PrEP Readiness Interventions for Sustained Motivation (PRISM)

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT06637436
Status
Recruiting
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Conditions

  • HIV
  • Methamphetamine Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Jan 28, 2025
Status verified
May 2026
Primary completion
Dec 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • Experimental: MI+CM
    Two session MI counseling intervention delivered in the three months after randomization with CM.

Primary Outcome Measure

Proportion of Participants with Verified PrEP or ART Use [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida International UniversityMiamiFlorida33199
Adam Carrico Professor, PhD
[email protected]
786-725-2034

Find similar trials in Miami, FL

By condition
HIV
By specialty
Infectious disease
By research site
Florida International University· Miami, FL

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