Recruiting

Behavioral Intervention

Sponsor:

Westat

Code:

NCT06444360

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Accepted

Interventions

IMPACT

eSOC

Study Details

Brief summary:

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

Conditions

HIV

Study ID

NCT06444360

Start date

Nov 4, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Accepted

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

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Distinct acts of condomless sex without the protection of PrEP or viral suppression. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Erin Ricketts

240-453-2786erinricketts@westat.com

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

IMPACT 170 Staff

310-825-3094impactstudy@ph.ucla.edu

Principal Investigator:

Matthew Mimiaga, ScD, MPH

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

IMPACT 170 Staff

401-863-3292impact170@brown.edu

Principal Investigator:

Katie Biello, PhD, MPH

More Information

Sponsor

Westat

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Westat on 2026-06-17.