PrEP Readiness Interventions for Sustained Motivation (PRISM)

NCT06637436 | Recruiting DMC

• 1 other identifier: UH3AI169652
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV; Methamphetamine Disorders

Keywords

HIV prevention; Methamphetamine; Motivational Interviewing; Contingency Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Median Time to Verified PrEP or ART Use

  12 Months

• Clinical Cut Points for Self-Reported Methamphetamine Use Severity

  12 Months

• Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)

  12 Months

• Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)

  12 Months

• Proportion of Participants with Prevention Effective PrEP or ART Use

  12 Months

Study Arms (2)

Contingency Management

EXPERIMENTAL

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)

MI+CM

EXPERIMENTAL

Two session MI counseling intervention delivered in the three months after randomization with CM.

Behavioral: Motivational Interviewing (MI); Behavioral: Contingency Management (CM)

Interventions

Motivational Interviewing (MI) BEHAVIORAL

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.

MI+CM

Contingency Management (CM) BEHAVIORAL

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

Contingency Management; MI+CM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Adam Carrico Professor, PhD

CONTACT

305-348-7887; acarrico@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: August 2027 (estimated start date) without an end date
• Access Criteria: These data will be publicly accessible.

Locations

US (1)