Summary

Eligibility
for males ages 18-30 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Matthew Spinelli, MD, MAS
Headshot of Matthew Spinelli
Matthew Spinelli

Description

Summary

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.

Details

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.

Keywords

Risk Reduction PrEP Young MSM POC monitoring adherence motivational interviewing urine test tenofovir Motivational Interviewing Counselling Point-of-care Urine Tenofovir Measurement

Eligibility

You can join if…

Open to males ages 18-30

  • 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

You CAN'T join if...

  • Participant living with HIV
  • Age > 30 years

Location

  • University of California, San Francisco/San Francisco General Hospital
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Matthew Spinelli, MD, MAS
    I am HIV/ID physician with training in implementation science methods who uses these approaches to support pre-exposure prophylaxis (PrEP) implementation, PrEP/HIV ART adherence, and PrEP persistence/HIV retention in care. A key tool we are using in this work is a point-of-care urine tenofovir test that can provide real-time adherence information to clinicians to drive adherence interventions.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05353283
Study Type
Interventional
Last Updated