RecruitingNot ApplicableNCT06444360

Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults

Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Adolescents and Young Adults (Project IMPACT)


Sponsor

Westat

Enrollment

360 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.


Eligibility

Min Age: 16 YearsMax Age: 24 Years

Inclusion Criteria9

  • Age 16-24 years, inclusive, at enrollment
  • Male or female
  • Self-reports condomless anal or vaginal sex while using stimulants (5 hour prior to, or during sex) within the last 4 months; stimulants is defined as crystal methamphetamine, cocaine, and MDMA (e.g., ecstasy, molly)
  • Willing and able to provide written informed consent for study participation
  • Access to a computer/smartphone/tablet that can use video chat (e.g., Zoom or Google Meet)
  • Provide a mailing address where they can receive a package
  • Access to stable internet that they can use for more than 2 hours at a time
  • Have a private place (where no one else can see or hear) where they can complete visits online
  • Reside within the continental U.S.

Exclusion Criteria7

  • Unable to provide informed consent due to severe mental or physical illness
  • Concurrent enrollment in another HIV prevention or treatment study (enrollment in a substance treatment program is acceptable)
  • Randomized to IMPACT arm prior to March 2025 study stop
  • Non-English-speaking
  • Is currently incarcerated or pending incarceration
  • Is currently pregnant or planning to become pregnant
  • Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Project Lead or designee, could interfere with the safety of participants or staff, adherence to study procedures, or compromise interpretation of study results

Interventions

BEHAVIORALIMPACT

The IMPACT intervention includes 10 sessions: 2 sessions of HIV sexual risk reduction (RR) counseling, 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and sexual RR counseling (including PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management.

BEHAVIORALeSOC

The eSOC group includes 2 sessions of HIV sexual RR counseling.


Locations(2)

University of California, Los Angeles

Los Angeles, California, United States

Brown University

Providence, Rhode Island, United States

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NCT06444360


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