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PrEP Readiness Interventions for Supporting Motivation (PRISM)

Primary Purpose

HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing (MI)
Contingency Management (CM)
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Contingency Management (CM) - Only

Motivational Interviewing (MI) - Only

CM+MI

MI+CM

Arm Description

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

Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
December 13, 2019
Last Updated
October 4, 2023
Sponsor
Florida International University
Collaborators
City University of New York, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04205487
Brief Title
PrEP Readiness Interventions for Supporting Motivation
Acronym
PRISM
Official Title
PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
City University of New York, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential Multiple Assignment Randomized Trial (SMART)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management (CM) - Only
Arm Type
Experimental
Arm Description
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
Arm Title
Motivational Interviewing (MI) - Only
Arm Type
Experimental
Arm Description
Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered.
Arm Title
CM+MI
Arm Type
Experimental
Arm Description
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.
Arm Title
MI+CM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Intervention Description
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management (CM)
Intervention Description
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
Primary Outcome Measure Information:
Title
Filling a prescription for PrEP
Description
The proportion of participants who provide evidence that they have filled a PrEP prescription
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Self-reported PrEP clinical evaluation by a medical provider
Description
The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.
Time Frame
6 Months
Title
Self-reported stimulant use severity
Description
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).
Time Frame
6 months
Title
Self-reported condomless receptive anal sex (Receptive CAS)
Description
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.
Time Frame
6 months
Title
Self-reported condomless insertive anal sex (Insertive CAS)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam W Carrico, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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PrEP Readiness Interventions for Supporting Motivation

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