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A short technical update on self‑testing for HIV
UNAIDS / JC2603E (English original, May 2014)
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A SHORT TECHNICAL UPDATE ON SELF-TESTING FOR HIV
1. What is HIV self-testing and what could it accomplish? 2
2. Current status and research 2
3. Programmatic approaches and models 4
4. Weighing potential benefits and risks 6
5. Policy and regulatory considerations 7
6. Other policy and programme considerations 8
7. Key points to remember about HIV self-testing 9 A short technical update on self-testing for HIV | 1
A SHORT TECHNICAL UPDATE ON SELF-TESTING FOR HIV
1. What is HIV self‑testing and what could it accomplish?
HIV self‑testing is a process whereby a person who wants to know his or her HIV status collects a specimen, performs a test and interprets the test result in private.1 HIV self‑testing does not provide a definitive diagnosis; instead, it is a screening test for the presence of HIV‑1/2 antibodies or the HIV‑1 p24 antigen. Any positive HIV result must be confirmed by a health worker in accordance with national testing algorithms.2,3 HIV self‑testing enables individuals to test themselves for HIV in private.
By providing an opportunity for people to test themselves discreetly and conveniently, HIV self‑testing may provide people who are not currently reached by existing HIV testing and counselling (HTC) services with infor‑ mation about their HIV status.
Policy development regarding HIV self‑testing varies across countries.5 Over‑the‑counter sale and use of the OraQuick In‑Home HIV Test began in the United States of America in 2012. In April 2014, the United Kingdom of Great Britain and Northern Ireland legalized the sale of HIV self‑test kits.6 France has also announced plans to approve over‑the‑counter sale of HIV 2 | A short technical update on self-testing for HIV
A SHORT TECHNICAL UPDATE ON SELF-TESTING FOR HIVself‑test kits in 2014. Kenya,7 has developed national HTC policies that include HIV self‑testing. Other countries—including Malawi,8 South Africa9 and Zimbabwe10—are considering its introduction. In some countries, HIV self‑testing is explicitly illegal,11 but in many others there are no formal regu‑ lations or policies. Despite this, HIV RDTs have been informally available and used by individuals for self‑testing for some time.
Current evidence on HIV self‑testing comes from high‑, middle‑ and low‑in‑ come countries in Africa, Asia, Europe and North America. Research findings (including those from pilot programmes) have shown promising results in both generalized and concentrated epidemic settings. However, more documenta‑ tion is needed to inform the development of WHO normative guidance.
HIV self‑testing studies generally report high levels of acceptability (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) initi‑ ation—improved linkage to services, uptake of (and retention of) ART and care at a population level (when compared to facility‑based HTC).12 Studies also report that HIV self‑testing with oral fluid self‑test kits is accurate, with sensitivity of at least 91.7% and specificity of at least 97.9%.13 Although HIV self‑tests are generally accurate, their sensitivity, specificity and positive/ negative predictive values can be affected by the prevalence of HIV among the population and by user errors. User‑friendly specimen collections allow RDTs to be performed by anyone and do not require medical training.
Error, which can take place with any test, occurs among both trained and untrained users, and it can result in incorrect test results. In studies of untrained self‑testers, the rate of operator error ranged from 0.37% to 5.4%.14 Reported errors include misinterpreting test results, failing to follow instruc‑ tions and performing the self‑test incorrectly.
For instance, a study of false‑positive test results found that trained staff in the Democratic Republic of the Congo did not follow standard operating procedures. A study based in the United States of oral fluid‑based HIV RDTs used by trained health workers also indicated that user error was the most common cause of lower sensitivity and specificity, attributing it to factors such as poor vision, inadequate lighting and failure to read the results within the specified time period.15,16 A short technical update on self-testing for HIV | 3
3. Programmatic approaches and models Researchers have proposed various approaches to delivering HIV self‑
testing. These approaches differ as to:
1. How support is provided to users before and after testing (e.g. demonstra‑ tions of the procedure, presence of peer support, telephone hotlines);
2. How the self‑test kits are distributed (e.g. facility, outreach, to the home or over the counter); and
3. How linkages are made from HIV self‑testing to further HIV testing for confirmation of test results and for linkages into HIV care.
PRIVATE OR SUPERVISED HIV SELF‑TESTINGPrivate and supervised approaches to HIV self‑testing differ as to (1) the amount of support provided to users and (2) where HIV self‑testing kits are administered or distributed.
Private HIV self‑testing is when a person self‑tests in private. 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).
Supervised HIV self‑testing involves support from a health worker or volunteer who is physically present before or after the individual self‑tests for HIV. Such support may include a demonstration of how to use the test, pre‑ or post‑test counselling and referrals to additional services.
ACCESS TO SELF‑TESTING Access to HIV self‑testing can be clinically restricted, semi‑restricted or non‑restricted.
Clinically restricted: health professionals only provide specific populations and groups with HIV RDTs for self‑testing, as decided by national policy or guidelines.
Semi‑restricted: health workers or volunteers provide some pretest instructions and counselling before distributing the HIV self‑test kits to individuals (e.g.
health workers distributing them through a health‑care facility, or trained staff distributing them to patients or the general public at pharmacies and workplaces).
4 | A short technical update on self-testing for HIV Non‑restricted (open access): HIV self‑test kits are made available through many types of programmes and locations, including pharmacies, clinics, convenience stores and vending machines.
DISTRIBUTION AND INITIATION OF HIV SELF‑TESTINGDistribution and initiation of HIV self‑testing can take place at a range of places within communities, including health‑care facilities and other suitable venues.
Community‑based approaches to HIV self‑testing involve distributing HIV self‑testing kits to community members through volunteers or community health workers. 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.
Facility‑initiated or facility‑based approaches allow clients to self‑test at home or in a private setting in a health facility. Health‑care providers may encourage individuals to take self‑test kits home for themselves and/or to give to their spouses and partners.
Alternative venue‑initiated or venue‑based approaches involve the public distribution or sale of HIV self‑test kits through pharmacies, convenience stores, the Internet and other venues. This open‑access approach is currently employed in the United States.17 A modification of this approach could include restricting access to HIV self‑test kits to pharmacies, where they would be distributed by pharmacists or on‑site nurses who have been trained to provide additional support and information about where to seek test confirmation and services for HIV prevention, care and support. HIV self‑test kits also could be clinically restricted and only made available by prescription to specific individuals.
Potential benefits of HIV self‑testing include increased access to testing and earlier diagnosis for people living with HIV. People who self‑test also experi‑ ence greater convenience, autonomy and privacy when testing, and this may provide an option for individuals who are not using existing HTC services or those who do not have regular contact with (or access to) health services where HIV testing is offered. Key populations (including men who have sex with men, transgender people, sex workers and people who inject drugs) may benefit from self‑testing, as might members of the general population in areas with a high prevalence of HIV (including health workers, couples and partners, serodiscordant partners, adolescents and retesters). Some research also suggests that HIV self‑testing may reduce sexual risk behaviour and increase testing frequency among men who have sex with men, and that HIV self‑testing may also facilitate voluntary disclosure within couples. These findings also indicate that HIV self‑testing may complement existing HTC and public health strate‑ gies to reduce risk of exposure to (and transmission of) HIV.
As for risks associated with HIV self‑testing, no adverse events or harm has been reported to date (e.g. there have been no human rights violations from the misuse of HIV self‑testing, nor have there been accounts of violence or self‑harm). Some stakeholders, however, have concerns about operational issues, including the slightly reduced sensitivity and specificity of RDTs in the hands of untrained or non‑proficient users, the risk of operator error, the potential for the misinterpretation of results, and the lack of linkages to care. 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.
WHO and UNAIDS provide clear guidance on the critical requirements for all forms of testing, including the guidance that all testing must be voluntary. Mandatory or coerced HIV testing of individuals is never warranted.18 6 | A short technical update on self-testing for HIV
A SHORT TECHNICAL UPDATE ON SELF-TESTING FOR HIV
5. Policy and regulatory considerations HIV self‑testing takes place in many countries that do not have policies that regulate the quality, sale, distribution or use of HIV self‑test kits. In order to optimize HIV self‑testing, a number of policies and regulations will likely need to be adapted or developed.
In particular, policy‑makers and implementers must consider:
■ Laws and regulations permitting the sale, distribution and use of in vitro medical devices will generally need to be adapted or developed.
■ Policies regarding access to HIV testing; for example, the age of consent may need to be adapted or developed to enable populations to self‑test for HIV (e.g. adolescents).
■ Human rights and protection laws, policies and regulations that address misuse and abuse (such as coercive testing, violence, discrimination and prosecution) may need to be developed or adapted to protect people who self‑test. Channels through which misuse or abuse can be reported and monitored also may need to be established (this includes the distribution or sale of HIV self‑test kits of poor quality).