1.5.1. Guideline contributors

These consolidated guidelines are a compilation of recommendations published between 2016 and 2021. All guidelines included have been developed in accordance with procedures established by the WHO Guidelines Review Committee (6). The recommendations in the guidelines are based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to reviewing evidence and formulating recommendations (7). Consistent with previous WHO guidelines, these guidelines are based on a public health approach that considers feasibility and effectiveness across a variety of settings. For each recommendation, the systematic reviews and evidence-to-decision-making tables, prepared in accordance with the GRADE process, were shared in advance and presented at the meetings, and the methodologist facilitated discussions. The methods, evidence and supporting information for each recommendation are available in the guideline in which it was originally published and cross-referenced in these consolidated guidelines.

The composition of the guideline development groups was in accordance with WHO procedures for developing guidelines (6) and included a range of representation from HIV experts, researchers, programme managers, epidemiologists, human rights experts, representatives of civil society organizations and networks of people living with HIV. The WHO HIV Civil Society Reference Group plays a role in advising on the selection of representatives from civil society. In selecting members, appropriate representation by region and gender is considered. The membership of the external review groups is selected to provide further geographical representation.

1.5.2. Competing interests

All external contributors to the development of guidelines collated here, including members of the guideline development groups and the external review groups, completed a WHO declaration of interests form. In accordance with the WHO declaration of interests policy for experts, a brief biography of all guideline development group members is published on the WHO HIV website for a period of 14 days prior to the guideline meeting.

The responsible technical officers for developing guidelines reviewed all the declaration of interests forms completed by the guideline development group members. A management plan for each declared conflict was agreed and recorded at the time of the meetings. All declared interests and management strategies were discussed with the chairs and methodologist for the respective meetings. Declared conflicts are shared at the start of each guideline development group meetings, and participation in decision-making where a potential conflict was involved is closely monitored by the WHO Guideline Steering Group and GRADE methodologist.

Every effort is made to ensure that any potential influence of conflicts of interest is minimized. The Guideline Steering Group assessed all completed declaration of interests forms for other external contributors to the guidelines. Individual participation was reviewed with regard to the interests declared. All declaration of interests forms are on electronic file at the WHO Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes and will be maintained for 10 years.

Funding from the Bill & Melinda Gates Foundation, the United States President’s Emergency Plan for AIDS Relief, the United States Agency for International Development, the United States Centers for Disease Control and Prevention and Unitaid supported the development of these guidelines.

1.5.3. Evidence synthesis

This publication summarizes guidelines that have already been published and compiles previously formulated recommendations. Typically, the process of developing recommendations begins with consultative meetings with experts, health ministries and communities, with research questions being developed and priorities set. A WHO steering group develops questions for systematic reviews using a PICO (population, intervention, comparator, outcomes) format. For WHO recommendations included in this publication, a GRADE approach (7) was used to appraise relevant evidence and was placed into an evidence-to-decision framework to help inform the discussions at guideline development group meetings.

1.5.4. Peer review

External peer review was conducted in accordance with WHO standards for all the individual guidelines included in this consolidated publication. An invited review group comprising broad expertise in public health, programme management and community representation reviewed a draft and provided comments on the validity, reliability and clarity of the content.

1.6.1. Chapter contents

The structure of the guidelines is based on the continuum of HIV testing, prevention, treatment and care (Fig. 1.1).

Fig. 1.1

Continuum of care and relevant sections of the guideline.

The chapters of the guidelines include the following information.

Chapter 2 summarizes existing WHO guidance on HIV testing services, including information to be provided during pre- and post-test counselling, approaches to service delivery and considerations for priority populations. New recommendations on the timing of and approaches to virological testing among infants and the use of new testing technologies are also provided.

Chapter 3 addresses the use of ARV drugs for HIV prevention. A new recommendation on the introduction of the dapivirine vaginal ring as an HIV combination prevention option for women with substantial risk of HIV infection is included (8,9). Recommendations on oral pre- and post-exposure prophylaxis, including infant ARV drug prophylaxis, are summarized and the importance of combination HIV prevention approaches is discussed.

Chapter 4 addresses ART for people living with HIV, including when to start treatment (first-line regimens for adults, adolescents and children) and what regimens to switch to (second- and third-line treatment). The chapter contains key recommendations on rapid ART initiation, the introduction of dolutegravir (DTG) as the preferred option in first-line regimens and in second-line regimens (if not previously used in first-line ART). Updated recommendations on the timing of ART for people with TB and infant feeding by women with HIV are summarized. The chapter includes new recommendations on the use of new point-of-care technologies for viral load testing and treatment monitoring as well as a detailed summary of guidance on managing toxicity related to ARV drugs and key ARV drug–drug interactions.

Chapter 5 summarizes the package of care for people with advanced HIV disease and the clinical management of cryptococcal disease and histoplasmosis. This package of advanced HIV care includes screening for TB, providing TB preventative therapy, testing and pre-emptive treatment for cryptococcal disease, providing co-trimoxazole and enhanced adherence counselling. It also links to the new WHO systematic screening guidance for TB and the most recent WHO guidance for TB preventive therapy.

Chapter 6 summarizes existing WHO guidance on the management of common coinfections and comorbidities associated with HIV, including the use of co-trimoxazole preventive therapy, TB case finding and treatment of latent and active TB and managing viral hepatitis. The chapter includes a new section on cervical cancer that introduces new recommendations and good practice statements on screening and treatment of cervical precancerous lesions among women living with HIV. New recommendations are presented for the diagnosis and management of HIV and Buruli ulcer coinfection and treatment of HIV and visceral leishmaniasis coinfection. The importance of assessing and managing the risk of noncommunicable diseases among people living with HIV is highlighted by recommendations on assessing and managing cardiovascular disease and mental health disorders.

Chapter 7 discusses key service delivery issues related to providing ART with a greater focus on person-centred care. Reduced frequency of clinic visits and medication refills for people established on ART and more convenient and accessible ARV drug distribution approaches are recommended to further reduce the burden on clients and health facilities. New recommendations are also provided to help strengthen linkage to care following HIV diagnosis and long-term retention in care, including community-based approaches to support adherence. Integration of sexual and reproductive health and rights services with HIV services has been revalidated, and a new recommendation on integrating noncommunicable disease services with HIV services has been made. Guidance on task sharing, integration and decentralization of services is summarized with new guidance on task sharing and integration of diagnostic services. New guidance in this chapter emphasizes the importance of providing psychosocial support interventions to meet the particular needs of adolescents. The chapter reiterates the importance that the health interventions for key populations, which do not differ from those for other people at risk of or living with HIV, reach these groups, whose access is often compromised, and the approaches for delivering services may therefore need to be adapted.

Chapter 8 summarizes a range of recommended approaches to monitoring and evaluating programmes along the continuum of testing, prevention and care, including using recommended programme indicators and strategies to monitor ARV toxicity and ARV drug resistance.

Chapter 9 outlines the processes for disseminating these new guidelines.

The annexes include reference tables to support key recommendations.

Supplementary materials will be forthcoming.

1.6.2. Presentation of the recommendations

Recommendations are typically presented in the following format to reflect the review of the evidence and other considerations by the guideline development groups and have been summarized where appropriate.

• Recommendation. The recommendation and the strength and certainty of evidence assessed using the GRADE method are stated.
• Background. Previous WHO guidance in this area and developments since the recommendations were last reviewed are described. When the recommendation relates to a specific population, key issues for that population may be briefly summarized.
• Rationale and supporting evidence. New evidence on which the recommendation is based and other key operational and programmatic considerations that informed the development of the recommendation is summarized.
• Implementation considerations. Key implementation issues specific to the recommendation are discussed.
• Research gaps. Issues requiring further research are summarized.