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Behavioral Intervention
Motivational Interviewing + Contingency Management for HIV Prevention (PRISM Trial)
Phase 3
Waitlist Available
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Assigned male at birth
Not on PrEP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing different methods to help people start or continue taking PrEP medication. They will compare the effectiveness of contingency management (CM), motivational interviewing (MI), and a combination of both (MI
Who is the study for?
The PRISM trial is for individuals with HIV/AIDS and methamphetamine disorder who are considering or re-considering pre-exposure prophylaxis (PrEP) treatment. Participants must be willing to engage in Telehealth sessions.
What is being tested?
This study tests the effectiveness of Motivational Interviewing (MI), Contingency Management (CM), and a combination of both (MI+CM) via Telehealth to encourage participants to fill their PrEP prescriptions, as part of HIV prevention efforts.
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications, traditional side effects are not applicable. However, participants may experience psychological discomfort during motivational interviewing or stress related to adherence to the contingency management program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was assigned male at birth.
Select...
I am not taking medication to prevent HIV.
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I am 16 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Verified PrEP Use
Secondary study objectives
Insertive Condomless Anal Sex (CAS)
Prevention Effective PrEP Use
Receptive Condomless Anal Sex (CAS)
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Motivational Interviewing (MI)Experimental Treatment1 Intervention
Two-session counseling intervention focusing on PrEP use (Session 1) as well as co-occurring substance use and HIV risk (Session 2)
Group II: MI+CMExperimental Treatment2 Interventions
Both the CM and MI interventions described above.
Group III: Contingency ManagementExperimental Treatment1 Intervention
Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency Management (CM)
2016
Completed Phase 2
~480
Motivational Interviewing (MI)
2010
Completed Phase 3
~2830
Find a Location
Who is running the clinical trial?
Florida International UniversityLead Sponsor
107 Previous Clinical Trials
18,095 Total Patients Enrolled