Behavioral activation to reduce stimulant use and HIV sexual risk in sexually active teens and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 16-24 years, inclusive, at enrollment
* Self-reports condomless 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 of study prior to March 2025 study pause
* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.