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Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Sponsor: University of California, San Francisco
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-03-02
Completion Date
2026-06-30
Last Updated
2025-10-27
Healthy Volunteers
No
Conditions
Interventions
UTRA
Collect urine on intervention participants and screen for presence of TFV.
UTRA feedback
Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
Locations (1)
Desmond Tutu Health Foundation, University of Cape Town
Cape Town, Western Cape, South Africa