The FDA is considering allowing the over-the counter sale of a rapid HIV test, the OraQuick(R) In-Home HIV Test (HT). Newspaper articles already discuss the possibility that this new technology could be used by individuals who are HIV uninfected to screen potential sexual partners. Our preliminary studies show that a sizable proportion of men who engage intentional unprotected intercourse are highly interested in using a HT to screen casual sexual partners. Focusing on English- or Spanish-speaking HIV-uninfected men who have unprotected intercourse in circumstances in which there is risk of HIV transmission, the goal of this project is to study the possible use of the HT as a tool for decision-making about sexual behavior. It has two Specific Aims (SA). SA1 is to elicit men's (a) motivation (or lack of motivation) to use OraQuick as a screening tool prior to intercourse;(b) anticipated strategies (or hindrances) to use and have a partner use OraQuick for testing prior to intercourse;and (c) anticipated ways (or problems) to handle test results. SA2 is to assess (a) men's frequency of use of a set number of OraQuick kits with sexual partners over 3 months;(b) factors associated with OraQuick use or lack of use;(c) condom use (following our recommendation to use them) with OraQuick unscreened partners vs. screened HIV-negative partners;(d) factors associated with changes in sexual risk behavior over 3 months;and (e) feasibility of conducting a larger and longer trial of HT use to develop a HT- based harm-reduction intervention. This 3-year study will consist of two phases. Phase 1 is hypothetical (""""""""Would you use HT to screen sexual partners for HIV if you had the chance?""""""""). In this phase, 60 MSM will undergo a quantitative, qualitative, and skill-demonstration assessment during a single study visit. Phase 2 moves from the hypothetical realm to the actual evaluation of HT use (""""""""With what proportion of your sexual partners and how frequently did you use HT as a screening tool in the past three months?""""""""). This phase is divided in two: Phase 2A, in which we will conduct a baseline CASI and skill-demonstration of about 60 new study candidates;and Phase 2B in which 30 MSM from Phase 2A who meet eligibility criteria will be invited to enroll in a 3-month study. These 30 men will be provided a set of HT kits and will have the choice to use them to screen sexual partners. During the three months, they will be asked to keep a phone tally of their sexual behavior and HT use (receiving incentives per call). At the end of the 3-month study, participants will undergo a quantitative and qualitative interview on experiences using (or not using) HT with partners. Data analysis of Phase 2 data will determine whether an intervention centered around the use of HT is feasible, practical, and worth pursuing.

Public Health Relevance

More than a quarter of a century into the HIV epidemic, it is evident that many individuals at high risk of contracting HIV cannot or will not use condoms with their partners. Given the documented emergence of serosorting as a risk-reduction strategy (often based on faulty heuristics), this study seeks to examine possible uses and misuses of a rapid HIV home test as a partner-screening device among HIV-uninfected men with knowledge about HIV and how to prevent its transmission who choose not to use condoms in circumstances in which there is risk of HIV transmission. This study will provide urgently needed information to harness the harm-reduction potential of this technology, develop interventions that may include it among an array of non- condom prevention tools, and anticipate rather than remediate possible problems.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH079692-02
Application #
7804611
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Pequegnat, Willo
Project Start
2009-04-15
Project End
2012-03-31
Budget Start
2010-04-01
Budget End
2011-03-31
Support Year
2
Fiscal Year
2010
Total Cost
$553,647
Indirect Cost
Name
New York State Psychiatric Institute
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032
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