Recruiting

CHAMPION Intervention

Sponsor:

UCLA

Code:

NCT07213258

Conditions

PrEP Adherence

Methamphetamine Use Disorder

HIV

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

CHAMPION Intervention

Delayed CHAMPION Package

Study Details

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

Study ID

NCT07213258

Start date

Apr 24, 2026

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

CHAMPION Intervention

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

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

Primary outcome measure

  • Feasibility & Acceptability of CHAMPION [ Time Frame: 6 months ]
  • PrEP adherence [ Time Frame: 6-Months ]

Central Contacts and Locations

Central contacts

Glenn-Milo Santos, PhD, MPH

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

Alexandrea Dunham, B.A.

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

Locations

Center on Substance Use and Health

Recruiting

San Francisco, California, United States, 94102

Contacts

Glenn-Milo Santos

628-217-6231Glenn-milo.Santos@ucsf.edu

Allie Dunham

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

More Information

Sponsor

University of California, San Diego

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-08-26.