Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV Prevention
- Stimulant Abuse
- Substance Abuse
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Three-arm RTC, randomized 2:2:1 to three arms: (1) the Project IMPACT intervention, "BA-RR" (behavioral activation and HIV risk reduction) counseling, which lasts ten sessions; (2) the time- and intensity-matched control condition, including ten sessions of relaxation therapy with educational support; and (3) the standard of care comparison condition, including two equivalent sexual risk reduction counseling sessions.Masking: Single (Outcomes Assessor)Masking Description: The outcome assessor will not be aware of the intervention assignment.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Project IMPACT targets both stimulant use and sexual risk reduction in effort to help individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity, incorporated with RR counse...
Project IMPACT targets both stimulant use and sexual risk reduction in effort to help individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity, incorporated with RR counseling aimed to reduce risky sexual practices, and potential HIV acquisition. This RCT is a three-arm efficacy trial, comparing the Project IMPACT Intervention with a time and intensity matched control arm and a SOC arm. Comparing Project IMPACT intervention against a credible time- and intensity-matched control will determine if the intervention is efficacious above general counseling with the same intensity and duration (e.g., attention spent with the therapist vs. the content). Relaxation therapy and educational support will be utilized for the time- and intensity- matched intervention. All participants will receive HIV testing, pre-/post-test risk reduction counseling, oral swab toxicology test at baseline and 12 months, assessment of interest/indication for Pre-Exposure Prophylaxis (PrEP) per Center for Disease Control guidelines, and active referral to local PrEP services as standard-of-care. Finally, the RCT will integrate resource utilization and cost-effectiveness analyses to examine cost efficiency of the Project IMPACT Intervention as a component of data analysis.
Tracking Information
- NCT #
- NCT03175159
- Collaborators
- University of Miami
- The Fenway Institute
- Investigators
- Principal Investigator: Matthew J Mimiaga, ScD, MPH Brown University, School of Public Health, Center for Health Equity Research Principal Investigator: Steve Safren, PhD University of Miami
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