# A mobile health diagnostic device for HIV self-testing

> **NIH NIH R61** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $537,000

## Abstract

PROJECT SUMMARY
Despite successful advancements in antiretroviral therapy (ART), a significant proportion of individuals
worldwide are unaware of their HIV-infection. Detecting persons with acute HIV infection is crucial since viral
replication and shedding occur in this stage before detectable HIV antibodies appear. Persons with acute HIV
infection can contribute substantially to HIV transmission. Viral rebound in individuals on ART can occur due to
drug resistance and ART non-adherence. Early detection of viral rebound can significantly affect the disease
management by allowing treatment intervention and preventing clinical progression. Furthermore, treatment
interruption has become a vital tool in the assessment of new therapies for achieving ART-free HIV remission.
However, these trials entail risks to the participants, which could be mitigated with more frequent self-directed
viral load monitoring. Despite the sensitivity and specificity, nucleic acid testing (NAT) cannot be implemented
at the point-of-care (POC) due to prohibitive cost and demand for skilled operators. Current antibody-based
POC technologies, such as dipsticks and enzyme-linked immunoassays (ELISA), are not effective to detect
either ART failure or acute HIV. It has been shown that p24 antigen results for a given viral RNA load may vary,
which makes p24 assays less trustworthy. In addition, p24 assays may provide false-negative results due to
the presence of p24-specific antibodies in serum. Thus, there is an immediate need for an easy-to-use,
portable, and inexpensive diagnostic tool for detecting acute HIV during the first two weeks after infection and
viral rebound in individuals on ART after treatment discontinuation or drug resistance. Viral load testing is the
most accurate and preferred approach for ART monitoring and acute HIV detection, and is highly
recommended by WHO guidelines as an important tool for HIV management and treatment monitoring. To
address this significant clinical barrier, we propose to develop a low-cost, rapid, and sensitive optical system
for rapid (<30 min) detection of acute HIV (first two weeks after infection) and viral rebound (after terminating
ART or due to drug resistance) using fingerprick volume (<100 µL) of whole blood placed on an inexpensive,
disposable, and mass-producible microfluidic device. The advances in microtechnologies and the surge in
consumer electronics have paved a solid foundation for developing mobile health (mhealth) technologies with
the potential to transform the current paradigm in global health. Smartphones can be seamlessly integrated
with hardware, software, and microfluidics to develop a true POC diagnostic device to address clinical gaps in
HIV management.

## Key facts

- **NIH application ID:** 10200655
- **Project number:** 5R61AI140489-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Hadi Shafiee
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $537,000
- **Award type:** 5
- **Project period:** 2019-08-09 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200655

## Citation

> US National Institutes of Health, RePORTER application 10200655, A mobile health diagnostic device for HIV self-testing (5R61AI140489-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10200655. Licensed CC0.

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