities Symptoms causing inability to perform usual social and functional activities 7.0−7.9 g/dl OR 70−79 g/l OR 4.31−4.92 mmol/l 750−999/mm3 OR 0.75−0.99/G/l* 50000−74999/mm3 OR 50−74.9/G/l* 6.5−6.9 g/dl OR 65−69 g/l OR 4.03−4.30 mmol/l 500−749/mm3 OR 0.5− 0.749/G/l* 20000−49999/ mm3 OR 20−49.9/ G/l* >1.5−2.5 x ULN 126−250 mg/dl >2.5−5 x ULN 251−500mg/dl >5 x ULN >500 mg/dl 55−64 mg/dl OR 3.01−3.55 mmol/l 116−160 mg/dl OR 6.44−8.90 mmol/l 40−54 mg/dl OR 2.19−3.00 mmol/l 161−250 mg/dl OR 8.91−13.88 mmol/l 30−39 mg/dl OR 1.67−2.18 mmol/l 251−500 mg/dl OR 13.89−27.76 mmol/l <30 mg/dl OR <1.67 mmol/l >500 mg/dl OR >27.76 mmol/l − 400−750 mg/dl OR 4.52−8.47 mmol/l >1.5−3.0 x ULN >2.5−5.0 x ULN >2.5−5.0 x ULN 751−1200 mg/dl OR 8.48−13.55 mmol/l >3.0−6.0 x ULN >5.0−10.0 x ULN >5.0−10.0 x ULN >1200 mg/dl OR >13.55 mmol/l >6.0 x ULN >10.0 x ULN >10.0 x ULN 8.0−9.4 g/dl OR 80−94 g/l OR 4.93−5.83 mmol/l 1000−1500/mm 3 OR 1.0−1.5/G/l* 75000–99000/mm3 OR 75−99/G/l* Chemistries Hyperbilirubinaemia >1.0−1.5 x ULN Glucose (fasting) 110−125 mg/dl Hypoglycaemia Moderate Grade 2 >1.0−1.5 x ULN 1.25−2.5 x ULN 1.25−2.5 x ULN Symptoms causing inability to perform basic self-care OR medical or operative intervention indicated to prevent permanent impairment, persistent disability or death <6.5 g/dl OR <65 g/l OR <4.03 mmol/l <500/mm3 OR <0.5/G/l* <20000/mm 3 OR <20/G/l* 82 Gamma-glutamyl transpeptidase (GGT) Alkaline phosphatase Bilirubin Amylase Pancreatic amylase Lactate Gastrointestinal Nausea Mild Grade 1 1.25−2.5 x ULN Moderate Grade 2 >2.5−5.0 x ULN Severe Grade 3 >5.0−10.0 x ULN Potentially LifeThreatening Grade 4 >10.0 x ULN 1.25−2.5 x ULN >2.5−5.0 x ULN >5.0−10.0 x ULN >10.0 x ULN 1.1−1.5 X ULN >1.0−1.5 x ULN >1.0−1.5 x ULN <2.0 x ULN without acidosis 1.6−2.5 x ULN >1.5−2.0 x ULN >1.5−2.0 x ULN >2.0 x ULN without acidosis 2.6−5.0 x ULN >2.0−5.0 x ULN >2.0−5.0 x ULN Increased lactate with pH <7.3 without life-threatening consequences >5 x ULN >5.0 x ULN >5.0 x ULN Increased lactate with pH <7.3 with life-threatening consequences Mild OR transient; reasonable intake maintained Moderate discomfort OR intake decreased for <3 days Moderate OR persistent; 4−5 episodes per day OR vomiting lasting >1 week Severe discomfort OR minimal intake for >3 days Hospitalization required Vomiting Mild OR transient; 2−3 episodes per day OR mild vomiting lasting <1 week Severe vomiting of all foods/fluids in 24 hours OR orthostatic hypotension OR intravenous Rx required Moderate OR Bloody diarrhea OR persistent; 5−7 orthostatic loose stools per day hypotension OR >7 OR diarrhea lasting loose stools/day OR >1 week intravenous Rx required Hypotensive shock OR hospitalization for intravenous Rx required Diarrhoea Mild OR transient; 3−4 loose stools per day OR mild diarrhea lasting <1 week Dyspnoea on exertion Dyspnoea with normal activity Dyspnoea at rest Dyspnoea requiring O2 therapy 2+ or 3+ 1 g to 2 g loss/ day OR 0.3% to 1.0% OR 3 g to 10 g/l Gross, no clots 4+ 2 g to 3.5 g loss/day OR >1.0% OR >10 g/l Gross plus clots Nephrotic syndrome Nephrotic syndrome OR >3.5 g loss/day Gross haematuria 1+ 200 mg to 1 g loss/ day OR <0.3% OR <3 g/l Microscopic only Miscellaneous Fever (oral, >12 hours) 37.7−38.5 0C OR 100.0−101.5 0F 38.6−39.5 0C OR 101.6−102.9 0F 39.6−40.5 0C OR 103−105 0F >40.5 0C OR >105 0F for ≥12 continuous hours Intractable Respiratory Dyspnoea Urinalysis Proteinuria Spot urine 24-hour urine Mild; no Rx required Moderate OR nonnarcotic analgesia Rx Severe OR responds to initial narcotic Rx Hypotensive shock OR hospitalization required Obstructive 83 Allergic reaction Mild Grade 1 Pruritus without rash Rash hypersensitivity Erythema, pruritus Fatigue Normal activity reduced by <25% Moderate Grade 2 Localized urticaria Severe Grade 3 Generalized urticaria, angioedema Diffuse Vesiculation OR maculopapular rash moist desquamation OR dry OR ulceration desquamation Potentially LifeThreatening Grade 4 Anaphylaxis ANY ONE OF: mucous membrane involvement, suspected StevensJohnson (TEN), erythema multiforme, exfoliative dermatitis Unable to care for self Normal activity Normal activity reduced by 25−50% reduced by >50%; cannot work From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. NOTE: There is a Grade 5 toxicity, which is death. For abnormalities not found elsewhere in the toxicity table, use the information on Estimating severity grade in the first column. 84 Table 21: Toxicities and recommended drug substitutions ARV drug TDF AZT EFV NVP ATV/r Common associated toxicity Asthenia, headache, diarrhea, nausea, vomiting, flatulence Renal insufficiency, Fanconi syndrome Osteomalacia Decrease in bone mineral density Severe acute exacerbation of hepatitis may occur in HBV-coinfected patients who discontinue TDF Bone marrow suppression: macrocytic anaemia or neutropaenia Gastrointestinal intolerance, headache, insomnia, asthenia Skin and nail pigmentation Lactic acidosis with hepatic steatosis Hypersensitivity reaction Stevens-Johnson syndrome Rash Hepatic toxicity Persistent and severe CNS toxicity (depression, confusion) Hyperlipidaemia Male gynaecomastia Potential teratogenicity (first trimester of pregnancy or women not using adequate contraception) Hypersensitivity reaction Stevens-Johnson syndrome Rash Hepatic toxicity Hyperlipidaemia Indirect hyperbilirubinaemia Clinical jaundice Prolonged PR interval — first degree symptomatic AV block in some patients Hyperglycaemia Fat maldistribution Possible increased bleeding episodes in individuals with haemophilia Suggested substitute If used in first-line therapy AZT (or d4T if no other choice) If used in second-line therapy Within a public health approach, there is no option if patient has failed AZT/d4T in firstline therapy. If feasible, consider referral to a higher level of care where individualized therapy may be available If used in first-line therapy TDF (or d4T if no other choice) If used in second-line therapy d4T NVP bPI if intolerant to both NNRTIs Triple NRTI if no other choice EFV bPI if intolerant to both NNRTIs Triple NRTI if no other choice LPV/r 85 LPV/r Nephrolithiasis GI intolerance, nausea, vomiting, diarrhea Asthenia Hyperlipidaemia (especially hypertriglyceridaemia) Elevated serum transaminases Hyperglycaemia Fat maldistribution Possible increased bleeding episodes in patients with hemophilia PR interval prolongation QT interval prolongation and torsade de pointes ATV/r From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 86 Table 22: ARV-related adverse events and recommendations Adverse events Dyslipidaemia Major first-line ARVs All NRTIs (particularly d4T) EFV Anemia and neutropaenia AZT Hepatitis All ARVs (particularly NVP) Lactic acidosis All NRTIs (particularly d4T) Lipoatrophy and lipodystrophy All NRTIs (particularly d4T) Neuropsychiatric changes EFV Renal toxicity (renal tubular dysfunction) TDF Peripheral neuropathy d4T Recommendations Consider replacing the suspected ARV. If severe (Hb <7.0 g/dl and/or ANC <750 cells/ mm3), replace with an ARV with minimal or no bone marrow toxicity (e.g. d4T or TDF) and consider blood transfusion. If ALT is at more than five times the basal level, discontinue ART and monitor. After resolution, restart ART, replacing the causative drug (e.g., EFV replaces NVP). Discontinue ART and refer. If severe give supportive treatment. After resolution, resume ART with TDF. Early replacement of the suspected ARV drug (e.g. d4T for TDF or AZT). Usually self-limited, without the need to discontinue ART. If intolerable to the patient, replace NVP with EFV or bPI. Single substitution recommended without cessation of ART. Dose adjustments according to creatinine clearance of ART and CTX. Consider substitution with AZT. Replacement of d4T with AZT, TDF. Symptomatic treatment (amitriptyline, vitamin B6). Adapted from: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 87 Table 23: Symptom-directed toxicity management Adverse events Acute pancreatitis Drug eruptions (mild to severe, including StevensJohnson syndrome or toxic epidermal necrolysis) Major firstline ARVs d4T NVP, EFV (less commonly) Recommendations Discontinue ART. Give supportive treatment with laboratory monitoring. Resume ART with an NRTI with low pancreatic toxicity risk, such as AZT or TDF. In mild cases, symptomatic care. EFV rash often stops spontaneously after 3−5 days without need to change ART. If moderate rash, non-progressing and without mucosal involvement or systemic signs, consider a single NNRTI substitution (i.e. from NVP to EFV). In moderate and severe cases, discontinue ART and give supportive treatment. After resolution, resume ART with a bPI-based regimen or triple NRTI if no other choice. All NRTIs Dyslipidaemia (particularl y d4T) EFV Consider replacing the suspected ARV. If severe (Hb <7.0 g/dl and/or ANC <750 cells/ mm3), Anemia and neutropaenia AZT All ARVs Hepatitis (particularl y NVP) All NRTIs Lactic acidosis Lipoatrophy and lipodystrophy (particularly d4T) All NRTIs (particularl y d4T) replace with an ARV with minimal or no bone marrow toxicity (e.g. d4T or TDF) and consider blood transfusion. If ALT is at more than five times the basal level, discontinue ART and monitor. After resolution, restart ART, replacing the causative drug (e.g. EFV replaces NVP). Discontinue ART and give supportive treatment. After resolution, resume ART with TDF. Early replacement of the suspected ARV drug (e.g. d4T for TDF or AZT). Usually self-limited, without the need to discontinue Neuropsychiatric changes EFV Renal toxicity (renal tubular dysfunction) TDF Peripheral neuropathy d4T ART. If intolerable to the patient, replace NVP with EFV or bPI. Single substitution recommended without cessation of ART. Consider substitution with AZT and dose adjustment of ARV drugs according to creatinine clearance. Replacement of d4T with AZT, TDF. Symptomatic treatment (amitriptyline, vitamin B6). Adapted from: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 88 SOP 13: Recognition of treatment failure and when to switch ART regimens Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose Purpose/Scope: To recognize treatment failure early and initiate timely, appropriate switch of ART regimen in adults with HIV, as part of pharmacologic vigilance in an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Pharmacist HIV Specialist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (Clinic treatment failure register, ART complications register, d4T register, HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. CTX, INH, pyridoxine, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure Diagnose treatment failure in a timely manner (within a week after abnormal results identified) and manage within available resources and according to national protocol: 89 Review patient records and progression of clinical and laboratory findings. Conduct directed medical history to assess any possible symptoms or signs of treatment failure. Conduct directed physical exam with focus on signs of OIs or other HIV-related infections, or other indications of treatment failure. Conduct or order laboratory tests, if required, to confirm clinical impressions. Discuss with patient to determine possible adherence challenges or treatment discontinuation — even temporary treatment interruption can be a potential contributing factor to treatment failure (See SOP 5 Adherence for more on assessing adherence and reasons for non-adherence). Utilize adherence confirmation methodologies including pill count, pharmacy refill data, patient-perceived barriers to adherence with drug regimen or visit schedule Cross-check adherence information with patient’s adherence support person if available (partner, family member, friend) If patient has discontinued treatment, it is important to address and resolve reasons for discontinuation of ART (or sub-optimal adherence, or loss to follow up/default) when modifying or restarting drug treatment. Review lab results as soon as possible after receipt — within 1 week if possible. Ensure that patient receives results and is counseled. Initiate required regimen changes within 1 month maximum. If treatment failure confirmed, in accordance with national guidelines: Select appropriate new regimen Counsel patient on reasons for change in regimen, differences in drug dosage, timing of administration Review possible side effects of ARVs in new regimen with client/adherence partner Schedule more frequent clinic visits (every 2 weeks if feasible) until efficacy of new regimen and adherence reestablished Make note in record to repeat viral load (if available) six weeks after treatment change Consult with HIV Specialist if there are any unresolved issues or need to confer on treatment plan As with any routine and non-routine visit: re-assess for social issues that could negatively influence adherence; provide counseling and take-home leaflets in response to emerging needs (see SOP 21); inquire about partner, children and other family members; review importance of clinic visit schedule and set date/time for next appointment 90 Schedule next clinic visit: Advise sooner return to clinic if signs and symptoms do not resolve or reoccur Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable Record all findings in clinic treatment failure register Table 24: ART switching criteria Failure Definition Comments Condition must be differentiated from immune reconstitution inflammatory syndrome (IRIS) Certain WHO clinical stage 3 conditions (e.g. pulmonary TB, severe bacterial infections), may be an indication of treatment failure Clinical failure New or recurrent WHO stage 4 condition Immunological failure Fall of CD4 count to baseline (or below) OR 50% fall from on-treatment peak value OR Persistent CD4 levels below 100 cells/mm3 Without concomitant infection to cause transient CD4 cell decrease Plasma viral load above 5000 copies/ml after 6 months on ART The optimal viral load threshold for defining virological failure has not been determined. Values of >5 000 copies/ml are associated with clinical progression and a decline in the CD4 cell count Virological failure Adapted from: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 91 Figure 4: Targeted viral load strategy for failure and switching Suspected clinical or immunological failure Test viral load VL > 5,000 copies/ml Adherence intervention Repeat VL VL 5,000 copies/ml VL > 5,000 copies/ml Do not switch to second line Switch to second line VL = viral load From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 92 Figure 5: Routine viral load strategy for failure and switching Routine Viral Load Testing (not a prerequisite for initiating ART) VL > 5,000 copies/ml Adherence intervention Repeat VL VL 5,000 copies/ml VL > 5,000 copies/ml Do not switch to second line Switch to second line VL = viral load From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 93 SOP 14: Switching to second-line ART regimens Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide timely and appropriate changes in ART when initial treatment failure is diagnosed in adults with HIV, as part of pharmacologic vigilance in an integrated HIV service package. Introduction Treatment failure, failure to suppress viral replication with development of viral resistance, can be clinical, immunologic or virologic. Treatment failure should only be diagnosed after a minimum of 6 months of ART. Common criteria use viral load greater than 5,000 copies/mL on two occasions, despite intensive adherence counseling. Two common scenarios are: 1) Early switching based on availability of viral load to detect failure 2) Late switching based on less sensitive monitoring using clinical and immunological criteria to define failure. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Pharmacist HIV Specialist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (treatment failure register, ART complications register, d4T register, HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale 94 e. Paper examination drapes f. Disposable exam gloves 4. ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure 14.1 Recognize need to switch from first-line to second-line ART regimen and implement switch in a timely manner (within one month after treatment failure confirmed) and within available resources, according to national protocol Review patient records to confirm accurate diagnosis of treatment failure and rule out poor adherence as contributing factor: Conduct or update directed medical history and directed physical exam to confirm symptoms, signs and timing of first-line regimen treatment failure Review CD4, viral load and other lab results that led to diagnosis of treatment failure, and conduct or order priority additional laboratory tests (CD4, viral load), if required, to confirm diagnosis Discuss in depth with patient, and partner/family, possible non-adherence or discontinuation as potential contributing factor to treatment failure. It is important to address and resolve reasons for non-adherence or discontinuation, if applicable. Adherence problems may continue on second-line ARVs, if cause is not resolved (See SOP 5 for details on assessing/addressing adherence). Criteria for switching to second-line ART include: Clinical signs/symptoms Immunologic criteria (CD4) to confirm clinical failure when available Where available, confirm treatment failure with viral load (viral load above 5,000 copies on two separate occasions). Note: capacity for viral load testing may be limited in Foundation-supported settings 14.2 When treatment failure is confirmed, select appropriate second-line regimen Select appropriate new regimen considering the following principles: A boosted protease inhibitor (PI/r or bPI) plus two nucleoside analogues (NRTIs) are recommended for second-line ART Atazanavir/ritonavir (ATV/r) and lopinavir/ritonavir (LPV/r) are the preferred boosted PIs for second-line ART Simplification of second NRTI option: If d4T or AZT used in first-line, switch to tenofovir + lamivudine or emtricitibine 95 (TDF+ 3TC or TDF + FTC) If TDF used in first-line, switch to zidovudine + lamivudine (AZT + 3TC) as the NRTI backbone for second-line regimen Initiate required regimen changes within 1 month maximum. Consultation with HIV specialist is no longer required for straightforward switch to second-line regimen. However, in patients with immunologic or clinical failure in the presence of complete viral suppression, consult HIV specialist if possible. Counsel patient on reasons for change in regimen, differences in drug types, dosages, timing of administration. Review possible side effects of ARVs in new regimen with client/adherence partner. As with any routine and non-routine visit: re-assess for social issues that could negatively influence adherence; provide counseling and take-home leaflets in response to emerging needs (see SOP 21); inquire about partner, children and other family members; review importance of clinic visit schedule and set date/time for next appointment. See Tables 24 (above) and Table 25 (below). 14.3 Conduct routine clinical and laboratory monitoring of patients switched to second-line regimen Order and review CD4: At start of second-line regimen At 3 months and at 6 months after treatment change At 1 year after switch Yearly if virologic suppression achieved Conduct or order viral load: At 6 weeks after treatment change At 6 months and then every 12 months 14.4 Educate patient about risks associated with d4T Discuss signs and symptoms of d4T toxicity with patients on d4T-containing regimens, and request prompt notification if these recur. 96 Phase out of d4T In 2010 WHO recommended that stavudine (d4T) be phased out of first-line therapy regimens and replaced by either tenofovir (TDF) or zidovudine (AZT). Use of d4T is associated with increased risk of lipoatrophy, peripheral neuropathy, lactic acidosis, and pancreatitis. Although d4T use has declined significantly, WHO estimates that in 2008, d4T was still part of the treatment regimen of 56% of adults on ART in low- and middle-income countries. d4T use is expected to be progressively reduced by: 1) Gradually replacing d4T, beginning with patients with actual clinical toxicity 2) Using initial regimens that do not contain d4T (for all new patients starting ART), where feasible 14.4 Transition from d4T (see Figure 6) Review patient record to assess for risk factors associated with specific d4T toxicities: Peripheral neuropathy associated with older age (over 35 years) Lipodystrophy and hyperlactatemia are associated with BMI greater than 25 and female gender Hyperlactatemia in women weighing more than 60 kg who gained weight rapidly after d4T (at least 6 kg during first six months of initiation of d4T- containing ART regimen) Conduct physical examination to identify physical signs of toxicity (lipodystrophy, peripheral neuropathy). Order appropriate laboratory tests to diagnose/confirm d4T toxicity: Hyperlactatemia (lactate levels 5 mmol/L= hyperlactatemia) If d4T is continued, use 30 mg twice a day according to current WHO recommendations; switch as soon as feasible. Do not re-start treatment with d4T if stopped secondary to severe lactate elevation. Review benefits of new regimen with patient and family, discuss importance of adherence. Refer to adherence counselor for additional adherence information if required. See Table 26. Schedule more frequent clinic visits (every 2 weeks if feasible) until efficacy of new regimen and adherence reestablished: Advise sooner return to clinic if signs and symptoms do not resolve or reoccur Record appointment in follow-up register 97 Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete ART enrollment form, ART treatment failure forms Complete paperwork for laboratory tests or other referrals, if applicable Table 25: Preferred second-line ART options Target population If d4T or AZT used in firstAdults and line therapy adolescents (including If TDF used pregnant in first-line women) therapy If rifabutin available Preferred options TDF + 3TC or FTC + ATV/r or LPVr AZT + 3TC + ATV/r or LPVr Same regimens as recommended above for adults and adolescents Comments NRTI sequencing based on availability of FDCs and potential for retained antiviral activity, considering early and late switch scenarios ATV/r and LPVr are comparable and available as heat-stable FDCs or copackage formulations No difference in efficacy between rifabutin and rifampicin Rifabutin has significantly less drug interaction with bPIs, permitting standard bPI dosing Same NRTI backbones as TB/HIV co infection If rifabutin not available recommended for adults and adolescents plus LPVr or SQV/r with super boosted dosing of RTV (LPV/r 400 mg/400 mg twice daily, OR LPV/r 800 mg/200 mg twice daily, OR SQV/r 400 mg/400 mg twice daily) Rifampicin significantly reduces the levels of bPIs, limiting the effective options. Use of extra doses of ritonavir with selected bPIs (LPV and SQV) can overcome this effect but with increased rates of toxicity In case of ART failure, TDF + Hepatitis B co infection AZT + TDF + 3TC or FTC + ATV/r or LPVr 3TC or FTC should be maintained for anti-HBV activity and the second-line regimen should include other drugs with anti-HIV activity From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 98 Table 26: ART switching criteria Failure Definition New or recurrent WHO Clinical failure stage 4 condition Comments Condition must be differentiated from immune reconstitution inflammatory syndrome (IRIS) Certain WHO clinical stage 3 conditions (e.g. pulmonary TB, severe bacterial infections), may be an indication of treatment failure Fall of CD4 count to baseline (or below) OR 50% fall from on- Immunological failure treatment peak value OR Persistent CD4 levels below 100 cells/mm3 Repeated Plasma viral Virological failure load above 5000 copies/ml Without concomitant infection to cause transient CD4 cell decrease The optimal viral load threshold for defining virological failure has not been determined. Values of >5 000 copies/ml are associated with clinical progression and a decline in the CD4 cell count Adapted from: WHO Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach 2010 revision. Table 27: Monitoring ART in those at higher risk of adverse events ARV drug Major toxicity d4T Lipodystrophy Neuropathy Lactic acidosis AZT Anemia Neutropaenia TDF Renal dysfunction EFV Teratogenicity Psychiatric NVP illness Hepatotoxicity High-risk situations Age >40 years CD4 count of <200 cells/mm3 BMI >25 (or body weight >75kg) Concomitant use with INH or ddI CD4 count of <200 cells/mm3 BMI <18.5 (or body weight <50 kg) Anemia at baseline Underlying renal disease Age >40 years BMI <18.5 (or body weight <50 kg) Diabetes mellitus Hypertension Concomitant use of a PI or nephrotoxic drugs First trimester of pregnancy (do not use EFV) Depression or psychiatric disease (previous or at baseline) HCV and HBV co infection From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 99 Figure 6: d4T toxicity assessment Does pt have cough, abdominal pain, and erythematous serpiginous lesions? Assess all patients on d4T first line regiment at their next clinic visit using algorithm below *Assess for possible 1st line ART failure Failure to 1st line ART not confirmed Failure to 1st line ART confirmed **Assess for d4T toxicity No suspected toxicity Suspected toxicity Continue with d4T first line regimen and monitor patient for treatment failure and d4T toxicity Substitute/change from d4T to TDF or AZT based first line regimen. Prepare the patient and switch to 2nd line ART as per national ART *Suspect failure if patient has or recently had any one of following: New or recurrent WHO stage 3 or 4 condition Last routine CD4 count show a 50% fall from on-treatment peak value OR is persistently <100 cells/mm3 Plasma viral load of above 5000 copies/ml (For clients with suspected failure, diagnose failure using viral load test as below (see information on availability of viral load test) **Suspect d4T toxicity if any of the following is present: Neuropathy: Recent or current symptoms of burning/tingling, numbness, weakness, unable to walk, sensory loss in limbs. Lipodystrophy: Any noticed changes to body shape or dimpling of the skin by the patient or clinician Lactic acidosis: Recent or current symptoms of weight loss, fatigue, muscle pain, abdominal pain and From: Republic of Kenya, Ministry of Health, NASCOP. 100 SOP 15: Switching to third-line ART regimens Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide timely and appropriate changes in ART when second-line treatment failure is diagnosed in adults with HIV, as part of pharmacologic vigilance in an integrated HIV service package. Introduction Third-line regimens should include new drugs such as second-generation NNRTIs (etravirine) and PIs (darunavir), and new classes of drugs such as integrase inhibitors (raltegravir) when feasible. Third line regimen decision-making and implementation should be made in consultation with an HIV specialist whenever possible. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment Pharmacist HIV Specialist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (treatment failure register, ART complications register, d4T register, HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. Second and third line ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required 101 Procedure 15.1 Recognize need to switch from second-line to third-line ART regimen and implement switch in a timely manner and within available resources, according to national protocol Review patient records to confirm accurate diagnosis of second-line regimen failure and rule out poor adherence as contributing factor: Conduct or update directed medical history and directed physical exam to confirm symptoms, signs and timing of second-line regimen treatment failure Review CD4, viral load and other lab results that led to diagnosis of second-line regimen treatment failure, and conduct or order priority additional laboratory tests (CD4, viral load) if required to confirm diagnosis Possible adverse drug reactions Rule out all possible non-resistance causes of treatment failure 15.2 When second-line regimen failure from drug is confirmed, select appropriate third-line regimen: Consider the following principles when switching from second-line to third-line regimens in resource-limited settings: Third-line regimen should include at least two new ARVs to which patient is likely susceptible Patients on failing second-line regimens with no new ARV options readily available should be maintained on a tolerated regimen if possible If patient develops WHO Stage 4 AIDS-defining illness while on second-line therapy, consult with HIV Specialist to consider stopping ART and institution of palliative care If third-line ARVs and genotype resistance testing are readily available: Order or refer for genotype resistance testing while patient is still on failing second-line regimen, or no more than 4 weeks after discontinuing failing regimen if possible Do not wait longer than 4 weeks for return of genotype resistance test results before consulting HIV specialist to change to an empiric third-line regimen Modify third-line regimen if indicated by resistance test results when they become available Discuss in depth with patient and partner/family possible non-adherence or discontinuation as potential contributing factor to treatment failure Provide option for intensive adherence counseling and active re-involvement of adherence partner to reduce adherence barriers 102 Schedule more frequent clinic visits (every 2 weeks if feasible) until efficacy of new regimen and adherence reestablished: Advise sooner return to clinic if signs and symptoms do not resolve or reoccur Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete ART enrollment form, ART treatment failure forms Complete paperwork for laboratory tests or other referrals, if applicable 103 Table 28: Toxicities of third-line ARVs ARV Toxicities Skin rash (10%) — DRV has a sulfonamide moiety; StevensJohnson syndrome and erythrema multiforme have been reported Hepatotoxicity Diarrhea, nausea Headache Darunavir (DRV) Hyperlipidaemia Transaminase elevation Hyperglycaemia Fat maldistribution Possible increased bleeding episodes in patients with hemophilia GI intolerance, nausea, vomiting, diarrhea Paresthesias — circumoral and extremities Hyperlipidaemia (especially hypertriglyceridaemia Ritonavir (RTV) Hepatitis (as Asthenia pharmacokinetic Taste perversion booster) Hyperglycaemia Fat maldistribution Possible increased bleeding episodes in patients with hemophilia Nausea Headache Raltegravir Diarrhea (RAL) Pyrexia CPK elevation Rash (2 % discontinuation because of rash during clinical trials) Hypersensitivity reactions have been reported, characterized by Etravirine (ETV) rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure Nausea From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 104 Integrated Sexual and Reproductive Health Background Although women and men with HIV and their partners need the same routine SRH care as those who do not have HIV, there are special SRH considerations that should be addressed as part of comprehensive HIV care. Regardless of HIV status, men and women of reproductive age need access to family planning services. Family planning allows individuals and couples to anticipate and attain their desired number of children and the spacing and timing of their births. It is achieved primarily through use of contraceptive methods. SOP 16 provides guidance on contraceptive services to men and women with HIV. STIs are a common and serious problem worldwide. Many STIs are curable with effective treatment, but they continue to be a major public health concern in both industrialized and developing countries. WHO estimates that, globally, more than 340 million new cases of syphilis, gonorrhea, chlamydia and trichomoniasis occur every year in men and women aged between15–49 years. Not only does the presence of STIs increase the likelihood of both transmitting and acquiring HIV, but many STIs are more difficult to treat in people who are immunosuppressed (e.g., chancroid and syphilis) — emphasizing the importance of STI prevention, early diagnosis and treatment, particularly in those living with HIV (see SOP 17). In women with HIV infection where routine pap smears are conducted, 30–60% of Pap smears exhibit cytological abnormalities and 15–40% have evidence of dysplasia. More than 40% of HIV positive women have low grade squamous intraepithelial lesion (LSIL). These rates are more than ten times higher than those observed among HIV-negative women. Progression of cervical disease is faster in HIV positive women as well, and invasive cervical cancer included in the list of AIDS-defining illnesses. All HIV positive women should have access to gynaecological services. HIV providers should be trained to conduct routine screenings and sources for referrals should be identified. In areas with high volume of HIV positive women, it is recommended that a gynecologist provide these much needed services. In many settings yearly Pap smear is not yet achievable and annual routine visual inspection is the current clinical norm. SOP 18 is included for use in settings where pap smears are available, with hope that the test will become more widely available in the near future. SOP 19 provides an overview of the HIV-related treatment for women of reproductive age. Women with HIV often face disproportionate responsibility for HIV and STI infection within their primary partnership/relationship, for prevention of transmission and reinfection, and for care of children and family regardless of their own health status. Men also need support to deal with the burdens resulting from HIV and fulfilling their responsibility of ensuring HIV is not further transmitted. As living with HIV can bring 105 with it a number of emotional, social and physician challenges, all men and women with HIV need access to counseling and support (SOP 20). They also need support and advice on how to prevent transmitting HIV to others (SOP 21). SOPs 16, 17, 18, 19, 20 and 21, although presented as separate SOPs for simplicity are all sexual and reproductive health services that need to be integrated into HIVrelated care and treatment services. They are unlikely to be offered as distinct separate services, as presented here, but rather as part of a continuum of care for the PLHIV. Definitions Unsafe sex HIV is mainly spread through unsafe sex. Unsafe sex is any kind of sex that puts a person, or his or her sexual partners, at risk of getting a sexually transmitted infection, including HIV, or unwanted pregnancy. It is very important for health workers to be comfortable talking about sex and reproduction with their clients. Frank, factual discussions about sex and sexuality can provide clients with the information they need to protect themselves and their partners from sexually transmitted infection and unplanned pregnancy. Sex (as a noun): Refers to the physiological attributes that identify a person as male or female (genital organs, predominant hormones, ability to produce sperm or ova, ability to give birth, etc.). Safer sex sexual activity with the use of measures (such as latex condoms) to avoid the transmission of HIV, other STIs and unintended pregnancy. Safer sex includes partner reduction, mutual monogamy, use of condoms, avoidance of sexual activity that involves exchange of body fluids (such as kissing, hugging, or mutual masturbation rather than intercourse), and abstinence (see also “dual protection” below). Dual protection: preventing STIs, HIV, and unwanted pregnancy at the same time. Various strategies include: Being abstinent or engaging in sexual behaviors that do not involve exchange of sexual fluids (hugging, kissing, holding hands, massaging, bathing or showering together, body rubbing (with clothes on), sharing fantasies, masturbation) Being in a monogamous relationship in which both partners are free of STIs and at least one partner is using effective contraception Using male or female condoms Using male or female condoms to protect against STIs and a second method to protect against unplanned pregnancy (often a hormonal method) Positive prevention: supporting clients to understand the transmission risk of certain activities and provide guidance to help them reduce risky behavior, have good sexual and reproductive health, and prevent new HIV infections. Positive living also includes: 106 Keeping the mind healthy (having a positive outlook toward living and life), Keeping the body healthy, Keeping the soul and spirit healthy (for example, the things we do to feel good on the “inside” and feel a sense of peace and contentment), and Living responsibly with HIV and preventing new HIV infections. Contraception: the intentional prevention of conception through the use of various devices, sexual practices, chemicals, drugs, or surgical procedures. This means that something (or some behavior) becomes a contraceptive if its purpose is to prevent a woman from becoming pregnant. Birth control techniques and methods include contraception (the prevention of fertilization), contragestion (preventing the implantation of the embryo) and abortion (the removal or expulsion of a fetus or embryo from the uterus). Family planning is the planning of when to have children, and the use of birth control and other techniques to implement such plans. Family planning encompasses birth control, as well as prevention and management of sexually transmitted infections, pre-conception counseling and management, and infertility management. Family planning is usually applied to a female-male couple who wish to control the number and spacing of pregnancies. Family planning services are the educational, comprehensive medical or social activities that enable individuals, including minors, to determine freely the number and spacing of their children and to select the means by which this may be achieved. Policy 1. Family planning and positive prevention services are most effective if presented to the client with HIV and his or her partner. 2. Clients with HIV may need to be referred to other health services or community services to ensure all sexual and reproductive health service needs are met. Care should be coordinated as much as possible to reduce the burden of visits. Responsibility at health facility A single individual should be assigned at each health facility to establish standards according to national guidelines and supervise not only the integration of sexual and reproductive health services into HIV treatment and care, but also the actual services, once established. Sexual and reproductive health services are provided by all health workers. In clinics with multidisciplinary teams, clinical staff provide contraceptive services and counseling while non-clinical staff — including peer educators — can provide clients with support on negotiating safer sex. 107 SOP 16: Contraception Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide safe and effective contraception for HIV positive women who wish to postpone pregnancy as part of an integrated HIV service package. Introduction Pre-conception counseling and pregnancy planning are important components of HIV care and treatment services for women of childbearing age and their partners. Contraceptive services can be provided as part of integrated maternal child health services, and incorporated into HIV care and treatment for men and women living with HIV attending CTCs. HIV positive women/couples can use most family planning (FP) methods. WHO has developed a Medical Eligibility Criteria for contraceptives (2004). There is emerging data on the use of hormonal contraception and increased risk of HIV acquisition. Currently there is no change in the guidance - women living with HIV can continue hormonal contraceptive use – but the WHO will review these guidelines in February 2012. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment and SRH Pharmacist Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, contraception/family planning register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes 108 f. Disposable exam gloves 4. Contraceptive supplies, antibiotics for STI treatment 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure Provide contraceptive advice and services to all women and men living with HIV who wish to prevent or postpone pregnancy, according to national guidelines At initial visit: Review and update patient record, medical history and past clinical and laboratory findings to assess current HIV status, treatment status and history of contraindications to any family planning methods Discuss particular importance of contraception for HIV infected women: to promote healthy timing and spacing of pregnancies Explain that for ART-eligible HIV positive women, pregnancy is best deferred until effective ART regimen has improved clinical and laboratory parameters (significant CD4 increase, viral load decrease to undetectable if possible) to increase viability of pregnancy, assure the mother’s health, and decrease risk of HIV transmission to the infant Discuss reproductive intentions of woman/partner and expectations of partner/family that might influence contraceptive use Provide counseling on FP methods, and assist in selection of medically and culturally appropriate method Explain potential side effects of individual FP methods as appropriate Define and explain dual protection and encourage regular and reliable condom use to prevent HIV transmission, even if using another FP method as primary means of preventing/postponing pregnancy Encourage use of female condoms and distribute if available. Encourage trial use in women who appear skeptical Dispense and encourage use of male condoms for FP or dual protection and offer assistance in condom negotiation skills Discuss possible interaction between certain ARVs and other HIV and non-HIV medications. For HIV positive women on ART, some drugs — including ARVs — can interact with hormonal contraceptives: Protease inhibitors (PIs): ritonavir, lopinavir/ritonavir and darunavir — decrease estrogen levels in combined oral contraceptive users 109 atazanivir — increases estrogen levels NNRTIs: nevirapine (NVP) — decreases estrogen levels efavirenz (EFV) — increases estrogen levels Rifampicin and certain antibiotics may reduce the effectiveness of hormonal contraceptive methods (among all women, not just HIV positive women) In the above cases, change contraceptive method or add a second method to current contraceptive choice and always recommend condoms for dual protection. Avoid use of EFV in first trimester of pregnancy or in HIV positive women unless assured of effective contraception as EFV can cause neural tube defects in first trimester. Conduct directed medical history and physical examination to rule out absolute contraindications to use of hormonal or intrauterine contraception. Conduct Hgb, STI screen and other laboratory tests as indicated to detect anemia or other conditions that could contraindicate use of hormonal or intrauterine contraception. Initiate family planning, using the method of client’s choice from among all methods appropriate for HIV positive women, including: Progesterone-only injectable methods (Depo-Provera): Advise HIV positive women to receive re-injection two weeks earlier than the scheduled three-monthly revisit Progestin-only contraceptive pills (minipills) can safely be used by HIV positive women; even those who are breastfeeding because they do not contain estrogen thus do not reduce breast milk production Combined oral contraceptives (birth control pills): Certain ARVs can influence estrogen levels and therefore reduce effectiveness of combined oral contraceptives (see above). Combined oral contraceptives should not be used by HIV positive breastfeeding women, as estrogen reduces breast milk production Intrauterine devices (IUD) can be used by HIV-positive women except in women with advanced HIV disease who are not on ART. Women who have a current STI or history of recurrent STIs should not use IUDs. Higher rates of pelvic inflammatory disease occur in the presence of some STIs. Condom use should be encouraged in women who select IUDs as their contraceptive method. IUDs insertion may be safest if delayed a month or more after delivery Voluntary sterilization (tubal ligation or male vasectomy) is an option to permanently prevent pregnancy. Women/partners should be thoroughly counseled and their absolute intention to permanently end fertility should be assessed and documented prior to performing sterilization Provide or refer for additional counseling HIV positive women/couples who desire a 110 pregnancy: Explain risks of unprotected intercourse in presence of HIV disease Explain that HIV positive couples and discordant couples who desire children should confine unprotected intercourse to fertile period Explain that adherence to ART and undetectable viral load may allow conception without transmission of HIV to partner Explain that genital ulcerative disease (GUD) if present during intercourse, can increase chance of viral transmission At follow-up visits: Review and update patient record Ask patient about changes in reproductive health status (new pregnancy, desire to become pregnant in near future, any gynecologic or STI diagnoses received since last visit) Review current use of and satisfaction with FP and offer to change method if appropriate Review rationale for FP, provide counseling on appropriate methods for people living with HIV and offer to initiate or resupply choice of method if appropriate At all visits: Emphasize dual protection: the use of a routine FP method as well as male or female condoms. For all visits, schedule next appointment: Advise patient to return sooner return if there are problems Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 111 SOP 17: STI screening for adults and adolescents Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide HIV positive clients screening for sexually transmitted infections (STI), according to national guidelines and STI protocols and as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment and SRH Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, STI register, followup/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves g. Speculums for internal vaginal examination, bright light source for cervical examination speculum h. Examination table and clean paper or cloth covering 4. Contraceptive supplies, antibiotics for STI treatment 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure Review and update patient record, medical history and past clinical and laboratory findings to assess current HIV status, treatment status and history of STIs or related gynecologic conditions. 112 Women: Conduct pelvic, genital, rectum and oropharynx examination, as directed by sexual history: Gently palpate the abdomen for pelvic masses and tenderness Palpate the inguinal region to detect the presence or absence of enlarged lymph nodes and buboes Examine the vulva, anus and perineum The physical examination may include, where possible, an internal pelvic examination involving (a) bimanual examination to check for active pelvic inflammatory disease; shape, size and position of uterus for uterine masses, for example, pregnancy and (b) speculum examination to check for the nature of the vaginal discharge, purulent cervicitis and/or erosions Record the presence or absence of buboes, ulcers, and vaginal discharge, noting the type, color and amount Men: Conduct genitalia/urethra, rectum and oropharynx examination, as directed by sexual history: Palpate the inguinal region for enlarged lymph nodes and buboes Palpate the scrotum, feeling for individual parts of the anatomy: testes, spermatic cord, and epididymis Examine the penis, noting any rashes or sores. Retract the foreskin if present, and look at the glans penis and urethral meatus If there is no obvious urethral discharge, milk the urethra or ask the patient to milk the urethra gently to express any discharge. If a discharge is present, wipe it with a swab and dispose Record the presence or absence of buboes, ulcers, and urethral discharge, noting the color and amount Collect samples of cervical and vaginal secretions, vaginal/penile discharge, exudates or scrape of abnormal tissue or lesions for laboratory evaluation if indicated. Conduct or refer for rapid syphilis test, wet mount and gram stain of vaginal/penile discharge, culture for gonorrhea, Chlamydia, viral culture for HPV if indicated. Conduct RPR at baseline visit. If laboratory testing not available or national guidelines recommend, use syndromic STI treatment algorithms. Treat according to WHO syndromic algorithms or test results, adhering to national STI and HIV guidelines (see Table 29, below). Refer for other gynecologic/genital evaluation and treatment, if required. Explain findings and referral or next steps to patient. 113 Discuss prevention of STIs: Initiate contact tracing, examination and treatment if required Define and explain dual protection and encourage regular and reliable condom use, even if using another FP method Encourage use of female condoms and distribute if available. Encourage trial use in women who appear skeptical Dispense condoms for FP or dual protection and offer assistance in condom negotiation skills Schedule next appointment: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable Table 29: STD treatment guidelines table for adults and adolescents Disease Recommended Regimens CHLAMYDIA Uncomplicated Azithromycin OR Genital/Rectal/P Doxycycllna haryngeal Infections Pregnant Women Gonorrhea Uncomplicated Genital/Rectal Infections Pharyngeal Infections Pregnant Women Azithromycin OR Amoxicillin Dual therapy with Ceftriaxone OR, if not an option Cefixime PLUS Azithromycin OR Doxycycline Dual therapy with Ceftriaxone PLUS Azithromycin OR Doxycycline Dual therapy with Ceftriaxone or, if not an Dose / Route 1 g po 100 mg po bid x 7 d 1 g po 500 mg po bid x 7 d 250 mg IM Alternative Regimens: To be used if medical contraindication to recommended regimen. Erythromycin base 500 mg po qid x Id OR Erythromycin ethylsuccinate 800 mg po qid x 7 OR Levofloxacin 600 mg po qd x 7 d OR Ofloxacin 300 mg po bid x 7 d Erythromycin base 500 mg po qld x 7 d OR Erythromycin base 250 mg po qid x 14 d OR Erythromycin ethyl succinate 800 mg po qid x 7 d OR Erythromycin ethyl succinate 400 mg po qid x 14 d Cefpodoxane 400 mg po OR Cefuroxime axetil 1 g po OR Azithromycin 2 g po in a single dose 400 mg po 1 g po 100 mg po bid x 7 d Azithromycin 2 g po in a single dose 250 mg IM 1 g po 100 mg po bid x 7 d 250 mg IM Cefpodoxane 400 mg po OR Cefuroxime axetil 1 g po OR 114 Disease Pelvic Inflammatory Disease Recommended Regimens option Cefixime PLUS Azithromycin Parenteral Either Cefotelan OR Cefoxilin PLUS Doxycycline OR Clindamycin PLUS Gentamicin IM/Oral Either Ceftriaxone OR Cefoxitin with Probenecid PLUS Doxycycline PLUS Metronidazole if BV is present OR cannot be ruled out Azithromycin OR Cervicitis Doxycycline PLUS Metronidazole if BV OR trichomoniasis is present Nongonococcal Azithromycin OR Urethritis Doxycycline Epididymitis Chancroid Likely due to Gonorrhea OR Chlamydia Ceftriaxone PLUS Doxycycline Likely due to enteric organisms Levofloxacin OR Ofloxacin Azithromycin OR Ceftriaxone OR Ciprofloxacin OR Erythromycin base Doxycycline Lymphogranuloma Venereum TRICHOMONIASIS Non-Pregnant Metronidazole OR Women Tinidazole Pregnant Metronidazole Women BACTERIAL VAGINOSIS Adults/ Metronidazole OR Adolescents Metronidazole gel OR Clindamycin cream Dose / Route Alternative Regimens: To be used if medical contraindication to recommended regimen. Azithromycin 2 g po in a single dose 400 mg po 1 g po 2 g IV q 12 hours 2 g IV q 6 hours 100 mg po OR IV q 12 hours Parenteral Ampicillin/Sulbactam 3 g IV q 6 hours PLUS Doxycycline 100 mg po OR IV q 12 hours 900 mg IV q 8 hours 2 mg/kg IV OR IM followed by 1.5 mg/kg IV OR IM q 8 hours Oral Levofloxacin 500 mg po qd x 14 d OR Ofloxacin 400 mg po bid x 14 d OR Ceftriaxone 250 mg IM in a single dose AND Azithromycin 1 g po once a week for 2 weeks PLUS Metronidazole 500 mg po bid x 14 d if BV is present or cannot be ruled out 250 mg IM 2 g IM,1 g po 100 mg po bid x 14 d 500 mg po bid x 14 d 1 g po 100 mg po bid x 7 d 500 mg po bid x 7 d 1 g po 100 mg po bid x 7 d Erythromycin base 500 mg po qid x 7 d OR Erythromycin ethyl succinate 800 mg po qid x 7 d OR Levofloxacin 500mg po qd x 7 days OR Ofloxacin 300 mg po bid x 7 d 250 mg IM 100 mg po bid x l0 d 500 mg po qd x 10 d 300 mg po bid x 10 d 1 g po 250 mg IM 500 mg po bid x 3 d 500 mg po tid x 7 d 100 mg po bid x 21 d Erythromycin base 500 mg po qid x 21 d or Azithromycin 1 g po q week x 3 weeks 2 g po 2 g po 2 g po Metronidazole 500 mg po bid x 7 d 500 mg po bid x 7 d 0.75%, one full applicator (5g) Intravaginally qd x 5 d Tinidazole 2 g po qd x 2 d OR Tinidazole 1 g po qd x 5 d OR Clindamycin 300 mg pa hid x 7 d OR Metronidazole 500 mg po bid x 7 d 115 Disease Recommended Regimens Metronidazole OR Metronidazole OR Clindamycin ANOGENITAL WARTS External Patient-Applied Genital/ Imiquimod 5% cream OR Perianal Warts Podofilox 0.5% solution gel OR Pregnant Women Sinecatechins 15%ointment Provider-Administered Cryotherapy OR Podophyllin resin 10%-25% in tincture of benzoin OR Trichloroacetic acid (TCA) 80%-90% OR Bichloroacetic acid 80%-90% OR Surgical removal Mucosal Genital Cryotherapy OR Warts TCA OR SCA 80%-90% OR Podophyllin resin 10%-25% in tincture of benzoin OR Surgical removal ANOGENITAL HERPES SIMPLEX VIRUS (HSV) First Clinical Acyclovir OR Episode of Acyclovir Anogenital OR Herpes Famcidovir OR Valacydovir Established Infection Acyclovir OR Suppressive Therapy Famcidovir OR Valacyclovir OR Valacyclovir Episodic Therapy for Recurrent Episodes HSV/HIV coinfected: Suppressive Therapy HSV/HIV coinfected: Episodic Therapy for Recurrent Episodes Acyclovir OR Acyclovir OR Acyclovir OR Famcidovir OR Famcidovir OR Famcidovir OR Valacyclovir OR Valacyclovir Acyclovir OR Famcidovir OR Valacyclovir Acyclovir OR Famcidovir OR Dose / Route 2%, one full applicator (5g) intravaginally qhs x7d 500 mg po bid x 7 d 250 mg po tid x 7 d 300 mg po bid x 7 d Topically qhs 3 x wk up to 16 wks Topically bid x 3 d followed by 4 d no tx for up to 4 cycles Topically lid, for up to 16 wks Alternative Regimens: To be used if medical contraindication to recommended regimen. Clindamycin ovules 100 mg intravaginally qhs x 3 d Alterative Regimen Intralesional interferon OR Laser surgery OR Photodynamic therapy OR Topical cidofovir Apply once q 1–2 wks Apply once q 1–2 wks Apply once q 1–2 wks Apply once q 1–2 wks Vaginal, urethral meatus, and anal Vaginal and anal Urethral meatus only Anal warts only 400 mg po tid x 7–10 d 200 mg po 5 x/day x 7– 10 d 250 mg po tid x 7–10 d 1 g po bid x 7–10 d 400 mg po bid 250 mg po bid 500 mg po qd 1 g po qd 400 mg po tid x 5 d 800 mg po bid x 5 d 800 mg po tid x 2 d 125 mg po bid x 5 d 1000 mg po bid x 1 d 500 mg once then 250 mg bid x 2 d 500 mg po bid x 3 d 1 g po qd x 5 d 400–800 mg po bid OR tid 500 mg po bid 500 mg po bid 400 mg po tid x 5–10 d 500 mg po bid x 5–10 d 1 g po bid x 5.10 d Valacyclovir 116 Disease Recommended Regimens SYPHILIS Primary, Benzathine penicillin G Secondary, and Early Latent 2.4 million units IM Late Latent and Benzathine penicillin G Latent of Unknown Duration Neurosyphilis 7.2 million units, administered as 3 doses of 2.4 million units IM each, at 1–wk intervals Aqueous crystalline penicillin 18–24 million units G daily, administered as 3–4 million units IV q 4 hours x 10–14 d Pregnant Benzathine penicillin G women: Primary, Secondary, and Early Latent Pregnant Benzathine penicillin G women: Late Latent and Latent of Unknown Duration Pregnant Aqueous crystalline penicillin women: G Neurosyphilis Alternative Regimens: To be used if medical contraindication to recommended regimen. Dose / Route 2.4 million units IM Doxycycline 100 mg po bid x 14 d OR Tetracycline 500 mg po qid x 14 d OR Ceftriaxone 1 g IM or IV qd x 10–14 d Doxycycline 100 mg po bid x 28 d OR Tetracycline 500 mg po qid x 28 d Procaine penicillin G, 2.4 million units IM qd x 10–14 d PLUS Probenecid 500 mg po qid x 10–14 d OR Ceftriaxone 2 g IM or IV qd x 10–14 d None 7.2 million units, administered as 3 doses of 2.4 million units IM each, at 1–wk intervals None 18–24 million units daily, administered as 3–4 million units IV q 4 hours x 10–14 d Procaine penicillin G, 2.4 million units IM qd x 10–14 d PLUS Probenecid 500 mg po qid x 10–14 d From: California STD/HIV Prevention Training Center California Department of Public Health STD Control Branch updated January 2011. 117 SOP 18: Cervical screening Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide cervical screening by visual inspection or Pap smear to all HIV positive women according to national guidelines and as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment and SRH Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, cervical screening, followup/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves g. Speculums for internal vaginal examination, bright light source for cervical examination speculum h. Culture materials i. High-level disinfectant j. Disposable examination gloves k. Examination table and clean paper or cloth covering l. Cotton-tipped swabs m. Dilute acetic acid solution (3–5%) or white vinegar n. Lugol’s iodine solution o. 0.5% chlorine solution for decontaminating instruments and gloves if reusable 118 p. Pap slides q. Spatula r. Fixative 4. Contraceptive supplies, antibiotics for STI treatment 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure 181 Conduct visual inspection of cervix on all HIV positive women if available and according to national guidelines Conduct screening for cervical cancer on all HIV positive women (regardless of whether she is on ART or not): As soon as possible after HIV diagnosis confirmed Every 12 months thereafter; if cervical changes have been noted, repeat screening 6 monthly Review and update patient record, medical history and past clinical and laboratory findings to assess current HIV status, treatment status and history of STIs or gynecologic conditions including previous abnormal visual inspection/pap smear. Conduct pelvic examination with special attention to detection of genital lesions or abnormalities. Collect samples of discharge, exudates or scrape of lesions for laboratory evaluation if indicated. Conduct visual inspection in all HIV-infected women who are not yet postmenopausal. Explain procedure to patient Insert speculum and adjust light source for optimum view of cervix Remove any discharge, blood or mucus from cervical os with cotton swab Identify squamocolumnar junction (or transformation zone) and surrounding area Apply acetic acid or Lugol’s iodine to cervix wait 1–2 minutes for color changes to take place, observe changes with special attention to transformation zone Note findings on patient record and draw image in patient record of where cervical changes were noted Acetic acid VI is positive if raised, thickened white plaques or acetowhite epithelium Lugol’s iodine VI is positive if mustard or saffron-yellow colored areas usually near squamocolumnar junction 119 Remove any remaining solution from cervix and inform/reassure patient she may notice some staining from solution the day of/ day after application of solutions Remove speculum Discuss results with patient. If negative, recommend repeat visual inspection in one year. If positive, consult with gynecologist if available or refer for further diagnostic testing/treatment. Refer for screening if not available at site, or for other gynecologic evaluation (colposcopy, biopsy) if required. 18.2 Conduct Pap smear on all HIV positive women, if available, and according to national guidelines Conduct cervical cancer screening on all HIV positive women (regardless of whether she is on ART or not): As soon as possible after HIV diagnosis confirmed Every 12 months thereafter Review and update patient record, medical history and past clinical and laboratory findings to assess current HIV status, treatment status and history of STIs or gynecologic conditions including previous abnormal pap smear. Conduct pelvic examination with special attention to detection of genital lesions or abnormalities. Collect samples of discharge, exudates or scrape of lesions for laboratory evaluation if indicated. Conduct pap smear. Refer for screening if not available at site, or for other gynecologic evaluation (colposcopy, biopsy) if required. Repeat abnormal screening examinations according to the result and adhering to national guidelines: Atypical cells of undetermined significance (ASCUS) repeat in one year and if still ASCUS, refer for baseline colposcopy LSIL, repeat in one year and if still LSIL, refer for baseline colposcopy (more than 40% of HIV positive women have LSIL) HSIL, refer for colposcopy if available Carcinoma in situ: refer immediately to gynecologist if available Explain findings and referral or next steps to patient if required. 18.3 Upon completion of all patient visits 120 Schedule next appointment: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 121 SOP 19: ART and HIV-related treatment for WRA Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide appropriate ART and HIV-related treatment to all HIV positive women of reproductive age (WRA) as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment and SRH Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Stethoscope b. BP monitoring equipment c. Thermometer d. Weighing scale e. Paper examination drapes f. Disposable exam gloves 4. CTX, ARV medications, multivitamins 5. Counseling materials as teaching aids and for distribution to patients 6. Laboratory test referral request form if required Procedure Provide appropriate ART and HIV-related treatment to all HIV positive WRA A guiding principle for ART in HIV positive WRA or pregnant women is that therapeutic decisions should be based solely on their need and eligibility for ART. Special circumstances that should be considered when initiating or evaluating ART in WRA include the following. 122 Prior to initiating ART in all WRA Evaluate women for any past history of sd-NVP and AZT/3TC tail for PMTCT within the previous 12 months. Assess reproductive potential and reproductive intentions. Determine baseline CD4 cell count regarding risk for NVP hepatotoxicity with high baseline values. Avoid NVP if baseline CD4 cell count > 250 (women) or > 400 (men) cells/L. Use AZT-containing ART for eligible pregnant women, if possible. Non-pregnant HIV-positive women Remind at every visit about the teratogenic effects of EFV during first trimester of pregnancy; need to use reliable contraception while on EFV; importance of returning to clinic immediately if pregnancy occurs or if pregnancy desired so EFV can be discontinued. Use LPV/r in women who received sd-NVP within past 6 months to reduce risk of virologic failure with NNRTI-based ART. Advise non-pregnant women on TDF to return to clinic immediately if pregnancy occurs or if pregnancy desired so switch from TDF to AZT can be considered to reduce potential risk of fetal bone mineral density changes. Lactic acidosis due to NRTIs is more common in women, especially when BMI is greater than 18.5 kg/m and/or when baseline CD4 count is greater than 250 cells/mL. Women already on ART who become pregnant: Maintain current ART regimen except: Switch EFV to NVP during first trimester of pregnancy; consider switch back to EFV beginning second trimester if indicated Switch patients already on TDF who become pregnant to AZT to avoid potential effects on fetal bone mineral density (as above) and to provide additional PMTCT effect. After delivery, discuss with patient and either continue AZT or switch back to TDF Pregnant women should discontinue fluconazole as it is teratogenic; if required for secondary prophylaxis, women who desire pregnancy should reliably delay pregnancy until fluconazole can be safely discontinued. Women with prior exposure to ARVs for PMTCT Initiate a non-NNRTI-based ART in women who have received single-dose nevirapine (sdNVP) — alone or in combination with other drugs without an NRTI tail — within 12 months of initiating ART. If an NNRTI-based regimen is started, conduct 123 viral load testing at 6 months and, if there are >5000 copies/ml, switch to a bPI-based regimen. Initiate a standard NNRTI-based ART regimen in women who have received sdNVP — alone or in combination with other drugs with an NRTI tail — within 12 months of initiating ART. Conduct viral load-testing at 6 months. If the viral load is >5000 copies/ml, change to a bPI. Initiate a standard NNRTI-based ART regimen in women who have received sdNVP — alone or in combination with other drugs with or without a NRTI tail — more than 12 months before starting therapy, if possible. The viral load should be evaluated at 6 months and if it is >5000 copies/ml, change bPI-based regimen. Initiate a standard NNRTI regimen in women who have received ARV drugs such as AZT alone — without sdNVP — for PMTCT. Upon completion of all patient visits Schedule next appointment: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines Complete paperwork for laboratory tests or other referrals, if applicable 124 Table 30: ART regimens recommended for women with prior exposure to PMTCT regimen Previous ARV exposure for PMTCT Recommendations for initiation of ART when needed for treatment of HIV for maternal health sdNVP1 (+/-antepartum AZT) with no AZT/3TC tail2 in last 12 months Initiate a non-NNRTI regimen PI preferred over 3 NRTI sdNVP (+/-antepartum AZT) with an AZT/3TC tail in last 12 months Initiate an NNRTI regimen. If possible, check viral load3 at 6 months and if >5000 copies/ml, switch to second-line ART with PI sdNVP (+/-antepartum AZT) with or without an AZT/3TC tail over 12 months ago Initiate an NNRTI regimen If possible, check viral load3 at 6 months and if >5000 copies/ml, switch to second-line ART with PI Option A4 Antepartum AZT (from as early as 14 weeks of gestation) sdNVP at onset of labour* AZT + 3TC during labour and delivery* AZT + 3TC tail for 7 days postpartum* Initiate an NNRTI regimen If possible, check viral load3 at 6 months and if >5000 copies/ml, switch to second-line ART with PI If no sdNVP was given, start standard NNRTI (viral load does not need to be checked unless clinically indicated as no sdNVP received) * sd-NVP and AZT + 3TC can be omitted if mother receives >4 weeks of AZT antepartum All triple ARV regimens (including Option B), irrespective of duration of exposure and time since exposure Option B4 Triple ARV from 14 weeks gestation until after all exposure to breast milk has ended AZT + 3TC + LPV/r AZT + 3TC + ABC AZT + 3TC + EFV TDF + [3TC or FTC] + EFV 1 2 3 4 Initiate standard NNRTI regimen If EFV-based triple ARV was used for prophylaxis and no tail (AZT + 3TC; or TDF + 3TC; or TDF + FTC) was given when triple ARV was discontinued after cessation of breastfeeding (or delivery if formula feeding), check viral load3 at 6 months and if >5000 copies/ml, switch to second-line ART with PI Single-dose nevirapine (sdNVP) is one 200-mg tablet of NVP. A tail is the provision of two NRTIs, typically AZT/3TC, for a minimum of 7 days following sdNVP or the cessation of any NNRTI-based regimen with the objective of minimizing NNRTI resistance. If viral load is not available, continue NNRTI regimen and monitor clinically (and immunologically if available). Options A or B are viewed as equally effective for PMTCT in women who do not require therapy for their own health and are recommended options in the 2010 update of Use of ARV drugs for treating pregnant women and preventing HIV infection in infants. From: WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision. 125 Table 31: ART options recommended for HIV-infected pregnant women who are eligible for treatment Target population Preferred treatment options AZT + 3TC + NVP AZT + 3TC + EFV* Pregnant women Comments Maternal antepartum daily ART, starting as soon as possible irrespective of gestational age, and continued during pregnancy, delivery and thereafter. TDF + 3TC (or FTC) + NVP Daily NVP or twice-daily AZT from birth until 4 to 6 weeks of age (irrespective of the mode of infant feeding). TDF + 3TC (or FTC) + EFV* *Avoid use of EFV in the first trimester and use NVP instead. From: WHO Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants, 2010 version. 126 SOP 20: Counseling and support for adults and adolescents living with HIV Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide counseling and support to all HIV positive WRA and their partners, as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment and SRH Counselors Peer counselors, patient advocates, community support workers Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Counseling materials as teaching aids and for distribution to patients Procedure As part of every visit, review psychosocial aspects of HIV disease with female clients: Adequacy of partner/family support Stigma, discrimination Family violence Additional help required for household duties and child care Difficulties adhering to ART regimen or visit schedule Discuss realistic solutions and suggest sources of additional support — peer educator, community home visitor, community-based organizations helping women and families living with HIV. Reinforce clinic staff’s commitment to family-based care and suggest HIV testing for partner/children/family members. Review importance of adherence to clinic visit schedule and referrals and treatment adherence once ART or preventive treatment (CTX, INH) initiated. 127 Assess for social issues such as client or family alcohol abuse, psychological or mental health problems, family violence, joblessness or other issues. Discuss sexual and reproductive health (see SOPs 16–19): Explain that although ART appears to significantly decrease sexual transmission of HIV, vigilance still required as unsafe sex while on ART regimen that is not maximally effective can result in HIV transmission, especially drug resistant HIV. Strongly recommend safer sex even while on ART to reduce risk of HIV transmission or reinfection Evaluate reproductive intentions and discuss need for contraceptives to avoid unplanned pregnancy; refer if required: occurrence of unwanted pregnancy while on ART suggests unsafe sex and associated risks to both HIV-negative sexual partners and infant Demonstrate proper use of male/female condoms and ensure adequate supplies are available Discuss the importance of circumcision for male partners Schedule next appointment: Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines 128 SOP 21: HIV prevention for people living with HIV Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To provide counseling to PLHIV to support them to reduce the risk of transmitting HIV to partners — including safer sex and risk reduction counseling — as part of an integrated HIV service package. Responsibility Physician or clinical officer Nurse trained in HIV care and treatment and SRH Counselors Peer counselors, patient advocates, community support workers Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Counseling materials as teaching aids and for distribution to patients Procedure As part of every visit, discuss how to reduce risk of passing or acquiring HIV: Reduce the number of sex partners you have Use condoms correctly during all sexual encounters Practice safer sex — choose sexual activities that do not allow semen, fluid from the vagina, or blood to enter the mouth, anus or vagina Avoid donating blood If pregnant, participate in PMTCT interventions — take ARVs during pregnancy, delivery and breastfeeding; feed your infant safely (breastfeed or formula feed exclusively for the first 6 months of life) and deliver in a healthcare facility Encourage excellent adherence to ART: clients whose HIV infection is well-controlled with ART have a dramatically reduced risk of passing HIV to sex partners. Stress to patients that HIV transmission can still occur even if a client is on ART, so he or she should still use condoms every time. Describe symptoms of STIs and stress the importance of prompt treatment if STI is 129 suspected. Discuss discordance: It is common for partners of PLHIV to still be HIV negative (discordance) HIV negative partners in discordant couples are at very high risk of infection If discordant couple, explain effective risk reduction options including condoms, abstinence, separation Dispel local myths that may impact on positive prevention, such as cleansing of HIV infection through sexual intercourse with virgins or minors, belief that condoms transmit HIV. Respond to concerns about sexual function. Emphasize that normal sexual activity can continue, with above stated precautions. Encourage questions from clients. Help patient assess current risk of transmission and make an individual risk reduction plan. Counsel on consistent and correct use of condoms during every sexual encounter: Use condoms consistently, even if already infected with HIV or if both partners are HIV-positive Use condoms for vaginal, anal and oral intercourse Put on condom before penetrative sex, not just before ejaculation Discuss the advantages/disadvantages of both male and female condoms Encourage use of water-based lubricants; discourage use of oil-based lubricants with male condoms Demonstrate how to use both male and female condoms using model to demonstrate correct use Request client to demonstrate correct use of condoms Discuss potential barriers to consistent and correct use of condoms; discuss strategies to address these barriers Provide techniques/skills for negotiating condom use according to the needs expressed by clients and role-play condom negotiation with client Provide condoms and discuss how client will assure a regular supply of condoms. Discuss and recommend disclosure and partner/family testing: Explore barriers and explore benefits of disclosure Develop individualized strategy for disclosure if client is ready Refer to PLHIV support groups or others for additional support, if required. 130 Schedule next appointment: Schedule earlier appointment if required for follow-up of barriers identified Record appointment in follow-up register Document: Record all findings, actions, and discussions in patient record Complete all relevant registers as per national guidelines 131 Nutrition Background Malnutrition, in every form, presents significant threats to human health. Today the world faces a double burden of malnutrition that includes both undernutrition and overweight, especially in developing countries. Routine assessment of nutritional status is an integral part of comprehensive HIV services. Hunger and inadequate nutrition contribute to premature illness and early death for many people with HIV, particularly if not yet on ART. Changes in nutritional status result from a combination of factors. HIV infection can impair intestinal absorption of nutrients and nutritional requirements also increase with increased severity of HIV infection. Changes in appetite and side effects associated with use of ART or other HIV-related drugs can also contribute to decreased nutritional intake, resulting in malnutrition. Energy (calorie) requirements increase as HIV progresses from asymptomatic to symptomatic: Asymptomatic clients with HIV require 10–15% more energy than people without HIV, i.e., they require an extra snack or additional small meal each day just to maintain their current weight. Symptomatic adults with HIV require 20–30% more energy intake — this translates to another full meal each day or 2–3 additional snacks. Wasting has been associated with decreased survival, making timely nutritional assessment and appropriate intervention before substantial deterioration of nutritional status occurs key. Definitions BMI: stands for body mass index. BMI is an individual's body weight divided by the square of his or her height or kg/m2. BMI can also be determined using a BMI chart, which displays BMI as a function of weight (horizontal axis) and height (vertical axis) using contour lines for different values of BMI or colors for different BMI categories. Interpretation is as follow: BMI less than 16: severely underweight 16–18.5: underweight 18.5–25: normal 25–30: overweight BMI of 30 or higher: obese Policy 1. The HIV epidemic is occurring in populations where malnutrition is already endemic. 132 As an urgent priority, greater political, financial and technical support should be provided for improving dietary quality and increasing dietary intake to recommended levels. In addition, focused evidence-based nutrition interventions should be part of all national AIDS control and treatment programs. 2. Nutrition counseling, care and support interventions for PLHIV will vary according to nutritional status and the extent of disease progression. Prompt diagnosis and treatment of HIV-related conditions, including use of ART when indicated, can contribute to improved nutrition and health. 3. Support should also be given to ensure the preparation of training and educational materials on nutritional care and support for people living with HIV. Responsibility at health facility A single individual should be assigned at each health facility to ensure staff training and quality assurance of all nutrition assessment, education, counseling and support. This individual should also ensure that all services meet or exceed national policies, practices and guidelines. All health workers responsible for providing patient care also need to be trained to provide education, counseling, and/or support for nutrition assessment, education, counseling and support. 133 SOP 22: Nutritional assessment Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To conduct nutritional assessment according to national guidelines for nutrition and HIV and as part of an integrated HIV service package. Responsibility Physician, clinical officer, or nurse Other health worker Nutrition counselor Peer educators, patient advocates, and community support workers Supplies 1. Counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, nutrition register, peer educator register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Adult weighing scale, calculator to determine BMI 4. Nutrition counseling materials as teaching aids and for distribution to patients 5. List of agencies that provide nutrition services by referral Procedure Greet client. Review medical records and/or referral forms from other health services for any previously identified nutritional deficits or nutrition interventions. Conduct directed patient history to assess: Date(s) of previous nutritional assessments if any HIV and non-HIV-related medications currently or previously taken and possible associated nutrition-related side effects (anorexia, change in taste of foods, inability to tolerate certain foods) Level of physical activity (field work, etc) and changes in activity level, ability to perform activities of daily life Traditional herbal or other remedies used 134 Presence of nutrition-related symptoms/signs or side effects including: weakness, weight loss, anorexia, nausea, abdominal pain, diarrhea, fever, thrush, anemia, oral lesions or pain, dysphagia Normal patterns of food intake and any recent appetite changes, use 24-hour recall method if time allows Patient history or current substance abuse (alcohol, drugs) Any psychological considerations that might influence food intake (fear, depression, hopelessness, suicidal tendency) Any family or social factors that might influence food intake (stigma, neglect, family violence, family alcohol abuse, food availability or intra-familial food distribution, food taboos, inadequate nutritional knowledge, inadequate assistance with household duties) Conduct directed physical exam. Measure and record height and weight. Compare weight to previous weight if available. Calculate BMI, and determine if measurements are within acceptable parameters: BMI = weight (kg) divided by height (m2) (see Table 33) Normal BMI is 18.5–24.9 kg/m2 Identify or rule out AIDS wasting syndrome (10% weight loss from baseline body weight with chronic diarrhea or weakness and fever for one month or more, in the absence of illness other than HIV infection). Identify typical ARV-related changes in body shape (lipodystrophy or changes in fat deposits and lean muscle distribution). Review most recent lab results to rule out anemia. Identify any other conditions that could influence nutritional status (OIs, psychological disorders). Schedule next appointment (keep in mind that nutritional assessment should be repeated at least every 3 months for asymptomatic patients and every 2 months for symptomatic patients): Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Document nutrition assessment and any other findings, actions, and discussions in patient record; document referrals for additional nutritional support Complete all relevant registers as per national guidelines Complete any nutrition monitoring forms and checklists. 135 Appendices Appendix C: How to do a 24-hour dietary recall Appendix D: Patient nutrition management form (adult) Appendix E: Nutritional assessment tool for PLWHIV Table 32: Modern medications and recommended food intakes and side effects of ARVs Medication (ARV) Abacavir (ABC) NRTI Didanosine (ddl) NRTI Lamivudine (3TC) NRTI Food recommendations Avoid Nausea, vomiting, fever, allergic reaction, anorexia, abdominal pain, diarrhea, anemia, rash, hypotension, pancreatitis, dyspnea, weakness and insomnia, cough, headache Can be taken without regard to food Take 30 minutes before or 2 hours after eating. Take with water only Can be taken without regard to food Possible side effects Alcohol, juice, antacids containing aluminum or magnesium Anorexia, diarrhea, nausea, vomiting, pain, headache, weakness, insomnia, rash, dry mouth, loss of taste, constipation, stomatitis, anemia, fever, dizziness, pancreatitis; do not take with antacid containing aluminum or magnesium Alcohol Nausea, vomiting, headache, dizziness, diarrhea, abdominal pain, nasal symptoms, cough, fatigue, pancreatitis, anemia, insomnia, muscle pain, rash. Limit alcohol Nausea, vomiting, diarrhea, peripheral neuropathy, chills and fever, anorexia, stomatitis, anemia, headaches, rash, bone marrow suppression, pancreatitis. May increase the risk of lipodystrophy. Stavudine (d4T) NRTI Can be taken without regard to food Tenofovir (TDF) NRTI Take with a meal Abdominal pain, headache, fatigue, dizziness Zidovudine (AZT) NRTI Better to take without food, but if it causes nausea or stomach problems, take with a low-fat meal. Do not take with a high-fat meal. Alcohol Anorexia, anemia, nausea, vomiting, bone marrow suppression, headache, fatigue, constipation, fever, dizziness, dyspnea, insomnia, muscle pain, rash Efavirenz NNRTI Can be taken with food, but do not take Alcohol Elevated blood cholesterol levels, elevated triglycerides levels, rash, 136 Medication (ARV) Food recommendations Avoid with a high fat meal Nevirapine (NVP) NNRTI Can be taken without regard to food Indinavir (IDV) PI Take on an empty stomach, one hour before or two hours after a meal. Or take with a light, non-fat meal. Take with water. Drink at least 1500 ml of fluids aily to prevent kidney stones. Possible side effects dizziness, anorexia, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence St John’s wort Nausea, vomiting rash, fever, headache, skin reactions, fatigue, stomatitis, abdominal pain, drowsiness, paresthesia; high hepatoxicity Grapefruit. St John’s wort. Nausea, abdominal pain, headache, kidney stones, taste changes, vomiting, regurgitation, diarrhea, insomnia, ascites, weakness, dizziness. May increase the risk of lipodystrophy. Lopinavir (LPV) PI Can be taken without regard to food St John’s wort Abdominal pain, diarrhea, headaches, headache, regard to food weakness nausea; may increase the risk of lipodystrophy and diabetes Nelfinavir (NFV) PI Take with meal or light snack St John’s wort Diarrhea, flatulence, nausea, abdominal pain, rash; may increase the risk of lipodystrophy Ritonavir (RTV) PI Take with meal if possible St John’s wort Nausea, vomiting, diarrhea, hepatitis, jaundice, weakness, anorexia, abdominal pain, fever, diabetes, headache, dizziness; may increase the risk of lipodystrophy Saquinavir (SQV) PI Take with meal or light snack; take within two hours of a high fat and high calcium meal Garlic supplements, St John’s wort Mouth ulceration, taste changes nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, weakness rash, headache; may increase the risk of lipodystrophy From: Pronsky, Z., S.A. Meyer, and C. Fields-Gardner, HIV Medications Food Interactions, 2001. Nerad, J., M. Romeyn, E. Silverman, J. Allen-Reid, D. Dietrich, J. Merchant, V. Pelletier, D. Tinnerello, and M. Fenton, “General Nutrition Management in Patients Infected with Human Immunodeficiency Virus.” Clinical Infectious Diseases. 2003:36. “Optimizing Anti-HIV Medications,” The Cutting Edge, 2001. [www.tceconsult.org] WHO. Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public Health Approach. 2003 Revision. Geneva, December 2003. 137 Table 33: Body mass index (BMI): Adults and adolescents Vertex42, Spreadsheet Templates, Calculators, and Calendars, The Guide to Excel in Everything. Available at: http://www.vertex42.com/ExcelTemplates/Images/body-mass-index-chart.gif 138 SOP 23: Determine level of nutritional support needed Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To determine appropriate level of nutritional support required according to national guidelines for nutrition and HIV and as part of an integrated HIV service package. Responsibility Physician, clinical officer, or nurse Other health worker Nutrition counselor Peer educators, patient advocates, and community support workers Supplies 1. Counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, nutrition register, peer education register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Adult weighing scale, calculator to determine BMI 4. Nutrition counseling materials as teaching aids and for distribution to patients 5. List of agencies that provide nutrition services by referral Procedure If all findings within normal limits based on nutritional assessment (see SOP 22), collaborate with patient and family to prepare a realistic patient nutrition plan to maintain continued adequate nutrition intake, or refer for nutrition counseling. Encourage all adults with HIV to become actively involved in monitoring their own nutritional status. If documented AIDS wasting syndrome or BMI extremely outside normal range, meet with partner or family and schedule urgent joint medical and nutrition consultation. Schedule appointment for follow up medical and/or nutritional consultation and food supplementation if: BMI less than 18.5 or unintended weight loss of 6–7 kg in one month regardless of BMI Patients not on ART with weight loss 10% or more within 2–3 months (to consider 139 ART initiation) Patients with weight loss more than 5% of baseline weight within past 2–3 months If Hgb levels less than 11mg/dl, dispense or recommend iron folate supplementation, increased consumption of iron-containing dietary sources, assessment of ART regimen (AZT). If changes in body shape or muscle tone noted, consider ARV regimen change or obtain medical consult to determine if side effects require change in ARV regimen. Depending on nutritional status of patient, document request for repeat nutritional assessment and weight measurement at least every 3 months for asymptomatic patients and every 2 months for symptomatic patients. Identify through discussion with patient, partner and family any household food security issues or other family/socioeconomic factors that could influence nutritional status. Counsel or refer to address household or community nutrition or food security barriers identified, and to assist with linkages to food supplementation programs or other available nutrition improvement programs and resources. Schedule next appointment (keep in mind that nutritional assessment should be repeated at least every 3 months for asymptomatic patients and every 2 months for symptomatic patients): Schedule earlier appointment if required for follow-up of problems identified during the visit Record appointment in follow-up register Document: Document nutrition assessment and any other findings, actions, and discussions in patient record; document referrals for additional nutritional support Complete all relevant registers as per national guidelines Complete any nutrition monitoring forms and checklists 140 SOP 24: Develop nutrition care plan Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To develop individualized patient nutrition care plan according to national guidelines for nutrition and HIV and as part of an integrated HIV service package. Note to health workers: all clinical staff should ensure that they have an understanding of factors influencing nutrition and nutrition intake in their HIV patients, local food preferences and food preparation methods, cultural norms that influence household food distribution, local food availability and affordability (“purchase power”). Responsibility Physician, clinical officer, or nurse Other health worker Nutrition counselor Peer educators, patient advocates, and community support workers Supplies 1. Counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, nutrition register, followup/default register, etc) as per national guidelines 3. Equipment/supplies: a. Adult weighing scale, calculator to determine BMI 4. Nutrition counseling materials as teaching aids and for distribution to patients 5. List of agencies that provide nutrition services by referral Procedure Support PLHIV to eat nutritious diet and maintain or gain weight by: Increasing amount and frequency of food consumed that are rich in energy/calories, protein, fats and micronutrients Eating between-meal snacks when possible, even if this is not cultural norm Taking vitamin supplements if recommended and available Adjust food intake to correspond with food-drug interactions and food 141 requirements of ART and other HIV-related drugs (some ARVs should be taken with food, iron supplements should not be taken with fiber-rich foods, etc) Encourage family members to actively observe patient’s nutritional status and provide support for improved dietary intake. Assure that individual nutrition plan addresses specific household or community food security barriers identified. Actively assist with referrals and linkages to food supplementation programs or other community-available nutrition improvement programs and resources. Consult with or refer to nutritionist or nutrition counselor to assure receipt of above nutrition planning if appropriate and available. Advise and discuss with patients, and their families, other factors that may affect nutritional and overall health status Recommend adequate water intake (8 glasses/day). All drinking water and water used to swallow medicines should be boiled or filtered. Discuss practices that may interfere with food intake or absorption including alcohol consumption, smoking or chewing tobacco, illegal drug use, excessive tea, coffee or soft drinks. Discuss basic concepts of food and water safety, personal hygiene (hand washing before eating or handling food, wash fresh fruits and vegetables in clean water, thorough cooking of meats and safe food storage). Recommend regular physical activity to promote body strength and prevent loss of muscle mass and tone. If living in hookworm-endemic area, recommend semi-annual de-worming treatment for all household members, except women in the first trimester of pregnancy. Schedule next appointment (keep in mind that nutritional assessment should be repeated at least every 3 months for asymptomatic patients and every 2 months for symptomatic patients): Schedule earlier appointment if required for follow-up of problems identified during the visit Document: Document nutrition assessment and any other findings, actions, and discussions in patient record; document referrals for additional nutritional support Complete all relevant registers as per national guidelines Complete any nutrition monitoring forms and checklists 142 Mental Health Background Purpose of SOPs 25, 26 and 27 is to support the assessment of patient mental health and determine the appropriate level of mental health/psychosocial support required as part of comprehensive care, treatment and support to adults with HIV. Mental health and HIV are closely interlinked. Mental health problems, including substance abuse, are associated with increased prevalence of HIV and can interfere with treatment. Conversely some mental disorders (HIV encephalopathy, depression, mania, cognitive impairment, and HIV-Associated Dementia) occur as a direct result of HIV infection. Also, some OIs and some ARVs can have side effects that influence psychiatric and mental health status. Alcohol/substance abuse is considered mental health disorders. Screening for substance use is particularly important in HIV-infected patients because both are risk factors for acquisition and transmission of HIV infection. Addressing alcohol/substance use can help patients improve adherence to HIV medications and adopt risk-reduction behaviors, such as practicing safer sex. Timely diagnosis and treatment of common mental health problems in HIV-infected individuals, including alcohol abuse and its consequences, and referral to specialized mental health and psychosocial support services when available presents an opportunity to improve the health and well-being of people with HIV. Mental health services should be an integral part of comprehensive HIV services, with close collaboration at all levels to facilitate coordinated action among health services and community-based resources. Definitions Mental health refers to a psychological or emotional state of an individual. Mental illness is any disease or condition affecting the brain that significantly influences or disrupts a person's thinking, feeling, mood, ability to relate to others and daily functioning. Psychosocial support: The counseling and support that is provided to address the range of social and psychological needs of families affected by HIV. Policy 1. Management of individuals with HIV infection should be based on a family-care model; the multidisciplinary team should assess the PLHIV in the context of the family and ensure family members are linked to appropriate care and treatment (including community psychosocial services as well as healthcare services). 2. Patients with HIV and their family members should be referred to other health services or community services as needed. Care should be coordinated as much as possible to reduce the burden of visits. 143 3. A chronic care model should be utilized so that clients are seen regularly and routinely for monitoring and health promotion activities as well as seen for episodic care in the event of acute illness. 4. A multidisciplinary team approach should be utilized for the care of clients living with HIV. Teams may include a nurse, prescribing clinician, pharmacist, counselor, social worker, community health workers, and others. Responsibility at health facility A single individual should be assigned at each health facility to ensure all services meet or exceed national policies, practices and guidelines. This individual should also establish standards where no local or national standards exist and supervise psychosocial support and family-centered care. Psychosocial support services are provided by all health workers. 144 SOP 25: Conduct mental health assessment Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To conduct mental health assessment as part of an integrated HIV service package. Responsibility Physician, clinical officer, or nurse Other health worker Mental health and/or psychosocial support workers Social workers Peer educators Patient advocates Community support workers Supplies 1. Counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Mental health/psychosocial referral forms b. Mental health status checklists 4. Mental health counseling materials as teaching aids and for distribution to patients 5. List of agencies that provide mental health services by referral Procedure Greet client and observe overall affect, appropriateness of dress, hygiene/personal grooming. Review medical records and/or referral forms for documented history of preexisting mental health problems and previous treatment interventions. Conduct directed patient history to assess: Date(s) of previous mental health assessments and diagnoses if any Pre-existing long-term decreased mental status such as mental retardation 145 Mental health-related medications currently or previously taken and possible associated side effects Level of physical activity (field work, etc) and changes in activity level, ability to perform activities of daily life Presence of mental health-related symptoms/signs including: weight loss, anorexia, changes in affect or mood swings (affective lability), excessive worry, sleep disturbances, changes in sexual desire or habits, decreased attention span or concentration Traditional herbal or other remedies used History of or current substance abuse (alcohol, drugs) Any psychological considerations that might influence mental status (the impact of HIV diagnosis, living with a chronic life-threatening illness, fear of inability to cope with complicated visit schedule and treatment regimens, fear of shortened life expectancy/death, concern over stigma and loss of social support depression, hopelessness, suicidal tendency) History of disinhibition, often substance abuse-related (sexual contact with multiple partners, abusive sexual practices, unprotected sex or low use of condoms) Any family or social factors that might influence mental health (stigma, neglect, family violence (see Table 34), family alcohol abuse, inadequate social support) Schedule next appointment: Schedule earlier appointment if required for follow-up of issues identified during the visit Record appointment in follow-up register Document: Document mental health assessment and any other findings, actions, and discussions in patient record; document referrals for additional mental health support Complete all relevant registers as per national guidelines Complete any mental health/psychosocial monitoring forms, mental health status checklists, as well as any referral forms 146 Table 34: Common indications for domestic violence mental health care for people with HIV Common Presenting Problems and History in Patients Involved in Domestic Violence Behavioral Cues of Domestic Violence Victims Batterer’s History and Behavior Stress and anxiety disorders including PTSD and panic attacks Alcohol or substance dependence or use Insomnia Eating disorders Fatigue, malaise, and vague or psychosomatic complaints Chronic pain Severe headaches Depression Trauma-related injuries Suicidal ideation or attempts Relationship problems Exacerbation of chronic illnesses (e.g., asthma, migraines) Change in appointment pattern Flat or incongruent affectation Fearfulness toward partner Apologizes for or rationalizes partner’s behavior (even non-abusive behavior) Bases plans and decisions on what partner wants rather than on his/her own wishes Performs degrading, inhumane, or inappropriate tasks Refers to partner’s temper frequently Focuses on how he/she harmed partner Flees from home or seeks shelter frequently Suicide attempts Intoxication, alcoholism, drug use Aggressive or abusive toward partner, practitioner, or other staff Overly attentive to partner Cancels partner’s appointments Aggressively presents self as victim Visible defensive injury pattern Refuses/resents needed medical or mental health care for partner From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner. 147 SOP 26: Conduct mental status examinations Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To conduct mental status and physical examinations (with focus on cognitive/motor and substance abuse related impairments) as part of an integrated HIV service package. Responsibility Physician, clinical officer, or nurse Other health worker Mental health and/or psychosocial support workers Social workers Peer educators Patient advocates Community support workers Supplies 1. Counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Mental health/psychosocial referral forms b. Mental health status checklists 4. Mental health counseling materials as teaching aids and for distribution to patients 5. List of agencies that provide mental health services by referral Procedure Conduct directed mental status examination with focus on: General assessment: appearance, behavior, attitude, speech Affective impairment: Apathy, irritability, mania (heightened self-esteem or grandiosity, decreased need for sleep, excessive often inappropriate speech (“flight of ideas”), anxiety (excessive worry, feelings of loss of control, fear of rejection/isolation/death), 148 memory deterioration Insight, judgment, daily functioning: adequate understanding of HIV diagnosis and progression of illness, risk of HIV transmission to others, medication and visit adherence Mood: sadness, depression, ability to enjoy life, anxiety, irritability, suicidal or homicidal ideation, violent urges or actions Behavioral impairment: psychomotor changes (slowed speech or response time) Substance-abuse related impairment: blackouts, retrograde amnesia (inability to remember events that occurred when under influence of alcohol or drugs), symptoms or signs of alcohol or drug withdrawal when patient attempts withdrawal of abused substance (tremors, extreme anxiety, visual/auditory hallucinations, psychomotor agitation, seizures) Conduct directed physical exam with focus on: Cognitive impairment: decline in memory, reasoning, judgment, concentration, and problem solving: inability to remember simple word sequences or perform simple tasks, to accurately identify date, year, day of week (temporal memory); decreased verbal fluency (decreased conversation or inappropriate comments) hallucinations or delusions (hearing voices), nightmares, paranoid ideation Motor impairment: unsteady gait, loss of balance, leg weakness, tremors, hypoactive or hyperactive reflexes, nystagmus or other abnormalities of eye motion, neurologic abnormalities (tremors, myoclonus, asterixis (abnormal tremor or involuntary jerking movements) nystagmus, ataxia, decreased sensation to pinprick or other stimulus, cranial nerve palsy) Substance-abuse related impairment: ascites, skin changes suggestive of alcohol related vitamin deficiency (Vitamin B12/folate deficiency), malnutrition, muscle wasting, peptic ulcer, gastritis Review recent CD4 count or order to determine level of immunosuppression: CD4 cell counts from 200 to 500/microL: HIV-associated cognitive and motor disorders are common CD4+ count falls to less than 200 cells/microL: rule out AIDS dementia complex or HIV associated dementia CD4 cell counts <200/microL: CNS mass lesions common. rule out OIs and AIDS-associated tumors, such as primary CNS lymphoma Review lab results or order lab tests to rule out anemia, electrolyte or glucose imbalances, liver enzyme abnormalities, syphilis Identify any other conditions or HIV-related central nervous system disorders that could influence mental status: OIs (including toxoplasmosis, cryptococcosis, lymphoma, progressive multifocal leukoencephalopathy (PML)), lymphoma 149 Psychological disorders: encephalopathy, depression, mania, cognitive disorder, HIV-associated dementia Review current ARV or other HIV and non-HIV related medication use and timing of occurrence of possible medication side effects: Determine if medication type(s) or schedule need to be adjusted/changed to control or diminish psychiatric symptoms or side effects, request consultation if required (see Tables 35 and 36) If traditional herbal medications or treatments used, consider possibility of psychiatric side effects/interactions with prescribed medications Schedule next appointment: Schedule earlier appointment if required for follow-up of issues identified during the visit Record appointment in follow-up register Document: Document mental health assessment and any other findings, actions, and discussions in patient record; document referrals for additional mental health support Complete all relevant registers as per national guidelines Complete any mental health/psychosocial monitoring forms, mental health status checklists, as well as any referral forms 150 Table 35: Neuropsychiatric side effects of selected medications used in HIV disease Drug Side Effects Acyclovir Visual hallucinations, depersonalization, tearfulness, confusion, hyperesthesia, hyperacusis, thought insertion, insomnia Amphotericin B Delerium, peripheral neuropathy, diplopia Lactam antibiotics Confusion, paranoia, hallucinations, mania, coma CTX Depression, loss of appetite, insomnia, apathy Cycloserine Psychosis, somnolence, depression, confusion, tremor, vertigo, paresis, seizure, dysarthria Didanosine Nervousness, anxiety, confusion, seizures, insomnia, peripheral neuropathy Efavirenz Nightmares, depression, confusion Foscarnet Paresthesias, seizures, headache, irritability, hallucinations, confusion Interferon Depression, weakness, headache, myalgias, confusion INH Depression, agitation, hallucinations, paranoia, impaired memory, anxiety Lamivudine Insomnia, mania Methotrexate Encephalopathy (at high dose) Pentamidine Confusion, anxiety, lability, hallucinations Procarbazine Mania, loss of appetite, insomnia, nightmares, confusion, malaise Quinolones Psychosis, delirium, seizures, anxiety, insomnia, depression Stavudine Headache, asthenia, malaise, confusion, depression, seizures, excitability, anxiety, mania, early morning awakening, insomnia Sulfonamides Psychosis, delirium, confusion, depression, hallucinations Thiabendazole Hallucinations, olfactory disturbance Vinblastine Depression, loss of appetite, headache Vincristine Hallucinations, headache, ataxia, sensory loss Zalcitabine Headaches, confusion, impaired concentration, somnolence, asthenia, depression, seizures, peripheral neuropathy Zidovudine Headache, malaise, asthenia, insomnia, unusually vivid dreams, restlessness, severe agitation, mania, auditory hallucinations, confusion From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner. 151 Table 36: Interactions between HIV-related medications and psychotropic medications: indications and contraindications Medication Contraindicated Possible Dose Adjustment Fluoxetine and fluvoxamine Carbamazepine, may increase PI phenobarbital, phenytoin concentration and toxicity. levels rise: monitor levels Carbamazepine, and adjust prn. phenobarbital, phenytoin, primidone, St. John’s wort reduce level of PI, and concurrent use should be avoided. Avoid pimozide if possible. Use With Caution Amprenavir Alprazolam, diazepam, midazolam, triazolam, zolpidem Clarithromycin None identified St. John’s wort may decrease level of clarithromycin. Carbamazepine level rises: monitor level and adjust prn. Initial dose of benzodiazepines (i.e., alprazolam, midazolam) should be reduced, as clarithromycin may increase levels. Delavirdine Alprazolam, midazolam, triazolam Fluoxetine, fluvoxamine and nefazodone may increase NNRTI level and increase toxicity. Carbamazepine, phenobarbital, phenytoin, St. John’s wort can lower delavirdine levels: avoid concurrent use if possible. Avoid pimozide if possible. Carbamazepine levels may rise: monitor and adjust prn. Didanosine (ddI) None identified Gabapentin levels decreased by antacid: ddI should be given 2 hours before or after. Methadone decreases ddI: consider increased dose. Efavirenz Alprazolam, diazepam, midazolam, pimozide, triazolam Fluoxetine, fluvoxamine, and nefazodone may increase NNRTI level and increase toxicity. St. John’s wort may decrease efavirenz levels and should be avoided. Methadone levels decreased: may need to increase dose. Carbamazepine levels may rise: monitor and adjust prn. Fluconazole None identified None identified Carbamazepine and phenytoin levels rise: monitor level and decrease dose prn. Due 152 Medication Contraindicated Use With Caution Possible Dose Adjustment to CNS effects, may need to decrease dose of benzodiazepines (i.e., alprazolam, midazolam, triazolam), methadone, or zolpidem. Levels of amitryptyline and nortriptyline may rise: monitor and adjust prn. Indinavir Diazepam, midazolam, St. John’s wort, triazolam, zolpidem Fluoxetine, fluvoxamine, and nefazodone increase PI level and increase toxicity. Carbamazepine, phenobarbital, phenytoin, and primidone reduce indinavir level. Avoid pimozide if possible. Carbamazepine level rises: monitor and lower dose prn. Ketoconazole Alprazolam, clonazepam, diazepam, midazolam, triazolam None identified Carbamazepine and ethosuximide levels rise: monitor toxicity and lower dose if necessary. Lamivudine None identified None identified None identified Lopinavir/ Ritonavir* Alprazolam, buproprion, clorazepate, clozapine, diazepam, estazolam, flurazepam, midazolam, pimozide, St. John’s wort, triazolam, zolpidem Fluoxetine, fluvoxamine, and PI levels may increase. Mexiletine levels rise and may cause greater cardiac/neurologic toxicity: use with caution. Phenobarbital and primidone levels may rise and PI level fall: avoid concurrent use if possible. Desipramine levels may rise significantly: consider 50% lower dose. Meperidine and methadone levels decrease: may need increased dose. Carbamazepine, clonazepam, nefazadone, and sertraline: initial dose should be reduced 70%. Trazodone levels may increase: start low. Phenothiazines, SSRIs, and TCAs should have initial dose reduced by 50% and be monitored closely for toxicity. Valproic acid, phenytoin doses may need to be higher. Ethosuximide level rises: may need to lower dose. 153 Medication Contraindicated Possible Dose Adjustment Fluoxetine and fluvoxamine None identified may increase PI level. Carbamazepine, phenobarbital, phenytoin, primidone may decrease PI: avoid concurrent use if possible. Avoid pimozide if possible. Use With Caution Nelfinavir Diazepam, midazolam, St. John’s wort, triazolam, zolpidem Nevirapine St. John’s wort Fluoxetine and fluvoxamine Methadone levels may increase NNRTI level. lowered: may need higher dose. Carbamazepine levels rise, PI level may drop: avoid concurrent use if possible. Pyrimethamine Lorazepam increases risk of hepatic toxicity (monitor LFTs). None identified None identified Rifabutin and Rifampin None identified None identified Methadone level decreases and higher dose may be needed. Carbamazepine, phenytoin, valproic acid levels may decrease: may need to increase dose based upon levels. Ritonavir Alprazolam, buproprion, clorazepate, clozapine, diazepam, estazolam, flurazepam, midazolam, pimozide, St. John’s wort, triazolam, zolpidem Fluoxetine, fluvoxamine, and PI levels may increase. Mexiletine levels rise and may cause greater cardiac/neurologic toxicity: use with caution. Phenobarbital and primidone levels may rise and PI level fall: avoid concurrent use if possible. Desipramine levels may rise significantly: consider 50% lower dose. Meperidine and methadone levels decrease: may need increased dose. Carbamazepine, clonazepam, nefazadone, and sertraline: initial dose should be reduced 70%. Trazodone levels may increase: start low. Phenothiazines, SSRIs, and TCAs should have initial dose reduced by 50% and be monitored closely for toxicity. Valproic acid, phenytoin doses may need to be 154 Medication Possible Dose Adjustment higher. Ethosuximide level rises: may need to lower dose. Contraindicated Use With Caution Saquinavir Diazepam, midazolam, St. John’s wort, triazolam, zolpidem Fluoxetine and fluvoxamine may increase PI level and toxicity. Phenobarbital and primidone can lower PI: avoid concurrent use if possible. Avoid pimozide if possible. Carbamazepine level rises (may need to lower dose prn) and PI falls when co-administered. Stavudine None identified None identified None identified Zalcitabine (ddC) None identified Disulfuram and phenytoin may increase risk for peripheral neuropathy. None identified Zidovudine None identified Methadone and valproic acid increase zidovudine levels: monitor for toxicity. None identified From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner. 155 SOP 27: Develop mental health care plan Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To develop an individualized patient mental health care plan based on integrated findings from mental status exam, physical exam and lab results, as part of an integrated HIV service package. Responsibility Physician, clinical officer, or nurse Other health worker Mental health and/or psychosocial support workers Social workers Peer educators Patient advocates Community support workers Supplies 1. Counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, follow-up/default register, etc) as per national guidelines 3. Equipment/supplies: a. Mental health/psychosocial referral forms b. Mental health status checklists 4. Mental health counseling materials as teaching aids and for distribution to patients 5. List of agencies that provide mental health services by referral Procedure Based on results of mental status exam, physical exam, laboratory parameters and other findings, determine need for: Initiation of ART (if findings indicate a new clinical stage 3 or 4 condition such as HIV encephalopathy) Initiation of other medical treatment for specific psychiatric condition/mental illness (antipsychotics, antidepressants, antianxiety agents), see Table 37 156 Change in HIV-related medication(s) Substance abuse treatment/counseling, or routine mental health counseling Psychosocial support for patient and family Depending on mental health status of patient, treat or request medical or psychiatric consultation to further assess and treat conditions diagnosed, especially in symptomatic patients. If alcohol abuse/dependence, substance abuse, or family violence documented, consider family consultation to determine need for active intervention to prevent or address alcohol abuse-associated family violence or other harmful behaviors. Refer to alcohol abuse counselor or program if available to develop a realistic plan for abstinence/withdrawal from abused substance. Prepare a realistic patient mental health plan based on assessment and available support services. Discuss mental health findings, options and follow-up actions required with patient and family: Provide reassurance, and provide or refer for counseling and psychosocial support sources for patient, partner and family Explain proposed drug treatment of mental illness and/or underlying medical condition(s) diagnosed Encourage active family participation in improving patient’s mental status and psychosocial well being Encourage patient to remain physically, mentally, and socially active as long as possible Schedule appointment: For follow up mental health consultation visit(s) if required For follow up psychosocial assessment visit and services if required With mental health appointments, it continue to be important to monitor adherence and missed appointments to avoid loss to follow up Document: Document mental health assessment and any other findings, actions, and discussions in patient record; document referrals for additional mental health support Complete all relevant registers as per national guidelines Complete any mental health/psychosocial monitoring forms, mental health status checklists, as well as any referral forms 157 Table 37: Drugs used to target symptoms of AIDS dementia complex Category Psychostimulant agents (for psychomotor slowing, apathy, and attention deficits) Drug Dosage Dextroamphetamine 5–15 mg/day Methylphenidate Initially 5–10 mg every morning; up to 3-times-aday dosing; maximum dose: 30–45 mg/day Pemoline 18.75 -75 mg every day; once-a-day dosing Antipsychotic agents Haloperidol 0.5–2 mg/day; up to tid Risperidone 0.5 -1 mg; up to tid Antimanic agents Lithium carbonate 600–1,200 mg/day up to blood levels of 0.6–1.2 mEq/L. Valproic acid 250 mg tid; titrate up to blood level of 50–100 mg/mL Carbamazepine to 4–12 µg/mL 200 mg bid; titrate up Gabapentin 100 mg tid; titrate to effect Olanzapine 2.5 mg qd; titrate up to 10 mg Paroxetine 10–20 mg q hs (up to 50 mg) Sertraline 25–50 mg q am (up to 200 mg) Fluoxetine 10–20 mg q am (up to 60 mg) Citalopram 10–20 mg q am (up to 40 mg) Desipramine 25 mg bid; titrate to 180 ng/mL Trazodone 50–100 mg hs Antidepressants (for depression) Comment Controlled substances Use lowest effective dose to avoid extrapyramidal effects, anticholinergic effects, or orthostasis; patients with AIDS are quite sensitive Use with caution; neurologic side effects and diarrhea may occur Use with caution; follow liver function tests Can cause leukopenia; monitor WBC Most sedating, so hs dose often preferred Most activating Used mainly as a sleeping aid; can be calming for agitated patient From: AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner. 158 SOP 28: Provide links to additional care sites Date of creation or Prepared by: revision: Reviewed by: Approved by: Purpose To determine the need for and manage the process of referral or transfer of patients, partners, children or other family members within the same facility, between facilities or levels of care, and to community sources of care and support for services beyond the scope of care of primary care site. Responsibility Physician, clinical officer, or nurse Triage staff Administrative staff Peer educator Patient advocates Community support workers Volunteers and other designated community members Supplies 1. Examination and counseling areas that offer adequate privacy 2. Medical record and relevant registers (HIV client register, referral/transfer register, peer educator registers, follow-up/default register, etc) as per national guidelines 3. Counseling materials as teaching aids and for distribution to patients 4. Two way referral forms and a list of agencies that provide mental health services by referral Procedure Determine the need for referral/transfer, at initial visit and at each monthly clinic visit Assess the patient to determine if additional treatment, care or support is required. Referral may be required for: HIV testing and counseling for partner, children or other family members Antenatal care clinic services if pregnancy occurs Maternal and child health clinic for testing of children in the family if not possible to 159 test infants/young children on-site Inpatient ward or special services (infectious disease, TB, gynecology, etc) Laboratory/radiology for further diagnostic work-up Facility-based support services such as peer educators Community support organizations Transfer may be required if: Patient requires chronic care beyond the scope of the primary care site Patient requests change of service location because of permanent move/ temporary change in primary household location Patient prefers to change treatment site for any other reason Determine specific types of referral/transfer required. Suggest an appropriate, realistic referral/transfer plan. Discuss the referral or transfer plan with the patient. Schedule a specific date and time for the patient to report to the referral or transfer site that is realistic for the patient and family. Provide sufficient amount of medication(s) to allow for the referral or transfer to take place, if required. Complete referral form containing reason for referral/transfer, summary of treatment and care received to date. Give a copy of the referral form to the patient/family and instructions to present it on arrival at the referral/transfer site. Discuss with patient and family to determine support required to facilitate referral/transfer. Assist patients with location additional referral support if required. Notify additional care site of referral/transfer plan and assure adherence to referral Make initial contact with the site for notification of patient referral or transfer using forms for two-way referral/transfer feedback process. Send form to referral site to be returned to your site at time of arrival/treatment of patient including: date patient arrives for additional continuing treatment, treatment provided, final treatment outcome. Contact the referral/transfer site to check if the patient completed the referral/transfer utilizing two-way referral/transfer mechanism. Check incoming referral reports regularly to assure adherence with referral /transfer, and that appropriate care was received. 160 Initiate tracking/follow up process if no return information received within two weeks to one month depending on circumstances. Assure that confidentiality is maintained throughout the referral/transfer process. Schedule appointment, if appropriate, for routine follow up: Record appointment(s) in follow-up register Document: Document all referrals in patient record Complete all relevant registers as per national guidelines 161 Appendices Appendix A: Patient adherence record form Folder No: Date: / / (dd/mm/yyyy) Treatment was initiated on: / / Duration of treatment: / (dd/mm/yyyy) (months / years) Begin by telling the patient that, “Most people with HIV have many pills to take at different times during the day. Many people find it hard to always remember to take their pills. It is important for me to understand how you are really doing with your medicine. Don’t worry about telling me if you don’t always take all your doses. I need to know what is really happening, not what you think I want to hear.” Self-Reporting Please mark the client’s response to the following questions. Question Yes No Do you sometimes find it difficult to remember to take your medicine? When you feel better, do you sometimes stop taking your medicine? Thinking back over the past four days, have you missed any of your doses? Sometimes if you feel worse when you take the medicine, do you stop talking it? Visual Analogue Scale (VAS) Ask the client to think back over the past four days and identify the times when he or she either missed a dose or took it at the wrong time. Show the client a copy of this visual analogue scale, or an unmarked enlarged version. While placing your finger on the appropriate place, tell the client that if he or she had taken all medicine doses to point to 10. If the client missed all the doses, he or she would point to 0 — in the meantime, you move your finger to 0. Now give the client an opportunity to point out their level of adherence. The health care worker then marks the visual analogue scale. If the scale is marked off at 4, then the percentage adherence would be 40 percent. 162 0 1 2 3 4 5 6 7 8 9 10 Score: % Pill Identification Test (PIT) Ask the client to inspect each container and its contents. He or she should then tell you the name of the medication, number of pills to take per dose, the times he or she takes the medication, and whether there are any additional instructions. Medication Knows the name (Y / N) Knows the number of pills per dose (Y / N) Time the medication is taken Judged Morning Evening correct (hour) (hour) (Y / N) Knows any additional instruction Pill Count Yes* Did the client return the medication containers? No *If yes, check that the client only used medication from this container since the date of their last visit. If leftover medication had been used or an emergency prescription obtained, then the calculation will be invalid—omit and move to Adherence Assessment. Dispensed Returned % Adherence = X 100 = X 100 = % Expected to be taken Adherence Assessment Self-reporting VAS PIT — Client knows the… Pill count Overall adherence No to all questions Yes to 1 question 95% or more Dose, time, and instructions 95% or more High 75–94% Dose and time 75–94% Moderate Yes to 2 or more questions Less than 75% Dose only or confused Less than 75% Low 163 Adherence Support Measures Code AS01 AS02 AS03 AS04 AS05 AS06 Notes Treatment preparednes Treatment buddy or community health work Home visit Medication counseling—dosing regimen and instructions Medication counseling—show and tell Medication counseling—safety AS07 AS08 AS09 AS10 AS11 AS12 Life style inventory AS13 AS99 Personalized printed medication information Medication diary Motivational interviewing Reminder such as a pill box Support groups Printed medication information Other—please specify under notes Comments (Insert comments as needed) Adherence Improvement Plan (Include details of plan agreed on with client) 164 Instructions for completing Patient adherence record form Background This tool has been designed to assist pharmacists, pharmacy assistants, nurses and doctors in the assessment and monitoring of adherence to long term therapies such as ART. The adherence record should be retained in the client’s medical records for future reference in planning adherence improvement interventions. The adherence assessment can be performed routinely. However if this is not possible it is recommended that adherence be assessed whenever a viral load is performed, treatment failure is suspected, adherence problems are suspected ,a step-up adherence intervention has been initiated and/or when a change in regimen is being contemplated. This medication adherence record is a multi-method tool comprised of four components that had been previously validated. This approach has been adopted based upon the WHO recommendation that states, “A multi-method approach that combines feasible self-reporting and reasonable objective measures is the current state-of-the-art in measurement of adherence behavior.” The four sections of the tool include: 5. Self-report 6. VAS 7. PIT 8. Pill count The tool’s fundamental premise is that the regimen, rather than the individual medicines, is the unit for assessing adherence. Selective adherence to some but not all of the medications in the combination regimen means that the intended benefits of combination therapy (pharmacological synergy) are not achieved, and in the instance of infectious disease, may precipitate resistance. Basic Methodology The data elements of this adherence assessment tool must be completed by the health care worker administering the tool and not the client. Before assessing the client’s adherence levels, it is important to set the scene by informing the client that this assessment is not punitive but rather aimed at helping them achieve optimal adherence. A recommended approach would be to tell the client that: “Most people with HIV have many pills to take at different times during the day. Many people find it hard to always remember to take their pills. It is important for me to understand how you are really doing with your medicine. Don’t worry about telling me if you don’t always take all your doses. I need to know what is really happening, not what you think I want to hear.” 165 In the self-report, the health care worker guides clients through a series of questions to which they respond yes or no. An adherent client will respond no to all questions. This helps validates responses since ordinarily clients tend to respond yes to any questions posed to them by a health care professional to please them. A visual analogue scale has been included to verify the verbal responses. In this question, clients are asked to rate their adherence to their medication over the past four weeks. The client then indicates on a graduated scale where they believe their adherence has been during this period. The pill identification test begins with the health care personnel familiarizing themselves with the last prescription that was dispensed. This is then followed by the client being shown a physical example or photograph of the same brand of the tablet, capsule, or bottle for liquid preparations that the client had been given in the preceding month —this is key. The client then attempts to name the product and describes: The number of tablets, capsules, and medicine measures that he or she consumes at each dosing interval. The exact time when he or she takes the dose. (As the client describes these times, pay careful attention to the spontaneity of the response and not merely the correctness on the dosing times. Probe for further responses.) Additional instructions he or she follows when taking the medication such as remembering to have a meal before taking the dose. (If the client does not provide the correct information use open-ended questions to verify how they take their doses.) Wait until the client has completed explaining all of the medications in the regimen before providing corrective counseling for any medication that requires it. In the pill count, the returned medication is counted and the percentage adherence is calculated using the equation provided. Note that the denominator is the amount of medication that the client is expected to have taken and not the amount that was dispensed. Detailed Instructions Folder No: Date: / / (dd/mm/yyyy) The folder number and date are recorded to allow copies of the form to be kept in the client’s folder. Changes in the client’s adherence can also be monitored over time. Ongoing monitoring of adherence is important as adherence generally tends to decrease with time. Treatment was initiated on: / / (dd/mm/yyyy) Duration of treatment: / (months / years) 166 Self-Report Clients tend to answer yes to questions posed to them by their health care provider to please them. Based upon this observation, the questions have been designed so that an adherent client gives a no response. Question Yes No A. Do you sometimes find it difficult to remember to take your medication? This question aims to test whether there are established dosing cues in the client’s daily routine. B. When you feel better, do you sometimes take a break from your medication? Clients frequently stop taking their medication when their presenting health problem has been resolved. C. Thinking back over the past four days, have you missed any of your doses? Try to get the client to think back over the past few days. It may help to identify a routine daily event such as meals, work, or television programs watched, and enquire about the nature of that event four days previously. For example, ask the client what they had for dinner on Tuesday. D. Sometimes if you feel worse when you take the medicine, do you stop taking it? If the presenting health problem has not produced symptoms or the problems have been resolved, and there are bothersome side effects from the medicine, clients find it difficult to rationalize continued adherence. Assessing Adherence Count the number of No answers to questions A through D. If all 4 answers are No, then the client is classified as being highly adherent. If there is 1 Yes answer, then the client is classified as being moderately adherent. Where there are 2 or more Yes answers, the client is classified as having low adherence. Visual Analogue Scale (VAS) Ideally, use a laminated visual analogue scale (ruler) that has been enlarged or the scale on the questionnaire. Whichever form of the scale you use, it is important that you use an unmarked one. While placing your finger on 10, tell the client to also point to 10 if he or she had taken all medicine doses. If the client missed all the doses, he or she would point to 0 — in the meantime, you move your finger to 0. For a client using the visual analogue scale for the first time, it may help to ask the client to indicate where a theoretical client who managed to take all the doses would point, then to indicate where the theoretical client who had missed all of his or her doses would point. Note that during this demonstration we are using the third person. Now ask the client to think back about the dosing of their medication over the past four days. Having 167 given the client time to reflect ask them to place their finger on the point on the scale (ruler) that best reflects his or her adherence during this time. 0 1 2 3 4 5 6 7 8 9 10 Score: % Now score the percentage on the box as follows if the client chose 4, then the score will be 40 percent. Pill Identification Test (PIT) Familiarize yourself with the last prescription that was dispensed to the client. Pay careful attention to the brand that was dispensed in order to identify the identical product that the client has been using. Show the client a physical example or photograph of the identical tablet, capsule, or bottle for liquid preparations that he/she was given in the preceding month. Ask the client to inspect the contents of each container and its contents, and tell you the Medication’s name Number of pills to take per dose The actual times he or she takes the medication If there are any additional instructions relating to the medication such as store in a refrigerator, take with food, or avoid other medications Medication Knows the name (Y / N) Knows the number of pills per dose (Y / N) Time the medication is taken Morning (hour) Evening (hour) Judged correct (Y / N) Knows any additional instruction Note: The grey shaded column is the judgment of the health care worker administering the questionnaire. In the left hand column under medication, record the medication that has been assessed— feel free to use abbreviations, e.g., 3TC, to reduce the amount of writing. Ask the client to provide the name of the medication. Record the response by recording a Y for yes (correct response) and an N for no (incorrect response). If the response is incorrect, teach him or her the name of the medication. Note — the client’s response to this question is not included in the adherence assessment. Ask clients how many tablets, capsules, or medicine measures they take in the morning and then in the evening. If their response is correct for both, place a Y in the column; if either or both of the dosing times are incorrect, place N in the box. Now ask the clients to identify the usual time they take their morning and evening doses. Record the actual times in the boxes provided. As the client describes these times, pay careful attention to the spontaneity of the response, not only the correctness of 168 responses in terms of the dosing times. If there is hesitation, it may mean that they are taking their medication at inconsistent times (e.g., 1700h today, then 2000h tomorrow). Explore with the client whether or not it is possible for them to take their medication at a consistent time. This is achieved by taking a brief inventory of their daily activities during a typical week day followed by differences in schedule over weekends. If the times they take the medication are within reasonable limits (one hour) of the dosing interval, place a Y in the column; if incorrect, place an N in the column. Example: If the first dose of a 12-hour regimen is taken at 0700h, then ideally the evening dose would be 1900h; however, if the client takes their medication any time between 1800h and 2000h, it is considered acceptable for most medications. If you are uncertain about this, contact a person knowledgeable in pharmacology. Where the regimen is associated with a particular additional instruction, ask the client if there is anything special that they have to do when taking the dose such as the need to take the dose before or after a meal. If the client does not provide the correct information use open-ended questions to verify how they take their doses. If correct, place a Y in the column; if incorrect, a N. Wait until the client has completed providing responses on all of the medications in the regimen before providing corrective counseling for any medication that may be required. Example: Time the medication is taken D4T Knows the name (Y / N) Y Knows the number of pills per dose (Y / N) Y Morning (hour) 0715h Evening (hour) 2000h Judged correct (Y / N) Y Knows any additional instruction Y 3TC Y Y 0715h 2000h Y Y Efavirenz Y Y 0715h N Y Medication Pill Count Did the client return the medication containers? Yes No Calculated percentage adherence Dispensed Returned % Adherence = X 100 = X 100 = % Expected to be taken If the client returns the container, then check the yes box; and if the client did not, check the no box. For those clients who have not returned their medication container, skip the pill count calculation and move directly to the adherence assessment section. Check that the client only used medication from this container since the date of his or her last visit. If leftover medication had been used or an emergency prescription obtained, then the calculation will be invalid and should not be completed. 169 Record the quantity dispensed during the last visit in the space that says dispensed. Count the remaining tablets and write it in the space that says returned. Next count the number of days since the medication has been dispensed. Multiply the number of days by the prescribed number of tablets to be taken in a day. Example: 2 tablets twice daily = 2 x 2 = 4 tablets per day for 27 days = 4 x 27 = 108. The percentage adherence is then calculated as the number dispensed minus the number returned which is then divided by the number of tablets the client should have taken. Example: If 120 were dispensed and the client returned with 17 tablets and the regimen required 2 tablets twice a day to be taken for 27 days, the percentage adherence is— 120 17 % Adherence = X 100 = 95% 108 Adherence Assessment Self-reporting VAS PIT — Client knows the… Pill count Overall adherence No to all questions Yes to 1 question 95% or more Dose, time, and instructions 95% or more High 75–94% Dose and time 75–94% Moderate Yes to 2 or more questions Less than 75% Dose only or confused Less than 75% Low Check the results in the columns provided: If all the results appear in the same column, e.g., “All No,” “VAS 95 % or more,” “Dose, Time, and Instructions,” and the pill count was 95 percent or more, then the overall level of adherence is “High.” Although you may not have responses to all the four methods, you can still use this tool. Remember that each one of these measures indirectly assesses adherence but is slightly over or under what the adherence really is. So, the more measures that can be recorded, the stronger the probability that the adherence assessment accurately shows how the client takes medicine. This multi-method approach provides data from different sources that can be compared to assess client adherence (triangulation) to verify the true level of adherence. At the very minimum you should record the results of the self-report. However, this has a tendency to measure higher levels of adherence than actually happened. When the results do not all line up in a single vertical column If they are spread over two columns, take the adherence level of the right hand column as the estimated adherence. If they are spread over three columns, then use the middle level of adherence. 170 Example: Self-reporting No to all questions Yes to 1 question Yes to 2 or more questions 95% or more 75–94% Less than 75% Dose, time, and instructions Dose and time Dose only or confused 95% or more 75–94% Less than 75% High Moderate Low VAS PIT – Client knows the… Pill count Overall adherence Note: We record the level of adherence as High, Moderate, or Low instead of as a percentage. The percentage is important in a clinical trial; however, in clinical practice, the question we are trying to answer is whether or not there is sufficient adherence to prevent resistance or whether adherence support interventions are needed. If the level of adherence is high, record it in the clinic record and provide the client with reinforcement. For moderate levels of adherence, discuss the result with the client and continue to measure adherence levels. If moderate levels of adherence have been observed for three sequential visits, institute an adherence support measure. If a low level of adherence or non-adherence has been observed: Refer the client to a pharmacist for a step-up adherence intervention such as motivational interviewing. Monitor CD4 count as per usual and monitor viral load as the client is at risk of developing resistance. Adherence Support Measures Review the clinic records as well as past adherence assessment records and verify with the clients whether or not they had any additional aids to assist them in remembering to take their medications and record the menu of measures in the boxes provided by checking off the appropriate box. It is likely with any given client that more than one of the measures may have been used. Code Notes AS01 Treatment preparedness AS02 AS03 Treatment buddy or community health work AS04 AS05 AS06 Home visit Medication counseling — dosing regimen and instructions Medication counseling — show and tell Medication counseling — safety 171 Code Notes AS07 Life style inventory AS08 AS09 AS10 AS11 AS12 AS13 Medication diary AS99 Other — please specify under notes Motivational interviewing Reminder such as a pill box Support groups Printed medication information Personalized printed medication information Tick off the corresponding blocks for those adherence support measures that the client has been exposed to. The notes section allows for an expanded description of other interventions or the success or failures of the interventions. This record allows the pharmacist to decide on adherence support measures in those clients who require an adherence improvement intervention. Comments (Insert comments as needed) The comments section allows the pharmacist to record: A more detailed description of any identified adherence barriers Counseling points to facilitate incremental counseling Any pertinent information that would enrich future adherence counseling or other improvement interventions Adherence Improvement Plan (Include details of plan agreed on with client) This block allows the pharmacist to develop an adherence improvement plans for those clients who require it. It also serves to record planned future interventions for clients who are being actively monitored for the need of additional adherence improvement interventions. Steel, G., J. Nwokike, M. Joshi. Management Sciences for Health (2007). Development of a Multi-Method Tool to Measure ART Adherence in Resource-Constrained Settings: The South Africa Experience, p 3143 172 Appendix B: Clinical algorithms Acute Diarrhea (<3 Weeks) Check vital signs. Is patient severely dehydrated? Check orthostatics (lying down and standing) and look for BP drop >15–20 mmHg or ↑pulse > 20 beats/minute YES Hx and Exam: duration, onset, stool appearance, bloody/non-bloody, large/small volume, ABX use, other people affected, N/V, fever, abdominal pain, frequency? FEBRILE OR BLOODY DIARRHEA RECENT ABX USE If severe, check HLT, BUN/Cr, WBC Stool culture/ analysis IV fluids ASAP Febrile? Bloody? NO SALMONELLA: Cipro 500 mg BD or Septrin DS mg BD x 2/52 SHIGELLA: Cipro 500 mg BD x 5/7 CAMPYLOBACTER: Erythromycin 500 mg BD or Cipro 500 mg BD x 5/7 AMEBIASIS: Flagyl 500 mg TID x 7–10 days followed by Diloxanide 500mg TID x 10 days FATTY (FLOATING) Malabsorption – check amylase YES ABX – assoc. diarrhea, should resolve WATERY DIARRHEA Consider HIV enteropathy – supportive care (bland foods, no caffeine or lactose) C. DIFFICILE: Flagyl 500 mg PO TID x 7–10 days. NO anti-motility drugs For all patients: Good hand washing, especially around children Boil water Avoid raw foods (meat) STD workup including syphilis, gonorrhea, chlamydia, HSV Stool culture/ O&C CRYPTOSPORIDIUM: Paromomycin 500 mg QID x 4/52 MICROSPORIDIA: Most cannot be tx but can try albendazole 400 mg BD x 2–4 wks CYCLOSPORA: Septrin DS 4 tabs OD x 10/7 ISOSPORA: Septrin DS 4 tabs OD x 10/7, then 2 tabs OD x 3/52 GIARDIA: Flagyl 500 mg TID x 7/7 If culture negative, consider enteric viruses. Tx w/ supportive care – IVF, antimotility drugs If persistent sx, consider stool AFB stain or blood cultures for MAC 173 Chronic Diarrhea (3 or more stools/ day for 4 or more weeks) Hx and Exam: onset, associated sx, weight loss, abdominal pain, fever, bloody, CD4 count, medications Assess vital signs. Is pt dehydrated? Orthostatic? Hypotensive? NO YES Is the diarrhea bloody? Does pt look critically ill? Are there pulmonary sx or exam abnormalities? NO YES NO Order stool O&P and fecal WBC Any recent ABX use or hospitalizations (+ fecal WBC)? Does stool exam (culture) clearly identify Salmonella, Shigella, or Campylobacter? See pg 2 of algorithm. Consider CXR If CXR shows bilateral patchy infiltrates that are consistent w/ ARDS, strongly consider admission and tx for strongyloides hyperinfection syndrome, especially if pt has cutaneous findings (serpiginous lesions) Treat accordingly. Salmonella: Septrin DS 2 tabs OD x 3/52 Shigella: Septrin DS 2 tabs OD x 5/7 Campylobacter: Erythromycin 1000 mg OD x 5/7 YES NO, or stool culture not available Does stool exam show Entamoeba YES w/- fecal WBC? Treat w/ ivermectin 12 mg OD x 3 days plus supportive care and fluids. Continue monthly suppressive tx w/ ivermectin 6 mg or albendazole 400 mg Tx for E. histolytica: Metronidazole 500 mg TD x 10/7, then paromomycin 500 mg QID x 7/7 NO MAC → treat empirically: 1. Azithromycin 500 mg OD OR clarithromycin 500 mg BD AND 2. Ethambutol 15 mg/kg/day AND 3. Ciprofloxacin 500 mg BD for at least 4 wks. Treatment failure is common. Tx w/ Septrin DS 2 tabs OD x 3 wks Septrin DS 2 tabs OD x 5 days Improvement? Give IVF Tx as C. difficile: Metronidazole 500 mg TD x 1/52 No antimotility drugs YES YES YES Relapse within 4 wks NO Ciprofloxacin 500 mg BD x 5 days Improvement? CMV colitis: 1. Treat empirically w/ valgancyclovir 900 mg BD x 3–4 wks NO Erythromycin 500 mg BD x 5 days Improvement? NO + Recheck stool leukocytes Is CD4 <50? 174 Chronic Diarrhea (2) YES See pg 1 of algorithm Is the diarrhea bloody? NO Does pt describe bloating/ flatulence? YES Tx for giardia: Metronidazole 500 mg TD x 5 dys NO YES Does pt have cough, abdominal pain, and erythematous serpiginous lesions? NO Tx for strogyloides: ivermectin 12 mg OD x 3 dys or albendazole 400 mg BD x 5 dys then monthly maintenance of either ivermectin 6 mg or albendazole 400 mg Get stool O&C and fecal WBC YES Obvious cause identified on O&C Treat accordingly NO Septrin DS 1 tab 4x/ day x 10 dys (empiric tx of Isospora/ Cyclospora) YES Improvement? Continue Septrin DS 1 tab PO OD NO YES Is CD4 <100 w/ abdominal pain and no fecal WBCs? Treatment for Cryptosporidiosis: Paramomycin 500 mg QID x 14 dys then 500 mg BD for maintenance. Can use antidiarrheal drugs. NO Try albendazole 400 mg BD x 3 wks for empiric tx of some types of microsporidia. Improvement? NO Ensure pt is on ARVs Pt has 1) untreatable microsporidia, 2) viral chronic diarrhea, 3) AIDS enteropathy. Offer supportive care – small meals, bland food, avoid caffeine/ lactose, provide antimotility drugs. 175 Cough < 2 Weeks (page 1) Hx and Exam: Pre-existing URI? Current other sx (fever, SOB)? GERD? Medications? Cough w/ severe dyspnea: Proceed to Page 2 of Algorithm for Cough < 2 weeks Cough w/ wheezing: Proceed to Page 2 of Algorithm for Cough < 2 weeks Dry cough? Afebrile? Normal physical exam? YES Cough suppressants Return in 1–2 weeks if Weight loss? Hemoptysis? no improvement YES CXR Sputum AFB + Anti-TB therapy Febrile? Sputum production? Crackles? WBCs? Consider other causes, i.e., pneumonia and atypical TB presentation Get CXR Focal Infiltrate: Tx as pneumonia w/ Augmentin Bilateral patchy opacities: Tx as PCP (especially if low O2 saturation) Effusion: Tap the fluid and tx accordingly for parapneumonic effusion vs. TB Air-fluid level: Tx as abscess w/ Augmentin or clindamycin x 3-4 weeks Improvement after one week? Consider empiric antiTB therapy Routine follow-up For all patients: Smoking cessation Ensure patients are on appropriate prophylaxis 176 Cough < 2 Weeks (page 2) History and Physical Examination Cough w/ wheezing Cough w/ severe dyspnea or O2 saturation (94% or less) YES CXR CXR Focal Opacity Suggestive of TB? Normal Bilateral patchy infiltrates Start anti-TB therapy Treat w/ abx for pneumonia Offer Ventolin Pneumothorax Also get surgery consult for chest tube inhaler Consider dx of asthma Offer Ventolin Consider a short (3-5 day) Treat for PCP course of prednisone Add steroids if pt has O2 sat < 90%, looks severely ill or has significant dyspnea Improvement after 7 days? YES Continue tx course Resume PCP prophylaxis after tx is finished NO Consider change to another regimen or add doxycycline. Also consider other diagnoses, e.g., community-acquired pneumonia 177 Cough < 2 Weeks (page 2) Hx and exam: Fever, night sweats, weight loss, hemoptysis, GERD sx, sick contacts, meds?, bronchial breath sounds, crackles, dull to percussion? Is cough productive? NO YES Pre-existing URI? Pharyngeal cobblestoning on exam? Fever? Sputum production? YES Post-nasal drip. Tx with antihistamines YES Discuss GERD, conservative tx measures: time between dinner & HS spicy/fatty/acidic foods YES Improvement after 1–2 months? NO CXR Focal opacity Normal, or patchy bilateral opacities Tx for pneumonia but consider atypical coverage Treat for PCP Sx worse at night? Sour taste in mouth? Cavitations, effusion, hilar LAD, military pattern NO Routine f/u Treat for TB NO Any newly added meds (like ACE inhibitors)? NO 6 wk trial of PPI or H2 blocker YES Stop medication Treat as asthma: YES Minimize Wheezing? Cough worse with exertion? irritants Use albuterol NO MDI PRN For all patients: Smoking cessation Crackles on exam? JVP? Leg edema? S3 or S4 on exam? heart size on CXR? YES EKG Treat as CHF: Furosemide for diuresis Consider ASA/-blocker especially if evidence of ischemic disease on EKG 178 Chest Pain Hx and Exam: location, duration, radiation, quality, associated sx, aggravating/ alleviating factors, past medical hx, meds, family hx, habits CP w/cough No cough Consider ischemic disease w/ CHF; get CXR/EKG. Tx HTN and lipids if high. Give Lasix if evidence of volume overload. L-sided pain? Intermittent, worse with exertion? (angina) Associated w/ dyspnea, N/V, diaphoresis? Radiation into arm face of neck? If no suspicion of ischemic heart disease, proceed to cough algorithm ST elevation EKG +/CXR ST depression, Q waves, T wave inversions Consider admission for acute MI. ASA, βblockers, nitrates (unless rt-sided), morphine, oxygen. NO Sx worse at night? Burning pain? Sour taste in mouth Sinus tachycardia or right heart strain (S1, Q3 or 3) YES Consider GERD or dyspepsia. PPI or H2blocker x 6–8 wks Admit to hospital. ASA, β-blockers, nitrates (unless rt-sided), morphine, oxygen. Consider lytic therapy. Consider PE, admit for heparin + coumadin. normal NO Consider EKG Low voltage on EKG, diffuse ST elevation, rub on exam abnormal Consider coronary problems (see rt side of algorithm) YES PCP tx w/ Septrin, steroids Normal or diffuse patchy opacities CXR focal Acute pericarditis. Tx w/ NSAIDs +/steroids Fever? Crackles on exam? ↓O2 saturation? NO Pain reproducible w/ palpation? Recent viral URI? Recent trauma or overactivity? YES Muscular strain or costochondritis. Tx w/ NSAIDs. Tx for bacterial pneumonia For all patients: If hypotensive, consider PE, esophageal perforation, pneumothorax, pericardial effusion w/ tamponade. Get CXR, EKG. Admit pt to hospital. Smoking, EtOH cessation 179 Headache Hx and Exam: duration, quality, location, associated sx, neurological sx, fever, good neurological exam, etc. Common causes of HA identified? Hypertension Sinus infection Migraine Cluster Treat appropriately: Tx HTN Abx if sinus infection or watch and wait Pain meds, antiemetics for migraine Pain meds for cluster HA YES NO Worst HA of life? YES Focal neurological findings? YES Start toxo treatment NO Meningeal signs? Consider CT head for subarachnoid hemorrhage and admission Conservative tx with NSAIDs Improvement after 4–7 days? Improvement after 7 days? NO NO YES FEVER? Continue tx + Consider CT scan then LP if no mass lesions YES Tx w/ PCN Is patient hypotensive, tachycardic, critically ill? YES NO NO Tx for sepsis → pan culture, broad spectrum ABX Tailor ABX based on organism identification CT scan of head Get CSF labs: +PMNs → tx as meningitis +AFB or lymphocytes → tx as TB meningitis +India ink, high opening pressure, low # of PMNs → tx as cryptococcal meningitis +EBV → tx as CNS lymphoma Check malaria, typhoid tests CT results: Lesions with mass effect → consider toxo or CNS lymphoma Multifocal areas of demyelination → consider PML Encephalopathic changes → consider HIV encephalopathy Check VDRL YES Resume routine follow-up YES + Consider CT, then do LP Treat accordingly If mass lesion present → consider steroids along with appropriate therapy For all patients: Ensure all patients are on HAART and prophylactic medicines 180 Hypertension Any BP measurement > 210/120 BP checks done at rest Recheck BP Ask about drug/ETOH overuse or withdrawal ETOH withdrawal Benzos Consider admit cocaine Benzos No -blockers NONE Check for end-organ damage: Fundoscopic exam EKG Renal function/UA Mental status ’s Pulmonary edema Chest pain YES IV anti-HTN meds to DBP to 100–110 over 1–2 hrs Avoid nifedipine Good hx and exam: Onset if known Sx Family/social hx Cardiac/eye exam Age of pt <30, >60 Age of pt 30–60 Start with same therapy but consider a sooner workup for 2 HTN if pt is < 30 or > 60 yrs NO PO anti-HTN No blockerFor all patients: Lifestyle modificatio n counseling Pt now has the dx of HTN. smoking/E Treat with oral agents asTOH output to keep BP < 135/80 diet/exercise sodium weight s y 25% every 4– 6 hours For all patients: Lifestyle modification counseling smoking/ETOH diet/exercise sodium weight 3 BP measurements 140/90 Labs to consider: blood glucose UA for protein renal labs thyroid lipids EKG Lifestyle changes: smoking/ETOH good diabetes control weight diet, exercise Don’t start meds @ 1st visit If BP still after 1–2 months, start HCTZ 12.5 mg PO OD, then to 25 mg PO OD If further BP control needed, slowly add CCB, ACEi (esp. if +proteinuria), -blockers If 3 or more medicines are used, consider causes of 2 HTN: Hyperaldosteronism renal disease pheochromocytoma renal artery stenosis Cushing’s syndrome Check labs, consider renal US, renal artery duplex or CT abd/pelvis 181 Oral Lesions Hx and Exam: duration, painful or painless, associated sx, meds, CD4 count. White pseudomembranous patches on buccal mucosa/ tongue Ensure patient on ARVs if CD4< 200 YES Painful swallowing? YES NO Systemic tx: fluconazole 200mg OD, can ↑ up to 800mg OD if needed NO Erythematous lesions or angular cheilitis YES Oral thrush: fluconazole 200mg x 1, then 100mg OD x 7/7 nystatin swish/ spit 5mL PO QID x 7/7 nystatin tablets 500,000 IU QID Do KOH if possible NO White lesions w/ folds located on lateral edge of tongue YES Oral hairy leukoplakia: no tx YES HSV: acyclovir 200 mg 5x/day x 7/7 YES Herpes zoster: acyclovir 800mg 5x/ day x 7 days YES KS: no systemic treatment YES Aphthous stomatitis: can try short course of prednisone or tetracycline 2500 cc dissolved in water (gargle and spit) YES Ulcerative or necrotizing gingivitis: Flagyl 500 mg TID x 7/7 Pen V 500 mg QID x 7/7 NO Small vesicles in groups, painful, erythematous base NO Vesicles in dermatomal distribution NO Papules, macules, nodules that are red, purple, black Ensure patient is on ARVs NO Oral ulcers, no vesicles, painful NO Gum inflammation/ destruction w/ bleeding 182 Peripheral Neuropathy Hx and Exam: Onset, duration, location, uni- vs. bilateral, hx of DM/ETOH/smoking, ARV hx, sensation testing Temporal association w/starting meds? DM w/ poor control? Reinforce d4T/ddI Topical lidocaine Capsaicin cream Amitriptylin e 25 mg daily, can as tolerated glycemic control Start DM meds if not yet started: use low dose oral meds first INH Pyridoxine 50 mg OD No improvement: dose to 100 mg OD If no improvement: Topical lidocaine Capsaicin cream Amitriptyline Heavy ETOH use Counsel to ETOH use Check B2, folate Give thiamine, Vitamin B complex Advise smoking cessation + Hx of STDs or syphilis Improvement? YES Follow patient closely NO Consider : d4T AZT ddI 3TC Check VDRL: If +, tx w/ penicillin No obvious precipitant Check TSH, vitamin B12, folate, RPR Normal Abnormal Treat accordingly Consider HIV neuropathy Start ARV if CD4 < 200 NO Weakness present? Consider referral for EMG, especially if asymptomatic Consider CT scan, then LP If CMV+, consider gangcyclovir Consider EMG referral Consider steroids For all patients: Daily foot care and foot checks, no barefoot walking, ETOH/tobacco 183 Rash, Generalized (page 1) Hx and exam: Onset, location, sx (itching, pain), spread, fever, other systemic sx, medications, CD4 count NO Recently added medications? Proceed to page 2 of rash algorithm YES Stop medication Give 0.3 mg epinephrine Pt should be in Wheezing, laryngeal edema, tongue swelling, nausea/vomiting, shock YES emergency No rechallenging NO YES Was Septrin recently started? NO Were ARVs recently started? < 30% of body affected, pruritic, +/- low-grade fever Fever and systemic sx: Cough, GI sx, arthralgias, lymphadenopathy Treat symptomatically. If severe rash, stop Septrin and change to Dapsone for PCP prophylaxis. Fever, skin blistering, mucous membrane involvement YES Supportive therapy with antihistamines and topical steroids. Do not need to stop drug if sx are mild. Is pt on nevirapine? NO Is pt on abacavir? YES Do sx worsen after each dose? YES SEVERE SX (blistering, mucous membrane involvement): Stop NVP to EFV MILD SX: dose to 200 mg OD Follow closely ABC hypersensitivity. Stop ABC and do not rechallenge. Stop the offending ARV Tx as SJS or TEN Admit for supportive care (treat as if it’s a burn) Avoid the offending ARV (no rechallenge) 184 Rash, Generalized (page 2) No new or recent medicines Treat as seborrheic dermatitis: Ketoconazole cream BD +/ketoconazole shampoo 2x/week YES Erythematous or white scaly/flaky patches, usually on forehead/scalp, sparing nose NO NO Umbilicated papules, nonpruritic Treat as candidiasis: Topical antifungals BD Fluconazole 100-200 mg OD OR Ketoconazole 200-400 mg OD YES Beefy red areas, moist, may be more common in intertriginous areas NO Molluscum Contagiosum. No specific tx. Fever? Pulmonary sx? YES Meningeal signs? Disseminated Cryptococcosis. YES NO Macules/papules, involving palms/soles, nonpruritic + India Ink YES Systemic sx? Recent hx of painless genital ulcer? VDRL + PCN tx Cryptococcal meningitis: Ampho B + flucytosine x 14 days then Fluconazole 400 mg OD x 10 weeks, then 200 mg OD lifetime NO YES Normal hyperpigmentation. Pt should be reassured. NO Red papules that evolve into larger papules/nodules YES Consider KS if CD4 low + India Ink Fluconazole 400 mg OD x 8 weeks then 200 mg OD Folliculitis: Tx initially with conservative measures. Can also try dicloxacillin Avoid Vaseline on arms and legs. YES Papules/pustules on arms, legs, scalp Perform LP NO Bacillary angiomatosis: Tx with erythromycin 500 mg QID x 3 mo, or doxycycline 100 mg OD x 3 mo YES NO Small pink or normal skin colored papules, excoriations, pruritic, found in interdigital areas, waistline, chest, back, abdomen NO Papules/pustules on body, severely ill YES Consider disseminated miliary TB: Tx for extrapulmonary TB No local tx YES Are large areas of the body involved? Are lesions crusted/hyperkeratotic? Norwegian scabies: YES Isolate Ivermectin 200 g/kg PO x 1 + benzyl benzoate lotion NO Scabies: Permethrin cream or ivermectin Tx entire family Wash all clothes 185 Appendix C: How to do a 24-hour dietary recall Dietary assessment is important to assess whether the quantity and diversity of food consumed is adequate to provide enough energy and the essential nutrients. The assessment can be done using the form below. Use the following questions to guide you. 1. Ask the client/caregiver what they ate and/or drank the previous day. Start by asking the foods eaten during a) breakfast b) lunch c) dinner d) Food and/or beverage eaten between the break snack e) other (specify). 2. Include everything that they ate and drank, including foods and drinks that were not prepared or consumed at home — include even juices, soda, milk, snacks, fruits, or other foods. WHEN RESPONDENT STOPS, ASK: Anything else? 3. Ask for the description of food and drinks: a. Was the food prepared at home or bought? What were the ingredients of each of the foods? b. Ask how the food was cooked (boiled, fried, stewed, roasted)? c. Ask for other ingredients added to the food, either during preparation or after (e.g. salt, sugar, spices, etc). 4. For each food item ask how much they actually ate/drank? a. Volume: How much? (Tsp, Tbsp, cup) or b. Weight: What was the weight of the portion eaten? (Only if applicable) c. Number: How many did they eat? d. Size: What size were they? [Big, large, medium, small] Use plate size to estimate quantities or use food atlas if available e. Shape: What shape were they? [Cubed, rounded, oval…] 5. REVIEW: to make sure all food items eaten the previous day are recorded. The table below can be used to record the foods eaten at different times. Dietary recall can then be used to compute the client’s food diversity. The patient should have eaten foods in each of the different food groups: (1) cereals, tubers and breads (2) oils, butter, ghee and fats (3) meats, fish, dairy, and beans/nuts, (4) fruits and vegetables and (5) water. The health worker can estimate whether the client ate enough food given his/her age, body size, activity level, and sex. One can also find out whether the reported frequency, kind of foods, amounts, etc. reflect the usual feeding patterns or not. If not, is it more or less? 186 24-Hour Recall Assessment Form Name: MEAL TIME Age: Sex: ITEM EATEN (FOOD AND DRINKS) Ref. No.: QUANTITY BREAKFAST SNACKS BETWEEN BREAKFAST AND LUNCH LUNCH SNACKS BETWEEN LUNCH AND DINNER DINNER SNACKS BEFORE/AFTER BEDTIME NOTES Nutritionist: Signature: Date: From: Republic of Kenya, Ministry of Health, NASCOP. (May 2007). Nutrition and HIV/AIDS: A Tool Kit for Service Providers in Comprehensive Care Centres. 187 Appendix D: Patient nutrition management form (adult) Reference No.: Date: Name: Visit Number: [ Age (yrs): ] ] Sex: Risk Factors (in last month?) Excellent/ No problem Good/ Not serious Poor/Severe Adequate Dietary practice put in place to manage it if poor? Y or N (or Not Quite?) Appetite Nausea and vomiting Sore mouth or when eating is painful Changed taste of foods Constipation and bloating Colds, coughs Anemia Diarrhea Others ++Judge whether dietary approach used is appropriate. Do you take alcohol? Yes No Do you smoke? Yes No Quantity Physical Activity: Ability to perform basic work since last session: Low Medium High Much Better Better Worse Medical History: What medicines are you taking? ARVs being taken Any Dietary Implications Observed the dietary implications? (Y, N, Not Always) 1. 2. 3. Other Medicines 1. 2. 3. 188 Anthropometric, Biochemical and Dietary Assessments Has client been weighed at least twice in the last 6 months? Yes No Blood pressure Patient knows target weight? Yes No Glucose Last weight (LW): (kg) Hours postprandial Current weight (CW): (kg) Cholesterol Height: (m) Triglycerides MUA: Current BMI: Body fat% Weight Change (CW-LW): (kg) Dietary action Consumed at least three meals in the last 3 days AND at least a snack in last 24 hours Consumed 1) fruit AND 2) vegetable AND 3) foods prepared with oils, fats; AND EITHER 4a) meat/fish/eggs/milk? OR 4b) nuts/legumes on the day prior to the client’s visit to the site in last 24 hours Drunk at least 8 glasses of boiled/clean safe water in last 24 hours Fat Mass Yes / No If not, why? Yes No Yes No Yes No Nutritional Management Plan Weight targets? Recommendation on Dietary symptom management? Recommendation on drug-food interaction? Recommendation on food intake (energy increase, food diversity, food accessibility) Any micronutrients given? Any demonstration made? Referral made? Yes Yes Type: Yes No Over how long (months) No Any food supplements distributed? Why? Which? How much? No Yes No If YES, to who? Screened by: Signature: Counseled by: Signature: From: Republic of Kenya, Ministry of Health, NASCOP. (May 2007). Nutrition and HIV/AIDS: A Tool Kit for Service Providers in Comprehensive Care Centres. 189 Appendix E: Nutritional assessment tool for PLWHIV Form to Monitor Nutrition Status Over Time Name: Age: Sex: In the form below, write down when patient was weighed. Take weight without shoes and wearing similar light clothes each time. Note any events, illnesses, or changes in eating habits and amount of foods eaten, etc. that might have caused weight loss. Where possible also note CD4 counts and hemoglobin (Hb). BMI is calculated as weight (kg)/height (meters²). Date of visit Height (cm) Weight (kg) Amount weight Increase↑ or Decrease↓ BMI CD4 Hb Remarks (specify any changes) From: Republic of Rwanda, Ministry of Health. National Guidelines for Food and Nutritional Support and Care for People Living with HIV/AIDS in Rwanda. Adapted from FAO, Living Well with AIDS, Rome: 2002. 190 Illustrative examples of national adaptations Illustrative Examples of national level adaptation of WHO Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach 2010 (or 2009 versions prepared after release of 2009 WHO Rapid Advice) can be found in the following documents: National Department of Health, South Africa (2010). Clinical Guidelines for the Management of HIV & AIDS in Adults and Adolescents NASCOP (2010). Revised National ART Guidelines Kenya. 191 List of tables and figures Table 1: WHO recommendations at a glance, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ................................................................................................ 11 Table 2: Summary of changes, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .......................................................................................................................... 12 Figure 1: Recommendations at a glance, AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner ........................................................................................................... 22 Table 3: Criteria for ART initiation in specific populations, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ........................................................................... 23 Table 4: WHO clinical staging of HIV disease in adults and adolescents, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ................................... 23 Table 5: When to start ART, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .......................................................................................................................... 33 Table 6: What ART to start, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .......................................................................................................................... 34 Table 7: Treatment adherence partners ....................................................................... 40 Table 8: Global technical treatment recommendations ................................................ 45 Table 9: Preferred first-line ART in treatment-naïve adults and adolescents, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ................................... 46 Table 10: Dosages of recommended ARV, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ............................................................................................... 47 Table 11: Acceptable ARV regimens for treatment-naïve patients, Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of ARV agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS) .............................................................................................. 48 Table 12: ARV components not recommended as initial therapy, Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of 192 ARV agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS) .............................................................................................. 50 Table 13: ARV regimens or components that should not be offered at any time, Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of ARV agents in HIV-infected adults and adolescents. Department of Health and Human Services (DHHS) ....................................................................................... 51 Table 14: Laboratory monitoring before, during and after initiating ART, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .................................... 55 Table 15: Initiation of CTX prophylaxis among adults and adolescents living with HIV, WHO. Guidelines on Co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. Geneva 2006 ................................................................................................ 61 Table 16: Summary of recommendations for discontinuing primary CTX among adults and adolescents, WHO. Guidelines on Co-trimoxazole prophylaxis for HIVrelated infections among children, adolescents and adults: recommendations for a public health approach. Geneva 2006 ........................................................................ 62 Table 17: CTX toxicity grading scale for adults and adolescents, WHO. Guidelines on Co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. Geneva 2006 ................................................................................................................ 63 Figure 2: Algorithm for diagnosis of TB in ambulatory HIV-positive patient, EGPAF Phase 1 Toolkit: Understanding the Revised WHO Recommendations and Supporting Their Adaptation into National Guidelines, 2010 .................................. 67 Figure 3: Algorithm for TB screening in adults and adolescents living with HIV in HIV-prevalent and resource-constrained settings, WHO Guidelines for intensified tuberculosis case finding and isoniazid preventive therapy for people living with HIV in resource constrained settings, 2011 ................................................................... 68 Table 18: Diagnostic criteria for staging of HIV-related clinical events, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .................................... 71 Table 19: Measures for facility-level TB infection control, WHO policy on TB infection control in health-care facilities, congregate settings and households, 2009 .............................................................................................................................. 79 Table 20: Grading of selected clinical and laboratory toxicities, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .................................... 83 Table 21: Toxicities and recommended drug substitutions, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ........................................................................... 86 193 Table 22: ARV-related adverse events and recommendations, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .................................... 88 Table 23: Symptom-directed toxicity management, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ................................................................................................ 89 Table 24: ART switching criteria, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .......................................................................................................................... 92 Figure 4. Targeted viral load strategy for failure and switching, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .................................... 93 Figure 5: Routine viral load strategy for failure and switching, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .......................................................................... 94 Table 25: Preferred second-line ART options, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ................................................................................................ 99 Table 26: ART switching criteria, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ........................................................................................................................ 100 Table 27: Monitoring ART in those at higher risk of adverse events, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .................................. 100 Figure 6: d4T toxicity assessment, Republic of Kenya, Ministry of Health, NASCOP ..................................................................................................................... 101 Table 28: Toxicities of third-line ARVs, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision .............................................................................................. 105 Table 29: STD treatment guidelines table for adults and adolescents, California STD/HIV Prevention Training Center California Department of Public Health STD Control Branch, 2011 ................................................................................................. 115 Table 30: ART regimens recommended for women with prior exposure to PMTCT regimen, WHO Antiretroviral Therapy for HIV infection in Adults and Adolescents: Recommendations for a public health approach, 2010 revision ............. 126 Table 31: ART options recommended for HIV-infected pregnant women who are eligible for treatment, WHO Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants, 2010 version. ................................................ 127 Table 32: Modern medications and recommended food intakes and side effects of ARVs, Tanzania National Guidelines ...................................................................... 137 194 Table 33: Body mass index (BMI): Vertex42, Spreadsheet Templates, Calculators, and Calendars, The Guide to Excel in Everything. Available at: http://www.vertex42.com/ExcelTemplates/Images/body-mass-index-chart.gif ............ 139 Table 34: Common indications for domestic violence mental health care for people with HIV, AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner ............................ 148 Table 35: Neuropsychiatric side effects of selected medications used in HIV disease, AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner................................................... 152 Table 36. Interactions between HIV-related medications and psychotropic medications: indications and contraindications, AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner ......................................................................................................... 153 Table 37: Drugs used to target symptoms of AIDS dementia complex, AIDS Institute New York State Department of Health. HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner ............................................................... 159 195 References and resources SOP 1: Registration and enrollment Centers for Disease Control and Prevention National Center for STD HIV Viral Hepatitis and TB Prevention, Global AIDS Program (November 2007). Couples HIV Counseling and Testing Intervention and Curriculum Global Network of People Living with HIV/AIDS (GNP+) (September 2009). Positive Health, Dignity and Prevention Technical Consultation Report 27-28 April 2009, Hammamet, Tunisia Ministry of Health and Social Welfare, Tanzania (March 2009). Standard Operating Procedures for HIV Testing and Counseling (HTC) Services Tanzania Uganda Ministry of Health, the Republic of Uganda (2005). HIV Counseling and Testing: A National Counselor Training Manual WHO HIV Testing and Counselling (TC) toolkit http://www.who.int/hiv/topics/vct/toolkit/en/index.html SOP 2: Initial assessment visit to determine eligibility SOP 3: Clinical Visit — clients not eligible for ART SOP 4: Clinical Visit — clients eligible for ART SOP 6: ART regimen selection SOP 8: Provide CTX prophylaxis SOP 9: Provide INH preventive therapy SOP 10: Management of common symptoms and complications of HIV SOP 11: Management of common HIV-associated coinfections SOP 12: Recognition of adverse events and ART toxicity SOP 13: Recognition of treatment failure and when to switch ART regimens SOP 15: Switching to third-line ART regimens SOP 19: ART and HIV-related treatment for WRA Bartlett, John, J. Gallant and Paul Pham (2009-2010). Medical Management of HIV Infection. Johns Hopkins School of Medicine Baltimore Department of Health and Human Services (DHHS), Panel on Antiretroviral Guidelines for adults and Adolescents (January 10, 2011). Guidelines for the use of ARV agents in HIVinfected adults and adolescents; 1-166 Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) (May 2010). Phase 1 Toolkit: Understanding the Revised WHO Recommendations and Supporting Their Adaptation into National Guidelines. Washington, DC. Family Health International Collaborative TB/HIV Services (October 2009). Standard Operating Procedures for Implementation of TB Activities at HIV/AIDS Service Delivery Sites 196 Guide to Primary Care of People with HIV/AIDS http://www.hab.hrsa.gov/tools/primarycareguide/index.htm HIV Medicine Association of the Infectious Diseases Society of America (2009). Primary Care Guidelines for the Management of Persons Infected with Human Immunodeficiency Virus: 2009 Update. Clinical Infectious Diseases 2009; 49:651–681 World Health Organization (2010). Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach World Health Organization, Department of HIV/AIDS; Stop TB Department (2011). Guidelines for intensified tuberculosis case finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings World Health Organization, Department of HIV/AIDS (2010). Priority interventions: HIV/AIDS prevention, treatment and care in the health sector SOP 5: Treatment readiness and adherence counseling Bannet Ndyanabangi (February 2006). Adherence to ART PowerPoint presentation. Management Sciences for Health (MSH): Nairobi Horizons/Population Council International Centre for Reproductive Health (2004). Adherence to antiretroviral therapy in adults: A Guide for Trainers. Coast Province General Hospital, Mombasa Ministry of Health, Kenya. Kobin AB, Sheth N.U., (2011). Levels of Adherence Required for Virologic Suppression among Newer Antiretroviral Medications. The Annals of Pharmacotherapy 2011; 45(3): 372-379. Mayer Kenneth H. et al. (2011). Pharmacy Adherence Measures to Assess Adherence to Antiretroviral Therapy: Review of the Literature and Implications for Treatment Monitoring Clin Infect Dis. (2011) 52(4): 493-506 first published online January 18, 2011 Steel G., Nwokike J., Joshi M. (August 2007). Development of a Multi-Method Tool to Measure ART Adherence in Resource-Constrained Settings: The South Africa Experience Rational Pharmaceutical Management Plus Program. Management Sciences for Health: Arlington, VA (Patient adherence record form p. 31-34 and Instructions for completing patient adherence record p. 35-43) World Health Organization (2009). Pharmacological treatment of mental disorders in primary health care World Health Organization (2008). Mental Health Gap Action Programme: scaling up care for mental, neurological and substance use disorders World Health Organization (2007). Chronic HIV care with ART and prevention: Integrated Management of Adolescent and Adult Illness, Integrated Management of Childhood Illness interim guidelines for health workers at health centre or district hospital outpatient clinic. World Health Organization Mental Health homepage http://www.who.int/mental_health/en 197 SOP 8: Provide CTX prophylaxis The following reference is in addition to those listed for SOPs 2, 3 and 4: World Health Organization, Department of HIV/AIDS (2006). Guidelines on co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. SOP 14: Switching to second-line ART regimens Bartlett, John, J. Gallant and Paul Pham (2009-2010). Medical Management of HIV Infection. Johns Hopkins School of Medicine Baltimore Department of Health and Human Services (DHHS), Panel on Antiretroviral Guidelines for adults and Adolescents (January 10, 2011). Guidelines for the use of ARV agents in HIVinfected adults and adolescents; 1-166 HIV Medicine Association of the Infectious Diseases Society of America (2009). Primary Care Guidelines for the Management of Persons Infected with Human Immunodeficiency Virus: 2009 Update. Clinical Infectious Diseases 2009; 49:651–681 Renaud-Théry, F. (15 February 2011). Annual 2010 Survey on ARV Use and Trends in Implementation of WHO 2010 ART Recommendations PPT (presented at WHO & UNAIDS Annual Consultation With Pharmaceutical Companies — Global Forecasts of Antiretroviral Demand 2011-2012, Geneva, 9&10 December 2010) World Health Organization (2010). Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach World Health Organization, Department of HIV/AIDS (2010). Priority interventions: HIV/AIDS prevention, treatment and care in the health sector SOP 16: Contraception SOP 17: STI screening for adults and adolescents SOP 18: Cervical screening SOP 20: Counseling and support for adults and adolescents living with HIV SOP 21: HIV prevention for people living with HIV Anderson, Jean (2005). A guide to the Clinical Care of Women with HIV. Health Resources and Services Administration (HRSA) US Department of Health and Human Services http://www.hab.hrsa.gov/ Centers for Disease Control and Prevention (2010). Sexually Transmitted Diseases Treatment Guidelines, MMWR 2010; 59 Ministry of Health Botswana (2008) STI Treatment Algorithms Botswana National HIV/AIDS Treatment guidelines 198 World Health Organization (2007). Training modules for the syndromic management of sexually transmitted infections. -- 2nd ed., “Module 3, History-taking and Examination”. Available at: http://www.who.int/reproductivehealth/publications/rtis/9789241593407/en/index.html World Health Organization Geneva (2006). Comprehensive cervical cancer control: a guide to essential practice World Health Organization (2003). Guidelines for the management of sexually transmitted infections. SOP 22: Nutritional assessment SOP 23: Determine level of nutritional support needed SOP 24: Develop nutrition care plan Department of Health South Africa (2001). South African National Guidelines on Nutrition for People Living with TB, HIV/AIDS and other Chronic Debilitating Conditions East, Central and Southern African Health Community Secretariat (ECSA-HC), Food and Nutrition Technical Assistance (FANTA) AED, USAID/East Africa (2008). Nutrition Care for People Living with HIV and AIDS: Training Manual for Community and Home-Based Care Providers Facilitators Guide and Participant Handouts Uganda. East, Central and Southern African Health Community Secretariat (ECSA-HC), Food and Nutrition Technical Assistance (FANTA) AED, USAID/East Africa (August 2008). Nutrition and HIV/AIDS: A Training Manual for Nurses and Midwives. Ministry of Health Kenya (May 2007). Nutrition and HIV/AIDS: A Toolkit for Providers in Comprehensive Care Centers Ministry of Health Republic of Rwanda (2006). National Guidelines for Food and Nutritional Support and Care for People Living with HIV/AIDS in Rwanda USAID (February 2007). Recommendation for the Nutrient Requirements for People Living with HIV/AIDS World Health Organization (2003). Technical Consultation on Nutrient Requirements for People Living with HIV/AIDS World Health Organization (2003). Nutrient requirements for people living with HIV/AIDS: report of a technical consultation, Geneva, 13–15 May 2003 199 SOP 25: Conduct mental health assessment SOP 26: Conduct mental status examinations SOP 27: Develop mental health care plan AIDS Institute New York State Department of Health. Mental Health Care for People With HIV Infection: HIV Clinical Guidelines for the Primary Care Practitioner Africa Mental Health Foundation website: http://www.africamentalhealthfoundation.org/ American Psychiatric Association Steering Committee on Practice Guidelines. Practice Guideline for the Treatment of Patients With HIV/AIDS World Health Organization (2008). HIV/AIDS and Mental Health. Report by the Secretariat Executive Board 124th Session World Health Organization (2005). Mental health & HIV/AIDS therapy series World Health Organization in collaboration with the Victorian Health Promotion Foundation and the University of Melbourne (2005). 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