Saturday, November 29, 2025 11/29/2025

Home Fingerprick Blood-Based HIV Self-Test For Quantitative Monitoring Of Viral Rebound

Award Number: R33AI147419
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: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Home Fingerprick Blood-Based HIV Self-Test For Quantitative Monitoring Of Viral Rebound - Project Summary/Abstract The advancement of antiretroviral treatment (ART) has significantly reduced the HIV mortality and morbidity by reducing the viral load (VL) to undetectable levels. Recently revised WHO guidelines strongly recommend routine VL testing to monitor ART adherence and minimize failure. To this end, HIV self-testing, a process in which individual who wants to know HIV status collects a specimen, performs a test and interprets the result in private, has become an empowering approach. While nucleic acid testing (NAT) is readily available in centralized laboratories for viral load quantification, its availability in self-testing has not been demonstrated due to sample processing and assay complexity. This project aims to develop a quantitative test on an ultra-compact USB device to detect viral rebound that is simple enough for laypersons to test themselves in the United States. The R61 phase of the project will develop the whole blood-based test that can quantitatively assess the presence of HIV-1 RNA at concentrations as low as 1000 copies/ml, threshold recommended by WHO for determining treatment failure. In aim 1, we will develop a disposable microfluidic chip for streamlined and automated plasma separation and viral RNA extraction from whole blood. In aim 2, we will optimize the HIV-1 RT-LAMP assay and explore the minimum copy number sensitivity. In aim 3, we will integrate the quantitative USB analyzer hardware and develop software for easy and robust operation. In aim 4, we will validate the prototyped test in the BSL-2 lab using HIV-1 plasma samples spiked into whole blood. The R33 phase of the project will assess the test performance, usability and stakeholder needs within the HIV Comprehensive Care Program at Penn State Hershey Medical Center. In aim 5, the performance of the proposed test on HIV-infected patients will be benchmarked with standard laboratory methods. In aim 6, we will evaluate the user’s experience, attitude and perception of HIV VL self-testing. Through innovations in microfluidic chips and the USB analyzer, we anticipate the test would be able to quantify HIV-1 VL as low as 1000 copies/ml directly from 100 µl of finger prick blood. The potential impact of this project is very high. If this proof-of-concept project is successful, it has the potential to significantly enhance the treatment outcomes for individuals of HIV under therapy. The potential transformative capacity warrants the challenges associated with this project.


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: 2026 ( Subtotal = $0 )
2026	2024	THE PENNSYLVANIA STATE UNIVERSITY	201 OLD MAIN	UNIVERSITY PARK	PA	16802	CENTRE	USA	Allergy and Infectious Diseases Research	000	5	11/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THE PENNSYLVANIA STATE UNIVERSITY	201 OLD MAIN	UNIVERSITY PARK	PA	16802	CENTRE	USA	Allergy and Infectious Diseases Research	000	5	8/18/2025	NON-COMPETING CONTINUATION	-$554,633
2025	2024	TRUSTEES OF INDIANA UNIVERSITY	107 S INDIANA AVE	BLOOMINGTON	IN	47405	MONROE	USA	Allergy and Infectious Diseases Research	001	6	8/18/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$554,633
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $806,713 )
2024	2024	THE PENNSYLVANIA STATE UNIVERSITY	201 OLD MAIN	UNIVERSITY PARK	PA	16802	CENTRE	USA	Allergy and Infectious Diseases Research	001	5	8/8/2024	NON-COMPETING CONTINUATION	$623,139
2024	2023	THE PENNSYLVANIA STATE UNIVERSITY	201 OLD MAIN	UNIVERSITY PARK	PA	16802	CENTRE	USA	Allergy and Infectious Diseases Research	000	4	5/28/2024	EXTENSION WITH OR WITHOUT FUNDS	$183,574
														Subtotal = $806,713

Issue Date FY: 2023 ( Subtotal = $700,749 )
2023	2023	THE PENNSYLVANIA STATE UNIVERSITY	201 OLD MAIN	UNIVERSITY PARK	PA	16802	CENTRE	USA	Allergy and Infectious Diseases Research	001	4	9/1/2023	EXTENSION WITH OR WITHOUT FUNDS	$5,397
2023	2023	THE PENNSYLVANIA STATE UNIVERSITY	201 OLD MAIN	UNIVERSITY PARK	PA	16802	CENTRE	USA	Allergy and Infectious Diseases Research	000	4	8/21/2023	EXTENSION WITH OR WITHOUT FUNDS	$695,352
														Subtotal = $700,749

Grand Total All Awards = $1,507,462

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Home Fingerprick Blood-Based HIV Self-Test For Quantitative Monitoring Of Viral Rebound

Award Number: R33AI147419

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: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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