CHAMPION Intervention for Pre-exposure Prophylaxis Adherence
(CHAMPION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new mobile health tools to help HIV-negative men who have sex with men adhere to their PrEP medication and reduce methamphetamine use. The trial employs an app called CHAMPION, which sends motivational messages and includes online therapy to support healthy habits. Participants will either start using the app immediately or after a 3-month wait. This trial may suit men in San Diego or San Francisco who use methamphetamine moderately, have been on daily PrEP for over a month but sometimes miss doses, and are open to using a health app for six months. As an unphased trial, this study offers participants the chance to contribute to innovative health solutions that could improve PrEP adherence and support healthier lifestyles.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
What prior data suggests that the CHAMPION intervention is safe for improving PrEP adherence?
Research has shown that the CHAMPION program helps people consistently take their PrEP medication and reduce meth use. This program employs a mobile health app and cognitive behavioral therapy to support participants. Developers created the app using data from previous surveys on health habits. No serious safety issues have emerged with these methods. The program primarily targets behavior changes, which typically carry a low risk of side effects. As the trial is in the "Not Applicable" phase, the program is in early testing stages and is generally considered safe.12345
Why are researchers excited about this trial?
Researchers are excited about the CHAMPION Intervention because it brings a fresh approach to improving adherence to pre-exposure prophylaxis (PrEP) for HIV prevention. Unlike traditional methods that often rely on personal reminders or counseling, this intervention uses a mobile health (mHealth) app to deliver motivational messages and incorporate computer-administered cognitive behavioral therapy (CBT). This tech-driven method is not only innovative but also potentially more engaging and accessible, offering a continuous support system that current options lack. By leveraging technology to promote adherence, this intervention could significantly enhance the effectiveness of PrEP, making it a promising tool in the fight against HIV.
What evidence suggests that the CHAMPION intervention could be effective for improving PrEP adherence among MSM with MUD?
Research has shown that mobile health (mHealth) tools can help individuals adhere to their HIV prevention medication, known as PrEP. In this trial, participants in the CHAMPION Intervention Arm will use an app that sends encouraging messages and includes therapy techniques to assist those with mild to moderate methamphetamine use disorder (MUD) in maintaining their PrEP routine. Studies have found that digital tools can facilitate adherence to daily medications. Although specific data on the CHAMPION program is limited, combining mHealth tools with therapy has proven effective in similar contexts. This approach aims to address both HIV prevention and substance use, potentially improving overall success.36789
Who Is on the Research Team?
Glenn-Milo Santos, PhD, MPH
Principal Investigator
University of California, San Francisco
Kiyomi Tsuyuki, PhD, MPH
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for HIV-negative men who have sex with men (MSM) and struggle with mild to moderate methamphetamine use. Participants should be interested in improving their adherence to PrEP, a medication that prevents HIV infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the CHAMPION mHealth intervention package to improve PrEP adherence and reduce meth use
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CHAMPION Intervention
Trial Overview
The CHAMPION study tests new mobile health tools designed to help participants stick to their PrEP regimen while also addressing methamphetamine use disorder. It compares the effectiveness of these tools against a waitlist control group over time.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention.
mHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of California, San Francisco
Collaborator
Citations
HIV pre-exposure prophylaxis champion preceptorship ...
We collected and reported self-reported data and have no objective outcomes such as number of PrEP prescriptions. Therefore, our results are ...
CHAMPION Intervention for Pre-exposure Prophylaxis ...
Participants receive the CHAMPION mHealth intervention package to improve PrEP adherence and reduce meth use. 6 months. Monthly self-reported data collection.
A double randomized intervention study protocol | PLOS One
We developed a study to compare the effectiveness of workplace-based PrEP provision to standard-of-care facility-based provision for PrEP initiation, retention ...
A Multicomponent Intervention to Train and Support Family ...
The primary outcomes are PrEP-Pro acceptability and feasibility, which would be assessed using validated instruments at months 3 (among pretest participants) ...
5.
bmchealthservres.biomedcentral.com
bmchealthservres.biomedcentral.com/articles/10.1186/s12913-025-12670-4A case study of the co-creation of the PrEP-SIC
The effectiveness of multiple formulations of biomedical HIV prevention has been established in clinical trials, demonstration projects, and ...
Project Details
Enrolled participants will be randomized to either receive the CHAMPION intervention package, or have a 3- month usual care waitlist control. Behavioral ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/174031b45cd6dae1/nct07213258-hiv-meth-prevention-treatment-msmCHAMPION: Combining HIV And Meth Prevention ... - MedPath
The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-
Mobile Health Intervention Tools Promoting HIV Pre-Exposure ...
Content for the app was informed by results from an SMS text message survey that collected fertility, PrEP, and ART adherence data. An ...
CHAMPION: Combining HIV And Meth Prevention and ...
The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.