Key Dates

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

PAR-20-154 - Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delievered Remotely or via mHealth (R01 Clinical Trial Required)

PAR-21-160 - NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

Issued by

National Institute of Mental Health (NIMH)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

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)

Office of Behavioral and Social Sciences Research (OBSSR)

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Purpose

NIH Institutes, Centers, and Offices participating in the Social, Behavioral, and Economic Impacts of COVID-19 in Vulnerable and Health Disparity Populations initiative are issuing this Notice of Special Interest (NOSI) to highlight interest in research to strengthen the understanding and response to the Coronavirus Disease 2019 (COVID-19) pandemic and help us prepare more effectively for future public health emergencies. While research related to the direct clinical effects of COVID-19 are supported by other funding opportunities, there are additional urgent public health needs, particularly in populations who experience health disparities and in vulnerable populations. The purpose of this Notice is to 1) emphasize the roles and impacts of interventions, particularly those under the umbrella of digital health, as well as community-engaged and multi-level interventions in healthcare settings to address access, reach, delivery, engagement, effectiveness, scalability, and sustainability of services that are utilized during and following the pandemic, and 2) encourage the leveraging of existing large-scale data sources with broad population coverage to improve prediction of various mitigation efforts (including vaccinations, masking, and physical distancing to inform the public health response) on transmission reduction and on social and economic impacts, and assess the downstream health and healthcare access effects, with an emphasis on underserved and vulnerable populations. Additionally, the use of large-scale data sources to study the indirect health impacts of the pandemic and subsequent social and economic changes is needed to understand the costs and benefits of various COVID-19 mitigation strategies.

Background

Across the lifespan, the COVID-19 pandemic has resulted in behavioral, social, and economic changes that impact health. Adoption and adherence to prevention and mitigation strategies have been uneven across the U.S. population due to issues related to trust in health systems, economic circumstances that limit access to paid leave or other accommodations to support testing and vaccination, conflicting information in the media, and challenges in sustaining long term adherence. Repeated surges of infections with SARS-CoV-2 over a prolonged period and with widespread regions affected, has resulted in profound secondary impacts including economic shocks that produce disparate levels of stress-induced poor health across socioeconomic and regional strata. Early data reveal exacerbations of symptoms among individuals with pre-existing health conditions and related comorbidities and a reduction in healthy behaviors that promote individual wellness. These adverse effects are compounded by disruptions in the provision and access to healthcare, including access to allied health clinicians, such as therapists and visiting nurses.

Of particular concern are the effects of the pandemic on populations that experience health disparities* (racial and ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities) and other populations with medical or social vulnerabilities. The latter includes people who are: part of communities with low adoption of public health mitigation measures (e.g., vaccination uptake, mask use, physical distancing), living on tribal lands or reservations, in congregate housing, community-dwelling older adults, homeless, incarcerated or involved with the criminal justice system, detainees in immigration centers, as well as people who are part of migrant communities. Other vulnerable groups specific to the COVID-19 pandemic are medical personnel with direct patient care, other medical support staff, home health aides, as well as family and informal caregivers, emergency responders, and frontline workers in essential businesses or services. Additional vulnerable populations include pregnant women, children, uninsured individuals, persons with cognitive impairment or dementia, people experiencing substance use disorder or severe mental illness, or people with visual, hearing, communication, or mobility impairment.

Research in the U.S. confirms consistent health disparities by race and ethnicity, with African American, Hispanic/Latino, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander people experiencing a greater COVID-19 burden than White persons. Reports by geographic locations indicate that COVID-19 cases are substantially greater in economically disadvantaged census tracts. Excess deaths above and beyond COVID-19 are also disproportionately distributed among African Americans, Latinos, and American Indian/Alaska Native populations. COVID-19 also disproportionately affects other vulnerable populations such as frontline health care workers and first responders, and all workers with direct patient contact as well as people living in communities with low adoption of public health mitigation measures. A sex and gender lens to the COVID-19 pandemic is an important consideration as well given that women are overrepresented among public-facing essential workers (e.g., women comprise more than 70% of healthcare workers globally) and are usually responsible for the majority of caregiving in a household.

The pandemic has altered health needs and the delivery of services. There are both new and worsening experiences of illness, particularly related to mental health as well as alcohol and drug use, but also related to chronic conditions. In many areas, the existing healthcare workforce cannot meet the current and anticipated needs. Simultaneously, adoption of digital health technologies delivered online across a variety of platforms for addressing health and disease management have rapidly accelerated, however with uncertain reach to populations that experience health disparities and other vulnerable groups. Digital health incorporates mobile health (mHealth), telemedicine/telehealth, and health information technology (mobile phones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data. To be successful in the digital health interventions space, researchers must acquire and leverage partnerships with digital health developers and existing well-established digital health delivery platforms, so that the research follows a deployment-focused model of services design and testing. Whether health care is delivered via digital health technologies or in person, interventions are needed to re-engage patients in care after service disruptions, and facilitate timely assessment, diagnosis, and treatment for chronic health conditions. Interventions are also needed to address COVID-19 related stress and burnout among healthcare workers.

Public health needs exacerbated by the pandemic may also require interventions outside of the traditional healthcare setting. Community interventions are those which are delivered outside of traditional healthcare settings, such as places of residence, community-based organizations, child welfare and human service settings, workplaces, businesses, stores and restaurants, schools, criminal justice settings, faith-based organizations, public works and facilities, recreational settings, and green spaces. Multi-level interventions that go beyond addressing individual-level determinants, to address interpersonal, family, organizational, neighborhood, and community-level factors are particularly important to effectively address the social, behavioral, and economic consequences of the pandemic on health. (See the NIMHD Research Framework for examples of health determinants at different levels of influence).

Providing an evidence base for effective policymaking to mitigate the negative health impacts of a pandemic requires an understanding of how institutional changes at different levels (e.g., firm, national, state, local, etc.) intended to manage viral spread influences health and health behaviors across diverse populations and regions. Efforts to improve mitigation practices and manage associated economic and health impacts will be enhanced if researchers have access to integrated established behavioral, economic, and public health datasets covering large populations to produce generalizable results. Existing datasets offer the advantage of continuous and historical data before and after the pandemic emerged, thereby facilitating analyses of the pandemic response and impacts. However, integrating diverse data sets also presents challenges, since many relevant datasets are discrete, not readily accessible or interoperable, and may lag in their data reporting. Additionally, there may be a need to improve the usefulness of existing data resources characterized by sparse data sampling by introducing novel data collection techniques to gather more temporally dense, real-time data. NIH has current investments in both interventions and social/population science which both model the kinds of research that are supported and can help inform novel research questions to address gaps in understanding. For example, the duration and impact of the pandemic are directly affected by the adoption, implementation, distribution, and ongoing adherence to public health mitigation efforts which include behaviors related to vaccination, mask wearing, physical distancing, and hand washing. Research on adherence to these preventive behaviors and to understand how personal and social factors promote or impede adherence will be key for developing and communicating effective public health recommendations for families, firms and government. Further, mitigation efforts may have indirect impacts that also must be understood to inform public health decision making in the future. Reduced rates of other respiratory infections due to mask wearing, changes in social connection, and job loss/reduction resulting in food insecurity and increased stress are emerging as examples of risks and benefits that may be weighed in a cost-benefit analysis of various mitigation strategies.

Understanding the multifaceted impacts of the COVID-19 pandemic, and public health interventions that mitigate risk and promote resilience in high-risk populations will help improve long-term response to the pandemic and prepare more effectively for future public health emergencies. In addition, tackling the complex drivers of health disparities requires strong partnerships between researchers, community organizations, health service providers, public health agencies, policymakers, and other stakeholders to ensure that relevant, culturally and contextually appropriate research is conducted, and more importantly, that findings can be translated into sustainable community and system-level changes that promote health equity.

Consideration of particularly vulnerable groups and populations with health disparities are critical to addressing the public health needs of the pandemic.

Research Objectives

To strengthen the understanding and response to social, behavioral, and economic impacts of the COVID-19 pandemic, NIH Institutes, Centers, and Offices participating in this NOSI are encouraging the submission of applications to address the following areas of scientific interest focused on COVID-19 health-related outcomes or behaviors with particular emphasis on populations with health disparities and vulnerable populations:

• Digital health or community interventions to increase the reach, access, engagement, efficiency, quality, and sustainability of interventions to accommodate individuals seeking screening, prevention, self-management, wellness behaviors, and treatment (especially using culturally and linguistically appropriate approaches).
• Digital health or community interventions that incorporate strategies to address the digital divide as it relates to vulnerable populations, including low-income communities, older adults, as well as their caregivers.
• Digital health or community interventions to address bereavement and loss across the lifespan, including family or community-level bereavement in highly affected populations, particularly where end of life or grieving rituals were disrupted by the pandemic.
• Digital health or community interventions to address new and worsening mental health and behavioral health (including mental health, alcohol and substance use).
• Digital health or community interventions addressing health needs of children and adolescents with attention to critical periods of development.
• Digital health or community interventions to address health needs of caregivers of older adults.
• Community directed behavioral or health communication interventions to promote understanding of and adherence to mitigation recommendations, particularly around vaccine hesitancy and uptake, including mechanisms that influence vaccination decision making.
• Healthcare interventions to re-engage patients in ongoing care for chronic health conditions and/or address negative health outcomes related to delayed diagnosis, medication non-adherence, or disruptions in treatment regimens.
• Healthcare-based interventions to address COVID-19 related stress and burnout among healthcare workers.
• Digital health or community interventions or data and social/population science research examining pandemic-related stress and mitigation isolation on interpersonal violence, intimate partner violence, child abuse/neglect, and general family strain.
• Community interventions as well as data and social/population science projects to understand or address health impacts of the pandemic and subsequent economic changes (e.g., food insecurity, housing insecurity, travel insecurity).
• Community interventions as well as data and social/population science projects to understand or address health impacts related to in-person work during the pandemic, job loss or reduction on parents with school-aged children, and eventual return to the workplace. Specific impacts by gender and disproportionate strain are relevant.
• Integration and analysis of data from multiple digital health platforms or systems leveraging common data elements to identify the long-term health impact and the cost effectiveness of providing digital health interventions at scale.
• Research to utilize electronic health record data in conjunction with digital health interventions to examine the clinical epidemiology, service utilization, and response to treatment, within or across large systems responsible for health service delivery to inform timing and targets for intervening.
• Examinations of local or state policy interventions to mitigate COVID-19, including around vaccination and masking in different settings (including businesses and schools) and their impact on COVID-19 cases, hospitalizations, or deaths.
• Projects exploring how public or private pandemic-related policies including mitigation (e.g., physical distancing, masking, lockdowns), vaccination (e.g., vaccination and/or testing requirements), and economic support programs (e.g., unemployment benefit extensions, eviction moratoriums, etc.) impacted health, access to health care, and health-related behaviors.
• Studies of the effects of pandemic mitigation practices and associated economic change on the health of healthcare and other frontline workers that can inform policy to reduce health disparities for workers, their families, and the patients or public they serve.
• Examination of local or state governmental and non-governmental programs that provide educational outreach and/or resources to promote adherence to mitigation strategies including vaccination uptake.

Across topic areas, projects that involve collaborations with relevant community partners, including but not limited to health service providers and systems; state and local public health agencies or other governmental agencies such as housing or transportation; criminal justice systems; school systems, patient or consumer advocacy groups; community-based organizations, and faith-based organizations, are strongly encouraged.

Investigators interested in responding to this NOSI are strongly encouraged to consult the Scientific/Research Contact(s) provided prior to the application due date so that NIH can provide technical assistance on whether the proposed project meets the goals and mission of the Institute, whether it addresses one or more high priority research areas (particularly in the context of rapidly changing landscape of COVID-19 related research), and to aid in the selection of the most appropriate FOA.

Areas that are low priority for Institutes/Centers participating in this NOSI:

• Projects that do not include a focus on one or more NIH-designated health disparity populations or COVID-19 vulnerable populations in the U.S.
• Projects that do not examine COVID-19 health-related outcomes or behaviors.
• Projects that are exclusively qualitative.
• Research to develop new digital health interventions, digital health tools, platforms, and/or non-validated treatments
• Digital health applications to adapt the translation of existing face-to-face treatments on new platforms (e.g, Skype, Zoom, or other video-based conferencing requiring 1:1 provider engagement).

Data Harmonization

The NIH is dedicated to advancing science by improving the yield and impact of its research portfolio. One way to accomplish this is to encourage investigators to use a common set of tools and resources to facilitate the collection of common data elements (CDEs) or, in the case of existing data/records apply common constructs. NIH has worked with relevant communities to develop and provide access to tools and resources that can improve consistency of data collection. NIH strongly encourages investigators collecting data to use these resources as they select COVID-related instruments for their proposed studies and devise programs to construct research data files. This is particularly important for efforts to rapidly assess the needs and impact of COVID-19 across different population groups, particularly vulnerable populations. Recipients of awards under this notice are encouraged to submit their COVID-19 specific instruments for inclusion into these resource sharing sites (see Data Collection Tools & Resources Form for DR2 and PhenX Repositories).

The NIH Public Health Emergency and Disaster Research Response (DR2) includes COVID-19 related survey instruments and additional information such as the domains assessed, protocols, and a wide array of data collection tools and resources used in other public health emergencies and disasters.

The PhenX Toolkit, hosts a collection of COVID-19 related item-module protocols drawn from the surveys listed in DR2. In addition, the PhenX Toolkit has a large collection of well-established and vetted phenotypic measurement protocols, including its newly released social determinants of health collections. These protocols are suitable for inclusion in COVID-19-related studies, enabling data harmonization across studies.

Data Sharing

Applicants, whether collecting new data or using existing data as part of proposed research are encouraged to submit a Data Sharing Plan. Projects collecting data should use best practices in data sharing to accelerate the scientific community’s ability to advance knowledge about the social, behavioral, economic and health impacts of COVID-19. As articulated in the NIH Strategic Plan for Data Science, NIH seeks to leverage its role as a funding agency to encourage rapid, open sharing of data, and greater harmonization of scientific efforts. Researchers are encouraged to ensure that the data resources that they produce meet the standard for being FAIR Findable, Accessible, Interoperable, and Reusable, and further elaborated upon by FORCE 11. Some tools to help researchers in the digital cloud environment have also been generated by the NIH Data Commons. NIH strongly encourages use of NIH-supported, domain-specific data repositories as a first choice for storing data and making it accessible (see NLM Data Sharing Resources). In instances where captured/re-used data is not directly sharable by the applicant, plans for providing access protocols and programs to allow third-party researchers to replicate proposed research data files are necessary to meet data sharing requirements. Specifically, this includes information describing the data source and how any investigator can apply for data access, computer code used to convert data from the capture source into research data files, explanations of any variables constructed by the investigators, and other relevant information required to assist the use of data from the source for replication studies. NIH requires researchers and publishers to make their COVID-19 publications immediately accessible in PubMed Central.

This guidance does not replace Institutes' and Centers'. For example, NIMH applicants are still expected to abide by the data sharing expectations in NOT-MH-19-033 and the common data element expectations in NOT-MH-20-067.

*This phrase is intended to refer to individuals who belong to a health disparity population as defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1): A population is a health disparity population if, as determined by the Director of the Institute after consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. https://www.govinfo.gov/content/pkg/USCODE-2018-title42/pdf/USCODE-2018-title42-chap6A-subchapIII-partC-subpart20-sec285t.pdf. As of October 2020, NIH-designated U.S. health disparity populations include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. Please see https://www.nimhd.nih.gov/about/overview/.

IC Specific Application and Submission Information:

Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.

In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

The National Institute of Mental Health (NIMH) accepts applications to the following or their subsequent reissued equivalents:
Note: NIMH only accepts mechanistic studies that meet NIH's definition of a clinical trial through PA-20-183 and PA-20-184. Applications directed to NIMH for intervention development must be submitted through PAR-21-130. For further information on NIMH clinical trial policies, see NOT-MH-20-105 and NOT-MH-19-006.

The National Institute of Dental and Craniofacial Research (NIDCR) accepts applications to the following FOAs or their subsequent reissued equivalents:
Note: Applications directed to NIDCR for intervention development or testing must be submitted through PAR-21-160.

The National Center for Complementary and Integrative Health (NCCIH) accepts applications to the following FOAs or their subsequent reissued equivalents:
Note: Applications directed to NCCIH for intervention development or testing must be submitted through PAR-20-154.

NEI, NIA, NIAAA, NICHD, NIDCD, NIDA, NINR, and NIMHD accept applications to the following FOAs or their subsequent reissued equivelants:

Application and Submission Information

This notice applies to due dates on or after October 5, 2021 and subsequent receipt dates through September 8, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)
• PAR-20-154 - Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delievered Remotely or via mHealth (R01 Clinical Trial Required)
• PAR-21-160 - NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-MH-21-330 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Email: haima@mail.nih.gov

Cheri Wiggs
National Eye Institute (NEI)
Phone: (301) 402-0276
E-mail: cheri.wiggs@nih.gov

John Phillips, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-4137
Email: john.phillips@nih.gov

Laura Elizabeth Kwako
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-451-8507
E-mail: laura.kwako@nih.gov

Kelly Anne King, Ph.D. Au.D.
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: 301-402-3458
E-mail: kingke@mail.nih.gov

William Elwood, PhD
Chief, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-402-0116
Email: william.elwood@nih.gov

Julia Beth Zur
National Institute On Drug Abuse (NIDA)
Phone: 301-443-2261
E-mail: julia.zur@nih.gov

Marcy Esther Fitzrandolph
National Institute On Drug Abuse (NIDA)
Phone: 301-443-9800
E-mail: marcy.fitz-randolph@nih.gov

Amanda Alise Price, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-8391
Email: amanda.price2@nih.gov

Nancy Lynne Jones
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8945
E-mail: nancy.jones@nih.gov

Rada K. Dagher, PhD, MPH
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-451-2187
E-mail: rada.dagher@nih.gov

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov

Jacqueline Lloyd, PhD, MSW
Office Of Disease Prevention (ODP)
Telephone: 301-827-5559
E-mail: lloydj2@mail.nih.gov

Rebecca Delcarmenwiggins
Office Of Research On Women's Health (ORWH)
Phone: 240-627-3866
E-mail: rdelcarm@mail.nih.gov

Damiya Eve Whitaker
Office Of Research On Women's Health (ORWH)
Phone: 240-276-6170
E-mail: damiya.whitaker@nih.gov

Christopher Barnhart, Ph.D.
Sexual & Gender Minority Research Office (SGMRO)
Phone: 301-594-8983
Email: Christopher.barnhart@nih.gov

Financial/Grants Management Contact(s)

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov

Rhashonda Cochran
National Institute on Aging (NIA)
Phone: 301-451-6645
Email: rhashonda.cochran@nih.gov

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: samantha.tempchin@nih.gov

Gabriel Hidalgo
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
Email: gabriel.hidalgo@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Priscilla Grant
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov