CHAMPION Study: Improving PrEP Adherence and Addressing Methamphetamine Use
This study, called CHAMPION, is testing a new mobile health (mHealth) program to help HIV-negative men who have sex with men (MSM) better take their PrEP (pre-exposure prophylaxis) medication and address mild to moderate methamphetamine use. PrEP is a daily medicine that can help prevent HIV. The CHAMPION program uses two mHealth tools, PrEPAPP and CBT4CBT, to help with both PrEP adherence and methamphetamine use. Researchers want to see if this program is practical and well-received, and if it helps people take their PrEP more consistently. You might be able to join if you are an HIV-negative cisgender man between 18 and 40, have mild or moderate methamphetamine use disorder, have had anal sex with men recently, and have not been taking your daily PrEP as prescribed for at least 30 days. The study plans to enroll 100 participants, but its current status is unclear.
- Study design
- This is a randomized controlled trial, meaning participants will be assigned by chance to either receive the CHAMPION program right away or after a delay. The study aims to enroll 100 participants.
- What's involved
- Participants will be followed for 6 months. Those in the intervention group will receive the CHAMPION program for 6 months, while the delayed group will receive informational resources for 3 months, then the CHAMPION program for the final 3 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months, with PrEP adherence measured at the 6-month mark.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CHAMPION: Combining HIV And Meth Prevention and Treatment Interventions Optimized for HIV-Negative MSM
At a glance
Conditions
NCT07213258
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Center on Substance Use and Health
San Francisco, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Glenn-Milo Santos, PhD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Kiyomi Tsuyuki, PhD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Diego
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Feasibility & Acceptability of CHAMPION6 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 adherence6-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.