Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Not Applicable

Completed

• Conditions: HIV Prevention; Substance Abuse; Stimulant Abuse
• Interventions: Behavioral: IMPACT; Behavioral: Standard of Care

• Registration Number: NCT03175159
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2018-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 205

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation & Risk Reduction Counseling	IMPACT	Behavioral activation with risk reduction counseling.
Standard of Care (SOC)	Standard of Care	Sexual risk-reduction counseling sessions.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reduction in the number of stimulant use episodes over study follow-up	Baseline, 4 month, 8 month, 12 month	A self reported change in the number of stimulant use episodes over study follow-up

Trial Locations

Locations (2)

Fenway Community Health Center; 🇺🇸 Boston, Massachusetts, United States

University of Miami; 🇺🇸 Miami, Florida, United States