2.1. Overview
The WHO HIV Department led the development of these guidelines in accordance with procedures and reporting standards laid out in the WHO handbook for guideline development (45), using the GRADE process. These consolidated guidelines on HTS combine existing WHO recommendations which had previously been developed through the GRADE process, guidance published by WHO together with UN partners and one new WHO recommendation. All current WHO recommendations that pertain to HTS are included.
2.2. Establishing the Guideline Development Group
The WHO HIV Department set up three groups to perform specific guideline development functions: (1) an internal WHO HTS Guideline Steering Group to lead the process, (2) a Guideline Development Group comprising 19 external experts responsible for the formulation of the new WHO recommendation, service delivery guidance and selection of case examples and for review and approval of the final content of the guidelines document, and (3) 120 external peer reviewers. Members of the groups were selected so as to ensure a range of expertise and experience, including appropriate geographical, gender and community representation. (See Acknowledgements for lists of participants.)
Involvement of key stakeholders
An important element of this work was engaging with a diverse set of stakeholders to update and synthesize key messages across existing WHO guidance on HTS. These stakeholders included countries (ministries of health and laboratory services), researchers, international and national implementing agencies, community networks and implementers, WHO regional and country offices and other UN agencies. Also, to maximize stakeholder engagement and ensure the relevance of the guidelines to countries, WHO solicited case examples from civil society, community-based organizations and networks, including key populations and people living with HIV, and additional experts in the field.
Declarations of interest
All Guideline Development Group participants and external peer reviewers submitted declarations of interest 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 and summary of the declarations are available in Annex 15; see http://www.who.int/hiv/pub/guidelines/.
2.3. Defining the scope of the guidelines
To develop these guidelines, the WHO Guideline Steering Group mapped all existing WHO guidance specifically concerned with HTS (see Table 1, page xix). Then, the Group reviewed these and other materials to identify areas requiring updating, gaps, overlaps and inconsistencies. The outcome of the mapping exercise was presented to the Guidelines Development Group at several virtual scoping meetings during November and December 2014. The group reviewed the mapping, advised on the scope of the guidelines and noted areas that did not need updating and areas requiring new guidance – specifically, HIV testing, using RDTs, by trained lay providers.
2.4. Review of the evidence
These guidelines include one new recommendation, on HIV testing by trained lay providers, as well as existing recommendations. Development of the new recommendation began with a systematic review of the evidence. The Guidelines Development Group recommended commissioning new literature reviews and appraisal of existing reviews to investigate values and preferences, along with reviews of the costs and feasibility of implementation (see Annex 1). Also, WHO commissioned a new descriptive review of current national policies on trained lay providers' involvement in HIV testing to inform consideration of the feasibility of the new recommendation (see Annex 2).
2.5. Development of the recommendation on HIV testing, using RDTs, by trained lay providers
As noted, the scoping exercise identified a need for evidence-based recommendations concerning trained lay providers performing HIV testing with RDTs. The question was framed in the PICO (Population, Intervention, Comparator, Outcome) format. The WHO Guideline Steering Group drafted the PICO question. The question was circulated to the members of the Guideline Development Group, who selected and ranked the importance of a range of outcomes and gave comments. Once the PICO question was completed and agreed, external researchers used it to develop search protocols and perform a systematic review of the available scientific evidence, as described below. See Annex 1 for details.
PICO question: Should trained lay providers, using HIV rapid diagnostic tests (RDTs), perform HIV testing?
P: People who receive HTS
I: HIV testing, using HIV RDTs, performed by trained lay providers
C: HIV testing, using HIV RDTs, performed by trained health professionals (for example, nurses or doctors), or no intervention
O: Primary: (1) Measures of testing quality (quality assurance) (for example, lost or damaged/uninterpretable specimens); (2) accurate test results (sensitivity and specificity); (3) adverse events (for example, coercion, inter-partner violence, psychosocial events and/or self-harm, stigma, discrimination); (4) uptake of HTS. Secondary: (5) Rate of CD4 measurement (among all participants found to have HIV, the percentage who reach this next stage of triage); (6) linkage to medical visit after diagnosis; and (7) initiation of ART (among participants eligible per national guidelines).
2.5.1. Systematic review of values and preferences
Researchers used the same search strategies to identify studies presenting information on end-users' values and preferences related to the PICO question. Researchers included studies in the values and preferences review if the studies presented primary data examining people's preferences regarding different cadres of health providers and HIV testing. These studies could be qualitative or quantitative in nature but had to present primary data; opinion pieces and review articles were not included. Researchers qualitatively summarized the values and preferences literature; this summary is presented in Annex 1.
2.5.2. Policy analysis
WHO conducted a separate analysis of national HIV testing policies to assess the overall feasibility of HIV testing provided by trained lay providers. Two researchers searched, reviewed and analysed national HIV testing policies from the Americas, Africa, Asia and Europe. From 1 November 2014 through 21 December 2014, the researchers conducted electronic searches for national HIV testing policies, using Google, governmental and nongovernmental websites and WHO databases. They also contacted WHO and UNAIDS regional technical advisors and key experts in the field. This report is presented in Annex 2.
2.6. Developing the recommendation
From January through March 2015, WHO convened 12 virtual guideline development meetings (two parallel morning and afternoon meetings on six separate occasions to allow participation from all time zones) and nine WHO Steering Group meetings. During these meetings participants considered the evidence for formulating a new recommendation and reviewed all relevant sections of the consolidated guidelines.
2.7. Review of service delivery, implementation approaches and case examples
In addition to the systematic review on trained lay providers conducting HIV testing and the review of 48 countries' policies on HIV testing (see Annex 2), two other literature reviews were conducted. Both were on community-based HTS: one among key populations and the other among the general population. Both inform the discussion of HTS approaches described in Chapter 4 and strategic decision-making described in Chapter 6.
WHO also identified examples of HTS practices in the field. These case examples offer insights into implementation of HTS, including services for key population groups. They explain why and how programmes have worked and the types of challenges faced during implementation. Case examples were solicited and collected specifically to illustrate effective and acceptable ways to deliver community-based HTS among key populations. The WHO Steering Group and Guideline Development Group then reviewed the case examples and selected the most relevant for inclusion in the guidelines. See Annex 3 for all case examples collected and more details.
2.8. Additional background work
As part of the guideline development process, WHO commissioned three other literature searches and mathematical modelling to provide the most up-to-date information. They include:
Attitudes, values and preferences on HIV self-testing among key populations. This review informs
Chapter 4 and discussion on HIV self-testing (see
Annex 4).
Review of the cost of different HIV testing approaches. The review informs
Chapter 6 on the strategic selection of HTS approaches (see
Annex 5).
Mathematical model on the cost of testing pregnant women in high and very low prevalence settings. This model informs
Chapter 6 on the strategic selection of HTS approaches (see
Annex 6).
Review of misdiagnosis of HIV status. This review informs
Chapters 7 and
8 on HIV diagnosis and the quality of services (see
Annex 14).
