NCT07213258 CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
| NCT ID | NCT07213258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | PrEP Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-04-24 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Glenn-Milo Santos, PhD, MPH
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07213258 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 40 Years, studying PrEP Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213258 currently recruiting?
Yes, NCT07213258 is actively recruiting participants. Contact the research team at glenn-milo.santos@ucsf.edu for enrollment information.
Where is the NCT07213258 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07213258 clinical trial?
NCT07213258 is sponsored by University of California, San Diego. The principal investigator is Glenn-Milo Santos, PhD, MPH at University of California, San Francisco. The trial plans to enroll 100 participants.