Status:
ACTIVE_NOT_RECRUITING
Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
University of Cape Town
University of Stellenbosch
Conditions:
Risk Reduction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
This is a randomised study, recruiting 200 people taking TDF-based ART. Participants will be randomised 1:1 to intervention versus standard enhanced adherence counselling. Intervention participants wi...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05333679
Start Date
March 2 2022
End Date
June 30 2026
Last Update
October 27 2025
Active Locations (1)
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1
Desmond Tutu Health Foundation, University of Cape Town
Cape Town, Western Cape, South Africa, 7925