PrEP Readiness Interventions for Sustained Motivation (PRISM) (PRISM)

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

This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. 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 effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).

Study Overview

• Status: Recruiting
• Conditions: HIV; Methamphetamine Disorders
• Intervention / Treatment: Behavioral: Contingency Management (CM); Behavioral: Motivational Interviewing (MI)

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Carrico Professor, PhD; Phone Number: 305-348-7887; Email: acarrico@fiu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Recruiting
      • Florida International University
      • Contact: Adam Carrico Professor, PhD; Phone Number: 786-725-2034; Email: acarrico@fiu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management; Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.	Behavioral: Contingency Management (CM); Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.
Experimental: MI+CM; Two session MI counseling intervention delivered in the three months after randomization with CM.	Behavioral: Contingency Management (CM); Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.; Behavioral: Motivational Interviewing (MI); This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with Verified PrEP or ART Use	The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record)	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cut Points for Self-Reported Methamphetamine Use Severity	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+).	12 Months
Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)	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.	12 Months
Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)	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.	12 Months
Median Time to Verified PrEP or ART Use	The number of days after randomization until evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record).	12 Months
Proportion of Participants with Prevention Effective PrEP or ART Use	Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels commensurate with at least four doses per week OR HIV viral load < 300 copies/mL from dried blood spot samples	12 Months

Collaborators and Investigators

• Sponsor: Florida International University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Motivational Interviewing; HIV prevention; Contingency Management; Methamphetamine
• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: UH3AI169652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be uploaded to a secure database after the team completes intent-to-treat analyses of the primary and secondary outcomes.
• IPD Sharing Time Frame: August 2027 (estimated start date) without an end date
• IPD Sharing Access Criteria: These data will be publicly accessible.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No