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

NCT05333679 | Completed Results FDA Device

• 2 other identifiers: AI1521195R01AI152119
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Risk Reduction

Keywords

UTRA; Point-of-care; Real-time; PLHIV; Adherence monitoring; ART

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants in Each Arm Achieving Viral Suppression to <50 Copies/ml

  Assess suppression rates (VL\< 50 copies/mL) in both study arms using an intention-to-treat analysis. Plasma will be stored an enrolment, month 6 and month 12 for viral load assay completion after the study. Samples are assayed either with the Alinity m HIV-1 assay (Abbott Laboratories. Abbott Park, Illinois, U.S.A.); lower limit of detection (LLD) 10 copies/mL or the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Roche Diagnostics, Basel, Switzerland); LLD 20 copies/mL. Whole blood will be centrifuged and plasma then tested on the automated analyzer according to national standard operating procedures

  12 months

Secondary Outcomes (3)

• Number of Participants Retained in Care

  12 months

• Viral Suppression (<50 Copies/mL)

  6 months

• 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)

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

POC adherence testing by a urine TFV assay with feedback

Device: UTRA; Behavioral: UTRA feedback

Standard of Care

NO INTERVENTION

Standard enhanced adherence counselling, SA Department of Health, March 2020

Interventions

UTRA DEVICE

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

Intervention

UTRA feedback BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Cape Town: collaborator
• University of Stellenbosch: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Desmond Tutu Health Foundation, University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (57)

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  PMID: 40578842 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Gert van Zyl
• Organization: Stellenbosch University

guvz@sun.ac.za

+27 219389691

Study Officials

• Monica Gandhi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: March 2, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 48 months from start of study
• Access Criteria: Investigators conducting PrEP research

Locations

ZA (1)