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

June 7, 2023 updated by: University of California, San Francisco

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Desmond Tutu Health Foundation, University of Cape Town
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine Orrell, MBChB, PhD
        • Sub-Investigator:
          • Yashna Singh, MBBS
        • Sub-Investigator:
          • Lauren Jennings, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
POC adherence testing by a urine TFV assay with feedback
Device: UTRA
Collect urine on intervention participants and screen for presence of TFV.
Behavioral: UTRA feedback
Feedback will be provided to the participant based on the UTRA results on their adherence with provision of standard adherence counseling.
No Intervention: Standard of Care
Standard enhanced adherence counselling, SA Department of Health, March 2020

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants in each arm achieving viral suppression to <50 copies/ml
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in care
Time Frame: 12 months
Follow up visits will occur in 12-week increments post-enrolment: at month 3, month 6, month 9 and month 12; and will be synchronized wherever possible with routine clinic visits. Visit windows will be continuous, with each window extending to 6 weeks before and 6 weeks after the visit target date. A visit will be considered missed if the participant does not attend during the 12-week visit window
12 months
Viral suppression (<50 copies/mL)
Time Frame: 6 months
Assess suppression rates (VL< 50 copies/mL) in both study arms using an intention-to-treat analysis. 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
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)
Time Frame: 12 months
The proportion of participants indicating "strongly agree" or "agree" averaged across 10 items, each item using a five-point Likert scale to measure aspects of acceptability of the adherence support intervention (i.e., by arm: UTRA-informed or standard of care), at month 12. Responses to the Likert scale range from "Strongly agree" to "Strongly disagree". Aspects of acceptability include domains on: support from health workers, time given by health workers to discuss the patients' treatment, patient perceptions of feeling informed about their adherence, feelings of surveillance (-vely scored), and self-satisfactions with adherence.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

University of Stellenbosch
University of Cape Town

Investigators

  • Principal Investigator: Monica Gandhi, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI152119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.

IPD Sharing Time Frame

48 months from start of study

IPD Sharing Access Criteria

Investigators conducting PrEP research

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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