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

Not Applicable

Completed

• Conditions: HIV; Substance Use
• Interventions: Behavioral: Substance Use Brief Intervention; Behavioral: Standard of Care (SOC)

• Registration Number: NCT02945436
• Lead Sponsor: University of Michigan

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Study Start: 2017-04-07
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

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Exclusion Criteria

°Anyone not meeting all 6 inclusion criteria will be excluded from the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SUBI + SUBI	Substance Use Brief Intervention	Participants will receive the SUBI at both visit 1 and visit 2.
SUBI + SOC	Standard of Care (SOC)	Participants will receive the SUBI at visit 1 and SOC at visit 2.
SOC + SOC	Standard of Care (SOC)	Participants will receive current standard of care (SOC) for HIV counseling, testing, and referral at both visit 1 and visit 2.
SOC + SUBI	Substance Use Brief Intervention	Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2.
SUBI + SOC	Substance Use Brief Intervention	Participants will receive the SUBI at visit 1 and SOC at visit 2.
SOC + SUBI	Standard of Care (SOC)	Participants will receive SOC at visit 1 and the experimental substance use brief intervention (SUBI) at visit 2.

Primary Outcome Measures

Name	Time	Method
Increases in repeat HIV testing	18 months	Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires

Trial Locations

Locations (1)

Center for Sexuality and Health Disparities; 🇺🇸 Ann Arbor, Michigan, United States