"HIV self‑testing may provide people with an additional pathway to HIV prevention, care and treatment."
This document is designed "to synthesize experiences, research and policies on HIV self‑testing to inform stakeholders who are considering or already implementing HIV self‑testing." It was created collaboratively by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/ AIDS (UNAIDS). [Footnotes are removed by the editor.]
Self-testing is of interest to those working in HIV because aspects of privacy, discretion, and convenience may help to reach those previously not tested. Policy development for self-testing varies across countries - the testing is recently legalised in some countries, illegal in others, and unregulated in still others. As stated here, research findings have shown promise, but more research is needed. Self-testing studies show a high level of acceptance "(74-96%), primarily for oral fluid‑based tests, among men who have sex with men adults, young people, health workers and couples who already self‑test for HIV (or want to do so).A study in Malawi reported that HIV self‑testing - combined with home‑based antiretroviral therapy (ART) initiation - improved linkage to services, uptake of (and retention of) ART and care at a population level (when compared to facility‑based HTC [HIV testing and counselling])."
Errors have been found as a result of not following the standard operating procedures as directed and misreading the test results is attributed to factors such as poor vision, inadequate lighting, and failure to read the results within the specified time period. To provide proper results, various programmatic models are suggested that include support to users either face-to-face or: "Support may or may not be indirectly provided via telephone hotlines, leaflets, referral information, support groups, legal aid demonstration videos and services for HIV treatment, care and prevention)."
Distribution depends on the choice of points of access (clinics, health workers, pharmacies, vending machines, etc.). For example: "Community‑based approaches to HIV self‑testing involve distributing HIV self‑testing kits to community members through volunteers or community healthworkers. This approach involves some supervision from a community health worker or volunteer before and/or after individuals test themselves for HIV in private. Pre‑test support may include a demonstration of how to use the test and interpret the result, as well as information on where and how to seek additional support, further testing and services for HIV prevention, care and treatment. Post‑test support may provide an opportunity for community members to disclose their result, and it also may include face‑to‑face counselling, peer support and referrals for additional services for HIV prevention, treatment and care."
Policy benefits and concerns, discussed in more detail on page 6, include reaching key populations and facilitating voluntary couples' disclosure, while risks include misuse of the product with resulting false results. "There are also ethical, legal and social concerns, such as potentially increased risks for vulnerable populations (through domestic violence, for instance, or through coercive testing). These considerations apply to all forms of HIV testing, however, and they are not unique to self‑testing." Page 7 lists policy and regulatory considerations, for example, as human rights laws and policies are adopted to include self-testing, channels for reporting misuse and abuse may need to be developed.
Policy and programmatic considerations include:
- "Appropriate and adequate instructions for use of the HIV self‑test kit are critical to reducing errors and maximizing its accuracy. Clear and concise printed instructions - written and/or pictorial - are essential to support correct use and interpretation. In particular, users need to understand that a reactive (positive) test result must be confirmed through further testing."
- "Providing pretest information and counselling can facilitate access linkages to care, as can post‑test referrals and follow‑up (through face‑to‑face counselling, telephone hotlines, videos, web‑based video chats, short message service (SMS) services and eHealth applications)."
- To reduce the risk of HIV self‑testing being used as a first‑line assay, policies and regulations may need to adapt national testing strategies and validate testing algorithms so that they include HIV self‑testing. Furthermore, health workers and health‑care facilities will need information on how to apply the national testing algorithm following the integration of HIV self‑testing.
- Because HIV self‑testing accuracy is dependent on a variety of factors, such as population and setting, there are "implications for the messaging around the use of HIV self‑test kits... to the person using self‑test kits."
"Key points to remember about HIV self‑testing
- "HIV self‑testing has the potential to increase access to HIV testing including among people living with HIV without their knowledge, and those who are in need of HIV care, treatment and support.
- Populations that may benefit from HIV self‑testing include the general population and health workers in settings with a high prevalence of HIV, key populations at higher risk in all settings, and those who frequently retest due to ongoing risk.
- HIV self‑testing shares many characteristics with current HTC approaches, including products, accuracy issues, linkages to prevention and care services, potential benefits and risks, and regulatory policies and frameworks.
- HIV self‑testing is already available - both formally and informally - in many places. Given the current demand for HIV self‑testing, its use and availability is likely to increase in many settings.
- Research on HIV self‑testing is continuing. It is essential to continuously expand the evidence base on HIV self‑testing to inform not only the development of national policy and regulations, but also WHO normative guidance.
- Programmatic approaches and implementation models for HIV self‑testing vary according to the type of support, the range of access self‑testing vary according to the type of support, the range of access and the site of sale or distribution. Although a number of models of RDTs [Rapid Diagnostic Tests] are currently in use, many others could be developed or adapted to suit the local context.
- Key concerns regarding HIV self‑testing also apply to all other types of HIV testing. The potential for harm can be minimized if HIV self‑testing is provided within a human rights framework, and if it is done with adequate information, regulated and high‑quality self‑test kits, and community involvement in decision‑making.
- National policies and regulations can be adapted to include HIV self‑testing in existing HIV testing, as well as current counselling strategies and policies."
UNAIDS website, July 27 2015.