Center for Sexuality and Health Disparities
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT02945436
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.
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Notify Me15 year–29 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
°Anyone not meeting all 6 inclusion criteria will be excluded from the study
SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.
Other names: SUBI
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.
Time frame: 18 months
Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires
Time frame: 18 months
Decreases in sexual risk behavior as measured by the "Sexual History" section of the questionnaires
Time frame: 18 months
Investigators will verify self-reported substance use by collecting and testing biological samples. Investigators will measure alcohol use with an Ethyl Glucuronide (ETG) urine test. Investigators will measure the use of other substances with an EZ Split Key Cup urine test.
Time frame: 18 months
Reduction in the number of participants who experience negative consequences of substance use as measured by the "Assist", "Audit" and "Overdose" sections of the questionnaires
Time frame: 18 months
Decreases in STI incidence as measured by the "STI History" section of the questionnaires
Time frame: 18 months
The investigators define engagement in HIV care as linkage and retention in HIV care (per the Institute of Medicine guidelines of linkage, or first HIV-care related visit, within 90 days of diagnosis and at least two physician visits with a CD4 and viral load test in 12 months) and achievement of viral suppression.
University of Michigan
Other
Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use
Acronym: Swerve
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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