Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults
NCT ID: NCT06444360
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
360 participants
INTERVENTIONAL
2025-11-04
2028-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
NONE
Study Groups
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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.
IMPACT
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.
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.
eSOC
The eSOC group includes 2 sessions of HIV sexual RR counseling.
Interventions
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IMPACT
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
The eSOC group includes 2 sessions of HIV sexual RR counseling.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
24 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
Westat
OTHER
Responsible Party
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Principal Investigators
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Katie Biello, PhD, MPH
Role: STUDY_CHAIR
Brown University
Matthew Mimiaga, ScD, MPH
Role: STUDY_CHAIR
University of California, Los Angeles
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Brown University
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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