PrEP Readiness Interventions for Supporting Motivation

HIV Infections Clinical Trial

— PRISM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205487
• Other study ID #: 20180823
• Secondary ID: R34DA046367
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: July 28, 2023

Study information

• Verified date: October 2023
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 28, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Pre-exposure Prophylaxis
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Motivational Interviewing (MI)
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
• Contingency Management (CM)
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.

Locations

Country	Name	City	State
United States	University of Miami School of Medicine	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida International University	City University of New York, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filling a prescription for PrEP	The proportion of participants who provide evidence that they have filled a PrEP prescription	6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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