Document text
Principal Investigator: Michael Cohen-Wolkowiez
Organization: DUKE UNIVERSITY
Fiscal Year: 2023
Award: $32,364,105
Funding agency: National Institute on Minority Health and Health Disparities
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 will
support 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 Research
Institute (DCRI), the UNC Center for Health Equity Research (CHER), and Community-Campus Partnerships
for 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 research
informatics 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-UP
Program. 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 the
RADx-UP Program in overarching administrative management. The COVID-19 Testing Core will advise and
guide COVID-19 testing protocols; curate emergent testing data; and administer the Rapid Pilot Studies
Program. 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, and
sharing for the RADx-UP Program including merging and harmonization of multiple and diverse data sources
and provide data standards, data collection design, and biostatistics consulting services. The RADx-UP CDCC
goals will be met using established infrastructure and subject matter experts and will be customized to meet
the 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.
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2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome related corona virus 2><Sight><Social Justice><Testing><Underserved Population><United States National Institutes of Health><Universities><Virus><Vision><Vulnerable Populations><Work><Wuhan coronavirus><adulthood><community center><community engaged research><community engagement><community involvement><corona virus disease 2019><corona virus disease 2019 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