June 12, 2020
NOT-OD-20-131 - Notice of Pre-Application Webinar for the RADx-UP Initiative
PA-20-135 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)
NOT-OD-20-121 - Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
NOT-OD-20-119 - Notice of Special Interest (NOSI): Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved and/or Vulnerable Populations
RFA-OD-20-013 - Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)
NOT-OD-20-141 - Notice of Correction to NOT-OD-20-120 Eligibility Section for Budget Request Information
NOT-OD-20-138 - Notice of Correction to NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section
Office of The Director, National Institutes of Health (OD)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute on Aging (NIA)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Sexual and Gender Minority Research Office (SGMRO)
Tribal Health Research Office (THRO)
Office of The Director, National Institutes of Health (OD)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
Environmental Influences on Child Health Outcomes (ECHO)
This Notice of Special Interest (NOSI) highlights the urgent need to understand and address COVID-19 morbidity and mortality disparities among underserved and vulnerable populations across the United States. These two-year community-engaged Testing Research Projects will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods through the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) initiative. The overarching goal is to understand factors that have led to disproportionate burden of the pandemic on these underserved populations so that interventions can be implemented to decrease these disparities. The funding for this supplement program is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.
The Office of the Director (OD) is therefore offering Emergency Competitive Revisions to active eligible grants and cooperative agreements addressing the objectives described below. This NOSI is one of four related RADx-UP funding opportunities. This Testing Research Projects NOSI will support supplements to individual NIH research awards that include community collaborations or partnerships to support COVID-19 testing (or have the capacity to ramp up quickly) to reach underserved and/or COVID-19 vulnerable populations.
The related program initiatives include:
NOT-OD-20-121 with a similar focus, but shifts the pool of eligible grants for supplementation to those that are part of large-scale networks, consortia, centers and other current programs that have adequate capacity, infrastructure, and established community-engaged relationships to support large-scale testing.
NOT-OD-20-119 which seeks research to understand the Social, Ethical and Behavioral Implications (SEBI) of COVID-19 testing in these populations.
RFA-OD-20-013 which is a U24 Coordination and Data Collection Center (CDCC) as a key component of the consortium.
Collectively, projects funded under these NOSIs will serve as one consortium of interlinked community-engaged research projects across the United States to understand COVID-19 health disparities, and to deploy implementation strategies to improve the reach, acceptance, uptake, and sustainability of COVID-19 testing.
NIH expects that all competitive revisions funded under this NOSI will actively coordinate, collaborate, and share data with other Testing Research Projects, the CDCC, and other research supported by the SEBI program, as allowed, and with considerations under tribal IRB processes. Researchers applying to this NOSI are strongly encouraged to read all four of these interrelated funding opportunities.
This NOSI is applicable to those populations that are underserved as well as populations that are COVID-19 vulnerable due to medical, geographic and social factors, as defined below (referred to as “underserved and/or vulnerable” elsewhere in this NOSI):
Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to accessing needed health care services or have inadequate health care coverage. A full description can be found at https://www.nimhd.nih.gov/about/overview/.
COVID-19 medically and/or socially vulnerable populations: 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 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.
Background and Goals
SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. United States Food and Drug Administration (FDA)-authorized/approved COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. NIH is committed to applying scientific methods to ensure that all populations have optimal access to and uptake of COVID-19 testing, and to build enhanced point-of-care infrastructures in advance of the impending influenza season, which requires swift action.
The overarching goal of the RADx-UP initiative is to understand the factors associated with COVID-19 morbidity and mortality disparities and to lay the foundation to reduce 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. This goal will be accomplished by strengthening the available data on disparities in infection rates and disease progression and outcomes and on differences in testing access and uptake patterns and identifying strategies to address disparities in COVID-19 diagnostics (and related repeat testing, contact tracing, and referrals). Testing Research Projects will both enable a targeted public health response to COVID-19 and build the evidence-base of approaches to identify and address disparities in COVID –19 diagnostic testing uptake and effectiveness in underserved and/or vulnerable populations. To maximize effectiveness, implementation approaches must include and leverage culturally appropriate community partnerships and strategies.
Approaches to increase COVID-19 testing may apply knowledge from effective interventions for increasing access and uptake of other viral diagnostic tests, vaccines, and therapeutics in underserved and vulnerable populations (e.g., human immunodeficiency virus [HIV], hepatitis B and C testing). Best practices from this work could be applicable for the ongoing COVID-19 public health efforts to reach and deliver evidence-based infection treatment and for future vaccination implementation efforts (particularly because testing strategies will be essential to accompany vaccine trials as they advance).
Applicants are urged to carefully consider the cultural, ethical, social, behavioral, historical, and economic implications associated with testing/diagnostic technologies and the collection, storage, and dissemination of health-related data for these underserved populations. Key issues to be considered and addressed include, but are not limited to: barriers to testing; returning of test results; understanding the implications of a negative or positive test result; stigma and financial burden associated with a positive test result and follow-up care; feasibility of effective self-isolation for positive results; referrals for contact tracing for under-resourced communities, patients and their families; and privacy, confidentiality and data sharing. Applicants should be aware of the possible discrimination faced by these populations when limited treatment resources are available. Specific coordination with federally funded services (e.g., Tribal facilities, Federally Qualified Health Centers, Rural Health Clinics, etc.), state and local health departments, or community-based organizations that can provide resources for follow-up care and public health mitigation, if there is a positive test, should be specified in the application.
RADx-UP implementation will occur in two-phases, and grants funded under this NOSI will collaborate as part of a Phase I consortium led by a CDCC (RFA-OD-20-013). The Phase I Testing Research Projects supported under this NOSI should work closely with communities to understand COVID-19 testing patterns, and implement strategies or interventions with the potential to rapidly (i.e., within six months of awards) increase reach, access, acceptance, uptake, and sustainment of FDA-authorized/approved diagnostics (especially viral tests) among populations and in geographic locations who are underserved and/or vulnerable, (See: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations and https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations, noting that the contents of these websites are updated regularly and applicants are expected to justify the testing they propose). Phase I Testing Research Projects must have established infrastructures and community partnerships to enable rapid and measurable impact in access and uptake of COVID-19 testing by underserved and/or vulnerable populations. They should also plan to collaborate with the RADx-UP Social, Ethical and Behavioral Implications (SEBI) program (NOT-OD-20-119), where possible, to support in depth examination of social, ethical and behavioral implications related to COVID-19 testing and vaccination research. With the significant investment in developing and validating new testing technologies (particularly the NIH-supported RADx initiatives), NIH anticipates significant changes in the landscape of testing and diagnostic approaches, as well as shifts in the pandemic itself over the next 3 to 6 months. Phase II of the RADx-UP initiative will be released at a later date and will address such developments for future community-engaged research.
RADx-UP Testing Research Projects will comprise community-engaged research studies (linked as a collaborative consortium) investigating a variety of COVID-19 diagnostic testing methods and approaches to improve understanding of COVID-19-related health disparities and enhance access and effectiveness of implementation in vulnerable and/or underserved populations. This consortium will serve as a resource for COVID-19 diagnostic testing and future public health pandemic outreach and mitigation activities, such as vaccine trials. The overarching goal of this program is to understand factors that have led to disproportionate burden of the pandemic on these underserved and vulnerable populations so that interventions can be implemented to decrease these disparities. Testing Research Projects will address key questions, including but not limited to:
This funding opportunity announcement encourages studies that move away from an exclusively "top-down" approach by emphasizing collaboration with community partners, leaders, and knowledge holders, leveraging community resources and local service delivery settings to address the needs of multiple stakeholders to enhance COVD-19 testing. Approaches such as team science, community engaged research, participatory action research, lay-person science, and related frameworks should be used to engage stakeholders and underserved and/or vulnerable populations throughout the research process.
RADx-UP testing intervention projects will use rapid scale-up of rigorous research strategies and integrate data collected across the sites to maximize improvements in public health control of the pandemic. To the extent possible, data acquisition, collection, and curation strategies should be coordinated with the CDCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing. Research designs may include randomized controlled trials (including group- or cluster-randomized), pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, and other dissemination and implementation science methods (including hybrid effectiveness/implementation designs). In many of these designs, special methods are required for analysis and sample size estimation to account for correlation of responses expected among responses from participants measured or treated in the same cluster. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
Applications should demonstrate a history of success in recruiting and retaining participants within the specified target populations and include sample size and power calculations to justify the anticipated reach. Given the RADx-UP goal of population-level impact, applications should also delineate outcomes and specify measures of COVID-19 diagnostic testing impact and other outcomes to inform future maintenance, sustainability and scale up.
RADx-UP projects are expected to demonstrate their ability to leverage existing partnerships (such as with Tribal governments and agencies, academic and community medical centers or health systems, safety-net health or social service systems, grassroots organizations, public health departments, community and faith-based organizations, and schools or child care settings) to complete the study aims. Projects are also expected to specify strategies to: a) address individual and structural social determinants of health (SDOH) that present barriers to participating in testing, follow-up, and retesting; b) create sustainable infrastructures that support rapid deployment of evidence-based approaches to testing, testing follow-up, and referral to treatment delivery or isolation systems; and c) conduct effective outreach, communication, and dissemination activities to inform communities about the project and its findings. Applicants are expected to provide evidence of partnerships with community organizations with whom they will work that include prior collaborations and must describe the roles of all partners. Study budgets should include funds for the community partners to be fully engaged and successfully participate in research design and implementation.
Testing capacity includes access to FDA-authorized/approved test kits and related supplies, as well as access to point-of-care testing (if and when FDA-authorized/approved) or certified laboratories (e.g., hospital, public health, or commercial) to administer the tests and return of test results as quickly as possible. Projects are encouraged to include active referral and contact tracing through partnerships (e.g., Tribal agencies and health departments) where this is possible. Repeat testing of symptomatic and asymptomatic persons, as well as individuals with previous positive COVID-19 tests, is encouraged to help understand the validity and reliability of tests in underserved and/or vulnerable populations and to help establish COVID-19 incidence rates in these populations. Strategies to maximize return of test results, plans for follow up, and familial and caregiver testing (when indicated) should consider literacy, health literacy, numeracy, cultural preferences, and language barriers.
To address expected impacts of COVID-19 on the scientific workforce, projects are also strongly encouraged to support early stage investigators, specifically targeting diversity in their research workforce.
Testing Research topics of interest include, but are not limited to, the following:
To maximize consortium research and rapidly implement approaches to address the COVID-19 pandemic, comparisons across datasets or studies and data integration are essential to collaboration. Projects funded through this NOSI are strongly encouraged to use the following resources:
Additionally, researchers with funding through this NOSI will be strongly encouragedto share their survey items to make them public for other researchers to consider by submitting their surveys to NIHCOVID19Measures@nih.gov.
The NIH also recognizes that other federal agencies who support research or demonstration projects may be strong collaborators for these types of research. NIH encourages collaboration with investigators funded by other agencies, as appropriate, including, but not limited to those funded by the Substance Abuse and Mental Health Services Administration, the Health Resources and Services Administration, the Administration for Children and Families, the Administration on Community Living and its divisions, the Centers for Disease Control and Prevention, the Indian Health Service, the Agency for Health Research and Quality, the Office on Minority Health, the Department of Defense, the Department of Agriculture, the Department of Education, the Department of Justice, the Department of Interior’s Bureau of Indian Affairs, and the Department of Veterans Affairs.
Applications nonresponsive to terms of this NOSI will not be considered. The following types of projects would generally not be appropriate and may be deemed non-responsive:
Applications will be evaluated for scientific and technical merit by an appropriate internal NIH staff review panel, in accordance with the review criteria specified in PA-20-135 as well as these additional review criteria:
Application and Submission Information
Applications in response to this NOSI must be submitted using the following targeted funding opportunity or its subsequent reissued equivalents:
Eligible existing grants that can be revised in response to this NOSI are limited to eligible non-fellowship active research and resource grants and cooperative agreements. Currently funded grantees may apply for work that is related to their funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in a no-cost extension are eligible to apply.
Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this NOSI well in advance of the applicationreceipt date to better determine appropriateness and interest of therelevant Institute. Applicants are also strongly encouraged to notify the Program staff listed on this NOSI that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.
Office of Behavioral and Social Science Research (OBSSR):
Scientific Program Contact: Dara Blachman-Denmer, PhD, 301-496-8522,firstname.lastname@example.org
The Office of Disease Prevention (ODP/DPCPSI/OD):
Scientific Program Contact:Jacqueline Lloyd, PhD, MSW; 301-827-5559, email@example.com
Office of Research on Women’s Health (ORWH):
Scientific Program Contact: Damiya S. Whitaker, Psy.D, M.A., 301-451-8206, firstname.lastname@example.org
Sexual and Gender Minority Research Office (SGMRO):
Scientific Program Contact:Christopher Barnhart, PhD., 301-594-8983, Christopher.email@example.com
Tribal Health Research Office (THRO):
Scientific Program Contact:Maria Jamela Revilleza, PhD, 301-451-0724, MariaJamela.Revilleza@nih.gov