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Rapid HIV Testing and Counseling in Drug Abuse Treatment

Phase 3
Completed
Conditions
Substance-Related Disorders
Registration Number
NCT00809445
Lead Sponsor
University of Miami
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1281
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Self-Report Receipt of HIV Test ResultsOne 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 BehaviorsSix 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 Outcome Measures
NameTimeMethod
Sharing of Needles Used in Drug UseSix 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.

Self-Report of Ever Having Been Tested1 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.

Trial Locations

Locations (12)

La Frontera Center, Inc.

🇺🇸

Tucson, Arizona, United States

Midwestern Connecticut Council on Alcoholism

🇺🇸

Danbury, Connecticut, United States

Wheeler Clinic

🇺🇸

Plainville, Connecticut, United States

Glenwood Life Counseling Center

🇺🇸

Baltimore, Maryland, United States

Gibson Recover Centers

🇺🇸

Cape Girardeau, Missouri, United States

The Life Link

🇺🇸

Santa Fe, New Mexico, United States

Daymark Recovery Services, Inc.

🇺🇸

Salisbury, North Carolina, United States

CODA

🇺🇸

Portland, Oregon, United States

Addiction Medicine Services (Western Psychiatric Institute)

🇺🇸

Pittsburgh, Pennsylvania, United States

Morris Village Alcohol and Drug Treatment Center

🇺🇸

Columbia, South Carolina, United States

Scroll for more (2 remaining)
La Frontera Center, Inc.
🇺🇸Tucson, Arizona, United States

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