Rapid HIV Self-testing: Long in Coming but Opportunities Beckon

Julie E. Myers; Wafaa M. El-Sadr; Allison Zerbe; Bernard M. Branson


AIDS. 2013;27(11):1687-1695. 

In This Article

Abstract and Introduction


The recent approval by the United States Food and Drug Administration of a rapid HIV self-test marks a significant milestone in the evolution of HIV testing approaches. With nearly one in five people living with HIV in the United States still undiagnosed and an even higher proportion unaware of their infection globally, this decision reflects a new willingness to offer diverse options to get tested for HIV. Rapid self-testing offers several distinct opportunities to improve testing among those with undiagnosed HIV: to encourage testing among those who might not otherwise be tested, to increase the frequency of testing among persons at highest risk for new infection, and to facilitate mutual HIV testing with sex partners. To date, the path to regulatory approval has been long but instructive. The studies and clinical trials required for regulatory approval in the United States provide insight into the performance and potential implications of HIV self-tests as they become available for sale directly to consumers. Although some persistent reservations about self-testing for HIV remain, including the 'window period' of the current test kit, its cost, and its effectiveness for facilitating entry to medical care, others have been dispelled. Self-testing in resource-constrained settings is also promising, including self-testing of health professionals. At present, although the impact has yet to be determined, availability of this new option might offer potential opportunities to improve HIV diagnosis and facilitate both treatment and prevention.


Nearly one in five people living with HIV in the United States are unaware they are infected.[1] Globally, approximately 60% of those with HIV are unaware.[2] Persons who are unaware of their infection account for almost half of all sexual transmissions in the United States[3] and contribute disproportionately to the continued spread of HIV. Thus, HIV testing remains essential to HIV prevention efforts in the United States[4,5] and worldwide.[6] Prompt identification of HIV infection offers many benefits to both the individual and community. In the United States, antiretroviral therapy (ART), with the goal of viral suppression, is now recommended for all persons with HIV infection;[7] in resource-constrained settings, WHO has recommended ART for all persons with a CD4+ cell count of less than 350 cells/μl and for the HIV-positive partner in serodiscordant couples.[8,9] Durable viral suppression improves immune function and quality of life, decreases morbidity, and improves survival.[7] HIV-positive persons in the United States appear to reduce high-risk sexual behavior after they become aware of their diagnosis, at least temporarily.[10] Mathematical models provide support that early ART initiation would decrease HIV transmission[11–15] and findings from the HIV Prevention Trials Network 052 study,[16] which documented this benefit, further stimulated interest in scaling up HIV testing and using of ART for prevention. Thus, additional effective methods are needed to increase HIV testing.

Self-testing, with its convenience, privacy, and anonymity, might present a promising option. With approximately 208 000 persons with undiagnosed HIV infection in the United States alone, 50 000 annual new infections in the United States[17] and 2.7 million globally,[2] it is essential to promptly identify HIV-infected persons.

Rapid Self-tests: Possible Roles

Rapid self-testing offers several potential opportunities. First, it might be used by persons in high-prevalence communities who have eluded previous prevention and testing efforts.[18] In the United States, the proportion of persons with undiagnosed infection is highest among racial and ethnic minorities and young people; an estimated 68% of all persons with undiagnosed HIV are black or Hispanic[1] and 60% of persons aged 13–24 years with HIV are unaware of their infection.[1] These same populations, that is, racial and ethnic minorities and young people, expressed high levels of interest in using rapid HIV self-tests in a 2006 population-based telephone survey in New York City (NYC).[19] MSM, a population at high risk in the United States,[5] were the subject of an online survey in six cities.[20] Among those who had never been tested for HIV, 86% of those likely to get a test in the next year expressed strong intentions to use a rapid self-test, if available. A majority (87%) of MSM surveyed online in France were interested in self-tests, if available; interested men were more likely to have never tested or to have not tested in the past year, and to live their sex lives with men 'in absolute secrecy'.[21] The small proportion of the MSM (3.5%) in the study who had already accessed unapproved tests online had similar characteristics.[22]

A second prospect for rapid HIV self-tests might be to facilitate more frequent testing among persons at highest risk for HIV. Centers for Disease Control and Prevention (CDC) guidelines recommend HIV testing at least annually for individuals at high risk of HIV.[23,24] More frequent testing is necessary for populations with high incidence, and the convenience of self-testing could facilitate this. In the 2008 US National HIV Behavioral Surveillance (NHBS), HIV prevalence was 19% among MSM; nearly half (44%) were unaware of their infection.[25] Although 61% of the MSM recruited from venues in 21 metropolitan areas reported testing for HIV within the preceding 12 months, 7% of these had a new, positive HIV test.[25] Fully 45% of the MSM who were unaware of their infection had been tested within the preceding 12 months.[25] Among MSM in a study of HIV self-testing at a Seattle sexually transmitted infection (STI) clinic, 84% said they would test more frequently with a rapid self-test – depending on its cost.[26]

A third potential for rapid self-test is that such tests might facilitate mutual HIV testing with sex partners or even 'point-of-sex' testing.[27] During in-depth interviews with HIV-negative MSM in NYC who never or rarely used condoms, 80% indicated that they would likely use an over-the-counter rapid HIV test to test sex partners (some with new partners and others indicated with established partners).[28] In a follow-up study, 27 participants who received rapid test kits used them before planned intercourse with approximately 100 prospective sex partners; some of the kits were also used to test acquaintances.[29] No sexual intercourse took place after a detected positive test, and most participants said that having and using rapid HIV test kits shifted their perceptions of risk and led to changes in behavior.[29]

Availability of rapid HIV self-tests offers a fourth opportunity. Such tests could be used to help detect 'window period' infections by repeat testing several weeks after a negative HIV test in persons with very recent potential exposure to HIV. Rapid tests in wide use in the United States and globally detect only IgG antibodies and have an estimated window period of 25–35 days.[30,31] Studies at HIV testing programs in STI clinics demonstrated that, among patients with undiagnosed HIV, 5% of those in Malawi, 9% of those in NYC, and 20% of MSM in Seattle had detectable HIV RNA despite a negative rapid antibody test.[32–34]