RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of California, San Diego • ClinicalTrials.gov ID: NCT07213258

Registry updated: 2026-08-26

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: 1. HIV-negative 2. Cis-gender male 3. Age 18-40 years old 4. Mild or moderate MUD (by DSM-5 SCID criteria) 5. Anal intercourse with one or more male partners in the past 6 months 6. 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) 7. Willingness to participate in an mHealth study with a 6-month follow-up 8. Residing in San Diego or San Francisco County Exclusion Criteria: 1. Residing outside of San Diego or San Francisco County 2. Any condition that, in the principal investigator's judgment interferes with safe study participation or adherence to study procedures 3. Not able/willing to complete virtual/remote visits 4. Not willing to learn to self-collect dried blood spots using a finger stick

Conditions

PrEP Adherence Methamphetamine Use Disorder HIV

Locations

Center on Substance Use and Health — San Francisco, California, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment