SADM #87 Nov/Dec 2019
Reaching people with undiagnosed HIV.
HIV self-testing (HIVST) is an empowering and innovative way to reach more people with HIV and help achieve the first of the United Nation’s 90–90–90 targets – for 90% of all people with HIV to know their status by 2020. Expanded use of HIVST can contribute to these global targets by reaching first-time testers, people with undiagnosed HIV or those at ongoing risk who are in need of frequent retesting.
HIV self-testing is a process in which a person collects his or her own specimen (oral fluid or blood) and then performs an HIV test and interprets the result, often in a private setting, either alone or with someone he or she trusts.
HIVST has been shown to be an empowering, discreet and highly acceptable option for many users, including key populations, men, young people, health workers, pregnant women and their male partners, couples and general population groups.
HIVST represents another forward step in line with efforts to increase patient autonomy, decentralize services and create demand for HIV testing among those unreached by existing services.
HIVST may enhance health system efficiency by focusing health services and resources on people with a reactive self-test result who are in need of further testing, support and referral, thereby directing services more appropriately. Also, by reducing the number of facility visits for frequent testers, and eliminating the need for individuals to travel distances or wait in long lines to access HIV testing, HIVST may be more convenient for users.
The WHO Guideline Development Group reviewed the evidence on HIVST and made the following recommendation:
HIV self-testing should be offered as an additional approach to HIV testing services.
[strong recommendation, moderate quality of evidence.]
For full WHO guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services see: http://www.who.int/hiv/topics/vct/en/
HIV self-testing strategy
The result of a single rapid diagnostic test (RDT) is not sufficient to make an HIV-positive diagnosis. HIVST requires self-testers with a reactive (positive) result to receive further testing from a trained provider using a validated national testing algorithm.
All self-testers with a non-reactive test result should retest if they might have been exposed to HIV in the preceding six weeks, or are at high ongoing HIV risk.
HIVST is not recommended for people taking anti-retroviral drugs, as this may cause a false non-reactive result.
Any person who is uncertain about how to correctly perform the self-test, or interpret the self-test result, should be encouraged to access facility- or community-based HIV testing.
Effective and safe
Key evidence has found that HIVST, when compared to standard HIV testing:
- More than doubles uptake of HIV testing among men who have sex with men and male partners of pregnant or post-partum women.
- Increases uptake of couples HIV testing among male partners of pregnant or post-partum women.
- Nearly doubles frequency of HIV testing among men who have sex with men1.
- Can result in identifying an equivalent or greater proportion of HIV-positive people.
- Does not increase HIV risk behaviours (such as condomless anal intercourse) or the number of bacterial sexually transmitted infections (STIs).
- Does not decrease uptake or frequency of testing for STIs.
- Does not increase reported social harm, adverse events or behaviours.
- Can perform as well as an HIV RDT used and interpreted by a trained health worker.
- Can achieve acceptable sensitivity (80–100%) and specificity (95.1–100%), especially using products that meet quality, safety and performance standards.
Considerations for success
For successful implementation of HIVST, programmes should consider:
- Quality-assured products. Any HIV RDT for self-testing, either oral or blood, which is procured or used for HIVST should be approved by the relevant regulatory authority or the results of an international regulatory review.
- Policy and regulatory frameworks. Adapt, develop and harmonize existing national policies on HIV testing to incorporate HIVST, such as:
- Laws permitting the sale, distribution, advertisement and use of quality-assured RDTs for HIVST;
- Age of consent to self-test;
- Human rights laws, policies and regulations to protect individuals and address misuse of HIVST if and when it occurs;
- National policies on how to confirm an individual’s HIV status following HIVST;
- Quality assurance and post-market surveillance systems for RDTs used for HIVST.
- Information, support and linkage. Regardless of approach, self-testers must be provided with clear information on how to correctly perform the test, interpret the result, as well as where and how to access stigma-free HIV testing, HIV prevention, treatment, care and support services. In particular, it is critical self-testers understand that:
- A reactive self-test result is not an HIV-positive diagnosis and requires further testing and confirmation. If a self-test result is confirmed, users must be provided with information on where and how to access treatment and care.
- A non-reactive self-test result is assumed negative. Users should be advised to retest if at high on-going HIV risk, or if potential exposure to HIV occurred in the preceding six weeks, and referred to a relevant HIV prevention service, such as post-exposure prophylaxis, pre-exposure prophylaxis (PrEP), or voluntary male medical circumcision (VMMC).
- Monitoring and reporting systems. Monitoring HIVST uptake by population, HIV positivity and linkage to services is important to evaluate the effectiveness of self-testing, and report on and address any related social harm.
1 WHO recommends men who have sex with men have an
HIV test every three to six month, depending on their risk