HIVPRISMNCT06637436
PrEP Readiness Interventions for Sustained Motivation (PRISM)
A study testing Motivational Interviewing (MI) and Contingency Management (CM) in people with HIV and Methamphetamine Disorders, run by Florida International University at 1 site in United States.
Trial summary
This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Methamphetamine 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
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Assigned male a birth
- Self-reported methamphetamine use in the past 3 months
- HIV-negative or unknown serostatus at baseline
- Has not filled a PrEP prescription in the past 6 months
Who cannot join
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida International University
Miami, Florida, 33199
Adam Carrico Professor, PhD, 786-725-2034, acarrico@fiu.edu
About this study
Official title: Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via telehealth. Monthly follow-up assessments will be completed over 12 months to examine effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).
- Conditions
- HIV, Methamphetamine Disorders
- Being tested
- Motivational Interviewing (MI), Contingency Management (CM)
- Keywords
- HIV prevention, Methamphetamine, Motivational Interviewing, Contingency Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.
Contingency Management (CM)Behavioural
Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization. Receives: Behavioral: Contingency Management (CM) |
| MI+CM | Experimental | Two session MI counseling intervention delivered in the three months after randomization with CM. Receives: Behavioral: Motivational Interviewing (MI); Behavioral: Contingency Management (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Verified PrEP or ART Use
The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record)
Measured: 12 Months
Secondary outcomes (5)
Median Time to Verified PrEP or ART Use
The number of days after randomization until evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record).
Measured: 12 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 for the severity of amphetamine and other substance use (Mild = 0-3; Moderate = 4-26; Severe = 27+).
Measured: 12 Months
Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)
Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS in the past 3 months. Changes in the mean number of insertive CAS partners will be examined.
Measured: 12 Months
Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)
Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS in the past 3 months. Changes in the mean number of receptive CAS partners will be examined.
Measured: 12 Months
Proportion of Participants with Prevention Effective PrEP or ART Use
Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels commensurate with at least four doses per week OR HIV viral load < 300 copies/mL from dried blood spot samples
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start28 Jan 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Carrico, PhD, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637436
- Sponsor's protocol ID
- UH3AI169652
- Acronym
- PRISM
- Status last verified
- May 2026
- First submitted
- 10 Oct 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be uploaded to a secure database after the team completes intent-to-treat analyses of the primary and secondary outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
- ClinicalTrials.gov ID
- NCT06637436
- Acronym / sponsor ID
- PRISM / UH3AI169652
- Conditions
- HIV, Methamphetamine Disorders
- Keywords
- HIV prevention, Methamphetamine, Motivational Interviewing, Contingency Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via telehealth. Monthly follow-up assessments will be completed over 12 months to examine effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency Management (CM)Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization. |
| MI+CM | Experimental | Behavioral: Motivational Interviewing (MI), Behavioral: Contingency Management (CM)Two session MI counseling intervention delivered in the three months after randomization with CM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Assigned male a birth
- Self-reported methamphetamine use in the past 3 months
- HIV-negative or unknown serostatus at baseline
- Has not filled a PrEP prescription in the past 6 months
Key exclusion criteria (1 listed)
- Unwilling or unable to provide informed consent
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)This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS. | Behavioural | MI+CM |
| Contingency Management (CM)Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization. | Behavioural | Contingency Management, MI+CM |
Primary outcome
Proportion of Participants with Verified PrEP or ART Use
Time frame: 12 Months
The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record)
5 secondary outcomes
Median Time to Verified PrEP or ART Use
Time frame: 12 Months
Clinical Cut Points for Self-Reported Methamphetamine Use Severity
Time frame: 12 Months
Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)
Time frame: 12 Months
Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)
Time frame: 12 Months
Proportion of Participants with Prevention Effective PrEP or ART Use
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be uploaded to a secure database after the team completes intent-to-treat analyses of the primary and secondary outcomes.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI) and Contingency Management (CM) in people with HIV and Methamphetamine Disorders, run by Florida International University at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Carrico Professor, PhD (305-348-7887, acarrico@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Verified PrEP or ART Use (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.