PrEP Readiness Interventions for Sustained Motivation (PRISM)

Florida International University (FIU)

Status and phase: Invitation-only; Phase 2

Conditions: HIV; Methamphetamine Disorders

Treatments: Behavioral: Contingency Management (CM); Behavioral: Motivational Interviewing (MI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06637436

UH3AI169652 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Assigned male a birth
• Assigned male at birth
• Self-reported methamphetamine use (past 3 months)
• Not on PrEP

Exclusion criteria

• Unwilling or unable to provide informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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840 participants in 3 patient groups

Contingency Management

Experimental group

Description:

Provides incentives for initiating PrEP care ($50) and filling a PrEP prescription ($50) in the three months following randomization.

Treatment:

Behavioral: Contingency Management (CM)

Motivational Interviewing (MI)

Experimental group

Description:

Two-session counseling intervention focusing on PrEP use (Session 1) as well as co-occurring substance use and HIV risk (Session 2)

Treatment:

Behavioral: Motivational Interviewing (MI)

MI+CM

Experimental group

Description:

Both the CM and MI interventions described above.

Treatment:

Behavioral: Motivational Interviewing (MI)

Behavioral: Contingency Management (CM)