EXPIRED
April 13, 2021
RFA-OD-22-011 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed).
NOT-OD-21-125 Notice of Correction to NOT-OD-21-103
NOT-OD-21-103 Notice of Special Interest (NOSI): Emergency Competitive Revisions for NIH Grants to Add or Expand Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADxSM-UP Phase II (Emergency Supplement - Clinical Trial Optional)
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
RFA-OD-21-008 - Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (U01 Clinical Trial Optional)
RFA-OD-21-009 Emergency Award: RADxSM-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- Notice of Intent to Publish a Research Opportunity Announcement for RADxSM-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)
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-21-072- Notice of Correction to 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 Required)" for Clinical Trial Requirements
NOT-HL-20-806- NHLBI confirms participation in NOT-OD-20-119, NOT-OD-20-120, and NOT-OD-20-121 (Research on COVID-19 Testing among Underserved and/or Vulnerable Populations)
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-20-120- Notice of Special Interest (NOSI): 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-20-138- Notice of Correction to NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section
NOT-HL-20-803- Notice of NHLBI Participation in NOT-OD-20-119
NOT-HL-20-804-Notice of NHLBI Participation in NOT-OD-20-120
NOT-HL-20-805- Notice of NHLBI Participation in NOT-OD-20-121
NOT-OD-20-157- Notice to Clarify and Correct Eligibility in Notices of Special Interest under the Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) Program
NOT-OD-21-038- Updated Instructions on Interim Reporting and Carryover for RADx-UP Recipients
Office of The Director, National Institutes of Health (OD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
Office of The Director, National Institutes of Health (OD)
This Notice of Special Interest (NOSI) seeks to support administrative supplements to Rapid Acceleration of Diagnostics-Underserved Populations (RADxSM-UP) recipients to address the urgent need to expand outreach and education efforts to promote testing and foster vaccine confidence, acceptance, and uptake in underserved and vulnerable communities. These 1-year projects will develop, implement, and evaluate brief interventions at RADxSM-UP testing sites to maximize effective outreach, education, communication, and facilitate the dissemination and uptake of testing and vaccines in underserved and vulnerable communities. The funding for this supplement program is provided from the American Rescue Plan Act of 2021.
Applications are being requested from current RADx-UP recipients from the following Funding Opportunity Announcements and Notices of Special Interest:
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-20-120- Notice of Special Interest (NOSI): 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
Key Definitions
This NOSI 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 NOSI):
Underserved: NIH-designated health disparity populations and 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: 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; and rural and remote communities.
Background and Goals
SARS-CoV-2 is the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe complications. United States Food and Drug Administration (FDA)-authorized/approved COVID-19 diagnostic testing and vaccine uptake are two essential tools 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 public health prevention and mitigation interventions, including SARS-CoV-2 testing and vaccines, as well as behavioral strategies (e.g., handwashing and sanitizing, wearing well-fit masks, avoiding indoor gatherings and physical distancing). NIH also seeks to combat widespread misinformation about COVID-19 through bidirectional and community responsive engagement, communication, and the dissemination of educational and other resources among underserved and vulnerable communities.
The overarching goal of the RADxSM-UP initiative is to understand and address factors associated with COVID-19 morbidity and mortality disparities among underserved and vulnerable populations. The RADxSM-UP consortium consists of 53 community-engaged research projects focused on building the evidence base of approaches to increase access to and uptake of COVID-19 diagnostics, and 16 projects are seeking tounderstand the social, ethical, and behavioral implications (SEBI) of testing. Collectively, RADxSM-UP projects aim to strengthen the available data on disparities in infection rates, 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).
Even with the availability of SARS-CoV-2 vaccines, testing will remain an important component of the public health response to the COVID-19 pandemic. Testing will also remain vital for individuals who will not accept vaccination due to concerns about safety, vaccine hesitancy, or other uncertainties. With the potential for SARS-CoV-2 reinfection, new viral variants arising that may be resistant to current vaccines, and possible transmission of SARS-CoV-2 from vaccinated to unvaccinated people, testing will remain a major component of the long-term strategy to control the spread of the virus.
To facilitate uptake of vaccines and testing, a number of current challenges require continued attention. Distrust of government-supported science and the health care system, vaccine hesitancy, and health misinformation have hampered the U.S. public health system’s response to the pandemic. To support a coordinated national strategy for implementing vaccinations and testing, we must apply evidence-informed outreach and communication strategies to foster trust, develop tailored and targeted communication efforts, address misinformation about vaccines and testing, and increase efforts to foster vaccine and testing confidence and uptake necessary to protect all Americans. Current national surveys point to lower willingness to accept a vaccine in some populations; more detailed and disaggregated data are needed to understand how to foster vaccine confidence to increase access to vaccines and testing across all underserved and vulnerable populations that are the foci of RADxSM-UP.
Understanding and addressing vaccine hesitancy and uptake is among the goals of a related NIH-wide initiative, the Community Engagement Research Alliance (CEAL) Against COVID-19 Disparities. The mission of CEAL is to provide trustworthy information through active community engagement and outreach to the people hardest-hit by the COVID-19 pandemic, including African Americans, Hispanics/Latinos, and American Indians/Alaska Natives, with the goal of building long-lasting partnerships as well as improving diversity and inclusion in our research response to the COVID-19 pandemic. CEAL has been developing evidence-informed communication resources to address COVID-19 misinformation, engage trusted partners and messengers in delivering accurate information, and to facilitate inclusion of racial/ethnic populations in COVID-19 clinical trials.
This NOSI will provide an opportunity for RADxSM-UP Phase I investigators to integrate vaccine hesitancy and uptake into their funded projects, which are designed to answer COVID-19 testing-related questions. The 1-year projects in response to this supplemental NOSI may develop, test, and evaluate brief interventions at RADxSM-UP testing sites with the goals of maximizing effective outreach and education, and facilitating the dissemination and uptake of testing and vaccines in underserved and vulnerable communities. RADxSM-UP Phase I projects will apply the program’s experience in community-engaged research, communication and behavioral science expertise, existing infrastructures, and extant findings from testing studies to address emerging testing and vaccination-related challenges. Applicants are strongly encouraged to form strategic collaborations with CEAL research teams working in the same geographic areas and/or with the same populations, leveraging the other’s existing resources to build a robust network aimed at increasing engagement with underserved communities to promote public health measures, clinical trial enrollment, testing for SARS-CoV-2, vaccination, and other mitigation measures, as well as to better understand the factors that prevent access and adoption of such actions. Proposals may also apply intersectional approaches to this work (e.g., underserved healthcare workers exhibiting significant vaccine hesitancy).
Projects will integrate targeted and tailored communication and educational interventions developed by CEAL, or other credible information sources (e.g., Centers for Disease Control and Prevention), to address vaccine hesitancy, distrust, and acceptance into RADxSM-UP diagnostic testing project sites. These collaborative projects will be part of the RADxSM-UP consortium and serve as a resource for COVID-19 diagnostic testing and expand the reach of CEAL’s communication and outreach campaigns.
Projects will address key questions, including but not limited to:
Research Topics
Scientific areas of interest for research supported by this NOSI among underserved and vulnerable populations include, but are not limited to:
The proposed RADxSM-UP and CEAL projects must demonstrate relevance of the scientific questions to COVID-19 among underserved and vulnerable populations. Projects should focus on developing and disseminating outreach, communication, and education programs based on available guidance (e.g., from CEAL https://covid19community.nih.gov/ and The COVID-19 Vaccination Communication https://obssr.od.nih.gov/wp-content/uploads/2020/12/COVIDReport_Final.pdf) through 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 designs, sequential multiple assignment trial (SMART) designs, and adaptive designs). Quasi-experimental designs and mixed methods studies are also acceptable, particularly for some vulnerable populations where randomization may not be possible due to small population sizes or other factors. Projects must describe research strategies that will reflect the evolving landscape and increased availability of COVID-19 testing and 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. Additional information is available at https://researchmethodsresources.nih.gov/.
Where possible, applications should work towards practical outcomes or products towards improving acceptability and access of COVID-19 diagnostics and vaccines. Researchers should address the outcomes deemed as high priority by members of the community where interventions take place. These studies will focus on specific communities, yet they should also consider the extent to which findings can be generalized or adapted and implemented across other underserved and vulnerable populations. Applications should briefly describe the potential, where possible, of study approaches and findings for broader scale-up and population health impact and include plans for the development of materials or toolkits to facilitate adaptation, dissemination, and potential for implementation and scale up in other populations or settings.
For projects incorporating testing, testing capacity should include 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 authorized 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.
Additional Requirements
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 RADxSM-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 RADxSM-UP Tier 1 Common Data Elements. Permission from participants to collect and share these CDEs will be given through specific language in the Informed Consent Form (ICF). Please refer to the public Link for CDCC reference Material and resources for testing: https://radx-up.org/learning-resources/testing-tip and the public link for CDCC reference materials for new project grant applications: Common Data Elements, Informed Consent Language, Data Use Agreement recommended language: https://radx-up.org/learning-resources/cdes/ to ensure alignment with data collection requirements.
Recipients will work closely with the CDCC on data sharing activities as part of the RADxSM-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 topermit re-contact of participants for future follow-up and participation in future research; and/or 4) sharing identifiable data to perform linkages with clinical and population data sets, 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.
Any data collected as part of this funding announcement will be archived as de-identified data in the NIH RADx Data Hub and will enable authorized community members, health researchers, and scientists in the Federal government to understand the impact of the COVID-19 pandemic on the well-being, risk, resilience and disparities in underserved and vulnerable communities across the U.S. and the U.S. Territories. Funded projects will share study data collection instruments and other research products with other RADxSM-UP funded projects through the CDCC.
Projects funded through this NOSI are strongly encouraged to use the following resources for the assessment of other constructs:
Additionally, researchers with funding through this NOSI are strongly encouraged to share their survey items to make them public for other researchers to consider by submitting their surveys to [email protected].
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:
Review Process
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-20-272.
Funds available
Reporting
Application and Submission Information
Applications in response to this NOSI must be submitted using one of the following target opportunities or subsequent reissued equivalent.
All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-20-272) must be followed, with the following additions
The Research Strategy section of the application is limited to 6 pages.
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 application receipt date to better determine appropriateness and interest of the relevant Institute.
Applications nonresponsive to the terms of this NOSI will not be considered for this NOSI.
Scientific/Research Contact(s)
Please contact the Program Officer for the Parent Award.
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Please contact the Grants Management Contact(s) for the Parent Award.