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Completed

NCT Number: NCT00809445

Rapid HIV Testing and Counseling in Drug Abuse Treatment

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

La Frontera Center, Inc., Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

On-site HIV rapid test and brief, prevention counseling

Behavioral

Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.

On- site HIV rapid test & information

Behavioral

Participants will be offered an on-site oral fluid HIV rapid test with basic info.

Referral for off-site HIV testing

Behavioral

Participants will be offered a referral list of HIV testing agencies in the community.

Primary outcomes

  1. 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.

  2. 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

  1. Sharing of Needles Used in Drug Use

    Time frame: Six months

    Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.

  2. Self-Report of Ever Having Been Tested

    Time frame: 1 month post-randomization

    The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco

Registry information

Official study title

HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 17, 2008
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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