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

NCT07213258 | Not Yet Recruiting DMC

• 1 other identifier: R21DA060856
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MSM; HIV Negative; mild MUD; moderate MUD; Methamphetamine Use Disorder (MUD); CBT4CBT; PrEPAPP; mHealth; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Feasibility & Acceptability of CHAMPION

  We will calculate the following feasibility and acceptability measures: 1. study completion rate (mean, standard deviation) 2. days of PrEPAPP use (mean, standard deviation) 3. CBT4CBT virtual sessions completed (mean, standard deviation)

  6 months

• PrEP adherence

  We will examine the preliminary efficacy of CHAMPION vs. a waitlist control on increasing PrEP adherence, compared to a waitlist control as determined by dried blood spot (DBS) tests. In preparation for a larger efficacy trial, we will explore the preliminary efficacy of CHAMPION vs. waitlist control in increasing PrEP adherence. PrEP drug levels in DBS samples will be dichotomized as PrEP adherence, or not, using established cut-offs for protective levels of PrEP. We will calculate the following outcome measure: 1.) Number and percent adherent to PrEP, based on DBS.

  6-Months

Other Outcomes (2)

• Meth use

  6 months

• Sexual risk behavior

  6 months

Study Arms (2)

CHAMPION Intervention Arm

EXPERIMENTAL

mHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period.

Behavioral: CHAMPION Intervention

Waitlist Control Arm

OTHER

3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention.

Behavioral: Delayed CHAMPION Package

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.

CHAMPION Intervention Arm

Delayed CHAMPION Package BEHAVIORAL

Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.

Waitlist Control Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Willingness to participate in an mHealth study with a 6-month follow-up
• Residing in San Diego or San Francisco County

You may not qualify if:

• Residing outside of San Diego or San Francisco County
• Any condition that, in the principal investigator's judgment interferes with safe study participation or adherence to study procedures
• Not able/willing to complete virtual/remote visits
• Not willing to learn to self-collect dried blood spots using a finger stick

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Center on Substance Use and Health

San Francisco, California, 94102, United States

Location

Study Officials

• Glenn-Milo Santos, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Kiyomi Tsuyuki, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn-Milo Santos, PhD, MPH

CONTACT

628-217-6231; glenn-milo.santos@ucsf.edu

Alexandrea Dunham, B.A.

CONTACT

530-925-3398; allie.dunham@sfdph.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Multi-Principal Investigator

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: October 8, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)