PrEP readiness support using motivational counseling plus incentive payments
Official title: Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
Run by Florida International University · NCT06637436 · Data updated 2026-11-12
This program will test whether adding short motivational counseling to incentive payments helps men who use methamphetamine start or restart PrEP or HIV treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | January 28, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | April 30, 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT06637436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older who were assigned male at birth, have used methamphetamine in the past 3 months, are HIV-negative or unsure of their status, and have not filled a PrEP prescription in the last 6 months are ideal candidates.
✕Probably not a fit
People who are already taking PrEP or ART, who are known to be HIV-positive on stable treatment, or who cannot or will not provide informed consent or use telehealth are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized trial that will enroll 400 adults assigned male at birth who report recent methamphetamine use and are HIV-negative or have unknown status, and who have not filled a PrEP prescription in the past 6 months. Participants are randomized 1:1 to contingency management (incentive payments) alone or contingency management plus brief motivational interviewing, with all visits delivered via telehealth. Monthly follow-ups over 12 months will track whether participants fill a PrEP or ART prescription (verified by a digital photo) as the primary outcome, plus self-reported clinical evaluation, substance use severity, and condomless sex as secondary outcomes. The trial focuses on remote delivery to improve access and measures uptake and behavior change over time.
Why it matters
Potential benefit: If successful, the approach could help more people start or restart PrEP or ART, reducing individual HIV risk and potentially lowering new infections in this high-risk group.
How similar studies have gone: Contingency management has strong evidence for improving engagement and reducing stimulant use and motivational interviewing has modest effects on behavior change, but combining them specifically to increase PrEP or ART uptake among methamphetamine users is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Assigned male a birth * Self-reported methamphetamine use in the past 3 months * HIV-negative or unknown serostatus at baseline * Has not filled a PrEP prescription in the past 6 months Exclusion Criteria: * Unwilling or unable to provide informed consent
Where it's running
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Florida International University
Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: Adam Carrico Professor, PhD
- Email: acarrico@fiu.edu
- Phone: 305-348-7887
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.