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

NCT ID: NCT05333679

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2026-06-30

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.

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 will receive an adherence support package informed by feedback from the urine-based test. The investigators will assess the impact of the adherence test on VL suppression rates in each arm (without necessitating a regimen switch) at 12 months after enrolment. Enrolling participants with adherence challenges increases efficiency and mirrors the population requiring adherence support in our setting.

The UTRA device used for this study has received a FDA Non-Significant Risk (NSR) designation and is IDE exempt.

FEASIBILITY:

The investigators will track retention in the study among participants in each arm, missed visits, and the number of urine assessments performed in the intervention arm.

ACCEPTABILITY:

All participants enrolled will also complete a standardised questionnaire about the acceptability of the adherence support they received. This measure of acceptability will be assessed as a secondary outcome by arm, along with socio-demographics profiles associated with low/high acceptability described within arm.

QUALITATIVE PROCEDURES:

1. Participant in-depth interviews: Qualitative data will include in-depth interviews of participants (n~20; ~3-4 interviews with each participant over 6-9 months of their treatment) using semi-structured guides conducted by experienced socio-behavioural scientists. The semi-structured interview guide will elicit feelings about the urine adherence metric and counseling messages, concerns regarding privacy, advantages/disadvantages of receiving such results, and the likely impact of this monitoring test on sustained adherence to ART or just on short-term adherence. Interviews will be conducted in participants' preferred language.

2. Health care worker interviews: The investigators will additionally assess the feasibility of the intervention by interviewing health care providers, who will be administering the UTRA test at the clinical point of care in the future. The study will examine provider perceptions of the assay at the end of the study using in-depth interviews (n~10), assessing perceived usefulness, complexity to use, stigma/social harm, and benefits. These interviews will also elicit barriers and facilitators to delivery of the urine assay-informed counseling messages.

Conditions

Risk Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

POC adherence testing by a urine TFV assay with feedback

Group Type: EXPERIMENTAL

UTRA

Intervention Type: DEVICE

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

UTRA feedback

Intervention Type: BEHAVIORAL

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

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

UTRA

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

Intervention Type: DEVICE

UTRA feedback

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: collaborator

University of Stellenbosch

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Gandhi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Desmond Tutu Health Foundation, University of Cape Town

Cape Town, Western Cape, South Africa

Countries

South Africa

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Other Identifiers

5R01AI152119

Identifier Type: NIH

Identifier Source: secondary_id

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AI152119

Identifier Type: -

Identifier Source: org_study_id