NCT06637436

PrEP Readiness Interventions for Sustained Motivation (PRISM)

Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM) alone or CM with motivational interviewing (MI) for optimizing entry or re-entry into the PrEP care continuum. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via Telehealth. Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription (verified using a digital photo or detectable tenofovir diphosphate). Secondary outcomes will include: self-reported PrEP clinical evaluation by a PrEP provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).

Conditions

• HIV
• Methamphetamine Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Motivational Interviewing (MI)	This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting pre-exposure prophylaxis (PrEP) in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.
BEHAVIORAL	Contingency Management (CM)	Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.

Timeline

• Start date: 2025-01-28
• Primary completion: 2027-12-30
• Completion: 2028-04-30
• First posted: 2024-10-15
• Last updated: 2026-02-18

Locations

2 sites across 1 country: United States