Summary

Eligibility
for people ages 16-24 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by Matthew Mimiaga, ScD, MPH
Headshot of Matthew Mimiaga
Matthew Mimiaga

Description

Summary

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

Official Title

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)

Details

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.

Keywords

HIV, Behavioral Activation, risk reduction, intervention, stimulant use, HIV sexual risk reduction, Risk Reduction Behavior, IMPACT, eSOC

Eligibility

You can join if…

Open to people ages 16-24

  • 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 CAN'T join 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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • Brown University accepting new patients
    Providence 5224151 Rhode Island 5224323 02912 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Westat
ID
NCT06444360
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated