2.1. Overview
The WHO Department of HIV led development of these WHO consolidated key populations guidelines, following the WHO procedures and reporting standards laid out in the WHO handbook for guideline development, 2012 (1).
These guidelines combine existing WHO recommendations, new recommendations and guidance published by WHO together with UN partners. Key recommendations from the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (2) are included, with specific considerations for each of the key population groups highlighted.
2.2. Establishing guideline groups
The WHO HIV Department set up four groups to perform specific guideline development functions. Members of the groups were selected so as to ensure a range of expertise and experience, including appropriate geographical, gender and key population representation and expertise. The four groups and their functions were:
The WHO Guideline Steering Group on HIV and Key Populations, chaired by the WHO Department of HIV, led the guideline development process. It included participants from the WHO Department of Maternal, Newborn, Child and Adolescent Heath, the Department of Mental Health and Substance Abuse, the Department of Reproductive Health and Research, the Global Hepatitis Programme, and the Global TB Programme.
The External Steering Group, composed of a geographically and gender-balanced group of 25 academics, researchers, programme managers, implementers and people from key population networks and organizations, provided WHO with guidance on scope, content and new areas to be addressed.
The 26-member Guidelines Development Group consisted of the majority of the External Steering Group along with some additional expert members. This group was responsible for formulating new WHO recommendations, good practice guidance and consensus on the final content.
The External Peer Review Group was selected in consultation with the WHO regional offices to assure geographical and gender balance. In total over 70 peer reviewers from academia, policy and research, implementing programmes and key population networks and organizations reviewed the guidelines. In general, reviewers made suggestions to improve the clarity of the document and provided minor additions and corrections to the narrative.
Involvement of key population groups and networks
Crucial to development of these guidelines has been the partnership with, and the engagement of, key population groups and networks at all stages of the process, both as members of the guidelines and peer review groups and as partners in developing the values and preferences investigation methodology and assessment, as described below.
Conflicts of interest
All External Steering Group participants, Guidelines Development Group participants and External Peer Review Group members submitted Declarations of Interest (DOI) to the WHO secretariat. The WHO secretariat and the Guidelines Development Group reviewed all declarations and found no conflicts of interest sufficient to preclude anyone from participating in the development of the guidelines. A full compilation of the declarations is available on request.
2.3. Defining the scope of the guidelines
To develop these guidelines, the WHO Guideline Steering Group mapped all existing WHO HIV guidance specifically concerned with the five key population groups; then it reviewed these and other materials to identify gaps, overlaps, inconsistencies and determine relevance. The outcome of the mapping exercise was presented to the External Steering Group at a scoping meeting in October 2013. The group reviewed the mapping and made recommendations on the scope of the guidelines (populations and range of interventions to be covered) and noted two areas needing new guidance: 1) pre-exposure prophylaxis (PrEP) and 2) opioid overdose prevention and management. Since publication of these guidelines in 2014 new recommendations have been issued by WHO in 2015 on these two topics. In this edition reference is made to these new recommendations on PrEP and ART where relevant.
Other guidelines under development
The Department of HIV and other WHO departments currently are developing or updating a number of guidelines relevant to key populations. These include:
hepatitis C treatment (completed by the global hepatitis team during the development of these guidelines and included here) and hepatitis B treatment and hepatitis B and C screening (completed during 2015);
contraception and HIV guidance (completed by the Department of Reproductive Health and Research and included here);
Audience
The External Steering Group identified the audience for these guidelines. Health services in low-resource settings will benefit most from the guidance presented here, as they face the greatest challenges in providing services tailored to key populations. However, these guidelines are relevant for all HIV epidemic and economic settings and are, therefore, considered global guidance. Regions and countries can adapt these global recommendations to local needs, HIV epidemic contexts and existing services in order to facilitate their implementation.
2.4. Review of the evidence
These guidelines include both relevant existing recommendations and new recommendations. Development of the new recommendations began with systematic reviews of the evidence. The Guidelines Development Group recommended the commissioning of new literature reviews and appraisal of existing reviews and surveys investigating values and preferences, along with reviews of the costs and feasibility of implementation. Also, WHO commissioned new studies and reviewed existing studies of values and preferences related to existing recommendations to help ensure that the guidance appropriately reflects the concerns of key populations.
2.4.1. Information on prisons and other closed settings
In 2007 an extensive literature review was conducted to inform the development of the WHO publication Effectiveness of interventions to address HIV in prisons (3, 4). In 2014 this work was updated for these guidelines, using an abbreviated literature review focusing on materials developed between 2007 and 2014. Results supported the 2007 review; no new evidence was found that would change the recommendations made in the 2007 guidelines. The Guideline Development Group and United Nations Office on Drugs and Crime (UNODC) reviewed, confirmed and accepted this conclusion. The 2014 review identified a need for further research in this area; Web Annex 4 includes potential research areas.
2.5. Development of the pre-exposure prophylaxis recommendations
To inform recommendations on PrEP, evidence questions were framed in the PICO format: Population, Intervention, Comparator, Outcome. External researchers used the PICO questions to develop search protocols and perform systematic reviews of the scientific evidence; Web Annexes 1 and 2 present details.
WHO convened the guideline development meeting in March 2014 to update recommendations regarding PrEP use among men who have sex with men (5) and to look at the evidence for formulating a new recommendation on PrEP use among people who inject drugs, as well as to review all sections of the consolidated guidelines. Individuals representing a broad range of stakeholders participated in the guideline development meeting as either Guideline Development Group members or expert observers. Participants at this meeting assessed the evidence for both PICO questions concerning PrEP, along with the risks and benefits, values and preferences and cost-benefits/feasibility associated with each possible intervention and made recommendations (see Section 4.1.5.1). In 2015, new WHO guidance on PrEP has been issued and is included here were relevant at http://apps.who.int/iris/bitstream/10665/186275/1/9789241509565_eng.pdf?ua=1
2.6. Evidence assessment
Under the WHO guideline development process, the guideline development group formulates the recommendations guided by the quality of available evidence. Other factors – values and preferences, costs and feasibility – are also taken into consideration when determining the strength of the recommendation.
2.6.1. How to interpret the quality of evidence
The higher the quality of scientific evidence, the more likely that a strong recommendation can be made. The GRADE approach to recommendation development, which WHO has adopted, defines the quality of evidence as the extent to which one can be confident that the reported estimates of effect (desirable or undesirable) available from the evidence are close to the actual effects of interest (6, 7, 8). The GRADE approach specifies four levels of quality of evidence (9) ().
Significance of the four GRADE levels of evidence.
2.6.2. Determining the strength of a recommendation
The strength of a recommendation reflects the degree of confidence of the guidelines group that the desirable effects of the recommendation outweigh the undesirable effects (). Desirable effects (potential benefits) may include beneficial health outcomes (e.g. reduced incidence of HIV and reduced morbidity and mortality); reduction of burden on the individual and/or health services; and potential cost-savings for the individual, communities, programme and/or health system. Undesirable effects (potential harms) include those affecting individuals, families, communities or health services. Additional burdens considered include the resource use and cost implications of implementing the recommendations that programmes, care providers or patients would have to bear; adverse clinical outcomes (e.g. drug resistance, drug toxicities); and legal ramifications where certain practices are criminalized.
Domains considered when assessing the strength of recommendations.
The strength of a recommendation can be either strong or conditional.
A strong recommendation (for or against) is one for which there is confidence that the desirable effects of adherence to the recommendation clearly outweigh the undesirable effects.
A conditional recommendation (for or against) is one for which the quality of evidence may be low or may apply only to specific groups or settings; or the panel concludes that the desirable effects of adherence to the recommendation probably outweigh the undesirable effects or are closely balanced, but the panel is not confident about these trade-offs in all situations.
If implemented, a conditional recommendation should be monitored closely and evaluated rigorously. Further research will be required to address the uncertainties and is likely to provide new evidence that may change the calculation of the balance of trade-offs.
The values and preferences of the end users (key populations), feasibility and cost as well as consideration of potential benefits and harms contribute to determining the strength of a recommendation.
Surveys, qualitative studies and literature reviews were commissioned and other available material was appraised to investigate the values and preferences of key populations and service providers and benefits, harms, cost and feasibility concerning new areas of guidance, existing recommendations and service provision issues. Specific attention was paid to the values and preferences of adolescents in key populations.1
Evidence on values and preferences included findings developed at workshops with members of key populations in a range of countries; a multi-regional, anonymous e-survey of men who have sex with men; in-depth key informant interviews with selected service providers and people who inject drugs; in-depth interviews with men who have sex with men; and a literature review of values and preference of key populations concerning PrEP. Web Annex 3 provides full reports and a table outlining the range of activities undertaken.
2.7. Review of service delivery, implementation approaches and case studies
A large-scale call for examples of good practices was undertaken to identify effective and acceptable delivery approaches for key populations. These case studies, presented in Chapters 5 and 6, offer insights into successful implementation of services for key population groups. Web Annex 5 presents more information on these case studies.
2.8. Producing the guidelines
Following the Guideline Development Group consultation, the full draft guidelines were revised and circulated electronically to both the Guidelines Development Group and the External Peer Review Group for comments and feedback. All responses were considered and, as appropriate, addressed in the final draft.
2.9. Plans for dissemination
The guidelines are being disseminated as a printed publication and electronically on the WHO web site including all Annexes.
2.10. Updating
The Department of HIV has committed to providing regular updates of consolidated key population guidelines when new or revised evidence becomes available, including relevant new guidance developed by other WHO departments.
- 1
WHO, UNAIDS, the United Nations Population Fund (UNFPA), the United Nations Children's Fund (UNICEF), the United Nations Development Programme (UNDP) and UNODC have developed four technical briefs on young people from key populations. These policy briefs are based on reviews of epidemiological data, the literature on service delivery, a policy analysis, and qualitative research on the values and preferences of young people from key populations. These guidelines include key messages from this work. See Web Annex 6.
