Rapid HIV Testing and Counseling in Drug Abuse Treatment

Phase 3

Completed

Conditions: Substance-Related Disorders

Interventions: Behavioral: On- site HIV rapid test & information
Behavioral: Referral for off-site HIV testing
Behavioral: On-site HIV rapid test and brief, prevention counseling

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

Arm && Interventions

Group	Intervention	Description
HIV rapid test and info	On- site HIV rapid test & information	Participants will be offered an oral fluid HIV rapid test (via oral swab). Prior to receiving testing, study participants must first provide consent for HIV testing. Again, consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test. Participants will receive rapid HIV testing and test results after signing the consent to be tested. In both Groups 1 and 2, participants who test reactive (preliminary positive) will be counseled on the sexual risk behaviors associated with transmission of HIV and the acquisition of STDs, as is current clinical practice with those testing HIV positive. Confirmed positives will be linked to HIV primary care.
HIV testing referral	Referral for off-site HIV testing	Participants randomized to group 3 will receive a referral list for HIV community-testing agencies. Each CTP site will have previously prepared an extensive referral list of testing sites in the surrounding geographic area. By virtue of their status as patients in the CTPs, they will receive whatever HIV testing and HIV education referrals the CTPs normally provide to their patients. This is the standard of care at CTPs that do not provide on-site testing.
HIV rapid test & counseling	On-site HIV rapid test and brief, prevention counseling	Participants will be offered an oral fluid HIV rapid test (via oral swab) and brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach (Project RESPECT-2 counseling). Prior to receiving testing, study participants must first provide consent for HIV testing. Consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test.

Primary Outcome Measures

Name	Time	Method
Self-Report Receipt of HIV Test Results	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	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 Outcome Measures

Name	Time	Method
Sharing of Needles Used in Drug Use	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.
Self-Report of Ever Having Been Tested	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.

Trial Locations

Locations (12): Chesterfield CSB Substance Abuse Service
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Chesterfield, Virginia, United States
Daymark Recovery Services, Inc.
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Salisbury, North Carolina, United States
Wheeler Clinic
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Plainville, Connecticut, United States
La Frontera Center, Inc.
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Tucson, Arizona, United States
Gibson Recover Centers
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Cape Girardeau, Missouri, United States
The Life Link
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Santa Fe, New Mexico, United States
Midwestern Connecticut Council on Alcoholism
🇺🇸
Danbury, Connecticut, United States
Glenwood Life Counseling Center
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Baltimore, Maryland, United States
CODA
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Portland, Oregon, United States
Morris Village Alcohol and Drug Treatment Center
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Columbia, South Carolina, United States
Addiction Medicine Services (Western Psychiatric Institute)
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Pittsburgh, Pennsylvania, United States
Lexington / Richland Alcohol and Drug Abuse Council
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Columbia, South Carolina, United States