PrEP Readiness Interventions for Sustained Motivation (PRISM)

Phase 3

• Conditions: HIV; Methamphetamine Disorders

• Registration Number: NCT06637436
• Lead Sponsor: Florida International University

Brief Summary

This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM), motivational interviewing (MI), and MI+CM for optimizing entry or re-entry into the PrEP care continuum. A total of 840 participants will be randomized to CM (n = 280), MI (n = 280), or MI+CM (n = 280), 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Study Start: 2025-01-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

• 18 years or older
• Sexual or gender minority (SGM) person
• Assigned male at birth
• Self-reported methamphetamine use (past 3 months)
• Non-reactive HIV antibody test results (past 3 months)
• Not on PrEP

Exclusion Criteria

• Unwilling or unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Proportion of Participants with Verified PrEP Use	12 Months	The proportion of participants providing evidence of PrEP use (i.e., a digital photo a PrEP medication bottle bearing their name, evidence of receipt of injectable PrEP from a medical record, or a dried blood spot with detectable tenofvir diphosphate for those taking daily oral PrEP)

Secondary Outcome Measures

Name	Time	Method
Median Time to Verified PrEP Use	12 Months	The number of days after randomization until evidence of PrEP use (i.e., a digital photo a PrEP medication bottle bearing their name, evidence of receipt of injectable PrEP from a medical record, or a dried blood spot with detectable tenofvir diphosphate for those taking daily oral PrEP).
Clinical Cut Points for Self-Reported Methamphetamine Use Severity	12 Months	Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores for the severity of amphetamine and other substance use (Mild = 0-3; Moderate = 4-26; Severe = 27+).
Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)	12 Months	Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS in the past 3 months. Changes in the mean number of insertive CAS partners will be examined.
Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)	12 Months	Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS in the past 3 months. Changes in the mean number of receptive CAS partners will be examined.
Proportion of Participants with Prevention Effective PrEP Use	12 Months	Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels of 700 mol/punch or greater

Trial Locations

Locations (1)

Florida International University Stempel College of Public Health and Social Work; 🇺🇸 Miami, Florida, United States