Motivational Interviewing + Contingency Management for HIV Prevention (PRISM Trial)

Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Florida International University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM), motivational interviewing (MI), and MI+CM for optimizing entry or re-entry into the PrEP care continuum. A total of 840 participants will be randomized to CM (n = 280), MI (n = 280), or MI+CM (n = 280), all delivered via Telehealth. Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription (verified using a digital photo or detectable tenofovir diphosphate). Secondary outcomes will include: self-reported PrEP clinical evaluation by a PrEP provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).

Eligibility Criteria

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.

Inclusion Criteria

I was assigned male at birth.

I am not taking medication to prevent HIV.

I am 16 years old or older.

Treatment Details

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.

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.

Contingency Management is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Contingency Management for: