The Approval of Over-the-Counter HIV Tests: Playing Fair When Making the Rules

Whellams, Melissa

doi:10.1007/s10551-006-9300-5

Cited by 9 publications

(5 citation statements)

References 12 publications

(13 reference statements)

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“…While the only HIV home test currently approved by the FDA is an oral fluid test, other tests, including blood-based ones, are likely to come on the market in the future. In fact, manufacturers of blood-based test kits are either seeking or have stated intentions to seek FDA approval for their products [7, 51]. Therefore, further studies are required to identify the factors that make blood-based tests more difficult to implement, factors that could include psychological ones such as the aversion that many people experience at the sight of blood.…”

Section: Discussionmentioning

confidence: 99%

Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests

et al. 2013

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The recent approval in the United States of the first rapid home test to diagnose HIV raises questions about its potential use and impact. We reviewed the existing literature on the unassisted use of home tests involving self-collection and testing of biological samples by untrained users – including existing HIV self-testing studies – to shed some light on what can be expected from the availability of the HIV home test. The studies reviewed showed that most participants could properly perform home tests, obtain accurate results, and interpret them – yielding high correlations with laboratory and health-professional performed tests. Users often had trouble performing blood-based tests. Participants generally understood the need to confirm positive test results. Materials accompanying HIV home tests should emphasize symptoms of acute infection and the need for additional testing when recent infection is suspected. Different home-test-based screening modalities, personalized HIV-counseling resources and HIV home test impact evaluation methods should be studied.

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Section: Discussionmentioning

confidence: 99%

Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests

et al. 2013

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“…A biomedical strategy that has received little attention despite its ready availability is the possible use of rapid HIV test kits at home (home testing or HT) to screen sexual partners. While advocates have touted the need for HT as a way to increase access to HIV testing, prompt earlier testing, and increase personal HIV status awareness and autonomy [ 8 , 9 ], very few [ 10 , 11 ] have recognized its potential for partner screening to reduce sexual risk. An HT kit that can deliver results almost immediately is not yet available for over-the-counter sale (OTC) in the United States, but this will soon change.…”

Section: Introductionmentioning

confidence: 99%

Use of a Rapid HIV Home Test Prevents HIV Exposure in a High Risk Sample of Men Who Have Sex With Men

et al. 2012

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The study assessed whether at-risk HIV-uninfected men who have sex with men (MSM) who never or rarely use condoms and have multiple partners would use a rapid, oral fluid, HIV home test (HT) to screen potential sexual partners. Participants received 16 HT kits, were monitored weekly for three months, and then interviewed in depth. Twenty-seven ethnically diverse MSM used HT kits before intercourse with approximately 100 partners in private and public spaces. Testing had high acceptability among ethnic minority participants. Ten tested individuals received HIV-antibody positive results. Seven were potential sexual partners, and three were acquaintances of the participants; six of the ten were unaware of their status. No sexual intercourse took place after positive tests. Very few problems occurred. Most participants strongly desired to continue using HT and to buy it freely. HT use results in detection of previously unknown infections. Making HT available within networks where high-risk sexual practices are common may be a cost-efficient and effective prevention method.

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“…Researchers believed that home testing could be valuable “in empowering individuals to manage their HIV risks; in helping couples to learn their partners’ HIV status before the initiation of sexual relations; and in addressing the three principal barriers to wider HIV-test acceptance: stigma, convenience, and privacy” (Walensky & Paltiel, 2006, p. 461). More recently, plans were announced to seek Food and Drug Administration (FDA) approval for over-the-counter (OTC) sale of an oral fluid HIV test that would allow individuals to self-administer the test at home, obtain the results in about 20 minutes, and interpret such results following written instructions without the need of external help, phone calls, or clinic attendance (Richmond, 2005; Whellams, 2008; Wright & Katz, 2006). …”

Section: Introductionmentioning

confidence: 99%

Will Gay and Bisexually Active Men at High Risk of Infection Use Over-the-Counter Rapid HIV Tests to Screen Sexual Partners?

Carballo‐Diéguez

Frasca

Dolezal

et al. 2012

Journal of Sex Research

125

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The Food and Drug Administration may license OraQuick™, a rapid HIV test, for over-the-counter (OTC) sale. We investigated whether HIV-uninfected, non-monogamous gay and bisexual men who never or rarely use condoms would use the test with partners as a harm-reduction approach. Sixty participants responded to two computer-assisted self-interviews, underwent an in-depth interview, and chose whether to test themselves with OraQuick™. Over 80% of the men said they would use the kit to test sexual partners or themselves if it became available OTC. Most participants understood that antibody tests have a window period in which the virus is undetectable yet saw advantages to using the test to screen partners; 74% tested themselves in our offices. Participants offered several possible strategies to introduce the home-test idea to partners, frequently endorsed mutual testing, and highlighted that home testing could stimulate greater honesty in serostatus disclosure. Participants drew distinctions between testing regular versus occasional partners. Non-monogamous MSM who never or rarely use condoms may nevertheless seek to avoid HIV. Technologies that do not interfere with sexual pleasure are likely to be used when available. Studies are needed to evaluate the advantages and disadvantages of using OTC rapid HIV tests as one additional harm-reduction tool.

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The Approval of Over-the-Counter HIV Tests: Playing Fair When Making the Rules

Abstract: biotechnology, business ethics, consumer autonomy, HIV testing, home diagnostics, marketing, regulatory capture,

Cited by 9 publications

References 12 publications

Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests

Home Testing Past, Present and Future: Lessons Learned and Implications for HIV Home Tests

Use of a Rapid HIV Home Test Prevents HIV Exposure in a High Risk Sample of Men Who Have Sex With Men

Will Gay and Bisexually Active Men at High Risk of Infection Use Over-the-Counter Rapid HIV Tests to Screen Sexual Partners?

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