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

NCT07213258 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

  • PrEP Adherence
  • Methamphetamine Use Disorder
  • HIV

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Glenn-Milo Santos, PhD, MPH · University of California, San Francisco

  • Kiyomi Tsuyuki, PhD, MPH · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2026-08-15
Completion
2026-08-15

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07213258 on ClinicalTrials.gov