Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention
Condition: HIV; Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

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).
    

Intervention name(s): Substance Use Brief Intervention; Standard of Care (SOC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of 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.
Other intervention name(s): SUBI
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention