Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
Overview
This study seeks primarily to test, in a two-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 equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) 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.
Full Title of Study: “Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Primary Purpose: Prevention
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: March 1, 2024
Detailed 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 two-arm efficacy trial, comparing the Project IMPACT Intervention with a SOC arm. 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.
Interventions
- Behavioral: IMPACT
- Ten counseling sessions
- Behavioral: Standard of Care
- Two counseling sessions
Arms, Groups and Cohorts
- Active Comparator: Standard of Care (SOC)
- Sexual risk-reduction counseling sessions.
- Experimental: Behavioral Activation & Risk Reduction Counseling
- Behavioral activation with risk reduction counseling.
Clinical Trial Outcome Measures
Primary Measures
- Reduction in Condomless Anal Sex Acts (CAS) over study follow-up
- Time Frame: Baseline, 4 month, 8 month, 12 month
- A self reported change in the number of CAS with men without protection of PrEP
Secondary Measures
- Reduction in the number of stimulant use episodes over study follow-up
- Time Frame: Baseline, 4 month, 8 month, 12 month
- A self reported change in the number of stimulant use episodes over study follow-up
Participating in This Clinical Trial
Inclusion Criteria
- Age 18 or older – Assigned male at birth – HIV-uninfected verified via rapid HIV test – Self-reports in the past four months: CAS receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of Pre-Exposure Prophylaxis (PrEP)* – Able to read, speak, and understand English – Willing and able to provide informed consent Exclusion Criteria:
- Does not live in the greater Boston or Miami areas, or will move away from Boston or Miami within the next 12 months – Self-reports being 100% adherent to PrEP in the last four months – Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview – Discovery of active suicidal ideation at the time of interview (participants will be referred immediately for treatment, but may join the study once resolved)- – Involvement in any other HIV Prevention study that may interfere with the ability to test major study outcomes (e.g. another sexual risk reduction intervention or PrEP adherence intervention)
Gender Eligibility: Male
Intervention addresses stimulant use and HIV risk reduction in MSM
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of California, Los Angeles
- Collaborator
- University of Miami
- Provider of Information About this Clinical Study
- Principal Investigator: Matthew Mimiaga, ScD, MPH, MA, Principal Investigator – University of California, Los Angeles
- Overall Official(s)
- Matthew J Mimiaga, ScD, MPH, Principal Investigator, University of California, Los Angeles, Fielding School of Public Health
- Steve Safren, PhD, Principal Investigator, University of Miami
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