NCT04205487: PRISM

PrEP Readiness Interventions for Supporting Motivation

Completed NA Results posted Last updated 29 June 2025

What this trial tests

NA trial testing Motivational Interviewing (MI) in HIV Infections in 70 participants. Completed in 28 July 2023.

Timeline

16 October 2020

Primary endpoint
20 July 2023

28 July 2023

Quick facts

Lead sponsor	Florida International University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	70
Start date	16 October 2020
Primary completion	20 July 2023
Estimated completion	28 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing (MI)
• Contingency Management (CM)

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Pre-exposure Prophylaxis — all drugs for Pre-exposure Prophylaxis →
• Substance Use Disorders — all drugs for Substance Use Disorders →

Sponsor

Florida International University

Who can join

18 and older, male only, with HIV Infections or Pre-exposure Prophylaxis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Filling a Prescription for PrEP Primary · 6 Months

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

Group	Value	95% CI
CM-Only (Non-Responder or Lost to Follow Up During Stage 1)	0
MI-Only (Non-Responder or Lost to Follow Up During Stage 1)	2
CM+MI	2
MI+CM	5
CM-Only (Responder)	11
MI-Only (Responder)	7
CM-Only (Non-Responder or Lost to Follow Up During Stage 1)	5
MI-Only (Non-Responder or Lost to Follow Up During Stage 1)	11
CM+MI	7
MI+CM	2
CM-Only (Responder)	0
MI-Only (Responder)	0

Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider Secondary · 6 Months

The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.

Group	Value	95% CI
Contingency Management (CM) - Only (Non-Responder)	3
Motivational Interviewing (MI) - Only (Non-Responder)	9
CM+MI	8
MI+CM	4
CM-Only (Responder)	11
MI-Only (Responder)	7
Contingency Management (CM) - Only (Non-Responder)	2
Motivational Interviewing (MI) - Only (Non-Responder)	4
CM+MI	1
MI+CM	3
CM-Only (Responder)	0
MI-Only (Responder)	0

Clinical Cut Points for Self-reported Methamphetamine Use Severity Secondary · 6 months

Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of methamphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).

Group	Value	95% CI
Contingency Management (CM) - Only (Non-Responder)	2
Motivational Interviewing (MI) - Only (Non-Responder)	7
CM+MI	2
MI+CM	4
CM-Only (Responder)	2
MI-Only (Responder)	6
Contingency Management (CM) - Only (Non-Responder)	1
Motivational Interviewing (MI) - Only (Non-Responder)	1
CM+MI	6
MI+CM	0
CM-Only (Responder)	3
MI-Only (Responder)	0
Contingency Management (CM) - Only (Non-Responder)	0
Motivational Interviewing (MI) - Only (Non-Responder)	4
CM+MI	0
MI+CM	1
CM-Only (Responder)	2
MI-Only (Responder)	1

Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) Secondary · 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.

Group	Value	95% CI
Contingency Management (CM) - Only (Non-Responder)	0
Motivational Interviewing (MI) - Only (Non-Responder)	6
CM+MI	4
MI+CM	2
CM-Only (Responder)	2
MI-Only (Responder)	3
Contingency Management (CM) - Only (Non-Responder)	3
Motivational Interviewing (MI) - Only (Non-Responder)	6
CM+MI	4
MI+CM	3
CM-Only (Responder)	5
MI-Only (Responder)	4

Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) Secondary · 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.

Group	Value	95% CI
Contingency Management (CM) - Only (Non-Responder)	2
Motivational Interviewing (MI) - Only (Non-Responder)	6
CM+MI	4
MI+CM	2
CM-Only (Responder)	5
MI-Only (Responder)	6
Contingency Management (CM) - Only (Non-Responder)	1
Motivational Interviewing (MI) - Only (Non-Responder)	6
CM+MI	4
MI+CM	3
CM-Only (Responder)	2
MI-Only (Responder)	1

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Davis-Ewart L, Grov C, Verhagen R, Manuel J, et al · · 2023 · cited 4× · PMID 37831485 · DOI 10.2196/48459
2. Getting to yes: Pilot sequential multiple assignment randomized trial of motivational enhancement interventions targeting preexposure prophylaxis use in sexual minority men who use stimulants.
   Davis Ewart L, Larson ME, Ghanooni D, Verhagen R, et al · · 2025 · cited 1× · PMID 39992777 · DOI 10.1037/hea0001489
3. "The familiar taste of poison": a qualitative study of multi-level motivations for stimulant use in sexual minority men living in South Florida.
   Davis-Ewart L, Lee JY, Viamonte M, Colon-Burgos J, et al · · 2023 · PMID 37101251 · DOI 10.1186/s12954-023-00787-w
4. Randomized Controlled Trial of Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants
   Davis-Ewart L, Grov C, Verhagen R, Manuel J, et al · · 2023 · DOI 10.21203/rs.3.rs-2787003/v1