Use of a Rapid HIV Home Test to Prevent Exposure in MSM
Use of a Rapid HIV Home Test to Prevent Exposure in MSM
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 3 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.
Biomedical strategies for the prevention of HIV transmission recently have met with considerable success. Tenofovir gel applied vaginally was initially shown to decrease HIV transmission by 39 % among women who have sex with men (although a later study did not replicate the findings), and Truvada (emtricitabine and tenofovir disoproxilfumarate) pills ingested daily as pre-exposure prophylaxis (PrEP) showed a 44 % transmission reduction among men who have sex with men (MSM). Although both strategies showed only partial efficacy against HIV transmission, they were hailed as breakthroughs given that more than 30 years into the HIV epidemic many people at risk of HIV infection cannot or will not be abstinent or use condoms consistently. Alternatives are sorely needed. Consequently, discussions are underway for FDA licensing of Tenofovir gel and Truvada for PrEP purposes. Truvada as PrEP is also being piloted in community demonstration projects in San Francisco and Miami.
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, very few 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. The FDA recently approved for OTC sale the OraQuick In-Home HIV Test, an oral fluid test that requires no professional training for its administration or interpretation, can deliver results in 20 min, and has a sensitivity of 92 % and a specificity of 99.98 %. An FDA advisory panel had previously unanimously recommended its OTC licensure. Once available, people may use HT to obtain information about the HIV status of a sexual partner prior to intercourse and to decide what protective strategy, if any, to use. A caveat is that OraQuick is an antibody test; therefore, an HIV-infected individual may appear uninfected until antibodies are generated. The window period of antibody tests lasts 25 days on average and in some cases as long as 8 weeks. Thus, despite the high sensitivity and specificity of OraQuick, using it to screen sexual partners still would not completely eliminate risk. However, it would be another partially efficacious strategy for HIV-transmission prevention like the microbicide gels and PrEP currently being studied and piloted, as well as other existing HIV harm reduction approaches. For populations with high HIV prevalence such as MSM, and especially in urban areas where ethnic minority men have HIV-prevalence rates comparable to those of sub-Saharan Africa, HT could offer higher levels of protection than inconsistent condom use. Prior studies have shown that even among MSM who intentionally engage in unprotected anal sex when risk of HIV infection is present ("barebacking") and who prioritize sexual pleasure and intimacy over protection against infection there is concern about and wish to avoid HIV infection.
Our study was designed to test whether MSM who seldom or never use condoms and have sex in risky circumstances would use HT to screen sexual partners prior to intercourse. The Information, Motivation and Behavioral Skills (IMB) model guided our inquiry into whether men with sufficient information on HT (including its limitations) would be motivated to use it to screen partners and what behavioral and negotiation skills they would employ to succeed at using HT for screening purposes. The results of the first stage of the study (hypothetical use), have already been published (also see commentary). Briefly, the men in the sample (N = 57) were able to understand the information we provided them on HT characteristics and limitations, specifically those referring to the window period and acute infection. Over 80 % of participants said they were motivated to use the kit to test sexual partners or themselves if the test became available OTC. Furthermore, 74 % of the participants in the first stage of the study demonstrated their skills by testing themselves unassisted in front of a research assistant in our offices and then correctly interpreting the test results.
We now present the results of the second (experiential) stage of the study. In this stage men were given HT kits to take home with the possibility of using them with their sexual partners over a 3-month period.
Abstract and Introduction
Abstract
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 3 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.
Introduction
Biomedical strategies for the prevention of HIV transmission recently have met with considerable success. Tenofovir gel applied vaginally was initially shown to decrease HIV transmission by 39 % among women who have sex with men (although a later study did not replicate the findings), and Truvada (emtricitabine and tenofovir disoproxilfumarate) pills ingested daily as pre-exposure prophylaxis (PrEP) showed a 44 % transmission reduction among men who have sex with men (MSM). Although both strategies showed only partial efficacy against HIV transmission, they were hailed as breakthroughs given that more than 30 years into the HIV epidemic many people at risk of HIV infection cannot or will not be abstinent or use condoms consistently. Alternatives are sorely needed. Consequently, discussions are underway for FDA licensing of Tenofovir gel and Truvada for PrEP purposes. Truvada as PrEP is also being piloted in community demonstration projects in San Francisco and Miami.
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, very few 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. The FDA recently approved for OTC sale the OraQuick In-Home HIV Test, an oral fluid test that requires no professional training for its administration or interpretation, can deliver results in 20 min, and has a sensitivity of 92 % and a specificity of 99.98 %. An FDA advisory panel had previously unanimously recommended its OTC licensure. Once available, people may use HT to obtain information about the HIV status of a sexual partner prior to intercourse and to decide what protective strategy, if any, to use. A caveat is that OraQuick is an antibody test; therefore, an HIV-infected individual may appear uninfected until antibodies are generated. The window period of antibody tests lasts 25 days on average and in some cases as long as 8 weeks. Thus, despite the high sensitivity and specificity of OraQuick, using it to screen sexual partners still would not completely eliminate risk. However, it would be another partially efficacious strategy for HIV-transmission prevention like the microbicide gels and PrEP currently being studied and piloted, as well as other existing HIV harm reduction approaches. For populations with high HIV prevalence such as MSM, and especially in urban areas where ethnic minority men have HIV-prevalence rates comparable to those of sub-Saharan Africa, HT could offer higher levels of protection than inconsistent condom use. Prior studies have shown that even among MSM who intentionally engage in unprotected anal sex when risk of HIV infection is present ("barebacking") and who prioritize sexual pleasure and intimacy over protection against infection there is concern about and wish to avoid HIV infection.
Our study was designed to test whether MSM who seldom or never use condoms and have sex in risky circumstances would use HT to screen sexual partners prior to intercourse. The Information, Motivation and Behavioral Skills (IMB) model guided our inquiry into whether men with sufficient information on HT (including its limitations) would be motivated to use it to screen partners and what behavioral and negotiation skills they would employ to succeed at using HT for screening purposes. The results of the first stage of the study (hypothetical use), have already been published (also see commentary). Briefly, the men in the sample (N = 57) were able to understand the information we provided them on HT characteristics and limitations, specifically those referring to the window period and acute infection. Over 80 % of participants said they were motivated to use the kit to test sexual partners or themselves if the test became available OTC. Furthermore, 74 % of the participants in the first stage of the study demonstrated their skills by testing themselves unassisted in front of a research assistant in our offices and then correctly interpreting the test results.
We now present the results of the second (experiential) stage of the study. In this stage men were given HT kits to take home with the possibility of using them with their sexual partners over a 3-month period.
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