J.15_Swaziland_Integrated_HIV_Management_Guidelines_2018.pdf

Preface

Preface

Swaziland has made significant strides towards achieving the UNAIDS 90-90-90 goals by 2020 and the 95-95-95 epidemic control goal by 2030. This is evidenced by the recent Swaziland HIV Measurement Survey 2 (SHIMS2) of 2016. SHIMS2 was a two-stage cluster ran-domised survey with a nationally representative sample. It showed that Swaziland has diagnosed 85% of all people living with HIV (PLHIV), 87% of which are currently taking antiretroviral therapy (ART), and 92% of those on ART are virally suppressed. At the population level, Swaziland has achieved viral suppression of at least 90% of the population on ARVs, with 73% viral suppression of all PLHIV regardless of ART status. Therefore, Swaziland is in a good position to achieve epidemic control by 2022 as envisioned by His Majesty, King Mswati III.

Deeper analysis of the SHIMS2 data, however, shows that there are sub-population differences with regards to service coverage and clinical outcomes. There are certain sub-populations exhibiting disparities in testing, treatment, viral suppression and prevention in-terventions. For example, adult and adolescent males and young people aged 15-24 years were found to have lower levels of aware-ness of their HIV status (77.5% and 66% respectively). Additionally, young people aged 15-24 years demonstrated low rates of ART uptake (76%) and lower levels of viral load suppression (VLS) (76%). This calls for targeted interventions to address these gaps in test-ing, treatment and VLS by sub-populations, geographies and modalities. Results also show that it is also essential to integrate HIV services with prevention and main stream health service delivery such as non-communicable diseases and mental health. As ser-vices expand, attention should be given to the quality of services provided. This is partly addressed by implementation of the Na-tional HIV Services Standards as well and the Site Improvement Monitoring Systems (SIMS) implemented at PEPFAR supported sites.

As we approach epidemic control, there is a greater emphasis on the need to sustain the success of the National HIV response. This requires a clear understanding of donor funded program and intervention components that are critical for the country to achieve and sustain ep-idemic control and how these components can be transitioned to government if not already within government structures. Additionally, healthcare workers across all cadres should maintain up to date on these innovated approaches, incorporating them into daily practice.

These guidelines address new innovations like HIV self-testing (HIVST), Pre-Exposure Prophylaxis (PrEP) for HIV prevention, a package of care for clients with advanced immunodeficiency and the introduction of better drugs and formulations (e.g. tenofovir, lamivudine, dolutegravir (TLD) a fixed dose combination (FDC) formulation) including differentiated ART delivery models (CommART). The guidelines will also bring clarity on quality related issues like re-testing for verification for clients who are initiating on ART and guidance to strengthen pharmacovigilance systems. These guidelines provide the standards and recommendations to move Swaziland forward in achieving the Government of the King-dom of Swaziland’s vision of zero new HIV infections (including elimination of Mother to Child Transmission of HIV) and ending AIDS. To achieve this vision we need a continued concerted effort from all stakeholders at all levels of service delivery to translate these guidelines into action.

I would like to take this opportunity to thank the Ministry of Health program leads, technical working group members, key stakeholders and implementing partners for their contribution and support in developing and implementing these guidelines.

Dr. Vusi Magagula

Director of Health Services, Ministry of Health

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Acknowledgements

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Acknowledgements The 2018 Swaziland Integrated HIV Management Guidelines have been made possible by the commitment of the members of the Nation-al Care and Treatment technical working group (TWG). This team worked tirelessly to ensure that guidance given in this document is up to date, evidence-based and applicable in the Swazi context. Appreciation goes to Dr. Nomthandazo Lukhele who chaired the guideline development process and Dr. Munyaradzi Pasipamire who helped coordinate and provided technical guidance to the various working groups. The guidelines content development was led by the many thematic leads and focal people within the MOH. Appreciation goes to the following, Dr. Nicholas Kisyeri (SNAP), Dr. Herve Nzereka Kambale (SNAP), Sindy Matse (SNAP), Lenhle Dube (SNAP), Nobuhle Mthethwa (SNAP), Bonisile Nhlabatsi (SRHU), and Dr. Simangele Mthethwa (SRHU). Special appreciation goes to the team of internal reviewers: Dr.

Sikhathele Mazibuko (CDC), Dr. Marianne Calnan, Dr. Gregory Jagwer (EGPAF), Dr. Pido Bongomin and Dr. Samson Haumba (URC).

Special thank goes to Julia Benjamin (CHAI) and Nicole Dagata (CHAI) for their secretariat role and impressive work coordinating the publi-cation process.

The Ministry of Health greatly appreciates the technical and financial support that has been provided towards the development of these guidelines. The Ministry of Health extends gratitude to WHO, PEPFAR, UNICEF, CHAI and implementing partners: URC, EGPAF, ICAP, MSF, Baylor and MSH for the technical input in the development of guidelines and also for financial support including printing of the guidelines.

Special appreciation goes to the many TWG members for their dedication to the development of these guidelines.

HIV Prevention Sindy Matse SNAP; MOH

Mpumelelo Mavimbela SNAP; MOH

Nduduzo Dube AHF

Anita Hettema CHAI

Dr. Sithembile Nqeketho WHO

HIV Testing Services

Chair: Lenhle Dube SNAP; MOH

Ayanda Sikhondze SNAP; MOH

Nokuthula Mdluli URC

Makhosazana Dlamini PSI

Anita Hettema CHAI

Nomenzile Mamba ICAP

Tesfay Abreha ICAP

Dr. Kikanda Kindandi EGPAF

Dr. Caspian Chouraya EGPAF

Dr. Sithembile Nqeketo WHO

Thembisile Dlamini UNAIDS

Sindisiwe Khumalo SHLS

Dumile Sibandze SHLS

Adult Care and Treatment

Chair: Dr. Nomthandazo Lukhele SNAP; MOH

Dr. Munyaradzi Pasipamire SNAP; MOH

Dr. Nicholas Kisyeri SNAP; MOH

Dr. Herve Kambale SNAP; MOH

Nompilo Gwebu SNAP; MOH

Ntombi Ginidza SNAP; MOH

Dr. Debra Vambe NTCP; MOH

Dr. Yohannes Gebreyesus URC

Dr. Altaye Kidane ICAP

Dr. Arnold Mafukidze ICAP

Dr. Nkululeko Dube AHF

Dr. Nduduzo Matse AHF

Dr. Joyce Mphaya UNICEF

Dr. Sithembile Dlamini WHO

Dr. Paola Lopez MSF

Charlotte Lejeune CHAI

Julia Benjamin CHAI

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Acknowledgements

PMTCT Chair: Bonisile Nhlabatsi SHRU; MOH

Dr. Simangele Mthethwa SHRU; MOH

Dr. Caspian Chouraya EGPAF

Dr. Christopher Makwindi EGPAF

Dr. Lydia Mpango EGPAF

Dr. Yohannes Gebreyesus URC

Joyce Mphaya UNICEF

Dr. Munamato Mirira USAID

Dr. Sithembile Dlamini-Nqeketo

WHO

Nozipho Hlatshwayo NERCHA

Dr. Rachel Mudekereza ICAP

Dr. Mtiti ICAP

Paediatric Care and Treatment

Chair: Nobuhle Mthethwa SNAP; MOH

Lenhle Dube SNAP; MOH

Dr. Simangele Mthethwa SRH; MOH

Makhosazana Hlatshwayo Baylor

Dr. Sarah Perry Baylor

Dr. Magnus Beneus Baylor

Dr. Florence Anabwani Baylor

Dr. Alexander Kay Baylor

Dr. Caspian Chouraya EGPAF

Dr. Lydia Mpango EGPAF

Harriet Mamba EGPAF

Thembisile Dlamini UNAIDS

Nozipho Mkhatshwa NERCHA

Laboratory Team

Sindisiwe Khumalo SHLS

Dumile Sibandze SHLS

Tesfay Abreha ICAP

Rumbidzai Ndungwani CHAI

Pharmacy Team

Pholile Maphalala CMS; MOH

Duga Alemayehu MSH

The following professionals are appreciated for their input and review:

Anna Grimsrud International AIDS Society

Tanya M. Ellman ICAP

Dr. Herb Harwell CHAI

Dr. Kinanga Magambo CHAI

Dr. Nagalingeswaran Kumarasamy YRGCARE Medical Centre

Dr. Stephen Arpadi Columbia University, Mailman School of Public Health

Contents

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Preface

Acknowledgements

Acronyms

Tables and Figures

Chapter 1: Introduction

1.1 Background

1.2 How to Use These Guidelines

1.3 Summary of Major Changes

Chapter 2: Prevention of HIV

2.1 HIV Prevention Approaches

2.2 Condoms

2.3 Sexually Transmitted Infections

2.4 Medical Male Circumcision

2.5 Post-Exposure Prophylaxis

2.6 Pre-Exposure Prophylaxis

2.7 ART for People Living with HIV

Chapter 3: HIV Testing Services

3.1 HIV Testing Services Approaches

3.2 Guiding Principles of HIV Testing Services

3.3 HIV Testing Screening Tool

3.4 Timing of HIV Re-Testing and Key Points for Targeted Groups

3.5 Settings for HIV Testing

3.6 Pre-Test Information

3.7 Types of HIV Tests for Diagnosis

3.8 HIV Testing Algorithm

3.9 Post-Test Counselling

3.10 Documentation and Reporting

3.11 Referral and Linkages

3.12 Quality Assurance in HIV Testing Services

Chapter 4: Basic Care Package for HIV-Positive Individuals

4.1 Basic HIV Chronic Care Package

4.2 Clinical Evaluation for PLHIV

4.3 Baseline Laboratory Evaluation of PLHIV

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4.4 Changing Role of CD4

4.5 Differentiated Service Delivery for Clients with Mild or Moderate Immunodeficiency

4.6 Differentiated Service Delivery for Clients with Advanced Immunodeficiency

4.7 Prevention, Screening and Management of Common Opportunistic Infections

4.8 Special Considerations: Oppotunistic Infections in Children

4.9 Sexual and Reproductive Health

4.10 Family Planning

4.11 Monitoring Clients in Chronic Care

4.12 Summary of Basic Care Package for PLHIV

Chapter 5: Antiretroviral Therapy

5.1 Preparing Clients for ART

5.2 When to Start ART

5.3 What ART Regimen to Start

5.4 ART for Clients with TB/HIV Coinfection

5.5 Clients with Viral Hepatitis Coinfection

5.6 Monitoring of Clients on ART

5.7 Clinical Monitoring of Clients on ART

5.8 Laboratory Monitoring

5.9 Managing Treatment Failure

5.10 Second-Line ART for Adults and Adolescents

5.11 Third-Line ART for Adults and Adolescents

5.12 Promoting Long-Term Care with PLHIV on ART

Chapter 6: Prevention of Mother-to-Child Transmission of HIV Strategy

6.1 Primary Prevention of HIV Infection among Women of Childbearing Age

6.2 Prevention of Unintended Pregnancies in Women Living with HIV

6.3 Antenatal Care for Pregnant Women to Prevent Mother to Child Transmission

6.4 Treatment for HIV-Positive Women in Antenatal Care

6.5 Services for Women during Labor, Delivery and Immediately After Delivery

6.6 Services for Lactating Women and their Children

Chapter 7: ART for Children and Adolescents

7.1 Preparations of Children and Adolescents for ART

7.2 Assessment of Children Prior to ART Initiation

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7.3 When to start ART for Children and Adolescents

7.4 What to start: ART for Children and Adolescents

7.5 Prophylaxis Therapy for HIV-Exposed or -Infected Infants and Children

7.6 ART for Children and Adolescents with TB/HIV Coinfection

7.7 Clinical Monitoring of Children and Adolescents on ART

7.8 Laboratory Monitoring of Children and Adolescents on ART

7.9 Managing Treatment Failure in Children and Adolescents

7.10 Second-Line ART for Children and Adolescents

7.11 Third-Line ART for Children and Adolescents

7.12 Special Considerations for Adolescents

7.13 Promoting Long-term Care with Children and Adolescents on ART

7.14 Elements of a Well-Functioning Paediatric HIV Program

7.15 Summary of Monitoring and Clinical Service Timelines for Paediatric and Adolescents

Chapter 8: Management of Non-communicable Diseases

8.1 Screening for Non-communicable diseases

8.2 Care and Management of Hypertension and HIV

8.3 Care and Management of Diabetes and HIV

8.4 Care and Management of Depression and HIV

8.5 Palliative Care and Management for PLHIV

8.6 Pain Assessment and Management

8.7 Control of Additional Symptoms

8.8 Psychosocial and Spiritual Support

Chapter 9: Annex

9.1 Pharmacovigilance in ART

9.2 Overview of ARV Drugs

9.3 ARV Drug Combinations to be Avoided

9.4 Potential ARV Interactions with Other Drugs,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

9.5 Potential Interactions Between ARVs and Pain Management Medicines

9.6 ARV Interactions with Contraceptives

9.7 Drugs that Should Not be Used with Selected ARV Regimens

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Chapter 9: Annex (continued)

9.8 Most Common Adverse Drug Reactions to ART Drugs

9.9 Grading of Severity of ARV Toxicities

9.10 Supplementary Information on Dolutegravir

9.11 Hepatitis B Virus Treatment Algorithm

9.12 Hepatitis B Virus Treatment and Clinical Considerations

9.13 Clinical Evaluation of Client with High Blood Pressure and HIV Infection

9.14 Baylor HIV/TB Hotline and Email Information

9.15 Initiation of Infants Less than 4 Weeks on Lopinavir/Ritonavir

9.16 Alternative ART for Paediatric Clients on TB Treatment

9.17 Paediatric ARV Dosing Card

9.18 HIV Testing Screening Tool

9.19 ART Readiness and Psychosocial Assessment Form

9.20 Depression Assessment

Depression Assessment (Siswati)

Depression Assessment (English)

9.21 Karnofsky Performance Status Scale

9.22 Summary of the Uses of CD4 Count and Viral Load Monitoring

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Acronyms

3TC lamivudine ABC abacavir ACEI angiotensin-converting enzyme inhibitor ALT alanine aminotransferase ANC antenatal care ARB angiotensin receptor blocker ART antiretroviral therapy ARV antiretroviral (drug) AST aspartate aminotransferase ATT anti-tubercular therapy AZT zidovudine BCG Bacillus Calmette-Guérin BDQ bedaquiline CAGs community ART groups CCB calcium channel blocker CIHTS client-initiated HIV testing services CommART Community-Centred Models of ART Delivery CPT Co-trimoxazole preventive therapy CrAg cryptococcal antigen DBS dried blood spot DMA delamanid DSD differentiated services delivery DTG dolutegravir ECP emergency contraception EFV efavirenz EIMC early infant male circumcision eIP enhanced infant prophylaxis EPI Expanded Programme on Immunization FDC fixed-dose combination FTC emtricitabine GBV gender based violence HBV hepatitis B virus HCTZ hydrochlorothiazide HCV hepatitis C virus HCW healthcare worker HIVST HIV self-testing

HPV human papillomavirus HTS HIV testing services IPT isoniazid preventive therapy IRIS immune reconstitution inflammatory syndrome IUD intrauterine device LAM lipoarabinomannan LDL low-density lipoprotein (cholesterol) LEEP loop electrosurgical excision procedure LFA lateral flow assay LF-LAM lateral flow urine lipoarabinomannan assay LPV lopinavir LPV/r lopinavir/ritonavir LTBI latent tuberculosis infection MDR-TB multidrug-resistant tuberculosis MNCH maternal, newborn and child health NNRTI non-nucleoside reverse-transcriptase inhibitor NRTI nucleoside reverse-transcriptase inhibitor NSAID non-steroidal anti-inflammatory drug NVP nevirapine PCR polymerase chain reaction PEP post-exposure prophylaxis PIHTS provider-initiated HIV testing services PJP Pneumocystis jiroveci pneumonia PLHIV people living with HIV PMTCT prevention of mother-to-child transmission PrEP pre-exposure prophylaxis RIF rifampicin STI sexually transmitted infection SUAC stepped-up adherence counselling TB tuberculosis TDF tenofovir VIA visual inspection with acetic acid VL viral load VMMC voluntary medical male circumcision WHO World Health Organization

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Table Title Page Number

2.1 Recommendations for Consistent and Correct Use of Condoms 25

2.2 Recommendations for Post-exposure Prophylaxis 27

3.1 HIV Self-Testing Approaches 35

3.2 The 5 Guidling Principles of HTS 36

3.3 Population-Specific HTS Guidelines 38

3.4 Summary of Pre-Test Information 42

3.5 Specific Pre-Test Information for Different Populations 43

3.6 Three Types of Laboratory Tests for HIV Diagnosis 44

3.7 Summary of HIV Tests Performed 45

3.8 Algorithm for HIV Testing for Infants and Young Children 46

3.9 Serial HIV Testing Steps for Rapid Testing in Adults and Children Over 18 Months 47

3.10 Summary of Post-Test Counselling 50

3.11 Additional Key Counselling Messages for Special Populations 51

3.12 Types of Linkages to Services 53

3.13 Summary of Referral and Linkages 54

3.14 Quality Assurance in HTS 54

3.15 Quality Assurance for Counselling 55

4.1 Definition of Client Categories for Differentiated HIV Service Delivery 59

4.2 Differentiated HIV services: Package of care for the different client categories 60

4.3 Elements of Clinical Evaluation for PLHIV 62

4.4 Baseline Laboratory Evaluation Differentiated by Client Category 63

4.5 Definitions of Advanced Immunodeficiency and High-Risk Groups 66

4.6 Co-trimoxazole Prophylaxis Dosing for Adults, Adolescents and Children 70

4.7 Co-trimoxazole Prophylaxis Toxicity Grading Scale for Adults and Adolescents 71

4.8 Co-trimoxazole Prophylaxis Desensitization for Adults and Adolescents 72

4.9 When to Start INH for LTBI in PLHIV, by Client Category 76

4.10 INH Dosing for Adults and Children 78

4.11 Reasons to Suspect Cryptococcal Meningitis 80

4.12 Diagnosis of Cryptococcal Meningitis 80

4.13 Management of Cryptococcal Meningitis 80

4.14 Treatment of Cryptococcal Meningitis 81

4.15 Symptoms of Kaposi Sarcoma 82

Tables and Figures

4.16 Staging Criteria and Prognosis for AIDS-Related Kaposi Sarcoma 83

4.17 Staging Criteria for Classic Kaposi Sarcoma 83

4.18 Treatment of Kaposi Sarcoma 85

4.19 Pneumonia Treatment for HIV-Positive Paediatric Clients 89

4.20 STIs Commonly Found as Coinfection with HIV 90

4.21 Differentiated Care for Clients Who Are Not Yet on ART 93

4.22 Basic Care for PLHIV 94

5.1 Preparing Clients and Providers for ART 97

5.2 Early Versus Delayed ART Initiation 100

5.3 Timing of ART Initiation Definitions 100

5.4 Alternative First-Line Regimens 101

5.5 Dose Reduction Guidelines for TDF and 3TC in Clients with Renal Dysfunction (CrCl <50 mL/min) 103

5.6 TB Treatment Drug Interactions 105

5.7 Clinical Review Schedule for the First Year on ART 109

5.8 Schedule for Laboratory Monitoring of Clients who have Initiated on ART 110

5.9 Viral Load Test Results 113

5.10 Interpreting Viral Load Test Results 114

5.11 Content of Stepped-Up Adherence Counselling Sessions 117

5.12 WHO Definitions of Types of Treatment Failure in Adults 118

5.13 Recommended Sequence of Second-Line NRTI Options 120

5.14 Options for Managing Clients 120

6.1 PMTCT Prongs 127

6.2 HIV Prevention Services for Non-Pregnant Women 127

6.3 Services to Prevent Unintended Pregnancies 129

6.4 Advice for Couples Who Are Considering Having a Child 129

6.5 Key Services for Pregnant Women in Antenatal Care 130

6.6 Key Considerations for HIV-Positive Women in Antenatal Care 132

6.7 Special Considerations for ART Regimens in Pregnant and Lactating Women 133

6.8 Follow-up and Monitoring of HIV-Positive Pregnant Women Summary 135

6.9 Infant Dosing Regimens of NVP and AZT 136

6.10 Infant Diagnostic Tests for Mothers of Varying HIV Status 137

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6.11 HIV Testing in Infants and Young Children 138

6.12 Package of Care for HIV-Exposed Infants 139

6.13 Special Considerations for Enhanced Infant Prophylaxis in Exposed Infants 141

6.14 Reccomendation for Infant and Young Child Feeding Based on HIV Status of Mother 142

6.15 Assessment for Replacement Feeding 143

7.1 Assessment for Children Prior to ART Initiation 147

7.2 Definitions of Advanced Immunodeficiency and High-Risk Groups 149

7.3 Recommended First-Line ART Regimens for Children and Adolescents 150

7.4 Alternative First-Line ART Regimens for Children and Adolescents 151

7.5 Example of lead-in dosing for routine NVP initiation using AZT-based FDCs 151

7.6 Special Situations for Children and Adolescent Clients 152

7.7 Co-trimxazole Preventive Therapy for Children and Adolescent Clients 154

7.8 Recommended ART for Drug-Sensitive TB/HIV Coinfection 156

7.9 Components of the Clinical Assessment for Children and Adolescents on ART 160

7.10 Repeat VL Test After Initial Non-suppression 162

7.11 WHO Definitions of Types of Treatment Failure in Children and Adolescents 164

7.12 Prevention and Management of Treatment Failure in Children and Adolescents 165

7.13 Recommended Second-Line Regimens for Children and Adolescents 168

7.14 Potential Third-Line Regimens for Children and Adolescents 169

7.15 General Principles for Effective Transition to Adult Care 172

7.16 Checklist for Successful Transition to Adult Care 173

7.17 Elements of a Well-Functioning Paediatric HIV Program 174

7.18 Summary of Monitoring and Clinical Service Timelines for Children and Adolescents 175

8.1 Recommended Drugs to Initiate in Special Cases 180

8.2 Pharmacotherapy and Drug Information for Treatment of Hyperlipidaemia 183

8.3 Clinical Diagnosis and Recommendations for Management of Depression 184

8.4 Drugs Used to Treat Depression 185

8.5 Antipsychotic Drugs 186

8.6 Common Sources of Pain in HIV and AIDS Clients 187

8.7 Pain Intensity 188

8.8 Specific Considerations for Pain in Children 190

8.9 Specific Pain-Related Syndromes in HIV 190

Figures

Figure Title Page Number

1.1 Differentiated service delivery as a tool to help achieve 95-95-95 by 2022 16

3.1 Targeted Testing 33

3.2 HIV Self-Testing Flowchart 35

3.3 HIV Screening Tool 38

3.4 Serial HIV Testing Algorithm - Rapid Testing in Adults and Children Over 18 Months 48

3.5 Re-testing for Verification Flow Chart 49

3.6 Linkages to HIV Care for PLHIV 53

4.1 Differentiated HIV Care and Treatment Services 58

4.2 LF TB-LAM Screening for PLHIV with Advanced Immunodeficiency 68

4.3 CrAg Screening for PLHIV with Advanced Immunodeficiency 69

4.4 Laboratory TB Diagnostic Algorithm 75

4.5 TB Screening Flowchart 77

4.6 Treatment Guidelines for Kaposi Sarcoma 84

4.7 Opportunistic Respiratory Infections in Children 88

5.1 Differentiated HIV Care and Treatment Services 108

5.2 Adult Viral Load Monitoring Algorithm 112

5.3 Management of Clients with VL >1000 copies/mL 115

5.4 Structure of the Stepped-Up Adherence Counselling Session 116

5.5 Timing of Stepped-Up Adherence Counselling Sessions 116

5.6 Adherence to Appointments 123

5.7 Available Care Models for Clients on ART 124

6.1 Timing of Viral Load and CD4 Monitoring for Pregnant and Lactating Women 134

6.2 Mother and Baby Appointment Schedule during Postpartum Care 162

7.1 Viral Load Timeline for Children and Adolescents 163

7.2 Steps for Management of Treatment Failure 166

8.1 Hypertension Management Algorithm 179

8.2 Evaluation of a Client with Diabetes and HIV Infection 181

8.3 Evaluation of a Client with Dyslipidaemia and HIV Infection 182

8.4 Numeric Pain Rating Scale 188

8.5 World Health Organization Analgesic Step Ladder 189

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Chapter 1:

Introduction

1.1 Background

The 2018 Swaziland Integrated HIV Management Guidelines are aligned with the National Health Sector HIV/AIDS response plan and current global guidance including the WHO’s Consolidated guidelines on the use of antiretroviral drugs for treating and pre-venting HIV infection (June 2016), and Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy (July 2017). These Guidelines replace the 2015 Integrated HIV Management Guidelines.

The Care and Treatment TWG led the development of these guidelines, providing leadership, coordination and critical reviews.

Sub-Technical working groups, such as HTS, PMTCT, Adult Care and Treatment and Pediatric Care and Treatment created specialized content for each chapter. Experts from the Ministry of Health, bilateral, multilateral, and implementing partner organizations drafted the respective sections of the guidelines. Additional input was received from WHO and other international experts.

The aim of these guidelines is to standardize and promote continued provision of comprehensive, quality, and client-centered prevention, care and treatment services. The goal of these new guidelines are to promote service uptake and retention, resulting in improved client outcomes, improved quality of life, and a decline in new HIV infections, HIV related illnesses and mortality.

Throughout the continuum of HIV care, from prevention to treatment, clients should be evaluated and offered differentiated care that takes into consideration their preferences and clinical conditions. Differentiated service delivery (DSD), is defined as “a cli-ent-centered approach that simplifies and adapts HIV services across the cascade, in ways that both serve the needs of people living with HIV better and reduce unnecessary burdens on the health system” (Journal of the International AIDS Society). DSD allows for integrated health services, high quality care, and been shown to improve uptake of services and retention. See figure 1 below.

All health facilities that provide HIV services in Swaziland should implement the HIV services packages as outlined in these guide-lines. A multi-disciplinary approach to care by clinicians, counsellors, expert clients, pharmacists, laboratory staff and community workers is critical for the successful implementation of these guidelines. Primary health care facilities are ideally placed to strength-en community health systems and empower communities with knowledge to facilitate uptake of HIV services as well as strengthen linkages and client follow-up systems.

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Figure 1: Differentiated service delivery as a tool to help achieve 95-95-95 by 2022

1.2 How to Use These Guidelines

The following images will appear throughout the guidelines to highlight:

Updates and changes to guidelines

Outside reference

Important messages

Tools

Dosing information

2018 INTEGRATED HIV MANAGEMENT GUIDELINES 17

1.3 Summary of Major Changes

2018 INTEGRATED HIV MANAGEMENT GUIDELINES18

Chapter 2:

Prevention

• At every visit, assess knowledge and skill of condom use in all populations.

• Early infant male circumcision is recommended for all male infants and can be done immediately after birth and up to 60 days after birth.

• Voluntary medical male circumcision is recommended for all men/boys. Priority groups include men/boys aged

10-19 and all sexually active men.

• Pre-Exposure Prophylaxis (PrEP) can be offered as an additional prevention choice for people at substantial risk of HIV infection, as part of a combination of prevention approaches.

• All persons exposed to HIV accidentally, occupationally, sexually or otherwise should be prescribed Post-Expo-sure Prophylaxis (PEP) (within 72 hours) by any registered nurse or clinician, to minimize the risk of transmis-sion of HIV and other blood-borne pathogens.

» Adults/adolescents at low risk: TDF + 3TC » Adults/adolescents at high risk: TDF + 3TC + ATV/r [Strongly recommended for all penetrative sexual assault cases.] » All children (<40 kg): AZT + 3TC + LPV/r

Chapter 3:

HIV Testing Services

• HIV testing service should be offered to all clients with unknown HIV status at every point of contact in health facility and community settings.

• The HIV testing screening tool will be used to determine how often a client with a previous HIV-negative result will need to be re-tested for HIV.

• Client-initiated HIV testing services and provider-initiated HIV testing services are two approaches to be used at the entry point to HIV prevention, care and treatment services.

• Targeted testing, including index testing (testing the family members and sexual partners of people diagnosed with HIV) and social network testing (testing the sexual partners and peers of HIV-positive key populations) are the preferred methods of testing.

• To encourage contacts of index clients with unknown HIV status to be tested, every HIV-positive client will be given information on client notification options, either through passive referral or assisted HIV partner notifi-cation services.

• HIV Self-test kits/Oraquick can be distributed at the health facility level and performed privately in the client’s home or facilitated by a healthcare worker in a private setting at a health facility. The age of consent for HIVST is 16 years.

• All HIV tests conducted must follow the National HIV Testing Algorithm for children and adults. Referral and linkages to prevention or care and treatment services should be provided to both negative and positive clients, respectively.

• Rapid tests (Determine™ and UniGold™) are antibody tests that can be used to definitively diagnose adults and children aged 18 months or older. DNA PCR is used to diagnose children less than 18 months of age and for inconclusive results according to the National HIV Testing Algorithm.

Chapter 3:

HIV Testing Services

• Retesting for verification - all clients with positive HIV results presenting for ART initiation should be re-tested, with a second specimen, preferably with a different tester, before ART initiation.

• DNA PCR has replaced Clearview tests as the tie breaker for inconclusive results when testing for HIV.

• Quality assurance for counselling for HTS providers, supervisors and laboratory/National HTS Program are outlined in Table 3.15.

Chapter 4:

Basic Care Package for HIV-Positive Individuals

• The basic HIV chronic care package must be provided to every client and differentiated based on client’s baseline CD4 count and clinical assessment findings at presentation (mild, moderate or advanced immunodefi-ciency).

• Baseline laboratory samples should be collected on the same day as HIV diagnosis

• All clients diagnosed with HIV should start on cotrimoxazole (CTX) at enrolment into HIV chronic care. Clients should continue CTX until clinically stable on ART, with evidence of immune recovery (i.e. CD4 counts > 350 cells/mm3 and an undetectable viral load.

• All HIV-positive clients who do not have active TB should be started on isoniazid (INH) treatment for latent TB infection (LTBI) from one month after ART initiation for a duration of 6 months and should be repeated every two years from date of completion.

• Clients who are over 5 years old with a CD4 count ≤200 cells mm3 (or a CD4 count less than 25% for children), or WHO clinical stage 3 or 4, or, children with HIV who are younger than 5 years old are classified as, and must receive the advanced immunodeficiency package.

• Clients with advanced immunodeficiency and CD4 ≤100 cells/mm3 receive Cryptococcal antigen (CrAg) screen-ing, and if positive, receive fluconazole prophylaxis for 6 weeks.

• Clients diagnosed with Cryptococcal meningitis should initiate ART 6 weeks after commencement of antifungal treatment.

• Clients who are TB-presumptive or are seriously ill with danger signs of advanced immunodeficiency, CD4 ≤100 cells/mm3 or are seriously ill with danger signs, receive LF TB-LAM testing and if positive, start DS-TB treatment.

• After one year on ART, adult clients who are clinically stable can receive ART refills every 3 months, and clinical assessments every 6 months.

• The basic HIV chronic care package includes routine screening and management of non-communicable diseas-es, mental health and palliative care services.

• All HIV-positive women should be screened at least once every year for cervical cancer.

• Family planning needs should be assessed and family planning commodities offered to every HIV-positive wom-an at every visit.

• All PLHIV should be assessed for symptoms of STIs at every clinical visit.

• Index testing of among PLHIV should be done at least annually.

• Treatment of Kaposi Sarcoma (KS) has been updated

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1.3 Summary of Major Changes (continued)

Chapter 5:

Antiretroviral Therapy

• Test and Start means all PLHIV are eligible to initiate ART as early as possible preferably within 2 weeks of HIV diagnosis.

• Every client should complete an individualized ART readiness assessment and counselling before ART initiation.

Same-day initiation is encouraged for clients who are ready to start ART.

• Clients who are diagnosed with advanced disease, under 5 years old, pregnant or lactating, have TB, HIV-posi-tive in a sero-discordant relationship, have hepatitis B co-infection or have HIV-associated nephropathy should be prioritized for rapid/early ART initiation.

• ART in TB clients should be started as soon as possible, preferably within 2 weeks of initiating TB treatment.

• The recommended first line ART regimen is (Tenofovir (TDF 300mg) + Lamuvidine (3TC 300mg) + Dolutegravir

(DTG 50mg) taken as a fixed dose combination (TLD) once daily preferably in the morning.

• Clients initiating on DTG should be closely monitored for IRIS for the first 6 months.

• Clients on a DTG-based regimen require active pharmacovigilance monitoring and reporting.

» Viral load (VL) should be undetectable when switching from TLE to TLD.

• For second line ART regimen: Initiate adults and adolescents on an ATV/r- based regimen. Clients can be switched from LPV/r regimens if they meet the requirements outlined in Chapter 5, Section 10.

• VL should be measured 6 months after ART initiation to confirm virologic response to ART. After 2 consecutive suppressed VL results 6 months apart, VL monitoring can be done annually

• Receipt of a high VL test result should trigger immediate action within the facility. Clients should be called to come to the facility within the next 7 days to begin SUAC. See Figure 5.3 for the management protocol.

• A viral load threshold of ≥1000 copies/mL should be used to determine virological failure when using plasma or dried blood spot specimens.

• HIV drug resistance testing (genotyping) requests should be submitted to SNAP for review for clients suspected to be failing second line regimen after completion of SUAC.

• Contact email for HIVDR support: snapthirdline@gmail.com.

• To promote long term adherence for children and adolescents every facility should have a teen club, support groups, and caregiver focus groups.

• After 1 year on ART, stable clients with undetectable viral load should be offered an opportunity to choose one of five ART service delivery models (or CommART/ Differentiated Service Delivery) for continued adherence

• For methods and reporting on pharmacovigilance, refer to Annex 9.1.

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Chapter 6:

Prevention of Mother to Child Transmission of

HIV (PMTCT)

• The recommended First-Line ARV for HIV-positive pregnant and lactating women is a once daily, fixed dose combination: TDF (Tenofovir 300 mg) + 3TC (Lamivudine 300 mg) + DTG (Dolutegravir 50 mg) » For methods and reporting on pharmacovigilance, refer to Chapter 9

• Initiate ART in maternity for all women who are HIV-positive regardless of WHO staging or CD4 count

• Viral load monitoring schedules specific for pregnant and lactating women are:

» All newly initiated on ART should receive first viral load test 3 months after starting ART.

» Women on ART enrolling for ANC should receive a repeated viral load test if the last VL is more than 3 months old. A subsequent viral laod test shoudl be conducted after 3 months.

» All lactating women should have a viral load at 6 weeks post-delivery regardless of previous viral load date.

• All HIV-exposed infants should be provided with enhanced infant prophylaxis (eIP):

» HIV-exposed infants should receive AZT and NVP until 6 weeks. This should be dispensed in maternity (if not given during ANC).

» HIV-exposed infants should receive NVP only from 6 weeks to 14 weeks. This should be dispensed during the 6 week postpartum care visit.

• Early infant diagnosis:

» All mothers should be tested at ANC and PNC to determine the HIV exposure of the infants.

» All HIV-exposed infants must be tested using DNA PCR at 6 weeks, 9 months, and 12 months. A rapid test should be done at 18 months.

• All mothers, including those living with HIV:

» Should exclusively breastfeed for the first 6 months.

» Should continue breastfeeding for at least 12 months and may continue breastfeeding for up to 24 months or beyond, with complimentary feeding after 6 months, while being fully supported to adhere to care and consistent condom use.

Chapter 7:

Paediatric Antiretroviral

Therapy

• All HIV-infected children and adolescents are eligible to start ART regardless of CD4 count or WHO clinical stage.

• All children, adolescents and caregivers should be well-prepared for ART to ensure good adherence and treat-ment success.

• TDF+3TC+DTG (TLD) is the preferred first line regimen for all adolescents weighing at least 40 kg. Alternative first line regimens are outlined in Table 7.4.

» For methods and reporting on pharmacovigilance, refer to Annex 9.1.

• Prioritize assessment and rapid ART initiation in children and adolescents with advanced immunodeficiency as soon as possible (within 7 days) from the day of HIV diagnosis.

1.3 Summary of Major Changes (continued)

Chapter 7:

Paediatric Antiretroviral

Therapy

• Paediatric and adolescent clients with advanced immunedeficiency should be screened for cryptococcal men-ingitis using a serum Cryptococcal antigen (CrAg) test and TB presumptive adolescents and children should receive an LF TB-LAM test.

• Children and adolescents with a VL > 400 copies/mL should be referred for stepped–up adherence counsel-ling.

• A viral load threshold of ≥1000 copies/mL should be used to determine virological failure when using plasma or dried blood spot specimens.

• For second line ART regimens: Initiate adolescents on Atazanavir (ATV/r) regimens to reduce pill burden. Cli-ents can be switched from LPV/r regimens if they meet the requirements outlined in Chapter 5 Section 10.

• Third line ART: Each child or adolescent should receive individualized treatment regimens based on HIV resis-tances testing/ genotyping results if second line ART failure is confirmed.

• Adolescents aged 17 to 19 years of age should be successfully transitioned to adult care. A detailed care pack-age and checklist for successful transition is provided in Table 7.15 and Table 7.16.

• To promote long term adherence and viral suppression, all facilities must have Teen Clubs. Facilities should also have dedicated days for children especially those that are failing treatment.

Chapter 8:

Management of

HIV and Non-communi-cable Diseases

• All clients infected with HIV should be routinely screened for cardiovascular risk factors, non-communicable diseases and mental health at enrolment and in subsequent visits.

• Blood pressure should be monitored at every clinical visit.

• Management of Hypertension in a client with HIV follows similar treatment protocols as for HIV-negative clients. However:

» Calcium channel inhibitors should be used with caution as they may interact with PIs producing increased serum level of the former. Therefore, dose titration and ECG monitoring are required.

» Caution should also be exercised when combining diuretics with TDF by monitoring renal function that could be impaired due to added risk for interstitial nephritis.

• A low-dose, enteric-coated aspirin 100 mg/day may be prescribed to reduce the risk of cardiovascular mor-bidity and mortality. Aspirin initiation should only be initiated by a doctor led service, following careful assessment of risk.

• Annual symptom screening for diabetes mellitus and random blood sugar testing is recommended for establishing diagnosis of diabetes among PLHIV. Care and management of clients with Diabetes and HIV is described in Chapter 8, Section 3.

• A high prevalence of depression is reported among PLHIV. Clients should be screened for depression using the PHQ9 assessment tool at initiation and every 6 months thereafter. Clients should be managed appropriately as described in Chapter 8, Section 4.

• All clients should be evaluated for pain at every visit using a validated pain scale.

• For methods and reporting on pharmacovigilance, refer to Annex 9.1.

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Chapter 2:

Prevention of HIV

CHAPTER 2

This chapter reviews the major recommended biomedical HIV prevention approaches in Swaziland. Preventing new HIV infections is critical to controlling the HIV epidemic in Swaziland. Combination HIV prevention is an approach that seeks to achieve maxi-mum impact on preventing new HIV infections by combining biomedical, socio-behavioral and structural interventions that are human-rights based and evidence informed and should be offered to all sexually active individuals, including adolescents.

2.2 Condoms

Consistent and correct use of condoms reduces sexual transmission of HIV, other STIs by up to 94%, and prevents unwant-ed pregnancies. Male and female condoms should be available at all health facilities and in communities.

All clients testing HIV-negative should be linked to HIV prevention services.

Biomedical interventions:

• VMMC

• PEP

• PrEP

• STI screening and treatment

• ART for all PLHIV

Structural interventions:

• Interventions to address inequality in access

• Decriminalization Laws protecting the rights of

PLHIV

• Reducing stigma and discrimination

Behavioural interventions:

• Condom use

• Delaying sexual debut

• Reducing number of sexual partners

HIV Combination Prevention Strategies

2.1 HIV Prevention Approaches

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2.4 Medical Male Circumcision

Medical male circumcision should be offered to all men/boys, especially those who are HIV-negative.

Early infant male circumcision

Early infant male circumcision (EIMC) is recommended for all male infants and can be done immediately after birth up to 60 days after birth.

Early infant male circumcision (EIMC) is promoted during antenatal care (ANC) and is offered in labour and post-delivery. Prefera-bly, EIMC should occur within the first 60 days of life (8 weeks). Refer to a trained healthcare worker (HCW) for the procedure.

For those who are not circumcised within 60 days, continue to offer male circumcision for infants during the scheduled Expanded Programme on Immunization (EPI) visits.

At every visit, assess knowledge and skill of condom use in all populations (sexually active or not) to ensure correct and consistent condom use.

Table 2.1: Recommendations for Consistent and Correct Use of Condoms

Priority Groups Key Actions Heterosexuals who engage in anal sex

• Counsel and demonstrate on correct and consistent condom use

• Provide adequate condoms and condom-compatible lubricants

• Provide information and counselling on HIV prevention for all, including adolescents

Men who have sex with men

Transgender people

Sex workers and clients of sex workers

Sero-discordant couples Specific couselling for couples who are trying to conceive, please refer to Chapter 6, Section 2

Adolescents (sexually active or not)

There is substantial scientific evidence demonstrating that the presence of STIs increases the likelihood of both transmitting and acquiring HIV. Early detection and treatment of STIs is an effective tool in combination prevention strategy of HIV. The treatment of STIs is the same for HIV-negative and HIV-positive individuals. For treatment of common STIs in Swaziland, see Chapter 4, Sec-tion 7.

2.3 Sexually Transmitted Infections

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VMMC is recommended for all men/boys.

Voluntary medical male circumcision

Voluntary medical male circumcision (VMMC) in Swaziland is provid-ed by trained HCWs at health facilities or during outreach programs to adolescent and adult males. Priority groups include men/boys aged 10–49 and all sexually active men.

VMMC service provision should be seen as an opportunity to address the sexual health needs of men; such services should actively counsel and promote safer sexual behaviour. Messaging should be targeted to reach both men and women.

The VMMC package includes the following HIV prevention messages:

• Emphasize correct and consistent use of condoms (dual protection).

• HIV testing services (HTS) and, if positive, linkages to care and treatment services.

• Prevention screening and treatment for STIs and, if positive, referrals to STI treatment and PrEP; see Section 2.4 and 2.5.

• Post medical male circumcision care.

HCWs and health facilities should routinely screen and refer men for

VMMC.

Prevention of HIV

CHAPTER 2

All individuals exposed to HIV are eligible for post-exposure prophylaxis (PEP) as prescribed by any registered nurse or clinician.

Adults/Adolescents at low risk: Tenofovir (TDF)* + lamivudine (3TC) Adults/Adolescents at high risk: Tenofovir (TDF)* + lamivudine (3TC) + atazanavir/ritonavir (ATV/r) All children (<40 kg): Zidovudine (AZT) + lamivudine (3TC) + lopinavir (LPV/r)

Post-exposure prophylaxis (PEP) is the use of ARVs by HIV-negative people after an exposure to HIV to prevent infection with HIV.

All persons exposed to HIV accidentally, occupationally, sexually or otherwise should access PEP to minimize the risk of transmission of HIV and other blood-borne pathogens.

All registered clinicians and nurses at all health facility levels can prescribe ARV-drugs for PEP for any individual who presents with a history of exposure to HIV in the past 72 hours.

Recommended ARV Regimen for Post-Exposure Prophylaxis

2.5 Post-Exposure Prophylaxis

HCWs should educate women on the benefits of male circumcision so that they may encourage their partners to circumcise.

*AZT can be used as an alternative.

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Table 2.2: Recommendations for Post-Exposure Prophylaxis

Consideration Recommendation

Eligibility

Must meet all of the following criteria:

• Exposed individual is HIV-negative at baseline.

• Exposure occurred within the past 72 hours.

• Risk assessment conducted:

» High risk (must be high-risk type AND source AND material):

* High-risk type of injury: Mucous membrane, non-intact skin, or percutaneous injury.

* High-risk source: HIV-positive or of unknown HIV status.

* High-risk material: Blood or bloody body fluids; breast milk; semen; vaginal secretions;

synovial, pleural, pericardial or amniotic fluids; cerebrospinal fluid; or HIV cultures in laboratory.

» Low risk:

* All other exposures not classified as high risk.

Management at initial contact

• Counsel on risks and benefits of PEP and obtain verbal consent for HIV testing.

• HTS for both exposed and source individuals (where possible and applicable).

• Offer PEP as soon as HIV risk exposure is established (as early as 1 hour and within 72 hours) and the exposed individual tests HIV-negative at baseline (if HIV testing is not available, HCWs can provide 1–2 days of PEP to cover the days until the HIV test can be performed).

• Test women of childbearing age for pregnancy.

• Do not delay administration of PEP while waiting for laboratory results. Special laboratory consid-erations: Creatinine (if TDF-containing regimen and diabetic or hypertensive) and haemoglobin (if AZT-containing regimen and suspect clinical anaemia); however, PEP should be offered even when laboratory tests are not available.

ARV regimen for PEP

Adults/adolescents at low risk: TDF* + 3TC

Adults/adolescents at high risk: TDF* + 3TC + ATV/r [Strongly recommended for all penetrative sexual asault cases.]

All children (<40 kg): AZT + 3TC + LPV/r

*AZT can be used as an alternative

Considerations for Post-Exposure Prophylaxis

PEP to be initiated without police form (RSP88) in all health care facilities.

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2.6 Pre-exposure Prophylaxis

PrEP is the use of ARVs by HIV-negative people who are at increased risk for acquiring HIV to prevent acquisition of HIV during periods of high risk.

PrEP should be offered as an additional prevention choice for people at substantial risk of HIV infection, as part of a combination of prevention approaches that include HTS services, risk reduction counselling, male and female condoms, lubricants, ART for all HIV-positive people, and

VMMC.

Consideration Recommendation

Dose of PEP Same as indicated for ART; use weight-based dosing for children.

Time of initiation

Initiate PEP within the first hour or as soon as possible after exposure, but no later than after 72 hours.

More than 72 hours: Conduct HTS and then repeat HTS after 8 weeks, but do not initiate on ART for PEP. If confirmed HIV-positive, the client should be referred to care and treatment.

Duration of PEP 28 days (dispense all 28 days of treatment at the first visit).

Follow-up

• Follow up with client at 7 days, 14 days, and 28 days after starting PEP.

• Provide follow-up HIV testing 8 weeks after exposure. For HTS guidelines; see Chapter 3, Section 2.

• Assess for and manage side-effects due to PEP.

Counselling Adherence counselling, HIV risk reduction, trauma and mental health counselling, social support and safety, and safe sex practices.

Other services for sexual assault and alleged sexual assault

• Special consideration for victims of sexual assult, particularly adolescents and children: offer supportive counselling as they are most likely to default on treatment

• Offer STI prophylactic treatment for all (treat for vaginal/urethral discharge syndrome follow-ing the national STI algorithms); see National STI Algorithm for more information.

• STI management and Hepatitis-B screening for penetrative cases is strongly recommended.

Alleged perpetrators are eligible for and should receive PEP services.

• Offer emergency contraception for non-pregnant women not on any contraceptive method or not compliant/adherent to dosing.

• Document clinical evidence of assault and alleged assault and collect forensic evidence for medical-legal purposes.

• Refer to the Health Sector Response to GBV - clinical management guidelines for additional details on post-rape care.

Repeat PEP users For clients who repeatedly use PEP, pre-exposure prophylaxis (PrEP) should be discussed as an option.

Table 2.2: Recommendations for Post-Exposure Prophylaxis (continued from previous page)

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Effectiveness and safety of pre-exposure prophylaxis PrEP and condom use have been shown to reduce the overall HIV transmission risk by more than 90% when clients are adherent. PrEP requires dai-ly usage to be effective. PrEP must be taken for 7 days before it becomes fully effective followed by daily use for the duration of possible exposure to HIV in order to maintain full protection.

Tenofovir (TDF) 300 mg and lamivudine (3TC) 300 mg by mouth daily (given as a fixed-dose combination).

Tenofovir (TDF) 300 mg and emtricitabine (FTC) 200 mg by mouth daily (given as a fixed-dose combination).

Eligibility for pre-exposure prophylaxis:

Clients determined to be at substantial risk for HIV infection must meet the following eligibility criteria before initiating PrEP.

Recommended ARV Regimen for Pre-exposure Prophylaxis

• Confirmation of HIV-negative status.

• Determined to be at substantial risk for HIV by a HCW.

• No clinical symptoms or signs of acute HIV infection…