Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stimulant Abuse HIV Prevention Substance Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor will not be aware of the intervention assignment.

Study Groups

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Standard of Care (SOC)

Sexual risk-reduction counseling sessions.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

Two counseling sessions

Behavioral Activation & Risk Reduction Counseling

Behavioral activation with risk reduction counseling.

Group Type EXPERIMENTAL

IMPACT

Intervention Type BEHAVIORAL

Ten counseling sessions

Interventions

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IMPACT

Ten counseling sessions

Intervention Type BEHAVIORAL

Standard of Care

Two counseling sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes