PrEP Readiness Interventions for Supporting Motivation

Not Applicable

Completed

• Conditions: Pre-exposure Prophylaxis; HIV Infections; Substance Use Disorders

• Registration Number: NCT04205487
• Lead Sponsor: Florida International University

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.

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-10-16
• Primary Completion: 2023-07-20
• Study Completion: 2023-07-28
• Results First Submitted: 2024-11-27
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Results First Posted: 2025-06-29
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Filling a Prescription for PrEP	6 Months	The proportion of participants who provide evidence that they have filled a PrEP prescription

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider	6 Months	The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.
Clinical Cut Points for Self-reported Methamphetamine Use Severity	6 months	Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of methamphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).
Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS)	6 months	Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported.
Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS)	6 months	Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported.

Trial Locations

Locations (1)

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States