Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)

Program Description

NIMHD supports research to strengthen the healthcare response to Coronavirus Disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This announcement seeks to provide expedited funds in order to establish a single Coordination and Data Collection Center (CDCC) as an integral part of the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) consortium. The CDCC will facilitate RADx-UP collaborative research by providing organizational and analytical infrastructure and expertise, supporting data integration and analysis, and coordinating across RADx-UP projects and the NIH-supported RADx initiatives that are developing and validating new COVID-19 testing technologies.

The overarching goal of the RADx-UP initiative is to reduce disparities in COVID-19 associated morbidity and mortality and to lay the foundation to reduce disparities for those underserved and vulnerable populations* that are disproportionately affected by the COVID-19 pandemic. COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Given this, there is an urgent public health need to ensure that all populations have access to and uptake of COVID-19 testing and to build effective point-of-care infrastructures.

This four-year cooperative agreement will fund a single CDCC to support research activities of the RADx-UP initiatives and is released in parallel with three companion emergency Notices of Special Interest (NOSIs) soliciting competitive revisions of existing funded grants.

• NOT-OD-20-121 encourages community-engaged Testing Research Projects to supplement large scale networks, consortia, or centers, and will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods.
• NOT-OD-20-120 encourages community-engaged Testing Research Projects for supplementation of individual research awards that include community collaboration or partnership, generally targeting specific populations.
• NOT-OD-20-119 seeks research to understand the Social, Ethical and Behavioral Implications (SEBI) of COVID-19 testing in these populations. Researchers applying to this FOA are strongly encouraged to read all four of these interrelated funding announcements.

Collectively, projects funded under these FOAs will serve as one consortium of interlinked community-engaged research projects across the United States to understand COVID-19 health disparities, and to deploy strategies to improve the reach, acceptance, uptake, and sustainability of COVID-19 testing. The CDCC is the coordination “hub” in a hub-and spoke organizational framework and the spokes will include the Testing Research and SEBI Projects. These projects will both enable a targeted public health response to COVID-19 and build evidence-based approaches to identify and address disparities in COVID-19 diagnostic testing uptake and effectiveness in underserved and vulnerable populations.

The CDCC will provide support and guidance in the following four domains:

1. Administration and coordination
2. COVID-19 testing technology
3. Community and health system engagement
4. Data collection, integration and sharing

CDCC research objectives and responsibilities include, but are not limited to:

• Providing management, direction, and overall coordination of the RADx-UP consortium.
• Serving as a spoke in larger NIH initiatives by providing deidentified individual data to the NIH-based data hub.
• Developing and revising the procedures for standardized collection of individual sociodemographic, psychosocial, and clinical data (i.e., common data elements) to maximize comparability across the consortium for longitudinal research and evaluation of program impact.
• Assisting research projects with linking these and other data to publicly available sources (e.g., Census data, Area Deprivation Index, etc.), electronic health records (EHR), administrative data, and others as needed.
• Facilitating cross-site pooling of data, creating a database across assessment modalities, and harmonizing with existing large-scale COVID-19 research efforts.
• Collaborating with trans-NIH efforts to support scientific collaboration and data-sharing.
• Enabling cross-consortium collaboration and evaluation of progress towards sustainable infrastructure and rapid dissemination of findings.

*NIH-designated U.S. populations experiencing health disparities include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

For the purpose of this FOA, medically and/or socially vulnerable populationsalsoinclude people who are: residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded or public housing; individuals with substance use disorders or serious mental illness; migrant and immigrant populations; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.

NIH Guide No.: RFA-OD-20-013

See current NIMHD-funding grants for this FOA on NIH RePORTER.

Page updated Jan. 12, 2024