N/A
N=70
PrEP Readiness Interventions for Supporting Motivation
HIV Infections · Pre-exposure Prophylaxis · Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04205487 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Proportion of Participants Filling a Prescription for PrEP — 0; 2; 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational Interviewing (MI) (Behavioral); Contingency Management (CM) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Florida International University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Filling a Prescription for PrEP |
0; 2; 2; 5; 11; 7 | — |
| SECONDARY Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider |
3; 9; 8; 4; 11; 7 | — |
| SECONDARY Clinical Cut Points for Self-reported Methamphetamine Use Severity |
2; 7; 2; 4; 2; 6 | — |
| SECONDARY Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) |
0; 6; 4; 2; 2; 3 | — |
| SECONDARY Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) |
2; 6; 4; 2; 5; 6 | — |
Summary
The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Sexually active cisgender sexual minority man
- Reports using stimulants in the past three months
- HIV-negative serostatus
- Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility
Exclusion Criteria
- Currently prescribed PrEP
- Unable to provide informed consent
- Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate
Data sourced from ClinicalTrials.gov (NCT04205487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.