Rapid HIV Testing and Counseling in Drug Abuse Treatment

University of Miami1,281 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,281

Conditions

Substance-Related Disorders

Interventions

On-site HIV rapid test and brief, prevention counselingBEHAVIORAL

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 & informationBEHAVIORAL

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

Referral for off-site HIV testingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Self-Report Receipt of HIV Test Results

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.

Time frame: One month post-randomization

Number of Risky Sexual Behaviors

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).

Time frame: Six months post-randomization

Secondary Outcomes

Sharing of Needles Used in Drug Use

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.

Time frame: Six months

Self-Report of Ever Having Been Tested

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

Time frame: 1 month post-randomization

Data from ClinicalTrials.gov

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