1.1. Progress and challenges with HIV testing services
People's knowledge of their own, and their partner's, HIV status is essential to the success of the global HIV response. The overarching goals of providing HIV testing services (HTS) are to deliver a diagnosis and effectively facilitate access to and uptake of HIV prevention, treatment and care, including antiretroviral therapy (ART), voluntary medical male circumcision, services for prevention of mother-to-child transmission, male and female condoms and lubricants, contraception, harm reduction services for people who inject drugs, pre-exposure prophylaxis and post-exposure prophylaxis. These high-impact interventions have the potential to reduce HIV transmission and HIV-related morbidity and mortality (1,8–10).
Over the past decade, the global scale-up of HTS has been substantial. In 2005 it was estimated that only 10% of people with HIV in Africa were aware of their HIV status and that, globally, only 12% of people who wanted to test for HIV were able to (11). In contrast, in 2015 it was estimated that 55% of all people with HIV in Africa and 60% of people with HIV globally knew their status (12) and that more than 600 million people received HTS in 122 low- and middle-income countries in the years 2010–2014 (13). These achievements have been possible largely because of the scale-up and use of effective HIV treatment and the wide availability of low-cost rapid diagnostic tests (RDTs). The growing availability and use of RDTs has made it possible to increase task sharing. This has enabled HTS to also be delivered by trained lay providers and to be implemented in more settings, ranging from routine testing in facilities to community-based outreach.
Many of those at highest risk of HIV remain unreached.
In spite of these achievements, a substantial testing gap remains. According to recent estimates, 77% of all people diagnosed with HIV are on ART; however, 40% of all people with HIV remain undiagnosed (12). Furthermore, despite the annual increases in HIV tests and HIV testing coverage (13), in many settings HTS is not sufficiently focused. Many of those at highest risk, such as men, partners of people with HIV, adolescents and young people in high HIV prevalence settings and key populations worldwide, remain unreached.
1.1.1. Men continue to lag behind
Globally, HTS uptake and coverage for men continues to be lower than for women (3). Nearly 70% of adult HIV tests reported in 76 low- and middle-income countries in 2014 were conducted for women (see ) (13). Global reporting suggests this is because HIV testing has been successfully integrated into reproductive health services, including antenatal care, but not consistently into other relevant clinic settings. Also, male partner testing is not widely implemented or, where offered, taken up (3). As of June 2014 only half of 58 low- and middle-income countries surveyed had policies supporting couples HTS (14). Fewer still reported couples HTS rates over 20% in antenatal care settings, with the offer of partner testing being even less likely outside of these settings (14); more than half of countries did not have policies recommending the offering of partner testing in all settings (see Annex 24 for details).
Men and women as a proportion of people older than 15 years who received HIV testing services in low- and middle-income countries, by WHO region, 2014. AFR = African Region; AMR = Region of the Americas; SEAR = South-East Asia Region; EUR = European Region; (more...)
Barriers hindering men's access to and uptake of HTS are often due to their perceptions that health services, particularly antenatal care settings, are not friendly to men (15). Other socio-cultural beliefs and behaviours are also contributing factors. As a result, many men remain untested, and those who are HIV-positive continue to be undiagnosed and, therefore, linked to treatment and care late. Consequently, in many settings, males have a higher HIV-mortality rate than their female peers (16).
Strategies are needed to increase men's uptake of HTS, including providing HTS in more accessible settings. Also needed are ways to encourage more testing of male partners in high prevalence settings and testing of male partners of women with HIV in all settings. As reported in recent systematic reviews, assisted HIV partner notification services, HIVST, male-focused interventions and outreach such as mobile or home-based HIV testing are particularly promising, having increased uptake of HTS among men in several settings (17,18).
1.1.2. Adolescents are also underserved
Adolescents, particularly girls, are also at significant risk of HIV infection. Risk is highest in sub-Saharan Africa, where nearly 90% of the world's HIV-positive adolescents (10–19 years of age) are estimated to be living (19). Additionally, an analysis across 19 countries in sub-Saharan Africa reports that, regardless of gender, adolescent orphans are more likely to be HIV-positive than other adolescents (20).
Despite the need for HIV testing among adolescents, coverage and uptake remain poor. In the WHO Africa Region it is estimated that fewer than one in every five girls (15–19 years of age) are aware of their HIV status (21,22). Poor access and uptake are often due to actual or perceived poor quality services as well as to restrictive laws and policies – for example, age of consent laws for testing that prevent adolescents from accessing HTS (23). Greater efforts are needed, in particular, to improve access to HTS among adolescents where HIV incidence is high, in sub-Saharan Africa and among young key populations in all settings.
1.1.3. Increasing access for key populations
Key populations are also disproportionately affected by HIV. They comprise approximately 36% of the 1.9 million new adult HIV infections that occur each year (8,12) (see ). Although countries are increasingly including key populations in their national HTS guidelines, implementation remains limited, and coverage continues to be low in most settings (13).
Global distribution of new HIV infections by population group, 2014. Source: UNAIDS, 2016 (12).
Poor coverage and low uptake of HTS among key populations is not only related to availability but also to acceptability of services. Low acceptability frequently reflects unfriendly services, fear of stigma, discrimination, and punitive laws and practices that criminalize behaviours and, thereby, discourage access to health services, including HTS (8).
These challenges require a new focus and new approaches to reach people with undiagnosed HIV. Many countries and programmes are looking for innovative approaches to delivering HTS so as to achieve national and global testing targets.
1.2. Guidelines rationale
These 2016 guidelines aim to address gaps in the WHO Consolidated guidelines on HIV testing services by providing recommendations and guidance on HIV self-testing (HIVST) and assisted HIV partner notification services. Countries are particularly seeking WHO guidance on HIVST because HIVST kits are increasingly available through informal channels, such as private pharmacies and the Internet, with products frequently of unknown quality (24–26). Likewise, although several countries have policies on HIV partner notification, it remains poorly implemented in practice – even though partner notification is simple, effective and can lead to the diagnosis of high proportions of persons with HIV infection. Furthermore, concerns about potential social harm, including violence resulting from partner notification, have not been borne out in the scientific studies conducted to date. While programme implementers should be sensitive to the potential for harm arising from disclosure of HIV status, this should be balanced against the benefit of diagnosing HIV infection and linking people to treatment. Offering voluntary assisted partner notification services for sexual and drug injecting partners of people with HIV will expand the number of people who are aware of their exposure to HIV infection.
Countries and other key stakeholders have indicated the importance of this new guidance to enable them to make decisions about whether, or how, to adopt these two approaches to HIV testing so as to enhance their ability to strategically focus on and scale up HTS, with a view to achieving the UN 90–90–90 goals and fast-tracking the end of HIV by 2030 (4).
1.3. Scope of guidelines
These new guidelines present two approaches to testing that were not covered in the 2015 Consolidated guidelines on HIV testing services (1). In particular, they present and discuss guidance to support the most ethical, acceptable and effective implementation of HIVST and assisted HIV partner notification services. The detailed methodology used to develop the guidelines is described in Annexes 16–19. Chapter 2 details the guidance and recommendations on HIVST, while Chapter 3 details the guidance and recommendations on assisted HIV partner notification services. These guidelines are also available in the 2015 consolidated guidelines as Chapters 10 and 11. They are also available as abridged policy briefs: http://www.who.int/hiv/pub/guidelines/.
1.4. Using the guidelines
These guidelines are intended to help countries implement a strategic combination of HTS approaches that address each specific epidemiological context in an appropriate way. They are aligned with a public health approach to HTS and are guided by the human rights principles outlined in the WHO 5Cs for HIV testing (see section 1.7).
The background documents developed to support these guidelines and the systematic reviews and Grading of Recommendations, Assessment, Development and Evaluation tables for new recommendations appear in the annexes listed in the table of contents, which are available on the Internet (http://www.who.int/hiv/pub/guidelines/).
1.5. Goal and objectives
The primary goal of these guidelines is to better support and complement existing HTS approaches in order to reach people who may not otherwise test.
The primary goal of these 2016 guidelines is to update the existing WHO Consolidated guidelines on HIV testing services and, thereby, better support countries and national programmes seeking to reach people who may not otherwise test.
Specific objectives in support of this goal include the following:
Strengthen existing guidance on HIVST, which encourages countries to conduct pilot services and demonstration projects.
Support the routine offering of voluntary assisted HIV partner notification services as part of the public health approach to delivering HTS.
Strengthen existing guidance to promote couples and partner HTS, in particular offering voluntary HTS to the partners of all people diagnosed with HIV.
Support the implementation and scale-up of HIVST and assisted HIV partner notification in the most ethical, effective, acceptable and evidence-based manner.
Provide guidance on how HIVST and assisted HIV partner notification services should be integrated into existing community-based and facility-based HTS approaches and tailored to specific population groups.
Position HIVST and assisted HIV partner notification services as part of the strategic combination of HTS approaches that will contribute to closing the testing gap and achieving the UN's 90–90–90 global goals.
1.6. Target audience
These guidelines are intended for national and sub-national HIV programme managers, particularly within ministries of health, who are responsible for the national health sector response to HIV, including HTS and prevention, care and treatment services, as well as officers at the national level responsible for other communicable diseases, especially other forms of sexually transmitted infections, tuberculosis and viral hepatitis.
Furthermore, these guidelines will be helpful to additional implementers of HTS, including international and national nongovernmental organizations, civil society and community-based organizations. They can also serve donors as the normative guidance to support effective funding, planning, implementation, and monitoring and evaluation of HTS.
1.7. Guiding principles
The main reasons for HIV testing must always be to both benefit the individuals tested and improve health outcomes at the population level.
It is important to deliver HTS with a public health and human rights-based approach that highlights priority areas, including universal health coverage, gender equality and health-related human rights such as accessibility, availability, acceptability and quality of services. For all HTS, regardless of approach, the public health benefits must always outweigh the potential harm or risk. Moreover, the main reasons for testing must always be to both benefit the individuals tested and to improve health outcomes at the population level. HTS should be expanded not merely to achieve a high rate of testing uptake or to meet HIV testing targets, but primarily to provide access for all people in need to appropriate, quality HTS, which is linked to prevention, treatment and care services. HIV testing for diagnosis must always be voluntary, and consent for testing must be informed by pre-test information.
All forms of HTS, including HIVST and HIV partner notification services, should adhere to the WHO 5 Cs: Consent, Confidentiality, Counselling, Correct test results and Connection (linkage to prevention, care and treatment services) (1). Coerced or mandatory testing is never appropriate, whether that coercion comes from a health-care provider or from a partner, family member, or any other person.
WHO 5 Cs of HIV testing services
The 5 Cs are principles that apply to all HTS and in all circumstances. They are:
Consent: People receiving HTS must give their informed consent to be tested and counselled. Verbal consent is sufficient; written consent is not required. They should be informed of the process for HIV testing and counselling and of their right to decline. It should not be assumed that people who request, or report, self-testing for HIV are giving or have implicitly given their consent. It is important that all people who self-test are informed that mandatory or coercive testing is never warranted.
Informed consent is necessary when programmes adopt assisted HIVST approaches. In addition, it is essential that all people with HIV are informed that assisted partner notification is voluntary, and that partners of HIV-positive clients are also made aware that HIV testing is voluntary, not mandatory.
Confidentiality: HTS must be confidential. Discussions held between the HTS provider and the client should not be disclosed to a third party without the express consent of the person being tested. Although confidentiality must be respected, it should never be used to reinforce secrecy, stigma or shame. Counsellors should always ask clients, among other things, who they wish to inform and how they would like this to be done. Shared confidentiality with a partner or family members – trusted others – and health-care providers is often highly beneficial to HIV-positive clients.
Counselling: Pre-test information and post-test counselling can be provided in a group setting if appropriate; however, all persons should have the opportunity to ask questions in a private setting if they request it. All HTS must be accompanied by appropriate and high-quality post-test counselling, based on HIV test results. Quality assurance (QA) mechanisms, as well as supportive supervision and mentoring systems, should be in place to ensure the provision of high-quality counselling.
In the context of HIVST, it is important to note that pre-test information and post-test counselling can be provided using a directly assisted approach (for example, in-person demonstration and explanation by a trained provider or peer) or using an unassisted approach (for example, use of manufacturer provided instructions), as well as a number of other support tools, such as brochures, links to Internet- or computer-based programmes or videos, or telephone hotlines or mobile phone applications or text message services.
Correct test results: Providers of HTS should strive to provide high-quality testing services and QA mechanisms that ensure people receive a correct diagnosis. QA may comprise both internal and external measures and should include support from the national reference laboratory.
A single reactive self-test result does not provide an HIV-positive diagnosis. It should be followed by further testing and confirmation by a trained provider. Additionally, all people who receive a positive HIV diagnosis should be retested to verify their diagnosis before initiation of ART or HIV care. Interpretation of a non-reactive self-test result will depend on the ongoing risk of HIV exposure. Individuals at high ongoing risk, or who are using anti-retroviral drugs for treatment or prevention, should be encouraged to retest.
Connection: Linkage to prevention, treatment and care services should include the provision of effective and appropriate follow-up. Providing HTS in situations where there is no access or poor linkage to care, including ART, has limited benefit for those with HIV.
In the context of HIVST, connection also includes linkage to further HIV testing in a stigma-free community- or facility-based setting, where test results can be confirmed and an HIV diagnosis given by a trained provider.
