NCT07213258

CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are: * To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates. * To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.

Detailed description

The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.

Conditions

• PrEP Adherence
• Methamphetamine Use Disorder
• HIV

Interventions

Type	Name	Description
BEHAVIORAL	CHAMPION Intervention	MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.
BEHAVIORAL	Delayed CHAMPION Package	Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.

Timeline

• Start date: 2025-10-22
• Primary completion: 2026-08-15
• Completion: 2026-08-15
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States