HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Substance-Related Disorders
- Sponsor
- University of Miami
- Enrollment
- 1281
- Locations
- 12
- Primary Endpoint
- Self-Report Receipt of HIV Test Results
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.
Detailed Description
This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors. Injection drug risk behavior will be a secondary outcome. Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results. At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.
Investigators
Daniel J Feaster
Associate Professor of Biostatistics
University of Miami
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age
- •HIV-negative or HIV status unknown
- •No receipt of results from HIV test initiated within last 12 months
- •Be able to communicate in English
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Self-Report Receipt of HIV Test Results
Time Frame: One month post-randomization
The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.
Number of Risky Sexual Behaviors
Time Frame: Six months post-randomization
The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).
Secondary Outcomes
- Sharing of Needles Used in Drug Use(Six months)
- Self-Report of Ever Having Been Tested(1 month post-randomization)