PrEP Readiness Interventions for Supporting Motivation

Not Applicable

Completed

• Conditions: Pre-exposure Prophylaxis; HIV Infections; Substance Use Disorders
• Interventions: Behavioral: Motivational Interviewing (MI); Behavioral: Contingency Management (CM)

• 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
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

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

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Exclusion Criteria

• Currently prescribed PrEP
• Unable to provide informed consent
• Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing (MI) - Only	Motivational Interviewing (MI)	Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered.
Contingency Management (CM) - Only	Contingency Management (CM)	CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
CM+MI	Contingency Management (CM)	CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. Participants who do not fill a PrEP prescription at 3 months will then receive 2 sessions of MI.
MI+CM	Motivational Interviewing (MI)	Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered. Participants who do not fill a PrEP prescription at 3 months will receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
CM+MI	Motivational Interviewing (MI)	CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. Participants who do not fill a PrEP prescription at 3 months will then receive 2 sessions of MI.
MI+CM	Contingency Management (CM)	Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered. Participants who do not fill a PrEP prescription at 3 months will receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription.

Primary Outcome Measures

Name	Time	Method
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
Self-reported 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.
Self-reported stimulant 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 cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).
Self-reported condomless insertive 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.
Self-reported condomless receptive 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.

Trial Locations

Locations (1)

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