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

NCT05353283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-02-13

Study results available
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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.

Conditions

  • Risk Reduction

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Matthew Spinelli, MD, MAS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-07-01
Completion
2025-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353283 on ClinicalTrials.gov