PrEP Readiness Interventions for Supporting Motivation (PRISM)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Substance Use Disorders; Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: Contingency Management (CM); Behavioral: Motivational Interviewing (MI)

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Carrico, PhD; Phone Number: 415-533-8653; Email: a.carrico@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management (CM) - Only; CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.	Behavioral: Contingency Management (CM); CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
Experimental: Motivational Interviewing (MI) - Only; Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered.	Behavioral: Motivational Interviewing (MI); Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
Experimental: CM+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.	Behavioral: Contingency Management (CM); CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.; Behavioral: Motivational Interviewing (MI); Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
Experimental: MI+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.	Behavioral: Contingency Management (CM); CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.; Behavioral: Motivational Interviewing (MI); Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filling a prescription for PrEP	The proportion of participants who provide evidence that they have filled a PrEP prescription	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported PrEP clinical evaluation by a medical provider	The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.	6 Months
Self-reported stimulant use severity	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).	6 months
Self-reported condomless receptive anal sex (Receptive CAS)	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.	6 months
Self-reported condomless insertive anal sex (Insertive CAS)	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.	6 months

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute on Drug Abuse (NIDA); City University of New York
• Investigators: Principal Investigator: Adam W Carrico, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 20180823; R34DA046367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No