PrEP Readiness Interventions for Sustained Motivation (PRISM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motivational Interviewing (MI), Contingency Management (CM).
- Who it may be relevant to
- Registry conditions: HIV, Methamphetamine Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
Overview
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).
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.
Primary outcome measures
- Proportion of Participants with Verified PrEP or ART Use [Time frame: 12 Months]
Secondary outcome measures (5)
- Median Time to Verified PrEP or ART Use [Time frame: 12 Months]
- Clinical Cut Points for Self-Reported Methamphetamine Use Severity [Time frame: 12 Months]
- Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS) [Time frame: 12 Months]
- Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS) [Time frame: 12 Months]
- Proportion of Participants with Prevention Effective PrEP or ART Use [Time frame: 12 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Florida International University — Miami
Identifiers
NCT: NCT06637436 · UH3AI169652