PrEP Readiness Interventions for Supporting Motivation

NCT04205487 | Completed Results DMC

• 2 other identifiers: 20180823R34DA046367
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Pre-exposure Prophylaxis; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Filling a Prescription for PrEP

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

  6 Months

Secondary Outcomes (4)

• 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 Arms (6)

Contingency Management (CM) - Only (Non-Responder)

EXPERIMENTAL

Non-responders to CM financial inancial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to assessments only in Stage 2.

Behavioral: Contingency Management (CM)

Motivational Interviewing (MI) - Only (Non-Responder)

EXPERIMENTAL

Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to assessments only in Stage 2

Behavioral: Motivational Interviewing (MI)

CM+MI

EXPERIMENTAL

Non-responders CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to receive two sessions of MI in Stage 2.

Behavioral: Motivational Interviewing (MI); Behavioral: Contingency Management (CM)

MI+CM

EXPERIMENTAL

Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 2.

Behavioral: Motivational Interviewing (MI); Behavioral: Contingency Management (CM)

CM-Only (Responder)

EXPERIMENTAL

Respnders to CM financial incentives for CM will include financial incentives for rEP clinical evaluation and filling a PrEP prescription in Stage 1.

Behavioral: Contingency Management (CM)

MI-Only (Responder)

EXPERIMENTAL

Responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered in Stage 1.

Behavioral: Motivational Interviewing (MI)

Interventions

Motivational Interviewing (MI) BEHAVIORAL

Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.

CM+MI; MI+CM; MI-Only (Responder); Motivational Interviewing (MI) - Only (Non-Responder)

Contingency Management (CM) BEHAVIORAL

CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.

CM+MI; CM-Only (Responder); Contingency Management (CM) - Only (Non-Responder); MI+CM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead
• City University of New York: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (4)

• Davis Ewart L, Larson ME, Ghanooni D, Verhagen R, Manuel J, McCollister K, Fardone E, DeVries B, Dilworth S, Blackstock M, Doblecki-Lewis S, Nahum-Shani I, Grov C, Carrico AW. Getting to yes: Pilot sequential multiple assignment randomized trial of motivational enhancement interventions targeting preexposure prophylaxis use in sexual minority men who use stimulants. Health Psychol. 2025 Mar;44(3):310-320. doi: 10.1037/hea0001489.

  PMID: 39992777 DERIVED

• Davis-Ewart L, Grov C, Verhagen R, Manuel J, Viamonte M, Dilworth S, O'Dell N, Valentin O, Carr S, Cherenack E, Henderson C, Doblecki-Lewis S, Nahum-Shani I, Carrico AW. Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial. JMIR Res Protoc. 2023 Oct 13;12:e48459. doi: 10.2196/48459.

  PMID: 37831485 DERIVED

• Davis-Ewart L, Grov C, Verhagen R, Manuel J, Viamonte M, Dilworth S, Valentin O, Cherenack EM, Carr S, Doblecki-Lewis S, Nahum-Shani I, Carrico AW. Randomized Controlled Trial of Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants. Res Sq [Preprint]. 2023 Apr 20:rs.3.rs-2787003. doi: 10.21203/rs.3.rs-2787003/v1.

  PMID: 37131755 DERIVED

• Davis-Ewart L, Lee JY, Viamonte M, Colon-Burgos J, Harkness A, Kanamori M, Duncan DT, Doblecki-Lewis S, Carrico AW, Grov C. "The familiar taste of poison": a qualitative study of multi-level motivations for stimulant use in sexual minority men living in South Florida. Harm Reduct J. 2023 Apr 26;20(1):58. doi: 10.1186/s12954-023-00787-w.

  PMID: 37101251 DERIVED

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

This was a pilot sequential multiple assignment randomized trial (SMART) of sequentially delivered CM and MI interventions. Only non-responders after three months (i.e., those who had not started or restarted PrEP) were randomized to Switch or Continue with assessments only. Given the sample size and sequential randomization, effect sizes should be interpreted with caution. In fact, the most appropriate purpose of a pilot trial is feasibility and acceptability to guide a more definitive trial.

Results Point of Contact

• Title: Adam W. Carrico, PhD
• Organization: Florida International University

acarrico@fiu.edu

305-348-7887

Study Officials

• Adam W Carrico, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Model Details: Sequential Multiple Assignment Randomized Trial (SMART)

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 19, 2019
• Study Start: October 16, 2020
• Primary Completion: July 20, 2023
• Study Completion: July 28, 2023
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)