PrEP AdherenceCHAMPIONNCT07213258
CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
A study testing CHAMPION Intervention and Delayed CHAMPION Package in people with PrEP Adherence and Methamphetamine Use Disorder, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- PrEP Adherence, Methamphetamine Use Disorder, HIV
- What is being tested?
- CHAMPION Intervention and Delayed CHAMPION Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- 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)
- Willingness to participate in an mHealth study with a 6-month follow-up
- Residing in San Diego or San Francisco County
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center on Substance Use and Health
San Francisco, California, 94102
Glenn-Milo Santos, 628-217-6231, Glenn-milo.Santos@ucsf.edu
Allie Dunham, 530-925-3398, allie.dunham@sfdph.org
About this study
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.
Read the detailed description
The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.
- Conditions
- PrEP Adherence, Methamphetamine Use Disorder, HIV
- Being tested
- CHAMPION Intervention, Delayed CHAMPION Package
- Keywords
- MSM, HIV Negative, mild MUD, moderate MUD, Methamphetamine Use Disorder (MUD), CBT4CBT, PrEPAPP, mHealth, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAMPION InterventionBehavioural
MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.
Delayed CHAMPION PackageBehavioural
Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CHAMPION Intervention |
| Waitlist Control Arm | Other | 3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention. Receives: Behavioral: Delayed CHAMPION Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility & Acceptability of CHAMPION
We will calculate the following feasibility and acceptability measures:
- study completion rate (mean, standard deviation)
- days of PrEPAPP use (mean, standard deviation)
- CBT4CBT virtual sessions completed (mean, standard deviation)
Measured: 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.
Measured: 6-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start24 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Francisco
- Responsible party
- Principal investigator, Kiyomi Tsuyuki, University of California, San Francisco
- Investigators
- Glenn-Milo Santos, PhD, MPH, Principal investigator, University of California, San FranciscoKiyomi Tsuyuki, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213258
- Sponsor's protocol ID
- R21DA060856
- Other IDs
- R21DA060856
- Acronym
- CHAMPION
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
- ClinicalTrials.gov ID
- NCT07213258
- Acronym / sponsor ID
- CHAMPION / R21DA060856
- Conditions
- PrEP Adherence, Methamphetamine Use Disorder, HIV
- Keywords
- MSM, HIV Negative, mild MUD, moderate MUD, Methamphetamine Use Disorder (MUD), CBT4CBT, PrEPAPP, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Francisco
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CHAMPION (Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM) study, a randomized controlled trial that aims to pilot test state-of-the-art multi-modal pharmaco-behavioral interventions to increase PrEP adherence among HIV-negative MSM who use meth, versus a waitlist control. The study will enroll 100 HIV-negative MSM with mild or moderate meth use disorder (MUD) and sub-optimal PrEP adherence. The study will follow participants for 6 months. The intervention arm will receive the 6-month mHealth intervention package, CHAMPION, at baseline, while the waitlist control will receive it at month-3 follow-up. Results of this pilot study will determine the viability of combining interventions that reduce meth use and enhance PrEP adherence, informing the direction of future interventions for MSM who use meth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHAMPION Intervention Arm | Experimental | Behavioral: CHAMPION InterventionmHealth app to track and promote PrEP adherence using motivational messages combined with computer-administered cognitive behavioral therapy for the full 6-month period. |
| Waitlist Control Arm | Other | Behavioral: Delayed CHAMPION Package3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHAMPION InterventionMHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm. | Behavioural | CHAMPION Intervention Arm |
| Delayed CHAMPION PackageInformational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months. | Behavioural | Waitlist Control Arm |
Primary outcome
Feasibility & Acceptability of CHAMPION
Time frame: 6 months
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)
PrEP adherence
Time frame: 6-Months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn-Milo Santos, PhD, MPH principal investigator
University of California, San Francisco
Kiyomi Tsuyuki, PhD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAMPION Intervention and Delayed CHAMPION Package in people with PrEP Adherence and Methamphetamine Use Disorder, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenn-Milo Santos, PhD, MPH (628-217-6231, glenn-milo.santos@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility & Acceptability of CHAMPION (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.