N/A
N=200
Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Risk Reduction
Bottom Line
View on ClinicalTrials.gov: NCT05333679 ↗Enrolled (actual)
200
Serious AEs
0.7%
Results posted
Apr 2026
Primary outcome: Primary: Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml — 59; 48 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UTRA (Device); UTRA feedback (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml |
59; 48 | — |
| SECONDARY Number of Participants Retained in Care |
59; 48 | — |
| SECONDARY Viral Suppression (<50 Copies/mL) |
— | — |
| SECONDARY The Proportion of Participants Indicating "Strongly Agree" or "Agree" Averaged Across 10 Items, Each Using a Five-point Likert Scale to Measure Aspects of the Adherence Support Intervention (i.e., by Arm: UTRA-informed or Standard of Care) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥18 years old
- Willing and able to provide written informed consent
- HIV-infected, receiving or (re-)starting a tenofovir-based ART regimen
- Current ART regimen includes at least one drug with a high genetic barrier to resistance e.g. dolutegravir, atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir.
- Any previous raised viral load >50 copies/ml (after ART initiation).
- Willing and able to comply with laboratory tests and other study procedures
Exclusion Criteria
- Not willing or able to provide informed consent in any of the languages provided
- Not receiving a tenofovir-based ART regimen
- Any other clinical condition that in the opinion of an investigator puts the patient at increased risk if participating in the study.
Data sourced from ClinicalTrials.gov (NCT05333679). 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.