Clinical trial NCT02945436: Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention
Official title: Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Substance Use
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-10-26
Enrollment: 258
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Increases in repeat HIV testing
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
measure: Decreases in sexual risk behavior
timeFrame: 18 months
measure: Reduction in substance use and abuse as measured by the "Assist", "Audit", "Medical Marijuana", Synthetic Cannabis", "Energy Drinks", and "Substance Use (past 30 days)" sections of the questionnaires
timeFrame: 18 months
measure: Reduction in consequences of substance use as measured by the "Assist", "Audit" and "Overdose" sections of the questionnaires
timeFrame: 18 months
measure: Decreased STI incidence
timeFrame: 18 months
measure: Increase in the number of participants who have been successfully engaged in care
timeFrame: 18 months
Locations:
city: Ann Arbor
country: United States
facility: Center for Sexuality and Health Disparities
state: Michigan
Study officials:
affiliation: Director, Professor
name: Rob Stephenson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker JN, Choi SK, Bauermeister JA, Bonar EE, Carrico AW, Stephenson R. HIV and Sexually Transmitted Infection Testing Among Substance-Using Sexual and Gender Minority Adolescents and Young Adults: Baseline Survey of a Randomized Controlled Trial. JMIR Public Health Surveill. 2022 Jul 1;8(7):e30944. doi: 10.2196/30944.
citation: Parker JN, Hunter AS, Bauermeister JA, Bonar EE, Carrico A, Stephenson R. Comparing Social Media and In-Person Recruitment: Lessons Learned From Recruiting Substance-Using, Sexual and Gender Minority Adolescents and Young Adults for a Randomized Control Trial. JMIR Public Health Surveill. 2021 Dec 1;7(12):e31657. doi: 10.2196/31657.
citation: Stephenson R, Bonar EE, Carrico A, Hunter A, Connochie D, Himmelstein R, Bauermeister J. Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 30;7(4):e114. doi: 10.2196/resprot.9414.