CHAMPION: Combining HIV Prevention and Meth Treatment for HIV-Negative MSM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot study tests a 6-month, multi-modal mobile health package (PrEPAPP and CBT4CBT) to improve PrEP adherence among HIV-negative MSM with mild-to-moderate meth use. The study will compare the CHAMPION intervention to a delayed-start control, focusing on feasibility, engagement, and preliminary effects on PrEP adherence measured by dried blood spots. Participants will be 100 HIV-negative cisgender men, aged 18–40, in San Francisco or San Diego with suboptimal PrEP use and DSM-5 criteria for MUD. The primary aims are retention and engagement, with secondary exploration of PrEP adherence outcomes to inform future larger trials.

Why it matters

Who can join: the full rules

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

Where it's running

• Center on Substance Use and Health
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Glenn-Milo Santos, PhD, MPH — University of California, San Francisco
• Study coordinator: Glenn-Milo Santos, PhD, MPH
• Email: glenn-milo.santos@ucsf.edu
• Phone: 628-217-6231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.