Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Young Gay/Bisexual Minority Men (IMPACT)
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 Genders
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Age 16-24 years, inclusive, at enrollment - Assigned male at birth - Identifies as a cisgender boy or man - Self-reports condomless anal sex (CAS) with another boy/man-receptive or insertive-while using stimulants (1 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 In addition, virtual participants must meet all the below criteria: - 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 - Non-English-speaking - Is currently incarcerated or pending incarceration - Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Site Consortium 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, multisite, and multiformat 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 young gay/bisexual sexual minority men. The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV RR, 1 session focused on orienting and rationale of BA, 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention. The enhanced Standard of Care (eSOC) group includes two HIV risk reduction intervention sessions.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IMPACT Group |
A multifaceted training and implementation strategy across sites and formats will be used. Participants who report stimulant use in the context of condomless anal sex (CAS), will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. The participants in this arm participate in 10 sessions (approximately 50 minutes each) delivered over the course of approximately 10 weeks. |
|
|
Active Comparator Enhanced Standard of Care (eSOC) Control Group |
The comparison arm will receive the same 2 HIV sexual risk reduction (RR) intervention sessions and referrals to substance use and mental health treatment, per SOC. |
|
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 across various settings for translation into real-world practice using a hybrid effectiveness-implementation design. The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV risk reduction (RR), 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention. The enhanced Standard of Care (eSOC) group includes two HIV RR intervention sessions.