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

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.

Study Overview

• Status: Completed
• Conditions: Risk Reduction
• Intervention / Treatment: Behavioral: Motivational Interviewing Counselling; Device: Point-of-care Urine Tenofovir Measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Indicating the Intervention Was Acceptable	Number of participants reporting the intervention to be "somewhat" or "very" acceptable 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 hair samples from baseline to 3 months using liquid chromatography-mass spectrometry assays.	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of Miami
• Investigators: Principal Investigator: Matthew Spinelli, MD, MAS, University of California, San Francisco

Publications and helpful links

General Publications

• Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Okochi H, Kuncze K, Mehrotra M, Defechereux P, Buchbinder SP, Grant RM, Gandhi M. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS. 2019 Apr 1;33(5):867-872. doi: 10.1097/QAD.0000000000002135.
• Stalter RM, Baeten JM, Donnell D, Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Mugo N, Mujugira A, Marzinke M, Hendrix C, Gandhi M; Partners PrEP Study Team. Urine Tenofovir Levels Measured Using a Novel Immunoassay Predict Human Immunodeficiency Virus Protection. Clin Infect Dis. 2021 Feb 1;72(3):486-489. doi: 10.1093/cid/ciaa785.
• Spinelli MA, Rodrigues WC, Wang G, Vincent M, Glidden DV, Okochi H, Stalter R, Defechereux P, Deutsch M, Grant RM, Ngure K, Mugo NR, Baeten JM, Gandhi M; Partners PrEP Study Team. Brief Report: High Accuracy of a Real-Time Urine Antibody-Based Tenofovir Point-of-Care Test Compared With Laboratory-Based ELISA in Diverse Populations. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):149-152. doi: 10.1097/QAI.0000000000002322.
• Gandhi M, Wang G, King R, Rodrigues WC, Vincent M, Glidden DV, Cressey TR, Bacchetti P, Spinelli MA, Okochi H, Siriprakaisil O, Klinbuayaem V, Mugo NR, Ngure K, Drain PK, Baeten JM. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255-260. doi: 10.1097/QAD.0000000000002395.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: tenofovir; adherence; PrEP; motivational interviewing; urine test; Young MSM; POC monitoring
• Additional Relevant MeSH Terms: Behavior; Risk Reduction Behavior; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: MH122286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
• IPD Sharing Time Frame: 48 months from start of study
• IPD Sharing Access Criteria: Investigators conducting PrEP research who contact the Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No