PrEP Readiness Interventions for Supporting Motivation (PRISM)

Florida International University (FIU)

Status: Completed

Conditions: Pre-exposure Prophylaxis; Substance Use Disorders; HIV Infections

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04205487

20180823

R34DA046367 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 6 patient groups

Contingency Management (CM) - Only (Non-Responder)

Experimental group

Description:

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.

Treatment:

Behavioral: Contingency Management (CM)

Motivational Interviewing (MI) - Only (Non-Responder)

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interviewing (MI)

CM+MI

Experimental group

Description:

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.

Treatment:

Behavioral: Contingency Management (CM)

Behavioral: Motivational Interviewing (MI)

MI+CM

Experimental group

Description:

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.

Treatment:

Behavioral: Contingency Management (CM)

Behavioral: Motivational Interviewing (MI)

CM-Only (Responder)

Experimental group

Description:

Respnders to CM financial incentives for CM will include financial incentives for rEP clinical evaluation and filling a PrEP prescription in Stage 1.

Treatment:

Behavioral: Contingency Management (CM)

MI-Only (Responder)

Experimental group

Description:

Responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered in Stage 1.

Treatment:

Behavioral: Motivational Interviewing (MI)