Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse

Conditions
-----------------
Stimulant Abuse, HIV Prevention, Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: IMPACT
* Behavioral: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Two-arm RTC, equally randomized between two arms: (1) the Project IMPACT intervention, BA-RR (behavioral activation and HIV risk reduction) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent sexual risk reduction counseling sessions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care (SOC)<br>Sexual risk-reduction counseling sessions. | Behavioral: Standard of Care<br>* Two counseling sessions<br>|
| Experimental: Behavioral Activation & Risk Reduction Counseling<br>Behavioral activation with risk reduction counseling. | Behavioral: IMPACT<br>* Ten counseling sessions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Condomless Anal Sex Acts (CAS) over study follow-up | A self reported change in the number of CAS with men without protection of PrEP | Baseline, 4 month, 8 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the number of stimulant use episodes over study follow-up | A self reported change in the number of stimulant use episodes over study follow-up | Baseline, 4 month, 8 month, 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk Reduction, Crystal Methamphetamine, Cocaine, Stimulant Abuse, HIV, Behavioral Activation