RecruitingNot ApplicableNCT06637436

PrEP Readiness Interventions for Sustained Motivation (PRISM)

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


Sponsor

Florida International University

Enrollment

400 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (PRISM) tests different programs designed to motivate gay and bisexual men who use methamphetamine to start taking PrEP — a daily pill that prevents HIV infection. Researchers want to help this high-risk group overcome barriers to HIV prevention. **You may be eligible if...** - You are 18 or older - You were assigned male at birth - You have used methamphetamine in the past 3 months - You have not filled a PrEP prescription in the past 6 months **You may NOT be eligible if...** - You are unwilling or unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMotivational 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.

BEHAVIORALContingency Management (CM)

Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.


Locations(2)

Florida International University Stempel College of Public Health and Social Work

Miami, Florida, United States

Florida International University

Miami, Florida, United States

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NCT06637436


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