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PrEP Readiness Interventions for Sustained Motivation (PRISM)

Study acronym: PRISM
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 2 to 1
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (5)
    v12
  2. Primary endpoint revised
    • Secondary endpoints revised (5)
    v11
  3. Phase: Phase 2 to Not applicablev10 Show 7 more changesShow less
    • Enrollment target: 840 to 400
    • Primary completion date: Apr 30, 2027 to Dec 30, 2027
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 1 to 2
    • Study completion date: Apr 30, 2027 to Apr 30, 2028
    • Eligibility criteria expanded, about 6 words
    • Study arms: 3 to 2
  4. Eligibility criteria shortened, about 2 wordsv9
  5. Phase: Phase 3 to Phase 2
    • Eligibility criteria shortened, about 8 words
    v8
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  1. Eligibility criteria revisedv7
  2. Trial status: Not Yet Recruiting to Enrolling by Invitationv6 Show 4 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Jan 7, 2025 to Jan 28, 2025
    • Secondary endpoints revised (5)
    • Site contact updated
  3. Start date: Dec 15, 2024 to Jan 7, 2025v5
  4. Secondary endpoints revised (5)v4
  5. Start date: Oct 22, 2024 to Dec 15, 2024
    • Secondary endpoints: details revised at 1 of 5 entries
    v3
  6. Study title shortened, about 8 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06637436
Lead Sponsor Florida International University
Conditions
(from sponsor)		 HIV, Methamphetamine Disorders
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov