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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Diego
Study ID
NCT07213258
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Methamphetamine Use Disorder
  • PrEP Adherence

Eligibility Criteria

Sex
MALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Oct 2025
Primary completion
Aug 15, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Feasibility & Acceptability of CHAMPION [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center on Substance Use and HealthSan FranciscoCalifornia94102
Glenn-Milo Santos

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
Center on Substance Use and Health· San Francisco, CA

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