NIH – Emergency Award: RADx-UP Community-Engaged Research on Rapid SARS-CoV-2 Testing among Underserved and Vulnerable Populations (U01 Clinical Trial Optional)

February 25, 2022 by


The National Institutes of Health (NIH) is issuing this Funding Opportunity Announcement (FOA) in response to the declared public health emergency issued by the Secretary, HHS, for the Novel Coronavirus 2019 (COVID-19). This FOA provides an expedited funding mechanism to support Phase III of the Rapid Acceleration of Diagnostics – Underserved Populations (RADx®-UP) initiative. This FOA highlights the urgent need to leverage rapid SARS-CoV-2 testing, which is often self-administered or administered outside of healthcare settings, to understand and address COVID-19 morbidity and mortality disparities among underserved and vulnerable populations across the United States. These two-year, community-engaged Rapid Testing Research Projects will examine SARS-CoV-2 infection patterns and interventions to increase access to and uptake of diagnostic methods through the RADx®-UP initiative. Successful applications will pose novel and adaptable scientific questions given new variants and the availability of SARS-CoV-2 vaccines.


The overarching goal of the RADx®-UP initiative, as seen in the Phase I and II funded projects, is to understand and address COVID-19 morbidity and mortality disparities for those underserved and vulnerable populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from the COVID-19 pandemic. Implementing effective strategies for testing, contact tracing, surveillance, and mitigation requires individuals and communities to avail themselves of testing when offered, adhere to isolation and quarantine restrictions if they test positive, and not lessen their adherence to mitigation strategies if they test negative. Public health officials, policymakers and communicators are hampered by limited evidence on individual, community, and population-level interventions to optimize testing and mitigation adherence. This is also of concern among groups (including persons with mental illness, autism, developmental disabilities) who have not been consistently identified as vulnerable in the pandemic and/or may have considerable barriers to testing and mitigation adherence (e.g., unable to miss work to self-isolate after a positive test or exposure to an individual who has tested positive). In school and childcare settings, better understanding of effective new testing models such as “Test-to-Stay” (i.e., close contacts who continue to test negative remain in the classroom instead of quarantining at home) and other testing implementation strategies are important for keeping children, household members, and school staff safe during in-person instruction. Precisely quantifying and addressing the benefits, risks, and efficacy of testing and mitigation strategies at multiple levels and rapidly evaluating individual, community, and population level interventions (e.g., via pragmatic trials) to optimize testing, vaccination, and mitigation adherence is a crucial component of any successful national strategy for testing, contact tracing, vaccination, surveillance, and mitigation implementation.

To properly address, mitigate, and navigate the ongoing effects of COVID-19, innovative and flexible research plans, procedures, and protocols are needed to expand the reach, scope, and effectiveness of rapid diagnostic tests for communities that are experiencing COVID-19 health disparities. Successful projects will accomplish this by developing scientific questions and methods that are forward-thinking and can be adapted as the trajectories of COVID-19 cases, variants, hospitalizations, and mortality change over time.

Key Dates:

Open Date (Earliest Submission Date): April 04, 2022
Letter of Intent Due Date(s): Not applicable
Applications Due: May 02, 2022

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Filed Under: Funding Opportunities