CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
UTRA +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05333679
NCT05333679N/ACompleted

Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)

University of California, San Francisco·interventional·Posted Apr 19, 2022·Updated Apr 28, 2026

In Brief

A clinical study evaluating UTRA and UTRA feedback for Risk Reduction. Completed, enrolled 200 participants across 1 site.

Detailed Summary

ART is given to people living with HIV in order to suppress the virus, resulting in improved health for the individual and decreased transmission of the virus to others. Success of ART is dependent on adherence. Currently, adherence is assessed by asking patients directly and then confirming with a viral load test, which is expensive and is often only done when the viral load is already raised. Therefore there is a need to find a method to detect problems with adherence early before the viral load rises. A urine-based test was recently developed, called UTRA (urine tenofovir rapid assay). This test can give clinic staff immediate results about a person's adherence to the antiretroviral medication Tenofovir (TDF). The study will compare the results of this urine test to drug levels found in blood, self-reported adherence and pharmacy collection records to see if this test can be used as part of routine care in ART clinics. If the test is effective it would allow clinic staff to identify people with adherence difficulties early and give them the necessary support before their viral load rises.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRisk Reduction
CountriesSouth Africa

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 19, 2022
Enrollment StartMar 2, 2022
Primary CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 4.2 years ago

Interventions

UTRAdevice

Collect urine on intervention participants and screen for presence of TFV.

UTRA feedbackbehavioral

Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.