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PrEP Readiness Interventions for Sustained Motivation (PRISM)

NCT06637436 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2027-12-30
Completion
2028-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06637436 on ClinicalTrials.gov