Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults (IMPACT)

Westat

Status: Enrolling

Conditions: HIV

Treatments: Behavioral: IMPACT; Behavioral: eSOC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06444360

UM2HD111076 (U.S. NIH Grant/Contract)

ATN170

UM2HD111102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

IMPACT Group

Experimental group

Description:

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.

Treatment:

Behavioral: IMPACT

Enhanced Standard of Care (eSOC) Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: eSOC