N/A N=63 Randomized Prevention

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

Risk Reduction

Bottom Line

View on ClinicalTrials.gov: NCT05353283 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: Number of Participants Indicating the Intervention Was Acceptable — 37 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Motivational Interviewing Counselling (Behavioral); Point-of-care Urine Tenofovir Measurement (Device)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: University of California, San Francisco
Primary completion: Jul 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Indicating the Intervention Was Acceptable	37	—
SECONDARY Long-term Adherence Outcomes	0.036; 0.04; 0.046; 0.037	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05353283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.