PrEP Readiness Interventions for Supporting Motivation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men

Conditions
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HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI)
* Behavioral: Contingency Management (CM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential Multiple Assignment Randomized Trial (SMART)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management (CM) - Only<br>CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. | Behavioral: Contingency Management (CM)<br>* CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.<br>|
| Experimental: Motivational Interviewing (MI) - Only<br>Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered. | Behavioral: Motivational Interviewing (MI)<br>* Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.<br>|
| Experimental: CM+MI<br>CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. Participants who do not fill a PrEP prescription at 3 months will then receive 2 sessions of MI. | Behavioral: Motivational Interviewing (MI)<br>* Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.<br>Behavioral: Contingency Management (CM)<br>* CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.<br>|
| Experimental: MI+CM<br>Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered. Participants who do not fill a PrEP prescription at 3 months will receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription. | Behavioral: Motivational Interviewing (MI)<br>* Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.<br>Behavioral: Contingency Management (CM)<br>* CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filling a prescription for PrEP | The proportion of participants who provide evidence that they have filled a PrEP prescription | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported PrEP clinical evaluation by a medical provider | The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP. | 6 Months | 
| Self-reported stimulant use severity | Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater). | 6 months | 
| Self-reported condomless receptive anal sex (Receptive CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported. | 6 months | 
| Self-reported condomless insertive anal sex (Insertive CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported. | 6 months |