RFA-OD-21-008-Full-Announcement-Text.pdf

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Attached to: Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (U01 Clinical Trial Optional)
Opportunity number: RFA-OD-21-008
Issued by: Department of Health and Human Services National Institutes of Health

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5/5/2021 RFA-OD-21-008: Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populati… https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-008.html 1/24

Department of Health and Human Services

Part 1. Overview Information Participating Organization(s) National Institutes of Health (NIH (http://www.nih.gov))

Components of Participating Organizations Office of The Director, National Institutes of Health (OD (https://www.nih.gov/institutes-nih/nih-office-director))

National Eye Institute (NEI (https://www.nei.nih.gov/))

National Heart, Lung, and Blood Institute (NHLBI (https://www.nhlbi.nih.gov/))

National Human Genome Research Institute (NHGRI (https://www.genome.gov/))

National Institute on Aging (NIA (https://www.nia.nih.gov/))

National Institute on Alcohol Abuse and Alcoholism (NIAAA (https://www.niaaa.nih.gov/))

National Institute of Allergy and Infectious Diseases (NIAID (https://www.niaid.nih.gov/))

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS (https://www.niams.nih.gov/))

National Institute of Biomedical Imaging and Bioengineering (NIBIB (https://www.nibib.nih.gov/))

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD (https://www.nichd.nih.gov/))

National Institute on Deafness and Other Communication Disorders (NIDCD (https://www.nidcd.nih.gov/))

National Institute of Dental and Craniofacial Research (NIDCR (https://www.nidcr.nih.gov/))

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK (https://www.niddk.nih.gov/))

National Institute on Drug Abuse (NIDA (https://www.drugabuse.gov/))

National Institute of Environmental Health Sciences (NIEHS (https://www.niehs.nih.gov/))

National Institute of General Medical Sciences (NIGMS (https://www.nigms.nih.gov/))

National Institute of Mental Health (NIMH (https://www.nimh.nih.gov/index.shtml))

National Institute of Neurological Disorders and Stroke (NINDS (https://www.ninds.nih.gov/))

National Institute of Nursing Research (NINR (https://www.ninr.nih.gov/))

National Institute on Minority Health and Health Disparities (NIMHD (https://www.nimhd.nih.gov/))

National Library of Medicine (NLM (https://www.nlm.nih.gov/))

National Center for Complementary and Integrative Health (NCCIH (https://nccih.nih.gov/))

National Center for Advancing Translational Sciences (NCATS (https://ncats.nih.gov/))

National Cancer Institute (NCI (https://www.cancer.gov/))

Tribal Health Research Office (THRO (https://dpcpsi.nih.gov/thro))

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.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP (https://prevention.nih.gov/))

Office of Behavioral and Social Sciences Research (OBSSR (https://obssr.od.nih.gov/))

Sexual and Gender Minority Research Office (SGMRO (https://dpcpsi.nih.gov/sgmro))

Office of Research on Women's Health (ORWH (https://orwh.od.nih.gov/))

Environmental Influences on Child Health Outcomes (ECHO (https://www.nih.gov/research-training/environmental-influences-child-health-outcomes-echo-program)) http://www.nih.gov/ https://www.nih.gov/institutes-nih/nih-office-director https://www.nei.nih.gov/ https://www.nhlbi.nih.gov/ https://www.genome.gov/ https://www.nia.nih.gov/ https://www.niaaa.nih.gov/ https://www.niaid.nih.gov/ https://www.niams.nih.gov/ https://www.nibib.nih.gov/ https://www.nichd.nih.gov/ https://www.nidcd.nih.gov/ https://www.nidcr.nih.gov/ https://www.niddk.nih.gov/ https://www.drugabuse.gov/ https://www.niehs.nih.gov/ https://www.nigms.nih.gov/ https://www.nimh.nih.gov/index.shtml https://www.ninds.nih.gov/ https://www.ninr.nih.gov/ https://www.nimhd.nih.gov/ https://www.nlm.nih.gov/ https://nccih.nih.gov/ https://ncats.nih.gov/ https://www.cancer.gov/ https://dpcpsi.nih.gov/thro https://prevention.nih.gov/ https://obssr.od.nih.gov/ https://dpcpsi.nih.gov/sgmro https://orwh.od.nih.gov/ https://www.nih.gov/research-training/environmental-influences-child-health-outcomes-echo-program

Key Dates

Funding Opportunity Title

Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations – RADx-UP Phase II (U01 Clinical Trial Optional)

Activity Code U01 (//grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity) Research Project – Cooperative Agreements

Announcement Type New

Related Notices See Notices of Special Interest (https://grants.nih.gov/grants/guide/NOSIs_targetingList.cfm?GuideDocID=35086) associated with this funding opportunity

April 22, 2021 - Notice of Pre-Application Webinar for Phase II of the RADxSM-UP Initiative. See Notice NOT-OD-21-115 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-115.html).

Funding Opportunity Announcement (FOA) Number

RFA-OD-21-008

Companion Funding Opportunity RFA-OD-21-009 (https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html) U01 (https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U01&&Search.x=0&&Search.y=0&&Search_Type=Activity) Research Project (Cooperative Agreements) NOT-OD-21-103 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html) NOT-OD-21-101 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html)

Number of Applications See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.310, 93.837, 93.839, 93.838, 93.840, 93.233, 93.121, 93.859, 93.313, 93.393, 93.865, 93.213, 93.394, 93.395, 93.396, 93.399, 93.350, 93.876, 93.172, 93.855, 93.846, 93.286, 93.847, 93.113, 93.143, 93.242, 93.853, 93.361, 93.866, 93.273, 93.173, 93.279, 93.307, 93.879

Funding Opportunity Purpose This funding opportunity announcement (FOA) uses an emergency U01 mechanism to support Phase II of the Rapid Acceleration of Diagnostics – Underserved Populations (RADx -UP) initiative. These two-year Testing Research Projects will (1) expand the scope and reach of RADx -UP testing interventions to reduce COVID-19 disparities among underserved and vulnerable populations and (2) address scientific questions on interventions to increase access and uptake of COVID-19 testing given the increasing availability of SARS-CoV-2 vaccines. The funding for this initiative is provided from the American Rescue Plan Act of 2021 .

Posted Date https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity https://grants.nih.gov/grants/guide/NOSIs_targetingList.cfm?GuideDocID=35086 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-115.html https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U01&&Search.x=0&&Search.y=0&&Search_Type=Activity https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html

Application Due Dates Review and Award Cycles

New

Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit

Review

Advisory Council Review

Earliest Start Date

July 07, 2021 Not Applicable Not Applicable July 2021 Not Applicable October 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Late applications will not be accepted for this Funding Opportunity Announcement.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide (//grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts (//grants.nih.gov/grants/guide/)).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST (https://public.era.nih.gov/assist) system to prepare, submit and track your application online.

Apply Online Using ASSIST

2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons (http://public.era.nih.gov/commons/) to track your application. Check with your institutional officials regarding availability.

3. Use Grants.gov (https://www.grants.gov/web/grants/applicants/download-application-package.html#search=true&oppNum=RFA-OD-21-008) Workspace to prepare and submit your application and eRA Commons (http://public.era.nih.gov/commons/) to track your application.

April 13, 2021

Open Date (Earliest Submission Date) June 07, 2021

Letter of Intent Due Date(s) Not Applicable

Expiration Date July 08, 2021

Due Dates for E.O. 12372 Not Applicable https://grants.nih.gov/grants/guide/url_redirect.htm?id=12000 https://grants.nih.gov/grants/guide/ http://public.era.nih.gov/commons/ https://www.grants.gov/web/grants/applicants/download-application-package.html#search=true&oppNum=RFA-OD-21-008 http://public.era.nih.gov/commons/ https://public.era.nih.gov/assist https://public.era.nih.gov/assist

Table of Contents Part 1. Overview Information

Key Dates Part 2. Full Text of Announcement

Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description The National Institutes of Health (NIH) are issuing this funding FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This FOA provides an expedited funding mechanism to support Phase II of the Rapid Acceleration of Diagnostics – Underserved Populations (RADx -UP) initiative. These two-year Testing Research Projects will

(1) expand the scope and reach of RADx -UP testing interventions to reduce COVID-19 disparities among underserved and vulnerable populations and (2) address scientific questions on interventions to increase access and uptake of COVID-19 testing given the increasing availability of SARS-CoV-2 vaccines. The funding for this program is provided from the American Rescue Plan Act of 2021.

The Office of the Director (OD) is issuing this FOA to address the objectives described below. This FOA is one of four related RADx - UP funding opportunities. This Testing Research Projects FOA will support research teams with established community-engaged partnerships to address the scientific objectives described herein.

The related program initiatives include:

NOT-OD-21-103 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html)– Notice of Special Interest (NOSI):

Emergency Competitive Revisions for Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations – RADx -UP Phase II (Emergency Supplement -Clinical Trial Optional) NOT-OD-21-101 (//grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html)- Notice of Special Interest (NOSI):

Administrative Supplements for Rapid Acceleration of Diagnostics-Underserved Populations (RADx -UP) Phase I Projects to Address Vaccine Hesitancy and Uptake RFA-OD-21-009 (https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html)- Emergency Award:RADx -UP -Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01, Clinical Trial Optional)

NOT-OD-21-097 (//grants.nih.gov/grants/guide/notice-files/NOT-OD-21-097.html)- Notice of Intent to Publish a Research Opportunity Announcement for RADx -UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

Collectively, projects supported under these funding opportunities will join the RADx -UP (https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up) consortium of community-engaged research projects across the United States to understand and mitigate COVID-19 health disparities, and to test interventions that improve the reach, uptake, and sustainability of COVID-19 testing in various settings.

NIH expects that all RADx -UP projects will actively coordinate, collaborate, and share data with other Testing Research Projects, the Coordination and Data Collection Center (https://radx-up.org/) (CDCC (https://radx-up.org/)), and research supported by the social, ethical, and behavioral implications (SEBI) program, as allowed, and with considerations under tribal Institutional Review Board (IRB) and data sovereignty processes. Researchers applying to this FOA are strongly encouraged to read all interrelated funding opportunities.

Key Definitions

This FOA is applicable to underserved and vulnerable populations that are COVID-19 vulnerable due to medical, geographic and social factors, as defined below (referred to as “underserved and vulnerable” elsewhere in this FOA):

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-103.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-101.html https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-21-009.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-097.html https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up https://radx-up.org/ https://radx-up.org/

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/ (https://www.nimhd.nih.gov/about/overview/).

COVID-19 medically and/or socially vulnerable populations: Homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); 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; communities with high levels of social vulnerability; 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; 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, dementia; and rural and remote communities.

Background

SARS-CoV-2 is the novel coronavirus and causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe complications and death. COVID-19 diagnostic testing with emergency use authorization (EUA) or (eventually) approval from the United States (U.S.) Food and Drug Administration (FDA) remains critical for tracking and 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—with the goal of reducing health disparities—and to building enhanced point-of-care infrastructures that can be sustained beyond the current pandemic.

Phase I of the RADx -UP initiative established a consortium of community-engaged research projects focused on increasing access to and uptake of COVID-19 testing as well as understanding the social, ethical, and behavioral implications of testing among U.S.

underserved and vulnerable populations. The overarching goal is to understand the factors that have led to the disproportionate burden of the pandemic on underserved populations and to implement interventions to decrease these disparities.

Phase II projects will apply scientific knowledge gained in 2020 and 2021 to develop and evaluate interventions with the goal of conducting testing to decrease disparities that contribute to the increased risk of COVID-19 infections, hospitalizations, and mortality.

Projects will help to understand and address disparities in testing and the effects of testing combined with other mitigation strategies (e.g., contact tracing, testing combined with behavioral mitigation strategies, education programs, self-isolation after exposure) on infection rates, transmission, and outcomes. Even with the availability of SARS-CoV-2 vaccines, testing will remain an important tool in controlling community spread. Phase II projects are required to include COVID-19 test completion as a primary outcome but should consider that COVID-19 testing interventions will occur in environments with increasing vaccine availability, distribution, and uptake.

Accordingly, funding opportunities may include scientific questions within the related topics of testing and vaccine uptake, focusing on interventions that have strong potential to reduce disparities in the real world. Successful Phase II awardees will propose innovative science to fill the gaps and address the new challenges that have arisen in the testing and virus mitigation landscape. Projects must have established research infrastructure and community-engaged partnerships to demonstrate measurable impact within 6 months post-award and across a two-year timeframe. Partnerships with locally relevant public health departments and health care organizations may also be desirable.

Applicants are encouraged to develop research or engagement partnerships with the Community Engagement Alliance (CEAL) Against COVID-19 (https://covid19community.nih.gov/)Disparities initiative, where geographically appropriate (i.e., CEAL study sites are geographically co-located or near the applicant’s proposed study site). Phase II projects can be expansions of Phase I projects or new projects.

Research Objectives

Specific research objectives of PhaseII studies will address key questions focused on underserved and vulnerable populations including, but not limited to:

What testing interventions can be implemented and evaluated rapidly to decrease COVID-19 disparities as COVID-19 vaccines become increasingly available? For example, for those who are unable or unwilling to be vaccinated, how can testing support their health and safety?

For those who are hesitant about getting vaccinated, would having testing available post-vaccination help reduce hesitancy and foster vaccine confidence?

What COVID-19 diagnostic options are most acceptable and in what setting?

What are the effective methods and interventions to incorporate testing and other strategies, such as genetic sequencing, to help identify and mitigate the transmission and population spread of existing or new variants of COVID-19?

How can research on the social determinants of health (SDOH) help identify, understand, and address testing and vaccine access and uptake in low-resourced geographic areas or communities with high levels of social vulnerability?

Does COVID-19 testing help address vaccine hesitancy and uptake, and if so, how?

https://www.nimhd.nih.gov/about/overview/ https://covid19community.nih.gov/

What community-driven interventions are effective to ameliorate stigma, bias, distrust, and fear regarding symptomatic and asymptomatic COVID-19 testing and vaccination?

How does COVID-19 vaccine availability affect attitudes, beliefs, and behaviors related to testing intentions in specific communities and how can this information be applied to improve testing uptake?

What is the role of frequent home testing with point-of-care methods in promotion of behavioral mitigation and vaccine uptake?

What consent approach, testing method, testing frequency, and contact tracing methodologies are most effective to identify COVID-19 and prevent transmission in school or childcare settings?

Are there existing prevention and health education programs in the school setting that can be adapted and scaled to promote COVID-19 safety measures, testing participation, testing literacy, and follow-up with health care providers at the child (across early childhood, elementary, middle and high school years), parent, and school staff levels? Could these programs be extended to address vaccine hesitancy and encourage vaccine uptake among adolescents?

Specific Areas of Research Interest

COVID-19 Testing Research Topics focused on underserved and vulnerable populations of interest include, but are not limited to, the following:

Studies using rapid cycle designs to examine evolving COVID-19 testing technologies to improve uptake of testing, vaccination, and repeat testing of communities and individuals across the lifespan due to changes in the nature of the virus (variant presentation, infection risk, transmission rates) Interventions to improve implementation and adherence to Centers for Disease Control and Prevention (CDC) behavioral mitigation (https://www.cdc.gov/coronavirus/2019-ncov/community/community-mitigation.html) guidance (https://www.cdc.gov/coronavirus/2019-ncov/community/community-mitigation.html) (e.g., masks, hand washing, physical distancing, and limited indoor gatherings) in settings that serve vulnerable communities or (non-healthcare) frontline workplaces in combination with frequent testing to identify COVID-19, prevent transmission, and promote vaccine uptake Development and testing of implementation strategies that increase the reach, access, uptake, and sustainability of COVID-19 testing in community-, workplace-, school-, or family-based settings (e.g., technology-based approaches, mobile health units) Pragmatic or theory driven behavioral intervention trials, including culturally adapted versions of evidence-based interventions, to increase motivation, and health literacy for testing and vaccination uptake in environments with known low testing and vaccination base rates Research to examine and address disparities in the availability, ease of use, and/or accessibility of at-home testing options, or other new FDA-authorized or approved point-of-care testing technologies Modeling and/or simulation studies using testing data, including that from RADx -UP Phase I, to understand drivers of COVID- 19 disparities; to predict the impact of testing and contact tracing strategies and development of interventions based on modeling and simulation findings to reduce COVID-19disparities Multilevel interventions that address barriers, knowledge and attitudes, and testing and vaccine uptake at individual, interpersonal/family, and/or community levels Role of test distribution on health disparities, including the examination of access to healthcare and specific diagnostics and systems-level barriers and facilitators for equitable uptake Research on which types of distribution channels (or combinations of distribution channels) and supports (e.g., financial, informational, or technology) are needed to acilitate access to and uptake ofCOVID-19 self-testing kits Post-vaccination testing studies to understand the effect of vaccination on healthcare utilization for chronic medical conditions, mental health care, and antibody production Post-vaccination testing studies to understand the effect of vaccination on behavior (e.g., mitigation strategies) and subsequent infection and testing among individuals with and without prior infection Effective testing strategies implementable across a range of school/childcare reopening policies and protocols to inform in-person return or maintenance of in-person return to school/childcare settings Testing, mitigation, and follow-up protocols for safe school reopening efforts (early childhood education through grade 12), including comprehensive vaccination education programs in school-based settings (including special education settings)

Design, Analysis, and Sample Size for Studies: RADx -UP Phase II projects must demonstrate relevance of the scientific questions to COVID-19 among underserved and vulnerable populations. Projects should utilize rigorous research designs (e.g., randomized controlled trials, stepped wedge designs, multiphase optimization strategy (MOST) designs, pragmatic clinical trials, interrupted time series, dynamic wait list design, hybrid effectiveness-implementation designs, sequential multiple assignment trial (SMART) designs, and adaptive designs). Group and individual randomization may not be feasible in nor acceptable to participants in some community-based interventions among populations who experience health disparities or express research distrust. Applicants should use methods that are appropriate given their plans for assignment of participants and delivery of interventions. Projects must describe research strategies that will reflect the evolving landscape and availability of COVID-19 vaccines. Projects must also demonstrate the ability to recruit and retain an adequate number of participants within the specified target populations and include sample size and power calculations. Given the RADx -UP goal of population-level impact, projects should also delineate testing as a primary outcome (e.g., COVID-19 test completion). Vaccination uptake and other psychosocial or behavioral variables would be acceptable as secondary outcomes. Additional information is available at https://researchmethodsresources.nih.gov/ (https://researchmethodsresources.nih.gov/).

https://www.cdc.gov/coronavirus/2019-ncov/community/community-mitigation.html https://www.cdc.gov/coronavirus/2019-ncov/community/community-mitigation.html https://researchmethodsresources.nih.gov/

All projects are expected to demonstrate their ability to leverage existing resources and expand community partnerships (e.g., Tribal governments and agencies, academic, private, safety-net health systems, grassroots organizations, public health departments, community and faith-based organizations, and schools or childcare settings) to complete the study aims, specify strategies or intervention components that address relevant social determinants of health that present barriers to test and vaccination completion and follow-up, and conduct evidence-based outreach and dissemination activities to inform communities about the project and its findings.

Approaches such as team science, community-engaged research, participatory action research, and related approaches should be used to engage stakeholders and underserved and/or vulnerable populations throughout the research process. Study budgets should include funds for the community partners to be fully engaged and successfully participate in research design and implementation.

Projects are also expected to specify how the proposed project will: a) address individual, interpersonal, community, psychosocial, and social determinants of health (SDOH) (see https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html (https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html) and https://www.phenxtoolkit.org/collections/view/6 (https://www.phenxtoolkit.org/collections/view/6)) 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.

Testing capacity includes access to FDA-authorized or approved test kits and related supplies (including point-of-care testing), and Clinical Laboratory Improvement Amendments (CLIA) certified laboratories (e.g., hospital, public health, or commercial) to administer the tests and return test results as quickly as possible. The proposed (and implemented) COVID-19 testing must be fully FDA EUA or approved. This includes sample collection, assays, and test performance. 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) in their research and practice workforce.

NIH is striving for consistency and high levels of rigor and reproducibility in all research, particularly in programs related to the COVID-19 pandemic. All researchers engaging human participants in their projects are required to use a set of Common Data Elements (CDEs) to standardize the collection of data and ensure that data can be aggregated and compared across study populations and research topics (where not otherwise prohibited such as by Tribal authority).This data standardization will permit evaluation of the overall RADx -UP consortium and impacts on COVID-19 disparities in specific populations, facilitate analysis of research questions and may inform policy at the local, community, and/or Tribal levels. Projects responding to this funding opportunity are required to collect the NIH RADx -UP Tier 1 Common Data Elements (https://radx-up.org/learning-resources/cdes/). Permission from participants to collect and share these CDEs will be given through specific language in the Informed Consent Form (ICF).

Recipients will work closely with the CDCC on data sharing activities as part of the RADx -UP consortium to advance the science of health disparities research in COVID-19 testing across the country. As an initiative that prioritizes community engagement, awardees will work with the CDCC to identify the scope of data sharing agreements that are acceptable to community partners, allow recruitment and retention of participants, and build trust, while contributing to consortium activities. The scope of data sharing may include the following:

1)depositing de-identified data in the CDCC and NIH RADx Data Hub, 2) sharing de-identified data with the CDCC and NIH for possible future scientific research, 3) sharing identifiable data to permit re-contact of participants for future follow-up and participation in future research; and/or 4) sharing identifiable data to perform linkages with external data sets, such as the Centers for Medicare & Medicaid Services (CMS), electronic health records (EHR), or other identifiable datasets, to understand health outcomes of the COVID-19 pandemic among underserved and vulnerable populations. Applicants are encouraged to discuss acceptability of one or more of these options for data sharing prior to application.

These data to be archived in the NIH RADx Data Hub will enable properly authorized community members, health researchers, and the Federal government to understand the impact of the COVID-19 pandemic on the well-being, risk, resilience and disparities in vulnerable communities across the United States and U.S. Territories. Funded projects will share study instruments and other research products with other RADx -UP funded projects through the CDCC.

Projects funded through this FOA are strongly encouraged to use the following resources for the assessment of other constructs:

Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (https://www.phenxtoolkit.org/collections/view/6 (https://www.phenxtoolkit.org/collections/view/6)).

Existing COVID-19 survey items and investigator contact information are publicly available through two NIH-supported platforms:

the NIH Public Health Emergency and Disaster Research Response (DR2) https://dr2.nlm.nih.gov/ (https://dr2.nlm.nih.gov/) and the PhenX Toolkit https://www.phenxtoolkit.org/index.php (https://www.phenxtoolkit.org/index.php). Researchers addressing

https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html https://www.phenxtoolkit.org/collections/view/6 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html https://radx-up.org/learning-resources/cdes/ https://www.phenxtoolkit.org/collections/view/6 https://dr2.nlm.nih.gov/ https://www.phenxtoolkit.org/index.php

COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

Additionally, researchers with funding through this FOA are strongly encouraged to share their survey items to make them public for other researchers to consider by submitting their surveys to NIHCOVID19Measures@nih.gov (mailto: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.

Additional Requirements

NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (i.e., Tribal data sovereignty). The NIH expects and supports the timely release and sharing of research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health https://grants.nih.gov/grants/policy/data_sharing/ (https://grants.nih.gov/grants/policy/data_sharing/).

Recipients are required to work with the RADx -UP Coordinating and Data Collection Center (CDCC) to submit CDEs on COVID-19 testing-related outcomes and implementation to the CDCC. Recipients should identify a dedicated unit responsible for these data reporting activities and at least one dedicated staff member for coordinating and data sharing activities.

Recipients are expected to obtain and retain personal identifiers on all research participants where it is not prohibited (e.g., Tribal data sovereignty) and where it is possible, for future longitudinal follow-up, to be leveraged for intervention research and for potential linkage to other sources of population health data. Data collected from this program will be protected by a Certificate of Confidentiality.

Recipients are expected to use guidance provided by the CDCC for data acquisition, collection and curation, including appropriate consent for data sharing and implementation of methods to enable data collected to be AI (artificial intelligence) ready.

Recipients are expected to work with the RADx -UP (https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up) consortium members, as appropriate.

Recipients must include measures and reporting of relevant testing implementation outcomes, to inform future community, local, state, and federal policies.

Projects must include a description of sustainability of their infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts.

Projects must include an evaluation plan demonstrating how the proposed COVID-19 diagnostic testing access and uptake strategies/activities will be assessed for effectiveness and impact.

Applications must include milestones towards progress and a timeline for completion. The timeline must include plans for regular reports of progress to be submitted to the CDCC and meetings with Community Advisory Boards. These reports will include both testing results and information regarding barriers and facilitators of COVID-19 testing, and vaccination where appropriate, and emerging challenges to implementation of the proposed research.

As with all NIH supported research, details regarding human subjects research are expected, including data safety and monitoring plans and, if needed, plans for a Data Safety and Monitoring Board (DSMB). Studies that have a DSMB are expected to coordinate with the CDCC (RFA-OD-20-013 (https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-20-013.html)) for DSMB activities.

Recipients are expected to disaggregate and analyze study results by sex/gender; race and ethnicity; age, a measure of socioeconomic status, birthplace, and other relevant demographic factors, and to consider intersectionality as appropriate.

Recipients are expected to participate in CDCC-organized activities, including monthly cross-site meetings, cross-site working groups, and dissemination activities (of effective implementation strategies, tools and measures, etc.).

Recipients are expected to demonstrate knowledge of and to comply with federal, state, local, and/or Tribal requirements on testing, reporting and surveillance policies in study protocols.

Recipients must provide letters of support from the community partners and should include community partners (where possible) as investigators. Budgets should reflect active participation by community partners to the extent possible. When required, Tribal resolutions should be included with the application if possible, but before funds are awarded in all cases. If school or childcare settings are incorporated, recipients must provide letters of support from the school setting, school district or state Department of Education as applicable.

Requests exceeding $750,000 for direct costs in any year

Applicants requesting greater than $750,000 in direct costs in any year (excluding consortium F&A) must submit a request to the NIH for prior approval. Such requests may be considered for approval if the following conditions are met:

mailto:NIHCOVID19Measures@nih.gov https://grants.nih.gov/grants/policy/data_sharing/ https://www.nih.gov/research-training/medical-research-initiatives/radx/radx-programs#radx-up https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-20-013.html

1. The applicant(s) will collaborate with one or more investigators from institutions that received no more than an average of $6 million NIH RPG funding (https://report.nih.gov/award/index.cfm) (Total Costs) per year over the fiscal years 2018 through 2020 who may serve as either multi-PI(s) or key collaborator(s) of the proposed study.

2. The applicant(s) agree that no less than 40% of the funds of the award will go to the collaborator institutions(s), that receive no more than $6 million NIH RPG funding.

Eligible applicants for requests exceeding $750,000 in direct costs in any year include the following, and must meet criterion 1 listed above:

Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Native American Tribal Organizations (other than Federally recognized tribal governments)

The request must be signed by the principal investigator(s), the partner(s), and the AORs of their home institutions and submitted to the scientific contact Lindsey Martin, Ph.D., lindsey.martin@nih.gov, 6 weeks prior to the application due date. After NIH’s review, the scientific contact will inform the principal investigator(s) and the AOR(s) of NIH’s decision no less than 4 weeks prior to the application due date.

Applications nonresponsive to the terms of this FOA will not be considered. The following types of projects would generally not be appropriate and may be deemed non-responsive:

Projects without a focus on one or more underserved and COVID-19 vulnerable populations Projects that have limited population reach (considering the size of the target populations and its COVID-19 epidemiologic profile) Projects that do not demonstrate a relationship with or engagement strategy with the populations of interest Projects that involve COVID-19 testing interventions outside of the United States Projects that are exclusively qualitative (though mixed quantitative and qualitative are acceptable) Projects that do not have an infrastructure to rapidly report study findings and impact to the CDCC Projects that have limited testing capacity, that do not include FDA-authorized or approved testing strategies or present a plan to incorporate approved testing strategies Project focusing exclusively on vaccination

[1] For the last Fiscal Year noted, research project grants are defined as projects with the following activity codes: DP1, DP2, DP3, DP4, DP5, P01, PN1, PM1, R00, R01, R03, R15, R21, R22, R23, R29, R33, R34, R35, R36, R37, R61, R50, R55, R56, RC1, RC2, RC3, RC4, RF1, RL1, RL2, RL9, RM1, UA5, UC1, UC2, UC3, UC4, UC7, UF1, UG3, UH2, UH3, UH5, UM1, UM2, U01, U19, and U34.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

[1]

Funding Instrument Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed New

New

The OER Glossary (//grants.nih.gov/grants/guide/url_redirect.htm?id=11116) and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

https://report.nih.gov/award/index.cfm https://grants.nih.gov/grants/guide/url_redirect.htm?id=11116

NIH grants policies as described in the NIH Grants Policy Statement (//grants.nih.gov/grants/guide/url_redirect.htm?id=11120) will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations Higher Education Institutions

Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses For-Profit Organizations (Other than Small Businesses)

Local Governments

Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized)

Other

Native American Tribal Organizations (other than Federally recognized tribal governments)

Foreign Institutions Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement (//grants.nih.gov/grants/guide/url_redirect.htm?id=11118), are not allowed.

Need help determining whether you are doing a clinical trial? (https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370)

Funds Available and Anticipated Number of Awards NIH OD intends to commit $100,000,000 in FY 2022 to fund 25-50 awards.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget Application budgets in general are limited to $750,000 per year in Direct Costs and need to reflect the actual needs of the proposed project. Application budget requests over $750,000 in Direct Costs for any year must meet the additional criteria described in Section 1.

Award Project Period The maximum period is 2 years.

https://grants.nih.gov/grants/guide/url_redirect.htm?id=11120 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11118 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82370

Required Registrations Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications (//grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html) states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) (http://fedgov.dnb.com/webform) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (https://www.sam.gov/portal/public/SAM/) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration.

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it. Updated May 6, 2021.