Rapid HIV Testing and Counseling in Drug Abuse Treatment

University of Miami

Status and phase: Completed; Phase 3

Conditions: Substance-Related Disorders

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00809445

20080379

U10DA013720 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,281 participants in 3 patient groups

HIV rapid test & counseling

Experimental group

Description:

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.

Treatment:

Behavioral: On-site HIV rapid test and brief, prevention counseling

HIV rapid test and info

Experimental group

Description:

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.

Treatment:

Behavioral: On- site HIV rapid test & information

HIV testing referral

Active Comparator group

Description:

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.

Treatment:

Behavioral: Referral for off-site HIV testing