Summary

Eligibility
for males ages 16-24 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Matthew Mimiaga, ScD, MPH (ucla)
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 Young Gay/Bisexual Sexual Minority Men (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 across various settings for translation into real-world practice using a hybrid effectiveness-implementation design.

The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV risk reduction (RR), 1 session focused on orienting and rationale of behavioral activation (BA), 6 sessions integrating BA and RR-including pre-exposure prophylaxis (PrEP) or antiretroviral therapy (ART) and HIV care-and 1 final session on relapse prevention.

The enhanced Standard of Care (eSOC) group includes two HIV RR intervention sessions.

Keywords

HIV, HIV Sexual Transmission Risk, Behavioral Activation, Risk Reduction Intervention, Stimulant Use, IMPACT, eSOC

Eligibility

You can join if…

Open to males ages 16-24

  • Age 16-24 years, inclusive, at enrollment
  • Assigned male at birth
  • Identifies as a cisgender boy or man
  • Self-reports condomless anal sex (CAS) with another boy/man-receptive or insertive-while using stimulants (1 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

In addition, virtual participants must meet all the below criteria:

  • 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
  • Non-English-speaking
  • Is currently incarcerated or pending incarceration
  • Any other medical condition, medical/behavioral intervention, or other condition that, in the opinion of the Site Consortium 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
    Los Angeles California 90025 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States

Lead Scientist at University of California Health

  • Matthew Mimiaga, ScD, MPH (ucla)
    Professor, Epidemiology, Public Health. Authored (or co-authored) 340 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Westat
ID
NCT06444360
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated