RADx-UP CDCC

Abstract: There is an urgent need to reduce disparities in COVID-19 associated morbidity and mortality outcomes in historically marginalized and vulnerable populations disproportionately affected by the COVID-19 pandemic. To address this need the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) program willsupport Community-Engaged Testing Research Projects and Social, Ethical and Behavioral Implications (SEBI) Research Projects to understand SARS-CoV-2 infection patterns and increase access and effectiveness of diagnostic methods in underserved and/or vulnerable populations. The Duke Clinical ResearchInstitute (DCRI), the UNC Center for Health Equity Research (CHER), and Community-Campus Partnershipsfor Health (CCPH) propose to serve as the Coordination and Data Collection Center (CDCC) to provide management, direction, and overall coordination of the RADx-UP consortium. Together, our multidisciplinary experience in project coordination; COVID-19 thought leadership; regulatory science; community engagement;health equity research; social justice; adult and child research; statistics; data science; and clinical researchinformatics will advance the objectives of the projects in the RADx-UP Program. Our overarching goal is to implement a community-centered approach and establish an effective, flexible, participatory, and sustainable CDCC that will serve as the infrastructure to maximize the community impact of projects in the RADx-UPProgram. To achieve this vision, we will establish a program framework comprised of four cores. Our Administration and Coordination Core, in collaboration with NIH scientific staff, will facilitate the work of theRADx-UP Program in overarching administrative management. The COVID-19 Testing Core will advise andguide COVID-19 testing protocols; curate emergent testing data; and administer the Rapid Pilot StudiesProgram. The Community and Health System Engagement Core will support a community of practice across the RADx-UP Program; provide support in exchanging best practices across communities on recruitment,engagement, and retention of study participants; and coordinate the dissemination of study findings from RADx-UP projects. The Data Science and Biostatistics Core will manage data collection, integration, andsharing for the RADx-UP Program including merging and harmonization of multiple and diverse data sourcesand provide data standards, data collection design, and biostatistics consulting services. The RADx-UP CDCCgoals will be met using established infrastructure and subject matter experts and will be customized to meetthe variable needs of the RADx-UP community. Using the highest research standards, our team will accomplish the goals set out by the NIH in managing this critically important collaborative effort.