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PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men (PrEP2-BAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05353283
Recruitment Status : Not yet recruiting
First Posted : April 29, 2022
Last Update Posted : April 29, 2022
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Risk Reduction Behavioral: Motivational Interviewing Counselling Device: Point-of-care Urine Tenofovir Measurement Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
POC adherence testing by a urine tenofovir assay with motivational interviewing counselling
Behavioral: Motivational Interviewing Counselling
Motivational interviewing-based counseling will be provided to the participant based on the results of the urine test

Device: Point-of-care Urine Tenofovir Measurement
Urine will be collected and the presence or absence of tenofovir will be measured with the point-of-care urine tenofovir test.

No Intervention: Standard of Care
Adherence counselling provided by the participant's PrEP care provider



Primary Outcome Measures :
  1. Number of participants indicating satisfied or very satisfied with the intervention [ Time Frame: 3 months ]
    Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience on a five-point Likert scale


Secondary Outcome Measures :
  1. Long-term adherence outcomes [ Time Frame: 3 months ]
    Measure change in tenofovir levels in dried blood spots and/or hair from baseline to 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05353283


Contacts
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Contact: Matthew A Spinelli, MD, MAS 415-476-4082 matthew.spinelli@ucsf.edu

Locations
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United States, California
University of California, San Francisco/San Francisco General Hospital
San Francisco, California, United States, 94110
Contact: Matthew A Spinelli, MD, MAS       matthew.spinelli@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
University of Miami
Investigators
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Principal Investigator: Matthew Spinelli, MD, MAS University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05353283    
Other Study ID Numbers: MH122286
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 48 months from start of study
Access Criteria: Investigators conducting PrEP research who contact the Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
PrEP
Young MSM
POC monitoring
adherence
motivational interviewing
urine test
tenofovir
Additional relevant MeSH terms:
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Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents