Project Summary/Abstract The University of North Carolina (UNC) Global HIV Clinical Trials Unit (CTU) has a well established track record of high-quality, innovative clinical research, strong scientific leadership (both in and outside the NIH HIV/AIDS Networks), and access to critically important infected and at-risk populations in the Southeastern US, Southeast Asia and in Southern Africa. Drawn from a diverse team of clinical innvestigators spanning two continents, our is led by experienced principal investigators (Joseph Eron MD and Mina Hosseinipour MD) and will support all 5 NIH HIV Clinical Trials Networks: Adult Therapeutic Strategies, Strategies to Address HIV and HIV- associated Infections in Pediatric and Maternal Populations, Integrated HIV Prevention Strategies, Microbicide Strategies, and Vaccine Strategies to Prevent HIV Infection. The Clinical Research Sites (CRS) include Chapel Hill CRS led by David Wohl MD (Adult Therapeutic Strategies, Integrated Prevention, Microbicide and Vaccine), Greensboro CRS led by Cornelius Van Dam MD PhD (Adult Therapeutic Strategy and Integrated Prevention), Malawi CRS led by Lameck Chinula MD (all 5 Networks) and Vietnam (protocol specific site) led by Vivian Go. Supporting this leadership is a well-organized research team, comprising global experts and site collaborators who will work to execute the network scientific agendas. The CTU has also assembled a diverse group of senior scientists and public health officials to serve on our Scientific and Strategic Advisory Group. The CTU administration incorporates a highly organized structure that will be responsive to our experienced research teams across the CRS and will provide ongoing evaluation to ensure optimal performance and efficiency. The CTU is supported by state-of-the-art communications and outstanding laboratory, pharmacy, quality assurance, data management and regulatory support. With its robust administrative framework, the UNC Global HIV CTU is optimally positioned to provide scientific leadership and clinical trials infrastructure to advance the field of agenda of the NIAID HIV networks and emerging infectious disease such as the SARS-CoV-2 pandemic.

NARRATIVE In response to the COVID-19 pandemic, we have developed a model of screening with high through-put (300-500 tests per day), strict adherence to infection control, and preservation of PPE. This model will be adapted to establish and augment testing and linkage to care in rural and urban areas where incidence is high and testing access is low.