CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
NCT ID: NCT07213258
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-10-22
2026-08-15
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
CHAMPION Intervention
MHealth intervention to enhance PrEP adherence, combined with computer-administered cognitive behavioral therapy for a 6-month period for the intervention arm.
Waitlist Control Arm
3-month waitlist period including informational resources, followed by 3-month CHAMPION intervention.
Delayed CHAMPION Package
Informational resources for first 3-months of study, followed by CHAMPION intervention for final 3-months.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
40 Years
MALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, San Francisco
OTHER
University of California, San Diego
OTHER
Responsible Party
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Kiyomi Tsuyuki
Multi-Principal Investigator
Principal Investigators
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Glenn-Milo Santos, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Kiyomi Tsuyuki, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Center on Substance Use and Health
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Glenn-Milo Santos
Role: primary
Other Identifiers
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