“The Point-of-Care Technologies for HIV Viral Load Program” (POC-HVL) is an administrative supplement to the Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN) Cooperative Agreement (U54 EB027049). POC-HVL will expand its current development pipeline of products for HIV/AIDS and its many morbidities and will develop a pipeline of needs-based, point-of-care technologies critical for improving the management of persons living with HIV/AIDS by specifically focusing on technologies that can measure plasma HIV RNA (viral load) at point-of-care. POC-HVL will harness the C- THAN expertise, research experience and clinical networks in the United States and Africa. The United Nations Program on HIV and AIDS (UNAIDS) has set the ambitious 95-95-95 goal to achieve detection of 95% of HIV cases, treatment for 95% of those cases, and viral suppression for 95% of those treated by 2025 and ending the HIV/AIDS pandemic by 2030. Significant progress has been made in controlling the HIV epidemic in the past 20 years, however, success in many areas has lagged and many countries have not reached the UNAIDS targets. In 2019, approximately 1.7 million people worldwide became infected with HIV, and 690,000 died from HIV-related illnesses. There has been substantial improvement in diagnosing infected patients and a significant improvement in overall generic drug pricing. The estimate cost of a one year course of TDF/3TC/DTG combination therapy is now $59. The total cost for that medical therapy in all 164 countries with treatment programs would be $2 billion annually; while global expenditure on HIV pharmaceuticals is $28 billion, this is now a feasible prospect. Lacking however, are broadly available tests that can measure treatment efficacy. The current standard is molecular-based, mostly performed in central labs, and relatively expensive. There is a need for accurate, rapid, and less expensive viral load testing at the point-of-care. Until this gap is filled, UNAIDS targets are unlikely to be achieved. C-THAN will serve as a platform for the support of products to develop POC technologies that address this unmet need to effectively monitor and document success of the current HIV treatment programs. Such a product can also serve as an effective diagnostic tool capable of diagnosing very early infection and infection in children <18 months of age. The C-THAN structure will incorporate clinical and user needs in project development while providing expertise and resources to address early barriers to commercialization and implementation. Its Core components will operate in an integrated manner to deliver a scope of work, entailing: 1) collaboration with relevant scientists, physicians, researchers, and engineers; 2) development of essential technical, clinical, industrial, and regulatory partnerships, and 3) testing of prototype POC devices in the field. The POC-HVL program will have a major impact on the management of...