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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• HIV-negative

• Cis-gender male

• Age 18-40 years old

• Mild or moderate MUD (by DSM-5 SCID criteria)

• Anal intercourse with one or more male partners in the past 6 months

• Started daily oral PrEP more than 30 days ago and self-reported not always taking PrEP as prescribed in the past 30 days (consistent with PrEP It! inclusion criteria)

• Willingness to participate in an mHealth study with a 6-month follow-up

• Residing in San Diego or San Francisco County

Locations
United States
California
Center on Substance Use and Health
RECRUITING
San Francisco
Contact Information
Primary
Glenn-Milo Santos, PhD, MPH
glenn-milo.santos@ucsf.edu
628-217-6231
Backup
Alexandrea Dunham, B.A.
allie.dunham@sfdph.org
530-925-3398
Time Frame
Start Date: 2026-04-24
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
Experimental: CHAMPION Intervention Arm
mHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period.
Other: Waitlist Control Arm
3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), University of California, San Francisco
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov