Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults
Purpose
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
Condition
- HIV
Eligibility
- Eligible Ages
- Between 16 Years and 24 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The study is a two-arm, multi-site, randomized controlled trial (RCT). IMPACT is a status-neutral intervention that uses behavioral activation (BA)-an evidence-based, cognitive behavior therapy-as a treatment for stimulant use and sexual risk reduction (RR) counseling for adolescents and young adults. 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.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IMPACT Group |
Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. |
|
|
Active Comparator Enhanced Standard of Care (eSOC) Group |
Participants who report stimulant use in the context of condomless sex will be randomized using a 2:1 allocation ratio with one-third being allocated to the eSOC intervention. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Westat
Detailed Description
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.