Last updated on April 2019

Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Brief description of study

This study seeks primarily to test, in a three-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be randomized 2:2:1 to three arms: (1) the Project IMPACT intervention, BA-RR 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 (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.

Detailed Study 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 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.

Clinical Study Identifier: NCT03175159

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