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

NCT06444360 | Recruiting

• 3 other identifiers: ATN170UM2HD111102UM2HD111076
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.

Conditions

HIV

Keywords

Behavioral Activation; risk reduction; intervention; stimulant use; HIV sexual risk reduction

Outcome Measures

Primary Outcomes (1)

• Distinct acts of condomless sex without the protection of PrEP or viral suppression.

  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).

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

IMPACT Group

EXPERIMENTAL

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.

Behavioral: IMPACT

Enhanced Standard of Care (eSOC) Group

ACTIVE COMPARATOR

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.

Behavioral: eSOC

Interventions

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.

IMPACT Group

eSOC BEHAVIORAL

The eSOC group includes 2 sessions of HIV sexual RR counseling.

Enhanced Standard of Care (eSOC) Group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Westat: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Katie Biello, PhD, MPH

  Brown University

  STUDY CHAIR

• Matthew Mimiaga, ScD, MPH

  University of California, Los Angeles

  STUDY CHAIR

Central Study Contacts

Erin Ricketts

CONTACT

240-453-2786; erinricketts@westat.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)