Clinical trial NCT06444360: Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Young Gay/Bisexual Minority Men (IMPACT)
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)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: HIV
Keywords: HIV Sexual Transmission Risk
Behavioral Activation
Risk Reduction Intervention
Stimulant Use
Lead sponsor: Westat
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2024-06-05
Enrollment: 360
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a two-arm, multisite, and multiformat 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 young gay/bisexual sexual minority men.

The IMPACT intervention includes 10 sessions: 2 intervention sessions of HIV RR, 1 session focused on orienting and rationale of 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 risk reduction intervention sessions.
Primary purpose: PREVENTION

Brief summary: The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 (5 hours 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.

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
* 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

Primary outcomes:
measure: Distinct acts of condomless anal sex (CAS) without the protection of PrEP or viral suppression.
timeFrame: Participants will recall and report acts of CAS and medication adherence for the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12 after enrollment
Secondary outcomes:
measure: Days of stimulant use
timeFrame: Participants will recall and report the number of days they used stimulants out of the 30 days prior to each of 4 visits: Baseline, Month 4, Month 8 and Month 12 after enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Atlanta
country: United States
facility: Emory Atlanta Adolescent Consortium
state: Georgia
city: Chicago
country: United States
facility: University Illinois Chicago
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Katie Biello, PhD, MPH
role: STUDY_CHAIR
affiliation: University of California, Los Angeles
name: Matthew Mimiaga, ScD, MPH
role: STUDY_CHAIR
References: