Clinical trial NCT05333679: Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Official title: Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Risk Reduction
Keywords: UTRA
Point-of-care
Real-time
PLHIV
Adherence monitoring
ART
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: University of Stellenbosch
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Proportion of participants in each arm achieving viral suppression to <50 copies/ml
timeFrame: 21 months
Secondary outcomes:
measure: Retention in care
timeFrame: 21 months
measure: Viral suppression (<50 copies/mL)
timeFrame: 21 months
measure: 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)
timeFrame: 21 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation, University of Cape Town
state: Western Cape
Study officials:
affiliation: University of California, San Francisco
name: Monica Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
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