Home Self-Testing for HIV to Increase HIV Testing Frequency in Men Who Have Sex With Men (The iTest Study)



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:July 2010
End Date:December 2013
Contact:David A Katz, PhD, MPH
Email:itestuw@uw.edu
Phone:206-744-5877

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Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection

The purpose of this study is to determine whether the availability of home self-testing for
HIV will increase HIV testing frequency among men who have sex with men without negatively
impacting their risk for HIV acquisition.

HIV counseling and testing remains one of the most effective HIV prevention interventions
because many individuals newly diagnosed with HIV infection will alter their behaviors to
reduce the risk of HIV transmission to others. In the U.S., men who have sex with men (MSM)
represent the group with the greatest risk for HIV acquisition despite a high penetrance of
testing, in part because their frequent exposures and infrequent testing can result in long
intervals between HIV acquisition and diagnosis. Efforts to prevent HIV transmission among
MSM must therefore increase the frequency of HIV testing and thereby decrease the time
interval that infected individuals are unaware of their status and their potential for
transmission. Home self-testing for HIV may increase the frequency of HIV testing, but
there are concerns that it may also have negative consequences, including decreased access
to risk reduction counseling.

We will randomize 246 MSM at high risk of HIV acquisition either to have access to home
self-testing for HIV using the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test or to standard,
clinic-based HIV testing for 15 months to determine the effects of home self-testing
availability on HIV testing frequency and markers of risk for HIV acquisition and to assess
the acceptability and ease of use of home self-testing. After screening to determine
eligibility, study visits will occur at baseline and at 15 months. Both visits will include
HIV/STD screening and surveys regarding HIV testing and risk behaviors. During follow-up,
participants will be asked to complete brief online surveys after testing for HIV.

Inclusion Criteria:

- Male

- Age ≥18

- Has sex with men

- HIV-negative

- Meets PHSKC HIV/STD Program definition of "high risk"

- Plans to live in Seattle for the next 15 months

Exclusion Criteria:

- Unable to safely and confidentially receive or store a home testing kit
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