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

IMPACT is a Human Immunodeficiency Virus (HIV) status-neutral, behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk. This study will evaluate the effectiveness of IMPACT and determine feasibility of implementing IMPACT for translation into real-world practice using a hybrid effectiveness-implementation design.

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 pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on strategies for slip-ups and recurrence management.

The enhanced Standard of Care (eSOC) group includes two HIV sexual RR sessions.

• IMPACT (Behavioral): 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.
• eSOC (Behavioral): The eSOC group includes 2 sessions of HIV sexual RR counseling.

Primary outcomes

• Distinct acts of condomless sex without the protection of PrEP or viral suppression. [Participants will recall and report acts of condomless sex and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12.]: The number of times participants report engaging in condomless sex without the protection of PrEP (for those not living with HIV) or viral suppression (for those living with HIV).

Secondary outcomes

• Days of stimulant use [Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits and will also have urine drug testing done. The visits are at: Baseline, Month 4, Month 8 and Month 12.]: The number of days participants report having used stimulants

Sex: All, ages: 16 Years to 24 Years, accepts healthy volunteers

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

• Katie Biello, PhD, MPH, Study chair, Brown University
• Matthew Mimiaga, ScD, MPH, Study chair, University of California, Los Angeles

NIH grants: UM2HD111102, UM2HD111076