Behavioral activation to reduce stimulant use and HIV sexual risk in sexually active teens 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)
This program will test a 10-session behavioral approach to help 16-24-year-olds who use stimulants and have condomless sex reduce their drug use and HIV sexual risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 16 Years to 24 Years |
| Sex | All |
| Sponsor | Westat Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06444360 on ClinicalTrials.gov |
What this trial studies
IMPACT is a 10-session, HIV status-neutral behavioral intervention that combines behavioral activation (BA) with sexual risk reduction counseling and linkage to PrEP or ART. Participants are randomized to IMPACT (10 sessions) or an enhanced standard of care group (two risk-reduction sessions), with sessions delivered remotely and a hybrid design measuring both effectiveness and feasibility. The intervention includes two initial HIV sexual risk reduction sessions, one BA orientation, six integrated BA+RR sessions (including PrEP/ART and HIV care coordination), and a final relapse-management session. The study enrolls sexually active 16-24-year-olds in the continental U.S. who report condomless sex within five hours of stimulant use and uses self-report and implementation metrics to track outcomes.
Who should consider this trial
Good fit: Sexually active 16-24-year-olds in the continental U.S. who have had condomless anal or vaginal sex within five hours of using stimulants in the past four months and can attend private video visits and receive mailed materials.
Not a fit: People who do not use stimulants during sex, cannot provide informed consent due to severe mental or physical illness, are enrolled in another HIV prevention or treatment study, or lack a private space or internet-enabled device for remote visits may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could lower stimulant use and reduce HIV transmission risk among young people by promoting safer-sex behaviors and connecting them to PrEP or ART and HIV care.
How similar studies have performed: Behavioral activation and risk-reduction counseling have shown promise in adult substance-use and sexual-risk studies, but integrated BA plus HIV prevention approaches for adolescents and young adults remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Los Angeles, California and 1 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Erin Ricketts
- Email: erinricketts@westat.com
- Phone: 240-453-2786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.