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Clinical Trials/NCT04205487
NCT04205487
Completed
Not Applicable

PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men

Florida International University1 site in 1 country70 target enrollmentOctober 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Florida International University
Enrollment
70
Locations
1
Primary Endpoint
Proportion of Participants Filling a Prescription for PrEP
Status
Completed
Last Updated
10 months ago

Overview

Brief 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.

Detailed Description

In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.

Registry
clinicaltrials.gov
Start Date
October 16, 2020
End Date
July 28, 2023
Last Updated
10 months ago
Study Type
Interventional
Study Design
Sequential
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Carrico, PhD

Professor and Chair

Florida International University

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

Outcomes

Primary Outcomes

Proportion of Participants Filling a Prescription for PrEP

Time Frame: 6 Months

The proportion of participants who provide evidence that they have filled a PrEP prescription

Secondary Outcomes

  • Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider(6 Months)
  • Clinical Cut Points for Self-reported Methamphetamine Use Severity(6 months)
  • Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS)(6 months)
  • Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS)(6 months)

Study Sites (1)

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