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NCT Number: NCT03175159

Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse

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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Key information

Conditions

Stimulant Abuse Behavior Chemically-Induced Disorders HIV Prevention Mental Disorders Risk Reduction Behavior Substance Abuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IMPaCT

Behavioral

Ten counseling sessions

Standard of Care

Behavioral

Two counseling sessions

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Brown University
  • The Fenway Institute
  • University of Miami

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2017
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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