HIV InfectionsPRISMNCT04205487

PrEP Readiness Interventions for Supporting Motivation

A study testing Motivational Interviewing (MI) and Contingency Management (CM) in people with HIV Infections and Pre-exposure Prophylaxis, run by Florida International University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders
What is being tested?: Motivational Interviewing (MI) and Contingency Management (CM)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 16 Oct 2020to 28 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami School of Medicine
Miami, Florida, 33136

Other trials in United States

About this study

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

Read the 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.

Conditions: HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders
Being tested: Motivational Interviewing (MI), Contingency Management (CM)
Medical subject headings: HIV Infections, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04205487
Study group	Role	What they receive
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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Motivational Interviewing (MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants Filling a Prescription for PrEP
The proportion of participants who provide evidence that they have filled a PrEP prescription
Measured: 6 Months

Secondary outcomes (4)

Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider
The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.
Measured: 6 Months
Clinical Cut Points for Self-reported Methamphetamine Use Severity
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).
Measured: 6 months
Proportion of Participants Who Reported Receptive Condomless 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.
Measured: 6 months
Proportion of Participants Who Reported Insertive Condomless 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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 202028 Jul 2023

First posted19 Dec 2019
Study start16 Oct 2020
Primary completion20 Jul 2023
Study completion28 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Model description: Sequential Multiple Assignment Randomized Trial (SMART)
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04205487
Sponsor's protocol ID: 20180823
Other IDs: R34DA046367
Acronym: PRISM
Status last verified: Jun 2025
First submitted: 13 Dec 2019
Last updated: 29 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39992777
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.
PubMed 37831485
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.
PubMed 37131755
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.
PubMed 37101251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men
ClinicalTrials.gov ID: NCT04205487
Acronym / sponsor ID: PRISM / 20180823
Conditions: HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
Collaborators: City University of New York, National Institute on Drug Abuse (NIDA)
Study start: 16 Oct 2020 (actual)
Primary completion: 20 Jul 2023 (actual)
Study completion: 28 Jul 2023 (actual)
First posted: 19 Dec 2019 (actual)
Results: Posted 29 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: Sequential Multiple Assignment Randomized Trial (SMART)

Arm	Type	Receives
Contingency Management (CM) - Only (Non-Responder)	Experimental	Behavioral: Contingency Management (CM)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.
Motivational Interviewing (MI) - Only (Non-Responder)	Experimental	Behavioral: Motivational Interviewing (MI)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
CM+MI	Experimental	Behavioral: Motivational Interviewing (MI), Behavioral: Contingency Management (CM)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.
MI+CM	Experimental	Behavioral: Motivational Interviewing (MI), Behavioral: Contingency Management (CM)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.
CM-Only (Responder)	Experimental	Behavioral: Contingency Management (CM)Respnders to CM financial incentives for CM will include financial incentives for rEP clinical evaluation and filling a PrEP prescription in Stage 1.
MI-Only (Responder)	Experimental	Behavioral: Motivational Interviewing (MI)Responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered in Stage 1.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Motivational Interviewing (MI)Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.	Behavioural	CM+MI, MI+CM, MI-Only (Responder), Motivational Interviewing (MI) - Only (Non-Responder)
Contingency Management (CM)CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.	Behavioural	CM+MI, CM-Only (Responder), Contingency Management (CM) - Only (Non-Responder), MI+CM

Primary outcome

Proportion of Participants Filling a Prescription for PrEP
Time frame: 6 Months
The proportion of participants who provide evidence that they have filled a PrEP prescription

4 secondary outcomes

Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider
Time frame: 6 Months
Clinical Cut Points for Self-reported Methamphetamine Use Severity
Time frame: 6 months
Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS)
Time frame: 6 months
Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS)
Time frame: 6 months

Results and safety

Results posted to the registry on 29 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Contingency Management (CM) - Only (Non-Responder or Lost to Follow Up During Stage 1)	15	5
Motivational Interviewing (MI) - Only (Non-Responder or Lost to Follow Up During Stage 1)	21	13
CM+MI	9	9
MI+CM	7	7
CM-Only (Responder)	11	11
MI-Only (Responder)	7	7

Primary outcome: Proportion of Participants Filling a Prescription for PrEP

Time frame: 6 Months. Count of participants. Unit: Participants

Measure	CM-Only (Non-Responder or Lost to Follow Up During Stage 1) n = 5	MI-Only (Non-Responder or Lost to Follow Up During Stage 1) n = 13	CM+MI n = 9	MI+CM n = 7	CM-Only (Responder) n = 11	MI-Only (Responder) n = 7
Yes	0	2	2	5	11	7
No	5	11	7	2	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for each participant for 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CM - Non-Responder	0 of 15 (0%)	0 of 15 (0%)	0 of 15
MI - Non-Resonder	0 of 21 (0%)	0 of 21 (0%)	0 of 21
CM+MI	0 of 9 (0%)	0 of 9 (0%)	0 of 9
MI+CM	0 of 7 (0%)	0 of 7 (0%)	0 of 7
CM - Responder	0 of 11 (0%)	0 of 11 (0%)	0 of 11
MI - Responder	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39992777Davis 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.
Derived from this study: PubMed 37831485Davis-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.
Derived from this study: PubMed 37131755Davis-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.
Derived from this study: PubMed 37101251Davis-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam W Carrico, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Filling a Prescription for PrEP (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04205487, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.