Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Young Gay/Bisexual Minority Men (IMPACT)

Not Applicable

Suspended

• Conditions: HIV
• Interventions: Behavioral: eSOC; Behavioral: IMPACT

• Registration Number: NCT06444360
• Lead Sponsor: Westat

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.

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-05
• Study Start: 2024-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Standard of Care (eSOC) Control Group	eSOC	The comparison arm will receive the same 2 HIV sexual risk reduction (RR) intervention sessions and referrals to substance use and mental health treatment, per SOC.
IMPACT Group	IMPACT	A multifaceted training and implementation strategy across sites and formats will be used. Participants who report stimulant use in the context of condomless anal sex (CAS), will be randomized using a 2:1 allocation ratio with two-thirds being allocated to the IMPACT intervention. The participants in this arm participate in 10 sessions (approximately 50 minutes each) delivered over the course of approximately 10 weeks.

Primary Outcome Measures

Name	Time	Method
Distinct acts of condomless anal sex (CAS) without the protection of PrEP or viral suppression.	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	The number of times participants report engaging in a CAS act without the protection of prevention-effective PrEP (for those not living with HIV) or viral suppression (for those living with HIV).

Secondary Outcome Measures

Name	Time	Method
Days of stimulant use	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	The number of days participants report having used stimulants

Trial Locations

Locations (7)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Emory Atlanta Adolescent Consortium; 🇺🇸 Atlanta, Georgia, United States

University Illinois Chicago; 🇺🇸 Chicago, Illinois, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

The Fenway Institute; 🇺🇸 Boston, Massachusetts, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States