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Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03175159
Enrollment
205
Registered
2017-06-05
Start date
2018-03-01
Completion date
2024-03-01
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stimulant Abuse, HIV Prevention, Substance Abuse

Keywords

Risk Reduction, Crystal Methamphetamine, Cocaine, Stimulant Abuse, HIV, Behavioral Activation

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.

Interventions

BEHAVIORALIMPACT

Ten counseling sessions

BEHAVIORALStandard of Care

Two counseling sessions

Sponsors

University of Miami
CollaboratorOTHER
The Fenway Institute
CollaboratorOTHER
Brown University
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Condomless Anal Sex Acts (CAS) over study follow-upBaseline, 4 month, 8 month, 12 monthA self reported change in the number of CAS with men without protection of PrEP

Secondary

MeasureTime frameDescription
Reduction in the number of stimulant use episodes over study follow-upBaseline, 4 month, 8 month, 12 monthA self reported change in the number of stimulant use episodes over study follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026