TRI-care: triplex cellphone assay for rapid evaluation of HIV, HBV and HCV viral load

The National Institutes of Health Fogarty International Center awarded Case Western Reserve University $440,709 on August 15, 2026, under the International Research and Research Training program (CFDA 93.989) to develop TRI-CARE, a mobile health platform for rapid viral load testing of HIV-1, hepatitis B virus, and hepatitis C virus.

TRI-CARE integrates cellphone-based, AI-powered diagnostics with a microfluidic cartridge system to enable decentralized, real-time viral load monitoring in settings with limited healthcare infrastructure. The R21 phase focuses on optimizing the microfluidic platform and functionalizing color-encoded beads with target-specific antibodies for direct capture and detection of HIV-1 RNA from blood samples, coupled with cellphone-based optical detection. The planned R33 phase will conduct clinical validation using 100–200 patient samples, including specimens from Nigeria, to assess sensitivity, specificity, accuracy, and usability against gold-standard qPCR-based testing. Nigerian samples provide validation across high HIV-1 and viral hepatitis burden contexts and real-world collection and handling variability.

Work is performed in Cleveland, Ohio, at Case Western Reserve University's Office of Research Administration, operating in affiliation with University Hospitals of Cleveland. The project period runs through June 30, 2028.

Abstract

Timely and accessible viral load (VL) monitoring is essential for early detection, optimizing treatment decisions, and preventing new infections; however, significant gaps in diagnostic access remain in the U.S., particularly in decentralized care settings, contributing to delayed treatment adjustments and ongoing transmission. These challenges are further amplified in settings where limited healthcare infrastructure constrains access to routine VL testing, providing a critical context for evaluating scalable diagnostic solutions. To address these barriers, our project aims to develop TRI-care, a mobile health (MHEALTH) platform for rapid HIV-1 VL testing, with the future goal of expanding the platform to include hepatitis B virus (HBV) and hepatitis C virus (HCV) testing. TRI-care leverages cellphone-based, AI-powered diagnostics integrated with an innovative microfluidic cartridge system to enable decentralized, real-time VL monitoring. The development of TRI-care follows a phased approach. In the R21 phase, we will optimize the camochip microfluidic platform and functionalize color-encoded beads with target-specific antibodies to enable direct capture and detection of HIV-1 RNA from blood samples, coupled with a cellphone-based optical detection system. In the R33 phase, we will conduct clinical validation using 100-200 patient samples, including specimens from nigeria, assessing sensitivity, specificity, accuracy, and usability relative to gold-standard qpcr-based testing. Samples from nigeria provide a uniquely valuable validation set due to the high burden of HIV-1 and viral hepatitis and the variability inherent in real-world collection and handling conditions-factors that are not readily captured in U.S.-based sample sets. This rigorous evaluation supports assessment of robustness and usability across viral variants and sample conditions, with relevance to decentralized care settings in the U.S. The proposed work has direct relevance to american health by advancing a portable, rapid, and low-cost viral load testing platform that can expand access to timely diagnostic monitoring in U.S. Settings with limited laboratory infrastructure, including rural communities, mobile and point-of-care environments, correctional facilities, and safety-net clinics. These settings often face delays due to centralized laboratory dependence, transportation barriers, and limited testing frequency. By enabling decentralized, real-time VL monitoring, TRI-care has the potential to improve treatment management, reduce transmission, and enhance continuity of care. In addition, validation across genetically diverse viral populations strengthens the generalizability of the platform to the heterogeneous U.S. Patient population. The development of a scalable, field-deployable diagnostic platform also supports U.S. Public health preparedness by enabling rapid and flexible responses to infectious disease outbreaks. TRI-care represents a transformative approach to viral load monitoring, offering a portable, affordable, and power-independent solution. Successful implementation will establish a scalable platform for multiplexed detection of HIV-1, HBV, and HCV, with broad applicability across both international and U.S. Healthcare settings.