NOT-OD-21-065 - Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

NOT-OD-21-097 - Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

Office of The Director, National Institutes of Health (OD)

National Institute of Mental Health (NIMH)

NIH Institutes and Centers likely to participate include some or all of the following:
Office of the Director (OD)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Cancer Institute (NCI)

National Center for Advancing Translational Sciences (NCATS)

National Center for Complementary and Integrative Health (NCCIH)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute on Drug Abuse (NIDA)

National Institute on Minority Health and Health Disparities (NIMHD)

National Human Genome Research Institute (NHGRI)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Library of Medicine (NLM)

The goal of RADx -UP is to reduce COVID-19 associated morbidity and mortality disparities for those vulnerable and underserved populations who are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from contracting the virus. The first two phases of RADx-UP established?and expanded a consortium of community-engaged research projects focused primarily on increasing access to and uptake of COVID-19 diagnostic testing among underserved and vulnerable populations across the U.S., with one facet of RADx-UP, the Return to School Diagnostic Testing Initiative, focusing specifically on school settings. Additional projects funded in the first two phases sought to understand the social, ethical, and behavioral implications (SEBI) of testing. To date, RADx-UP has funded over 100 projects and a Coordination and Data Collection Center (CDCC).

Phase III of RADx-UP will encourage novel ideas that have not been examined adequately in the first two phases and are responsive to the dynamics of the pandemic. Specifically, applicants will be encouraged to explore novel interventions to increase access to and uptake of rapid SARS-CoV-2 testing (e.g., rapid antigen testing) in an environment of widespread vaccine availability; the social, ethical, and behavioral implications associated with testing; and specific strategies for scalable and sustainable testing programs to enable safe in-person school instruction. This Notice encourages researchers to leverage partnerships with key stakeholders to conduct community-engaged research to understand COVID-19 disparities and implement testing interventions to reduce differences in the context of testing among underserved and vulnerable populations. Applicants will be encouraged to develop partnerships with the Community Engagement Alliance (CEAL) Against COVID-19 Disparities awardees within the same geographical region, where appropriate.

NIH plans to publish two RFAs and one ROA:

1. To seek community-engaged and partnership-driven research to implement and evaluate SARS-CoV-2 rapid testing (e.g., antigen testing) among underserved and vulnerable populations (RFA)
2. To seek research to understand the social, ethical, and behavioral implications (SEBI) of COVID-19 testing in these populations. (RFA)
3. For administrative supplements to expand the RADx-UP Return to School testing projects to generate evidence for scalable and sustainable approaches to safely maintain students in schools serving underserved and vulnerable populations. (ROA)

The NIH intends for the awardees of the two FOAs and one ROA to participate in RADx-UP as part of the consortium of interlinked, community-engaged, intervention projects across the United States to improve the reach, acceptance, uptake, and sustainability of testing and ultimately mitigate COVID-19 health disparities. Awardees will be expected to partner and align with the RADx-UP Coordination and Data Collection Center (CDCC) at Duke University/University of North Carolina, conforming to CDCC guidance and requirements from NIH on data collection and common data elements (https://dr2.nlm.nih.gov/radx-up), benchmarking, and data harmonization and sharing.

NIH requires that FDA-cleared or FDA emergency use authorized (EUA) tests and supplies be used on-label (in the way authorized by FDA) for all testing. Laboratory Developed Tests (LDT) that have not received FDA clearance or EUA are not allowed for RADx-UP projects. All parts of testing, collection, and processing, including any requirements on CLIA certification, must be covered by FDA authorization on label.

NIH has developed the NIH RADx-UP Common Data Elements, which are standardized for multiple data sets across different studies.? All RADx-UP projects are required to collect the NIH RADx-UP Tier 1 Common Data Elements, including person-focused and COVID-19-focused variables, and share them with the RADx-UP Coordination and Data Collection Center (CDCC) at the cadence defined by the CDCC and NIH. Common Data Elements must be collected as specified in the NIH RADx-UP CDE code book and conformant with the code book specification to facilitate harmonization across COVID-19 projects. The RADx-UP Tier 1 Common Data Elements and code book are available in English and Spanish at https://radx-up.org/learning-resources/cdes/.

TBD