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Urine tenofovir point-of-care test to identify patients in need of ART adherence support

Award Number: R01AI152119
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/07/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Urine tenofovir point-of-care test to identify patients in need of ART adherence support - PROJECT SUMMARY Adequate adherence to combination antiretroviral therapy (ART) is required to suppress HIV viral loads among individuals living with HIV, which is essential both for individual-level benefits and to prevent the onward transmission of HIV. While newer ART regimens are better tolerated, have fewer side effects and a lower risk of drug resistance than older regimens, treatment success nevertheless remains dependent on patient adherence. Current approaches to identify inadequate adherence are either subjective or insensitive, whereas objective markers of treatment exposure (drug levels) in hair, dried blood spots or plasma require expensive instrumentation and are therefore not scalable. As the ultimate aim of treatment is to achieve HIV viral load suppression, use of HIV viral load testing is being expanded worldwide. As it remains an expensive test, it is often performed infrequently and therefore treatment failure is detected late, resulting in missed opportunities to improve adherence. A low-cost point-of-care (POC) assay to assess adherence to ART, objectively at clinic visits, in resource limited settings (RLS), could: 1) Provide immediate information on recent adherence which can then be followed with appropriate adherence support; 2) Allow for more frequent assessment of adherence and reinforcement of appropriate adherence behavior before virologic failure occurs; 3) Differentiate patients with virological failure due to poor adherence from those with drug resistance. Finally, with the current roll-out of tenofovir, lamivudine and dolutegravir (TLD) in RLS, failure rates are expected to be low and resistance rare, necessitating a monitoring strategy primarily focused on identifying patients with inadequate adherence. Recently the University of California, San Francisco (UCSF) Hair Analytical Laboratory and Abbott™ Rapid Diagnostics has developed a urine-based immunoassay for tenofovir (TFV). This antibody-based assay detects the presence of TFV in urine accurately, is easy-to-perform, and is both low-cost (< $2 dollars per test) and point- of-care (POC), which allows for immediate adherence feedback to both patient and provider. We will therefore conduct a study with the following aims: 1) Investigate the ability of the urine-based tenofovir rapid assay (UTRA) to detect virologic failure in a cross-sectional study, along with the association of UTRA with self-reported adherence and long term TFV exposure as measured in dried blood spots (120 patients); 2) Qualitatively assess the acceptability of UTRA in patients (25) and health care workers (5); 3) Perform a pilot randomized controlled study among adherence-challenged patients to investigate the usefulness, feasibility and acceptability of UTRA-supported adherence counseling, compared to standard of care counseling, to impact long-term HIV viral load outcomes (100 patients in each arm). The envisaged overall impact is that by study end, we hope to have validated this novel real-time urine-based treatment adherence monitoring tool, in a resource- limited setting, and inform a larger trial to trigger immediate adherence support and ration more expensive laboratory testing, using the practical POC test, to improve long-term virologic outcomes worldwide.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $326,142 )
2024	2024	STELLENBOSCH UNIVERSITY	ADMINISTRATION BUILDING B, VICTORIA ST	STELLENBOSCH				ZAF	Allergy and Infectious Diseases Research	000	5	7/29/2024	NON-COMPETING CONTINUATION	$326,142
														Subtotal = $326,142

Issue Date FY: 2023 ( Subtotal = $331,897 )
2023	2023	UNIVERSITEIT STELLENBOSCH	ADMINISTRATION BUILDING B, VICTORIA STREET	STELLENBOSCH				ZAF	Allergy and Infectious Diseases Research	001	4	7/6/2023	NON-COMPETING CONTINUATION	$331,897
2023	2022	UNIVERSITEIT STELLENBOSCH	ADMINISTRATION BUILDING B, VICTORIA STREET	STELLENBOSCH				ZAF	Allergy and Infectious Diseases Research	000	3	4/21/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $331,897

Issue Date FY: 2022 ( Subtotal = $338,904 )
2022	2022	UNIVERSITEIT STELLENBOSCH	ADMINISTRATION BUILDING B, VICTORIA STREET	STELLENBOSCH				ZAF	Allergy and Infectious Diseases Research	000	3	7/6/2022	NON-COMPETING CONTINUATION	$338,904
														Subtotal = $338,904

Issue Date FY: 2021 ( Subtotal = $343,910 )
2021	2021	UNIVERSITEIT STELLENBOSCH	ADMINISTRATION BUILDING B, VICTORIA STREET	STELLENBOSCH				ZAF	Allergy and Infectious Diseases Research	000	2	8/4/2021	NON-COMPETING CONTINUATION	$343,910
														Subtotal = $343,910

Issue Date FY: 2020 ( Subtotal = $343,464 )
2020	2020	UNIVERSITEIT STELLENBOSCH	ADMINISTRATION BUILDING B, VICTORIA STREET	STELLENBOSCH		7600		ZAF	Allergy and Infectious Diseases Research	000	1	7/6/2020	NEW	$343,464
														Subtotal = $343,464

Grand Total All Awards = $1,684,317

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Urine tenofovir point-of-care test to identify patients in need of ART adherence support

Award Number: R01AI152119

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/07/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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