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NCT05333679

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

Active, enrolled NA Last updated 27 October 2025
What this trial tests

NA trial testing UTRA in Risk Reduction in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
2 March 2022
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment200
Start date2 March 2022
Primary completion30 June 2026
Estimated completion30 June 2026
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Risk Reduction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Real-Time Urine Tenofovir Assay Improves Drug Adherence Among People With HIV With Prior Virologic Failure in a Randomized Controlled Trial.
    van Zyl GU, Decloedt E, Jennings L, Kellermann T, et al · · 2025 · PMID 40578842 · DOI 10.1093/cid/ciaf337

Verify or expand the search:

Other recruiting trials for Risk Reduction

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05333679.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing