Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention

Study Overview
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Brief Summary
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A sample of 300 young (15-29) men who have sex with men (MSM) and transgender persons living in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based sampling and online ads to examine the efficacy of adding a substance use brief intervention (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful engagement in HIV care. The investigators will partner with Detroit-area AIDS Service Organizations (ASOs) to deliver the intervention.

Detailed Description
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The research activities involve a prospective 4-arm factorial RCT (SOC-only, SOC+SUBI, SUBI+SOC, SUBI+SUBI) of approximately 300 ATOD-using high-risk YMSM aged 15-29 in the DMA. The intervention comprises of two intervention visits, at which time participants may get either standard of care only (SOC-only) or standard of care plus SUBI. All participants will receive standard of care (SOC; i.e., Comprehensive HIV Testing and Counseling) at each visit. The substance use brief intervention (SUBI) will be added to SOC within the experimental arms. At intervention visit one, standard of care is the same for all participants: standard of care is Counseling Testing and Referral (CTR).CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients. Hence at visit one, 150 YMSM will receive CTR and 150 YMSM will receive CTR+SUBI. The investigators expect approximately 10-15% of participants to test HIV positive at intervention visit one. For intervention visit two, standard of care is sero-status specific. For HIV-negatives standard of care remains CTR. For HIV-positives standard of care is case management, as offered routinely by each ASO, which involves counseling on linkage to care and the importance of care retention. To examine how the sequencing and dosing of interventions impacts efficacy, the investigators propose to randomize at baseline into a factorial randomized controlled trial. The control arm will receive SOC-only at both intervention visit one and two (SOC-only). Experimental arm one (SOC+SUBI) will receive SOC at visit one and SUBI at visit two. Experimental arm two (SUBI+SOC) will receive SUBI at visit one and SOC at visit two. Experimental arm three (SUBI+SUBI) will receive the intervention condition at visits one and two. The RCT thus answers two important questions: 1) What is the impact of the addition of SUBI to SOC on HIV engagement in care and sexual and substance-related risk-taking behaviors among high-risk YMSM? and 2) What combination of services (SOC-only, SOC+SUBI, SUBI+SOC, SUBI+SUBI) has the greatest impact on engagement in HIV prevention? (where engagement in care is defined as routine HIV testing for sero-negative YMSM and linkage/retention in care for sero-positive MSM).

Official Title
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Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use

Conditions
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HIV, Substance Use

Intervention / Treatment
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* Behavioral: Substance Use Brief Intervention
* Behavioral: Standard of Care (SOC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants must be ages 15-29 All participants must currently reside in the DMA (verified by zip code) All participants must self-report as HIV sero-negative All participants must report at least one sexual experience with a man in the previous 6 months All participants must report either at least one binge-drinking episode and/or use of illicit substances in the previous 3 months All participants must identify as either a man who has sex with men (MSM) or as transgender All participants must speak English Exclusion Criteria: °Anyone not meeting all 6 inclusion criteria will be excluded from the study

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SOC + SOC<br>Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2. | Behavioral: Standard of Care (SOC)<br>* Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.<br>|
| Experimental: SOC + SUBI<br>Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2. | Behavioral: Substance Use Brief Intervention<br>* SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.<br>* Other names: SUBI;Behavioral: Standard of Care (SOC)<br>* Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.<br>|
| Experimental: SUBI + SUBI<br>Participants will receive the SUBI at both visit 1 and visit 2. | Behavioral: Substance Use Brief Intervention<br>* SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.<br>* Other names: SUBI;|
| Experimental: SUBI + SOC<br>Participants will receive the SUBI at visit 1 and SOC at visit 2. | Behavioral: Substance Use Brief Intervention<br>* SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.<br>* Other names: SUBI;Behavioral: Standard of Care (SOC)<br>* Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increases in repeat HIV testing | Increases in repeat HIV testing as measured by the HIV Testing Questions section of the questionnaires | 18 months |