Rapid HIV Testing and Counseling in Drug Abuse Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Behavioral: On-site HIV rapid test and brief, prevention counseling
* Behavioral: On- site HIV rapid test & information
* Behavioral: Referral for off-site HIV testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV rapid test & counseling<br>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. | Behavioral: On-site HIV rapid test and brief, prevention counseling<br>* 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.<br>|
| Experimental: HIV rapid test and info<br>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. | Behavioral: On- site HIV rapid test & information<br>* Participants will be offered an on-site oral fluid HIV rapid test with basic info.<br>|
| Active Comparator: HIV testing referral<br>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. | Behavioral: Referral for off-site HIV testing<br>* Participants will be offered a referral list of HIV testing agencies in the community.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Six months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 month post-randomization |