Lesotho_ART-Guidelines_2016.pdf

NATIONAL GUIDELINES ON THE USE

OF ANTIRETROVIRAL THERAPY FOR

HIV PREVENTION AND TREATMENT

Fifth Edition

Government of Lesotho

April 2016

Ministry of Health

Nat ional Guidel ines for HIV & AIDS Care and Treatment (5t h Edit ion) Nat ional Guidel ines for HIV & AIDS Care and Treatment (4t h Edit ion)

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TABLE OF CONTENTS

TABLE OF CONTENTS ...................................................................................................... i ABBREVIATIONS AND ACRONYMS ............................................................................... iii FOREWORD ...................................................................................................................... v

ACKNOWLEDGMENTS ................................................................................................... vii EXECUTIVE SUMMARY ................................................................................................... ix

CHAPTER 1: INTRODUCTION

CHAPTER 2: PREVENTION

Section 2.1 Treatment as Prevention Section 2.2 Prevention of Mother-to-Child Transmission of HIV Section 2.3 General HIV Prevention Methods Section 2.4 Voluntary Male Medical Circumcision Section 2.5 Pre-exposure Prophylaxis Section 2.6: Post-Exposure Prophylaxis

CHAPTER 3: HIV DIAGNOSIS

Section 3.1: HIV Testing Section 3.2: HIV Diagnosis in Children Section 3.3: Diagnosis of HIV in Adults, Adolescents, and Children ≥ 18 Months Section 3.4: Documentation of Test Results

CHAPTER 4: HIV CARE AND TREATMENT

Section 4.1: HIV Care and Treatment Package Section 4.2: Clinical Evaluation of the HIV Infected Patient Section 4.3: Co-trimoxazole Prophylaxis and Isoniazid Preventive Therapy Section 4.4: Baseline Laboratory Investigations Section 4.5: Primary and Supportive Care Section 4.6: Education and Counselling Section 4.7: When to Start Antiretroviral Therapy Section 4.8: Adults and Children Not Yet Initiated on ART Section 4.9: Clinical Management of Patients Presenting with Advanced HIV Section 4.10: Care of the HIV-Exposed Infant

CHAPTER 5: ANTIRETROVIRAL TREATMENT REGIMENS

Section 5.1: General Principles of Antiretroviral Therapy Section 5.2: Antiretroviral Therapy for Adults and Adolescents Section 5.3: Antiretroviral Therapy for Children < 10 Years Section 5.4 Third-line Regimens

CHAPTER 6: PATIENT MONITORING

Section 6.1: Clinical and Adherence Monitoring Section 6.2: Laboratory Monitoring Section 6.3 Antiretroviral Treatment Failure Section 6.4 Monitoring and Substitutions for ARV Drug Toxicities Section 6.5 Drug-Drug Interactions

CHAPTER 7: ADHERENCE AND DISCLOSURE

Section 7.1: Introduction Section 7.2: Adherence Preparation Section 7.3: Maintaining Adherence Section 7.4: Enhanced or Intensive Adherence Counselling Section 7.5: Disclosure

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CHAPTER 8: OPPORTUNISTIC INFECTIONS, CO-INFECTIONS & CO-MORBIDITIES 67

Section 8.1: Management of Opportunistic and Co-infections Section 8.2: Tuberculosis Section 8.3 Management of Cryptococcal Disease Section 8.4 Pneumocytis jirovecii Pneumonia (PCP) Section 8.5 Other HIV-Associated Illnesses Section 8.6 Mental Health Problems in Relation to HIV Section 8.7 Malignancy and HIV

CHAPTER 9: NUTRITION AND HIV

CHAPTER 10: WELLNESS INFORMATION

CHAPTER 11: INFECTION CONTROL

CHAPTER 12: OPERATIONAL AND SERVICE DELIVERY

Section 12.1 Decentralization of HIV Care and Treatment Section 12.2 Retention Across the Continuum of Care Section 12.3 Service Integration and Linkages Section 12.4 Human Resources Section 12.5 Laboratory and Diagnostic Services Section 12.6 Procurement and Supply Management (PSM) System

CHAPTER 13: PROGRAMME MONITORING AND EVALUATION

Section 13.1: Definitions Section 13.2: Overview of the Patient Monitoring System Section 13.3: Monitoring Implications of 2016 Recommendations Section 13.4: Other Monitoring Considerations

ANNEXES

Annex 1: Developmental Milestones in Infants and Young Children Annex 2: Developmental Red Flags Annex 3: Gross Motor Milestones in Infants and Young Children Annex 4: Weight-based Dosing of Antiretrovirals and Prophylactics Annex 5: Talking About HIV to HIV-Infected Children Annex 6: Grading of ARV Toxicities Annex 7: HIV Chronic Care/ART REFERRAL FORM Annex 8: Adherence Contract Annex 9: Drug-Drug Interactions Annex 10: How to Analyse Indicators and Identify Problems Annex 11: Weight-Based Dosing of Anti-TB Fixed-Dose Combination Medications Annex 12: Reference Values For Weight-For-Height And Weight-For-Length Annex 13: Ready-to-Use Therapeutic Food (RUTF) Dosing Annex 14: Components Of A Comprehensive History And Physical Examination Annex 15: WHO Clinical Staging Annex 16: National TB Diagnostic Algorithm Annex 17: TB Screening Tool Annex 18: National HIV Rapid Testing Algorithm

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ABBREVIATIONS AND ACRONYMS

ABC Abacavir AFASS Affordable, Feasible, Acceptable, Sustainable and Safe AFB Acid-fast bacilli AIDS Acquired Immune Deficiency Syndrome ALT Alanine aminotransferase ANC Antenatal care ART Antiretroviral therapy ARV Antiretroviral ATT Anti tuberculosis treatment ATV Atazanavir AZT Azidothymidine, also known as Zidovudine CDC Centres for Disease Control and Prevention CSF Cerebro-Spinal Fluid CTC Care and Treatment Clinics CTX Co-trimoxazole CRAG Cryptococcal antigen CXR Chest X-ray d4T Stavudine DBS Dried Blood Spot DNA Deoxyribonucleic Acid DRV Darunavir DST Drug Susceptibility Testing DTG Dolutegravir EC Emergency Contraceptive EFV Efavirenz ELISA Enzyme-linked immunosorbent assay EPTB Extra-pulmonary tuberculosis ETV Etravirine FBC Full Blood Count FP Family Planning FTC Emtricitabine HCW Healthcare worker Hb Haemoglobin HBsAg Hepatitis B surface antigen HCV Hepatitis C Virus HIV Human Immunodeficiency Virus HPV Human Papilloma Virus HRZE Isoniazid, Rifampicin, Pyrazinamide, Ethambutol HTS HIV Testing Services INH Isoniazid IPT Isoniazid Prophylaxis Therapy IUD Intra-Uterine Device LFTs Liver Function Tests LPV/r Lopinavir/Ritonavir boosted MCH Maternal and Child Health MDR-TB Multi-Drug Resistant TB MOH Ministry of Health MTCT Mother-to-Child Transmission of HIV

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MUAC Mid-Upper-Arm Circumference NGO Non-Governmental Organisation NVP Nevirapine NRTI Nucleoside Reverse Transcriptase Inhibitor NtRTI Nucleotide Reverse Transcriptase Inhibitor NNRTI Non-nucleoside Reverse Transcriptase Inhibitor NSAIDs Non-steroidal Anti-Inflammatory Drugs OI Opportunistic Infection PCP Pneumocystis jirovecci Pneumonia PCR Polymerase Chain Reaction PEP Post-Exposure Prophylaxis PITC Provider Initiated Testing and Counselling PLHIV People Living With HIV PMTCT Prevention of Mother-to-child Transmission of HIV PrEP Pre-exposure prophylaxis RAL Raltegravir RH Rifampicin, Isoniazid RPR Rapid plasma regain (syphilis test) RTV Ritonavir RUTF Ready-to-use Therapeutic Food SJS Stevens-Johnson Syndrome STI Sexually Transmitted Infection TB Tuberculosis 3TC Lamivudine TDF Tenofovir Disoproxil Fumatrate TLC Total Lymphocyte Count TNA Trained Nurse Assistant VDRL Venereal Disease Research Laboratory (syphilis test) VHW Village Health Worker WBC White Blood Count WFP World Food Programme WHO World Health Organization XDR-TB Extensively Drug Resistant TB ZDV Zidovudine; also known as Azidothymidine (AZT)

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FOREWORD

With the revision, publication and implementation of the Fifth Edition of the National ART Guidelines, the Government of Lesotho is embracing the most up to date global evidence to redouble its commitment and efforts to halt and reverse the HIV epidemic plaguing Lesotho. In order to do this, Lesotho has adopted the ‘Test and Treat’ strategy, which means antiretroviral treatment is offered to every person living with HIV in Lesotho as soon as they know their HIV status. In 2004, the Government through the Ministry of Health made a momentous decision to provide comprehensive HIV care and treatment in the public sector utilizing a nurse-driven service delivery model to scale up ART for the Basotho people. Since then Lesotho has continued in the forefront in the adoption and scaling up of the most cost effective interventions to improve the quality of life of people living with and affected by HIV. By November 2007, the CD4 criteria for initiating patients on ART was increased from 200 to 350 cells per mm3. Since 2010, a tenofovir-based regimen has been used as the preferred first-line ART regimen, including the scaled up use of a single fixed-dose combination pill taken once per day while third-line ARV options with raltegravir, darunavir, and etravirine were introduced. Furthermore, since 2012, ART has been offered to every HIV-positive pregnant woman to prevent mother-to-child HIV transmission and improve their health outcomes. Most recently, treatment was being offered to every HIV-positive adult and child aged 5 years or more with a CD4 <500, those diagnosed with TB or active hepatitis B, those in a discordant relationship with a HIV-negative partner, and all children less than 5 years of age regardless of their CD4 count.

The fifth edition of these guidelines represents a determined commitment of the government to achieve and contribute to the ambitious global target of reaching 90-90-90 by 2020, which aims to diagnose 90% of people living with HIV, place 90% of those diagnosed on ART, and suppress HIV viral replication in 90% of those on ART by 2020. Reaching these goals will help reverse and end the AIDS epidemic by 2030. Lesotho has one of the highest HIV prevalences in the world at 23% and an estimated 319,000 people living with HIV. At the end of 2014, 41% of Basotho infected with HIV were receiving ART: 41% of adults and 40% of children. The Government of Lesotho through the Ministry of Health has made the commitment to scale up the number of people on ART dramatically to reach the 90-90-90 goals by 2020. Embracing the ‘Test and Treat’ strategy is a key recommendation in these guidelines that will enable the country to reach these bold targets.

Twelve years of establishing and expanding HIV care and treatment services to nearly every health facility in Lesotho, both public and private, and scaling up ART to reach 41% of people with HIV has built a strong foundation for HIV service provision, even in the poorest and most remote areas of the country. The Ministry of Health is committed to decentralizing care even closer to communities, which is essential as the number of people on ART continues to increase.

Studies done across the world have now clearly demonstrated that antiretroviral treatment is the best treatment for HIV. ART reduces HIV-related opportunistic infections and cancers, deaths, as well as diseases not traditionally considered to be associated with HIV, such as non- HIV related cancers, cardiovascular disease, kidney failure, and liver failure. Suppression of HIV replication with ART reduces the risk of HIV transmission by over 90%. ‘Test and Treat’ is also known to be the most cost effective approach to controlling the HIV epidemic. These guidelines adopt the ‘Test and Treat’ approach to HIV treatment in order to provide the best care to people living with HIV in Lesotho and help stop the further spread of HIV. These guidelines emphasize the importance of the HIV ‘care cascade’ – identifying people with HIV as early as possible after infection, promptly linking them to HIV care and beginning preparations for starting ART, and retaining them on treatment through robust adherence support and monitoring systems.

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ACKNOWLEDGMENTS

The revision of these guidelines was done under the distinguished leadership of the Director General of Health Services, Dr. Nyane Letsie. The Ministry expresses sincere thanks to its HIV development partners for their technical inputs. These partners include but are not limited to:

WHO, UNAIDS, UNICEF, PEPFAR, USAID, CDC, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Baylor College of Medicine, AIDS Healthcare Foundation (AHF), SolidarMed, PSI, JHPIEGO, LENASO, LENEPWA, LPPA, ICAP, and Partners in Health. The academic institutions which participated in the process are also acknowledged for their contributions.

Revision of the ART guidelines would not have been accomplished without the inputs of both Government and CHAL institution health personnel as well as private practioners represented by the Lesotho Medical Assocation. The Ministry therefore acknowledges their contribution to the process.

The MOH wishes to acknowledge EGPAF for the financial support which it provided during the revision of the national ART guidelines. The MOH would also like to extend its sincere gratitude to WHO, EGPAF and UNICEF for the technical support provided in the revision and final review of the Guidelines.

The Ministry of Health wishes to acknowledge members of the ART guidelines committees and their respective organizations for their technical expertise during the revision of the Lesotho National ART guidelines; in particular members of the task team who provided direction, assistance and guidance during the entire period of this exercise:

Dr. Mosilinyane Letsie, Director Disease Control – MOH Dr. Llang Maama, National TB Program Manager – MOH Dr. Simon Marealle, National TB Program, MOH Mrs Matsitso Mohoanyane, Pediatric HIV Program Manager – MOH Mrs Rosina Phate, HIV Program Manager – MOH Mrs Moseneke Masheane, TB/HIV Program Officer – MOH Mrs Mphotleng Tlhomola, Lead Counsellor – MOH Mrs. Irene Seipati, PMTCT Program Manager – MOH Mrs Mathato Nkuatsana, Adolescent Program Manager – MOH Ms. Itumeleng Tshabalala, MOH Dr. Appolinaire Tiam, Country Director – EGPAF Dr. Esther Tumbare, Director of Technical Services – EGPAF Dr. David Holtzman, Senior HIV Care and Treatment Advisor – EGPAF Mr Tony Isavwa, Director of Strategic Information & Evaluation - EGPAF Mrs Mamorapeli Putsoane, HIV Care and Treatment Advisor – EGPAF Mrs Tendayi Chipango, Health Economist – EGPAF Dr. Jill Sanders, Associate Director – BCMCF – Lesotho Dr. Mosa Molapo Hlasoa, Program Manager – BCMCF – Lesotho Dr. Susan Tembo, WHO Ms Puleng Letsie, Mobilization and Networking Advisor – UNAIDS Mrs. Blandinah Motaung, Health Officer (PMTCT) – UNICEF Dr. Justine Mirembe, Care and Treatment Advisor – USAID Dr. Fred Asiimwe, Care and Treatment Advisor – CDC Dr. Tapiwa Tarumbiswa, Medical Director - AHF Dr. Olatunbosun Faturiyele, SolidarMed Dr. Daniel Puga, Partners in Health Dr. Raute Molise, President – Lesotho Medical Association Dr. Tlali Mpholo, Senkatana Center

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Ms. Motsoane Tsietso, Director Laboratory Services – MOH Ms. Lucy Tsehloane, LENASO Mr. Boshepha Ranthithi, LENEPWA Ms. Likopo Letsabisa, Lesotho Planned Parenthood Association

The leadership and support to the team by Dr. Nyane Letsie, DGHS and Dr. Mosilinyane Letsie, Director Disease Control, in the development of this document are highly appreciated.

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EXECUTIVE SUMMARY

While the global response to HIV and AIDS has resulted in a more than 15 million people being on ART by the end of 2015 and new HIV infections and AIDS deaths have decreased, the epidemic continues to have devastating effects on communities.

According to the most recent UNAIDS report, there were an estimated 36.9 million people living with HIV, 3.3 million of whom were children; 2 million people were newly infected with HIV and 1.2 million people died from AIDS in 2014.

At 23%, Lesotho has one of the highest adult HIV prevalence rates in the world. There are an estimated 52 new HIV infections and 26 deaths due to AIDS each day. An estimated 319,000 people are living with HIV in Lesotho. Of these, 19,000 are children and 300,000 are adults. Although the HIV epidemic has been stable, there has been no significant change in the national adult HIV prevalence since 2005. The sentinel surveillance conducted in 2013 showed that there is no major difference in HIV prevalence among women attending ANC clinics, which stands at 25.9%. Five districts, Mafeteng, Mohale’s Hoek, Maseru, Leribe, and Berea account for 75% of all of the people living with HIV in Lesotho.

Lesotho continues to focus on scaling up its ART program to reach more people with life-saving ART after reaching universal provision of HIV care and treatment services in public facilities. Currently, 41% of people living with HIV in Lesotho are on ART. The goal is to expand that figure to attain the 90-90-90 targets by 2020: diagnosing 90% of people with HIV, putting 90% of those on ART, and suppressing the viral load of 90% of those on ART. To achieve these targets, the Ministry of Health has put in place programs and developed policies to provide guidance in the areas of HIV Prevention, Care, Support and Treatment.

These guidelines are focused on HIV prevention, diagnosis, treatment, care and support. Specific issues regarding adults, adolescents, pregnant women and children have been addressed. The guidelines are linked to other HIV-related documents including: HIV testing services; prevention of mother-to-child transmission of HIV; home-based care; nutrition and HIV; male medical circumcision; TB; behavior-change communication strategy; Infection Prevention and Control; HIV post-exposure prophylaxis; programme monitoring and evaluation; and sexually transmitted infections guidelines.

The decision to revise the National ART Guidelines was based on the need to update Lesotho’s HIV treatment guidelines to provide people living with HIV in Lesotho with the best care possible in order to reduce the morbidity and mortality burden caused by HIV and halt further HIV transmission. In particular, the guidelines provide a comprehensive approach to ART and include several important updates such as:

o Recommend initiation of ART for everyone living with HIV regardless of CD4 or clinical stage (‘Test and Treat’) o Introduction of confirmatory HIV testing before ART initiation to ensure correct diagnosis based on new National HIV Testing Services Guidelines o Provision of ARVs to HIV-negative individuals at high risk of being infected by HIV (pre-exposure prophylaxis – PrEP) o Increased emphasis on use of viral load to monitor success of ART and identify treatment failure o Guidance on evaluation of treatment failure and conducting enhanced adherence counselling sessions o Recommended management of patients presenting with advanced HIV o Addition of new ARV options for 1st, 2nd and 3rd line ART regimens

| x o Prompt identification of HIV-infected infants through DNA PCR tests and presumptive HIV diagnosis o Revision and development of tools and reports to support programme monitoring and evaluation of key indicators

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CHAPTER 1: INTRODUCTION

The fifth edition of the National ART Guidelines comes following a review of the fourth edition of the guidelines from 2014 and an adaptation process of the Early Release Guideline on When to Start Antiretroviral Therapy and on Pre-exposure Prophylaxis for HIV and Policy Brief:

Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: What’s New released by the World Health Organization in September and November 2015 respectively. The process of developing these guidelines was led by the Ministry of Health and involved multiple stakeholders who reviewed the scientific evidence, rationale, and feasibility of translating the global recommendations into country-specific national ART guidelines.

Recent evidence has clearly demonstrated that starting ART as soon as possible after HIV diagnosis improves the health outcomes of people living with HIV and prevents HIV transmission regardless of the HIV clinical stage or CD4 count. This has led to the World Health Organization, UNAIDS, and the other leading international HIV organizations to support this approach, which is often referred to as ‘Test and Treat’ or ‘Test and Start’.

Highlights of the 2016 National ART Guidelines

Prevention Pre-exposure prophylaxis with oral TDF/3TC should be offered to HIV-negative individuals at significant risk of HIV infection

HIV diagnosis Individuals who test positive for HIV should be retested to confirm the diagnosis of HIV prior to starting ART

Antiretroviral treatment

ART Initiation Every person living with HIV should be started on ART regardless of their CD4 count or HIV clinical stage

First-line ART Fixed-dose combination TDF/3TC/EFV remains the preferred first-line ART regimen for adults and adolescents ABC/3TC/EFV remains the preferred first-line ART regimen for children 3-9 years and ABC/3TC/LPV/r remains the preferred first-line regimen for children <3 years

Second-line ART Patients failing a NNRTI-based first-line regimen should be switched to a PI-based second-line regimen All patients failing a PI-based first-line regimen should receive a genotypic resistance test to determine the best second-line regimen When a genotypic resistance result is not available for patients failing a PI-based first-line regimen, the integrase inhibitors dolutegravir and raltegravir are the preferred second-line ARVs in combination with a NRTI backbone

Third-line ART All patients failing second-line ART should receive a genotypic resistance test to determine the best third-line regimen

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ART

monitoring

Viral load monitoring remains the preferred method for assessing the success of antiretroviral therapy and diagnosing treatment failure

Viral load should be checked 6 and 12 months after starting ART and annually thereafter if suppressed. Pregnant and breastfeeding women and children under 5 should have viral load checked every 6 months.

Adherence monitoring should be continuous for all ART patients.

Patients with treatment failure should receive enhanced adherence counselling and close follow-up CD4 still has an important role for assessing degree of immune suppression from HIV, risk of developing opportunistic infections, and need for co-trimoxazole prophylaxis

The frequency of CD4 monitoring can be reduced to annually if the viral load is <1000 copies/ml and CD4 count is >350 cell/mm3

The absence of laboratory monitoring tests should not delay ART initiation

Service delivery

Stable patients should be given ARV refills lasting 3-6 months Community adherence groups should be established for stable patients to decongest health facilities Appropriately trained lower-level cadres of health workers can initiate and re-prescribe ART ART initiation and refills should be decentralized as close to the community as possible, including health outreaches and health posts

The guidelines present opportunities to reach out to all people living with HIV earlier, in line with the Government of Lesotho’s commitment to reach the 90-90-90 treatment targets by 2020. The 90-90-90 treatment targets state that by the year 2020, 90% of all people living with HIV should be diagnosed with HIV, 90% of those people diagnosed with HIV should be receiving antiretroviral treatment, and 90% of those on ART should have their viral load suppressed. The overall goal of the 90-90-90 targets is to end the HIV epidemic in Lesotho by 2030.

The structure of these guidelines is consistent with the HIV treatment cascade from prevention of HIV to HIV diagnosis to enrolment in HIV care and initiation on ART to retention in chronic care and treatment and, ultimately, HIV viral suppression (see Figure 1.1). Specific chapters are dedicated to patient monitoring, ART adherence counseling support, disclosure, management of comorbidities and co-infections, nutrition, infection control, operational and service delivery guidance, and programme monitoring and evaluation.

Prevention HIV Testing Linkage to Care

Antiretroviral Treatment Impact

Figure 1.1: The HIV Care Cascade

Confirmed

HIV

Diagnosis

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CHAPTER 2: PREVENTION

Preventing new HIV infections is critical to controlling the HIV epidemic in Lesotho.

Providing HIV testing services in health facilities and communities is essential for identifying people who are HIV-negative and providing them with appropriate education, counselling, and prevention strategies to help them stay negative (see Chapter 3). Treating people living with HIV with life-long ART to prevent new HIV infections has emerged as a powerful additional prevention tool benefiting people of all ages. This chapter reviews the major recommended HIV prevention approaches in Lesotho inclusive of those using antiretrovirals and non-medical strategies.

SECTION 2.1 TREATMENT AS PREVENTION

Treating people living with HIV with ART has been shown to be the most effective strategy for preventing new HIV infections – ‘Treatment as Prevention’. Studies have demonstrated a 93% reduction in HIV transmission in HIV within serodiscordant couples when the HIV-positive partner was on ART. When the viral load of the HIV-positive partner is fully suppressed by ART, the protective effect of ART on preventing new infections approaches 100%. ‘Treatment as Prevention’ is an effective strategy regardless of the route of HIV exposure (vaginal, rectal, or percutaneous) and patient group (heterosexual men and women, homosexual men and women, transgender persons, commercial sex workers, and people who inject drugs).

Significantly increasing the number of HIV-positive people on ART with suppressed viral replication is a key strategy for halting the spread of HIV and eliminating the HIV epidemic.

SECTION 2.2 PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV

Prevention of mother-to-child transmission (PMTCT) of HIV is composed of four prongs:

1. Preventing HIV infection in women

2. Preventing unintended pregnancies among women with HIV

3. Preventing vertical transmission of HIV from mothers to their infants during pregnancy, delivery, and breastfeeding

4. Providing care, treatment, and support for mothers with HIV and their children

Women in Lesotho have higher rates of HIV than men starting from late adolescents until mid-adulthood where the prevalence rates are similar. This discrepancy is due to biological and social factors. Risk of HIV transmission from men to women during vaginal intercourse is greater the risk of transmission from women to men. Societal and gender norms often make it difficult for women and adolescent girls to negotiate safer sexual practices with their partners. It is important to ensure that women and adolescent girls are regularly tested for HIV (see Chapter 3) and provided with comprehensive prevention services if found to be HIV-negative.

Clinicians should discuss pregnancy desires and plans regularly with women and adolescent girls with HIV and family planning services should be provided to those who do not wish to become pregnant.

PMTCT services have evolved over the past 12 years from limited maternal ARV prophylaxis for HIV-positive women with advanced stages of HIV to the provision of life-long ART to all pregnant woman as soon as HIV is diagnosed. HIV care and treatment services for pregnant and postpartum women are well integrated into routine antenatal and postpartum services in Lesotho. Despite this, PMTCT coverage in Lesotho was estimated at 72% and early infant diagnosis (EID) coverage with DNA PCR testing was only 55% at the end of 2014. Additonal efforts are needed to ensure that all pregnant women and adolescent girls are tested for HIV and enrolled into PMTCT services and their infants are

| 4 enrolled and retained in exposed infant care. Infant ARV prophylaxis is recommended for all HIV-exposed infants from birth until 6 weeks or 14 weeks of life depending on the mother’s ART status and viral load (see Chapter 3.10).

SECTION 2.3 GENERAL HIV PREVENTION METHODS

General HIV prevention methods include condom and lubricant education and provision, risk reduction counselling, and STI diagnosis and management. Risk reduction messages focus on encouraging abstinence, avoiding having multiple concurrent sexual partners if an individual is sexually active, and using condoms consistently and correctly during sexual intercourse (vaginal, anal, and oral).

SECTION 2.4 VOLUNTARY MALE MEDICAL CIRCUMCISION

Voluntary male medical circumcision (VMMC) has been shown to reduce a HIV-negative man’s risk of HIV infection by up to 60% in combination with general HIV prevention strategies, such as condom provision. Males of all ages are recommended to be evaluated for VMMC services, which includes provision of HIV testing services to all clients with linkage to HIV care and treatment services for individuals identified as HIV positive. VMMC services for infant boys (early infant male circumcision – EIMC), adolescent boys, and adult men are available in Lesotho. See the National VMMC Guidelines for further recommendations.

SECTION 2.5 PRE-EXPOSURE PROPHYLAXIS

Pre-exposure prophylaxis (PrEP) is the use of antiretroviral drugs in HIV-negative people to reduce their risk of acquiring HIV infection. Studies have demonstrated that oral PrEP containing TDF reduces the risk of HIV infection by 51% in the setting of other HIV prevention services, including condom provision and education, STI treatment, VMMC referral and risk reduction counselling. PrEP has been shown to be effective in many different groups of people, including men and women in serodiscordant couples, men who have sex with men, transgender people, commercial sex workers, people who inject drugs, and incarcerated persons. Adherence to PrEP is crucial in order to realize the protective benefits: the risk of HIV was reduced by up to 90% or more among patients with the highest adherence rates to PrEP.

Oral PrEP is recommended for HIV-negative individuals at ‘significant risk’ of becoming infected with HIV. ‘Significant risk’ is defined as a 3% risk of being infected with HIV in 1 year. An individualized risk assessment should be performed for HIV-negative individuals in order to determine if PrEP is an appropriate HIV prevention strategy. The risk assessment should inquire about known high risk behaviors for acquiring HIV. Although it is important to conduct a risk assessment for each HIV-negative person before offering PrEP, the following groups of people are suggested for targeting of PrEP services based on high risk behaviors:

Exchanged sex for money Paid for sex Men who have sex with men and transgender people People who inject drugs In serodiscordant relationship and HIV-positive partner is not on ART In serodiscordant relationship and HIV-positive partner has been on ART for <12 months In serodiscordant relationship and HIV-positive partner’s viral load is 1000 copies/ml or recent viral load is not known but partner’s ART adherence is documented to be poor

Multiple concurrent sexual partners Incarcerated individuals

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Table 2.1 Summary of PrEP recommendations PrEP regimen TDF/3TC 300/300mg once daily Duration Until individual is determined to no longer be at significant risk of

HIV infection Stop immediately if patient seroconverts to HIV-positive and start full ART regimen Patient opts to stop PrEP

Frequency of HIV testing

Every 3 months while on PrEP

Clinic visits Initial visits 2 and 4 weeks after PrEP initiation for adherence assessment and monitoring for side effects

Routine visits every 3 months thereafter for:

Adherence assessment and monitoring for side effects HIV testing Repeat risk assessment Provision of ongoing HIV prevention counselling and services, such as condom provision and education, STI screening and treatment, and VMMC referral

PrEP refill if repeat HIV testing remains negative

Lab monitoring Baseline serum creatinine and urine dipstick for glucose and protein (TDF is contraindicated if creatinine clearance is <50 ml/min)

6 monthly urine dipstick for glucose and protein. Send serum creatinine if glucose or protein detected in urine

Patients should be counselled when starting PrEP that full protection is not obtained until 4 weeks after initiating PrEP. Patients with known HIV exposure within the past 72 hours should be offered post-exposure prophylaxis (PEP) for 28 days based on PEP guidelines (see Section 2.5). PrEP can then be started after completing PEP if the patient remains HIV-negative. Continuous adherence to PrEP should be reinforced: PrEP ARVs should be taken once daily every day. There are currently no studies demonstrating the effectiveness of intermittent dosing of TDF/3TC for PrEP. Patients discontinuing PrEP should not stop taking the ARVs until 28 days after their last potential HIV exposure.

Providing PrEP should not displace or threaten the implementation of other effective and well-established HIV prevention interventions, such as condom distribution and education and risk reduction counselling.

SECTION 2.6: POST-EXPOSURE PROPHYLAXIS

The term post-exposure prophylaxis (PEP) is generally understood to mean the medical response given to prevent the transmission of blood-borne pathogens following a potential exposure. In the context of HIV, post-exposure prophylaxis refers to the set of services that are provided to manage the specific aspects of exposure to HIV and to help prevent HIV infection. The services include first aid; counselling, including the assessment of risk of infection from the exposure; HIV testing; and depending on the outcome of the exposure assessment, a prescription for a 28-day course of ARVs with appropriate support and follow-up.

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People exposed to HIV and other pathogens through sexual assault or occupational exposure merit close monitoring. In addition to the risk of infection, these experiences cause significant psychological damage that can be long-lasting. For these reasons, avoidance of occupational exposure and proper management of sexual assault victims should be given top priority.

It is imperative that HIV post-exposure prophylaxis policies reinforce the importance of primary risk prevention in all settings where HIV could be transmitted. PEP should never be provided in isolation but should form part of a wider strategy for preventing exposure to HIV. It should also be associated with measures to prevent other bloodborne diseases, such as Hepatitis B and C.

Non-Discriminative Provision of PEP

The policy for PEP eligibility should be founded on the principles of equity and non-discrimination. Decisions about whether or not to offer post-exposure prophylaxis should be based purely on clinical considerations of risk and should not be tied in any way to a person’s decision to file a police report or to pursue legal action.

Individuals should be assessed for PEP regardless of their involvement in any activities considered to be illegal by national legislation such as injection drug use, sex work, or men having sex with men. There should also not be any unnecessary financial or administrative barriers preventing an individual from accessing PEP.

Indications for PEP

PEP is aimed at preventing HIV from invading sites such as the lymph nodes and testis.

Within the first 72 hours of HIV exposure, these sites are thought to be invaded by the virus, which remains there permanently. Therefore, administering PEP within 72 hours of exposure to HIV is the most effective way of preventing HIV infection; PEP should NOT be initiated more than 72 hours after the event as it has not been shown to be effective after this time.

Occupational Exposure Incidents

Management of Occupational Exposure

Cleanse the wound thoroughly with soap and water. Do not use antiseptics or squeeze the injured site

Report the incident to the supervisor Document the incident Evaluate the exposure incident Evaluate the exposure source

When available, obtain the HIV status and Hepatitis B status of the source patient. If the source is HIV-infected and information is available, determine:

Stage of disease Current and previous antiretroviral therapy Viral load Antiretroviral resistance information

It is also important to know the HIV status and Hepatitis B status of the exposed person.

A complete history should be taken to identify other medical conditions (renal disease, liver disease, diabetes, or mental health diagnosis), drug allergies, and pregnancy or breastfeeding status.

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Non-healthcare Related Exposures

Sexual Assault Police service men Crime scene attendants Accident attendants Unprotected consensual sexual intercourse Condom breakage

Providing PEP

Table 2.2: RECOMMENDATIONS FOR PEP Exposure HIV status of source patient

Unknown Positive High Risk Intact Skin No PEP No PEP No PEP

Mucosal splash/non intact skin

Consider 2-drug regimen

Recommend 2-drug regimen

Recommend 2-drug regimen

Percutaneous (sharps)

Recommend 2-drug regimen

Recommend 2-drug regimen

Recommend 3-drug regimen

Percutaneous (needle in vessel or deep injury) Recommend 2-drug regimen

Recommend 3-drug regimen

Recommend 3-drug regimen

TABLE 2.3: RECOMMENDED PEP DRUG REGIMEN

Population Drug Dose Frequency Duration

Adults TDF/3TC 300/300mg Once daily 28 days

Children ABC/3TC Weight-based (Annex 4) Once daily 28 days

Adults and children

Lopinavir/ritonavir (3rd drug in cases of high risk exposure)

400mg/100mg 12 hourly 28 days

STEP 1: REPORT AND DOCUMENT

Document all HIV exposures in the PEP register, incident report book and exposed person’s bukana.

Confidentiality - PEP evaluations for both the exposed and source individual (if known) should be treated with confidentiality.

Circumstances of the exposure and PEP management should be recorded in the exposed person’s incident report. Details should include:

Date and time of exposure Details of the incident: where and how the exposure occurred, exposure site(s) on body Details of the exposure: type and amount of fluid or material, severity of exposure

STEP 2: EVALUATE THE EXPOSURE

The exposure should be evaluated for potential to transmit HIV based on the type of body substance involved, the route, and HIV status of the source patient.

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TABLE 2.4: RELEVANT HISTORY TO OBTAIN REGARDING THE EXPOSURE

SOURCE PATIENT

Known HIV infection

� Obtain history of antiretroviral medications, recent viral load, CD4 cell count and date of results

� Consider drawing HIV viral load, CD4 cell count and resistance testing

� Consider evaluation and testing for other sexually transmitted infections, including Hepatitis B and Hepatitis C

Unknown HIV infection

� Obtain risk history and rapid HIV test � Consider evaluation and testing for other sexually transmitted infections, including Hepatitis B

STEP 3: EVALUATE THE EXPOSURE SOURCE

Regardless of HIV status, assess and assist with access to medical care, social support services, and risk reduction counseling.

STEP 4: MANAGEMENT OF POTENTIAL EXPOSURES

1. Baseline Evaluation

For all exposed people, the following baseline tests are recommended:

HIV testing Serologic testing for Hepatitis B Pregnancy testing, as appropriate

Exposures from sexual assault, consensual sex, condom breakage also need:

Screening and prophylaxis for other sexually transmitted infections Assess need for emergency hormonal contraception

Note: If consultation is not immediately available, PEP should not be delayed; changes can be made as needed after PEP has been started. If the source patient is found to be HIV uninfected, PEP should be discontinued. If the exposed person found to be HIV infected, eligibility to initiate ART should be assessed.

Exposed persons are frequently unable to complete PEP regimens due to side effects.

Providing prophylactic symptom management can improve adherence.

A starter pack of 3 days may be prescribed initially with a scheduled follow-up appointment for HIV test, evaluation for potential medication side effects, and continue counseling on risk reduction, support and adherence.

2. Counseling after HIV exposure:

Advise an exposed person to refrain from donating blood and utilize risk reduction methods including use of condoms during sex, not sharing injection equipment, and/or abstaining from high risk behaviors.

Offer mental health counseling as needed.

Counsel the exposed individual about the signs and symptoms of acute retroviral syndrome (flu-like syndrome), and the need to come in for additional testing should these symptoms develop.

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SPECIAL CONSIDERATIONS

1. Pregnancy risk o Provide emergency contraception o Bear in mind drug interactions

2. Known or suspected pregnancy o Does not preclude the use of optimal PEP regimens o Do not deny PEP on the basis of pregnancy.

3. Children o PEP should be offered, using paediatric dosing of ARVs.

o Offer psychosocial support and counselling for assault victims.

o Provide prophylaxis or treatment for STIs as needed o Offer emergency contraception for all pubertal girls – Tanner Stage 3 and above

4. Sexual assault survivors o Provide prophylaxis or treatment for STIs.

o Offer emergency contraception for any woman who may become pregnant o Offer psychosocial support and counselling o Do not deny or delay PEP if a patient does not have a Sexual Assault Form

(police form) or intention to pursue legal action.

5. Injection-drug users and sex workers o PEP should not be refused for high risk incidents and risk reduction strategies should be discussed.

STEP 5: FOLLOW-UP

TABLE 2.5: HIV FOLLOW UP TESTING

Test Baseline 6 Weeks 3 Months 6 Months

HIV Testing X X X X Pregnancy X X Hepatitis B X X

Resistance of the source virus to antiretroviral agents

If the source person’s virus is known or suspected to be resistant to one or more of the drugs considered for the standard PEP regimen, alternate drugs are to be selected in consultation with an HIV expert.

Toxicity of the initial PEP regimen

Adverse symptoms such as nausea, diarrhea, and headaches are common with PEP.

Symptoms can often be managed without changing the PEP regimen by prescribing analgesic, antidiarrhoea and/or antiemetic agents.

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FIGURE 2.1: ALGORITHM FOR EVALUATION AND TREATMENT OF POSSIBLE NON

OCCUPATIONAL HIV EXPOSURES

Substantial Exposure Risk

Exposure of vagina, rectum, eye, mouth, or other mucous membrane, non intact skin, or percutaneous

Contact with blood, semen, vaginal secretions, breast milk, or any body fluid that is visibly contaminated with blood when the source is known to be HIV-infected

Negligible Risk for HIV Exposure

Exposure of vagina, rectum, eye, mouth, or other mucous membrane, intact or non intact skin, or percutaneous

Contact with urine, nasal secretions, saliva, sweat, or tears if not visibly contaminated with blood

Regardless of the known or suspected HIV status of the source

72 hrs since exposure

72 hrs since exposure

PEP

recommended

Case-by-case determination

PEP not recommended

Source patient known to be HIV positive

Source patient of unknown HIV status

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CHAPTER 3: HIV DIAGNOSIS

SECTION 3.1: HIV TESTING

People access HIV treatment, care, and prevention through the gateway of HIV testing services (HTS). The overall goals of HTS are to properly identify as many people living with HIV as early as possible after acquiring HIV infection, link them appropriately in a timely manner to prevention, care, and treatment services, and link HIV-negative people to appropriate prevention services. Diverse models of HTS are available to increase access to HIV diagnosis, including testing services in health care facilities, free standing sites and a wide range of community based approaches. Priority attention should be given to adolescents, pregnant women, and infants due to the high rates of new infections among adolescents and pregnant women and the rapid progression of HIV disease in infants.

However, it is crucial that all Basotho know their HIV status if the HIV epidemic is to be reversed and stopped.

The recommendations in this chapter reflect those in the 2016 National HIV Testing Services Guidelines. Please refer to those guidelines for complete guidance on HTS in Lesotho.

The process of HIV testing services should follow the minimum standards of Consent, Confidentiality, Counselling, Correct results, and Connection (linkage to care and treatment), the so-called 5 C’s.

Consent for HIV Testing Adults and children 12 years and above have the right to give their own informed consent for HIV testing in Lesotho. For children under 12 years, a parent or caregiver who brings the child for care can give written or verbal consent for testing. Pre and post-test counselling must be offered to the patient and/or caregiver.

If the health care provider determines that an adult or child is at risk of HIV exposure or infection, consent is not required, and the provider may initiate testing with the understanding that the individual maintains the right to ‘opt out’.

Who Can Conduct Rapid Tests and Perform DBS for DNA PCR?

All those trained and accredited in HTS including:

Counsellors, including lay counsellors who are adequately supervised Midwives Nurses Trained Nursing Assistants Physicians Laboratory Technicians and Technologists Pharmacists and Pharmacy Technicians Social Workers Ward Attendants Village/Community Health Workers who are adequately supervised Expert Patients (PLHIV) who are adequately supervised

Provider-Initiated Testing and Counselling The need for HIV testing should be assessed for all people at every health care service delivery point during each clinical interaction and those found to be in need of testing should be offered HTS on-site.

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The importance of knowing one’s HIV status so appropriate care can be received should be emphasised. All individuals should be tested unless they opt out. Those who test should receive post-test counselling whether the result is positive or negative. Individuals who opt out should be further counselled on prevention, the benefits of knowing one’s status, and different ways of getting tested if desired in the future.

HIV testing should be offered to all people with unknown status during all clinical interactions with a health facility. The need for HIV testing should be assessed for all people at every health care service delivery point during each clinical interaction and those found to be in need of testing should be offered HTS on-site.

Clients may seek HTS to guide personal life decision making; plan for their future or the future of their families; understand symptoms they might be experiencing; or to support personal HIV prevention efforts.

Frequency of HIV Testing Most individuals who test negative for HIV in routine clinical and community settings will not be at risk for recent HIV exposure. Retesting to rule out acute infection is needed only for HIV-negative individuals who report recent or ongoing risk of exposure. For most people who test HIV-negative, additional retesting to rule out being in the window period is not necessary and may waste resources. People who are diagnosed HIV-negative but remain at high risk, such as some people from key populations, may benefit from regular retesting at more frequent intervals (3 monthly) (see Table 3.1 below).

Retesting gives these people both the opportunity to ensure early HIV diagnosis and to receive ongoing health education on HIV prevention. All sexually active adolescents and adults in Lesotho should be tested at least annually. It is important that all individuals are routinely assessed for their need for HIV testing and their risk for recent HIV exposure at every health service delivery point.

Examples of groups and behaviors with ongoing high risk for HIV exposure and infection include:

Unprotected intercourse with an HIV-positive partner or partner with unknown HIV status (risk of HIV infection is significantly reduced if HIV-positive partner’s viral load is <1000 copies/ml)

Men who have sex with men and transgender persons Commercial sex workers and their clients Exchange sex for money or having paid for sex Incarcerated individuals Injection drug use Multiple sexual partners

All HIV-negative individuals receiving antiretrovirals for pre-exposure prophylaxis (PrEP) must be tested every 3 months as a condition for ongoing receipt of PrEP (see Chapter

2.5 on PrEP).

Self Testing HIV self testing refers to situations where individuals collect their own specimen (usually a oral swab), performs a HIV test, and interprets the test result themselves. Self testing reduces barriers to HIV testing, particularly among certain populations that have low HTS utilization rates, such as, adolescents, key populations, and individuals fearful of testing in health facilities due to stigma or poor treatment by health care providers. Support systems are critical to ensure appropriate linkage to confirmatory HIV testing services as well as HIV care and treatment if HIV infection is confirmed. HIV self testing does not provide a definitive diagnosis. A reactive self test always requires additional testing according to the national HIV testing algorithm.

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Refer to the National HIV Testing Services Guidelines for complete guidance on HIV self testing. HIV-positive clients already on ART should be discouraged from performing HIV self testing as a false negative result can be obtained due to viral suppression from ART leading to low levels of HIV antibodies that are not detected by some rapid tests.

HIV Testing and Counselling for Specific Populations Index Patient/Family Tree Testing Ensuring that all partners, children, and other household members of HIV-positive individuals have been tested for HIV is a key strategy for identifying HIV-positive people in the community. Persons living with HIV should be routinely asked about the HIV status of their sexual partners and children and the statuses of these family members should be clearly documented in the index patient’s medical record to allow for further follow-up (see Annex 18 for an example index patient / family tree testing form).

Couples Couples counseling is a key strategy to identify people living with HIV. HTS should be offered to married and cohabiting couples, premarital couples, polygamous unions and any other partnerships. Health providers must be aware of the potential for intimate partner-based violence and should support individuals when they do not want to test with their partners. Couples HTS can be offered in all settings where HTS are provided.

Offer couples and partners HIV testing services with support for mutual disclosure

Pregnant and breastfeeding women PITC for pregnant and breastfeeding women with appropriate linkage and retention to prevention, care and treatment services are needed to promote the mother’s health and to prevent new paediatric infections.

Provide HTS for women as a routine component of antenatal, childbirth, postpartum and paediatric care settings.

Test…