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

Hybrid Type 2 Effectiveness-Implementation Trial of Status Neutral, Integrated Behavioral Activation and Risk Reduction Intervention for Stimulant Use Among Sexually Active Adolescents and Young Adults (Project IMPACT)

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

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: IMPACT; Behavioral: eSOC

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Ricketts; Phone Number: 240-453-2786; Email: ErinRicketts@westat.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California, Los Angeles
      • Principal Investigator: Matthew Mimiaga, ScD, MPH
      • Contact: IMPACT 170 Staff; Phone Number: 310-825-3094; Email: impactstudy@ph.ucla.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Brown University
      • Principal Investigator: Katie Biello, PhD, MPH
      • Contact: IMPACT 170 Staff; Phone Number: 401-863-3292; Email: impact170@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: eSOC; The eSOC group includes 2 sessions of HIV sexual RR counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of stimulant use	The number of days participants report having used stimulants	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.

Collaborators and Investigators

• Sponsor: Westat
• Collaborators: National Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Katie Biello, PhD, MPH, Brown University; Study Chair: Matthew Mimiaga, ScD, MPH, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Behavioral Activation; intervention; risk reduction; HIV sexual risk reduction; stimulant use
• Additional Relevant MeSH Terms: Behavior; Risk Reduction Behavior
• Other Study ID Numbers: ATN170; UM2HD111076 (U.S. NIH Grant/Contract); UM2HD111102 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No