NCT06444360

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Westat · Academic / Other
• Sex: All
• Age: 16 Years – 24 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	IMPACT	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 PrEP or ART and HIV care), and 1 final session on strategies for slip-ups and recurrence management.
BEHAVIORAL	eSOC	The eSOC group includes 2 sessions of HIV sexual RR counseling.

Timeline

• Start date: 2025-11-04
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2024-06-05
• Last updated: 2026-01-12

Locations

2 sites across 1 country: United States