PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men

Study Overview
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Brief Summary
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Despite advances in HIV prevention, the HIV incidence among young men who have sex with men (YMSM) is increasing, threatening to derail achievement of the United States End the HIV Epidemic goals. Although, pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method, adherence was sufficiently low to comprise efficacy among a high proportion of YMSM in multiple clinical trials and demonstration projects. In this study, the investigators will leverage a novel urine point-of-care drug-level test for PrEP adherence, to both enhance and target motivational-interviewing-based adherence counseling among YMSM, with the goal of preventing HIV infections among this critically at-risk group.

Detailed Description
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Young men who have sex with men (YMSM; ages 15-29 years) have rising HIV incidence in the United States. Pre-exposure prophylaxis (PrEP) is a highly effective medication prevent HIV infection, both at the individual and population level. However, in several clinical trials and demonstration projects among YMSM, a majority of participants had adherence to PrEP sufficiently low to compromise efficacy throughout the study. Unfortunately, pill-counts and self-reported adherence have limitations in this population, and therapeutic drug monitoring using previously available methods requires expensive equipment and specialized staff, meaning it cannot be implemented at the point-of-care (POC). The investigators have developed a novel POC test to measure urine drug-levels to PrEP for the first time, providing the opportunity to target and enhance adherence counseling during a routine clinical visit. Substantial knowledge gaps on the correct counseling approach and framing of the drug-level feedback message must be addressed to use this strategy to improve adherence among YMSM. This study will use a mixed methods approach to test the central hypothesis that an intervention leveraging a POC urine bioassay to detect PrEP adherence can both target and enhance adherence counseling. Brief interventions are a motivational interviewing (MI) counseling approach with wide uptake by primary care providers for substance use prevention and medical therapy adherence. PrEP2-BAY proposes a brief intervention be used as the framework for POC drug-level feedback among YMSM using PrEP. This study will test the acceptability, feasibility, and preliminary impact on long-term adherence, measured through hair tenofovir levels, of the brief intervention in a pilot randomized controlled trial among YMSM. This proposed research plan has the goal of optimizing PrEP's impact through a novel adherence support intervention. The findings of this proposal will lead to a R01 application to test a POC bioassay-enhanced adherence brief intervention among YMSM in a multi-city trial, with the goal of reducing the burden of HIV among MSM.

Official Title
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PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men

Conditions
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Risk Reduction

Intervention / Treatment
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* Behavioral: Motivational Interviewing Counselling
* Device: Point-of-care Urine Tenofovir Measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex at birth who has sex with men Age 18-30 years-old Currently receiving tenofovir-based oral PrEP Plans to continue taking daily PrEP over the upcoming 3 months Exclusion Criteria: Participant living with HIV Age > 30 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>POC adherence testing by a urine tenofovir assay with motivational interviewing counselling | Behavioral: Motivational Interviewing Counselling<br>* Motivational interviewing-based counseling will be provided to the participant based on the results of the urine test<br>Device: Point-of-care Urine Tenofovir Measurement<br>* Urine will be collected and the presence or absence of tenofovir will be measured with the point-of-care urine tenofovir test.<br>|
| No Intervention: Standard of Care<br>Adherence counselling provided by the participant's PrEP care provider | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants indicating satisfied or very satisfied with the intervention | Number of participants reporting to be satisfied or very satisfied about their overall experience on a five-point Likert scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term adherence outcomes | Measure change in tenofovir levels in dried blood spots and/or hair from baseline to 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Young MSM, POC monitoring, adherence, motivational interviewing, urine test, tenofovir