Key Dates

Related Announcements

NOT-AG-20-060 - Notice of NIA Withdrawal from Participation in NOT-MD-20-022

NOT-MD-21-002 - NIMHD Withdraws Participation in NOT-MD-20-022.

PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

NOT-HL-20-802

Issued by

National Eye Institute (NEI)

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 of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Heart, Lung, and Blood Institute (NHLBI) participation withdrawn as of August 2, 2020 (see NOT-HL-20-802)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Purpose

Key Definitions for this NOSI

NIH-designated U.S. health disparity populations: Racial and ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities (see https://www.nimhd.nih.gov/about/overview/).

COVID-19 vulnerable populations: Residents of chronic care and assisted living facilities; community-dwelling older adults; individuals with cognitive impairment or dementia; homeless populations; incarcerated populations and those involved with the criminal justice system (e.g., participants of re-entry programs); adults with medical comorbidities; pregnant women; children and adolescents; individuals with substance use disorders or severe mental illness, those living in congregate housing (e.g., shelters, residential treatment or assisted living); persons who are deaf or with disabilities including visual, hearing, communication, or mobility impairment; detainees in immigration centers; migrant communities; individuals living on tribal lands or reservations; and communities that are exposed to high rates of air pollution or other toxic exposures. Vulnerable groups also include those on the frontlines of healthcare during the COVID-19 pandemic, and those working in essential business operations (e.g., grocery and pharmacy workers, transportation, hospital and community janitorial/sanitation workers, waste collectors, postal and other delivery services, warehouse personnel, etc.).

Multilevel Intervention: An intervention at two or more levels of influence, including policy (governing bodies or others who establish policies, rules, or guidelines), community (a group of people living in a defined geographic area or having particular characteristics in common, structural, and/or environmental determinants of health), organizational (large healthcare systems, community health clinics, public health organizations, community-based organizations, social services, schools, workplaces, other service providers, etc.), interpersonal (e.g., communication, social supports, relationships with others), and individual (e.g., community residents, employees, caregivers, family members, providers;). See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence).

Background
The COVID-19 pandemic and its associated mitigation strategies are expected to have significant psychosocial, behavioral, and socioeconomic impacts on health, which are exacerbated in populations that experience health disparities and other vulnerable groups, leading to disproportionately adverse consequences. Those experiencing health disparities prior to the COVID-19 pandemic are at increased risk of infection and other COVID-19 related consequences (e.g., job loss, unpaid leave, lost wages).

Research is needed to test community interventions focused on the prevention (or slowing) of COVID-19 transmission, evaluate local and state policies and programs intended to mitigate COVID-19 exposure and improve adherence, and reduce the negative impact of the multifaceted consequences on the health of populations who experience health disparities and other vulnerable groups. This work may includeleveraging and scaling existing resources (e.g., health education materials, technology, social media, mass media, social support networks, social services). In domains and populations in which the evidence base is limited, the development, testing, and implementation of novel or adapted interventions to address the negative health consequences of the COVID-19 pandemic (including the unintended health consequences of population-level interventions) may also be needed to address the unique needs of populations.

Research Objectives

Projects may evaluate existing or ongoing community-based programs or policies (i.e., natural experiments), or prospectively test new or adapted interventions. Multilevel interventions that do not solely target individuals, but also address the upstream determinants that influence individual functioning and health outcomes are strongly encouraged. Projects should be designed to test hypotheses about mechanisms of action that account for an intervention’s effects; mechanisms may operate at any level of analysis.

Key questions include: To what extent do existing interventions slow the spread of COVID-19 in specific populations and geographic hotspots? To what extent do policies, guidelines, and other interventions facilitate adherence and mitigate the multifaceted impacts of COVID-19 on health in populations that experience health disparities and vulnerable groups? Can established models of crisis and disaster response and management be applied to address the needs of health disparity and other vulnerable populations?

Outcomes of interest include, but are not limited to, COVID-19 incidence, hospitalizations, and mortality rates in defined populations or geographic locations, indicators of community functioning and/or family functioning related to health, changes in the physical or built environment, preventative behaviors, adherence to mitigation strategies, access and utilization of health care, management of chronic conditions (provider-delivered care and/or self-management), mental health, substance abuse, tobacco use, dietary intake, sleep health, quality of life (QoL), physical activities, activities of daily living (ADLs), instrumental activities of daily living (IADLs), and biomarkers and other outcomes of health.

Projects must include a focus on one or more NIH-designated populations that experience health disparities in the United States, or a population identified as vulnerable to COVID-19 infection, hospitalization,or mortality.

Research topics of interest include, but are not limited to, the following:

Mitigation strategies in populations who experience health disparities and other vulnerable groups

• Local or state policy interventions to mitigate COVID-19 exposures and their impact on COVID-19 cases, hospitalizations, or deaths
• Potential unintended consequences of local or state policy interventions related to COVID-19, such as barriers to seeking or receiving appropriate healthcare; lack of access to affordable medications, health and cleaning products; unintentional overdose or poisonings related to promoted treatments or mitigation strategies; harm caused by self-administered and non-evidence based treatments; or psychosocial distress, or victimization related to COVID-19 related stigma and discrimination
• Local or state governmental and non-governmental programs to provide educational outreach and/or resources to promote adherence to mitigation strategies
• Behavioral or health communication interventions to promote understanding of and adherence to mitigation recommendations
• Communication interventions aimed at providing accurate and reliable information (or dispelling misinformation) to mitigate the negative impact of COVID-19
• Innovative technologies to promote protective/preventive behaviors across individual and community contexts
• Culturally and linguistically appropriate interventions to promote adherence to mitigation strategies within the home, including addressing structural or interpersonal factors that may make adherence difficult (e.g., lack of running water, overcrowded housing, exposure to indoor air pollution, child abuse, intimate partner or family violence)
• Structural and behavioral interventions to reduce risk of infection in public or social settings, such as educational, criminal justice, work, recreational, behavioral health, or faith-based settings, on public transportation, and multi-media platforms
  

Evaluating community interventions (existing, new, or adapted) to ameliorate the negative health impacts of the COVID-19 pandemic in heath disparity and other vulnerable populations

• Local or state policies, or organizational practices, to reduce the psychosocial and health consequences related to COVID-19
• Effects, sustainability, and scalability of behavioral interventions (e.g., social media, digital approaches, social support systems)
• Addressing food insecurity, home environmental exposures, lack of physical activity, poor sleep, social isolation, or mental health or emotional wellbeing concerns related to mitigation strategies (e.g., stay at home orders, school closures)
• Reducing distress and adverse health behaviors (e.g., smoking, excessive alcohol use, substance misuse, risky sexual behavior, violence, inadequate sleep, sedentary behavior, etc.) associated with COVID-19 related life changes
• Helping families, and organizations cope with COVID-19-related caregiving stress, illness, death, and bereavement
• Addressing COVID-19-related posttraumatic stress symptoms among first responders and human services providers and their families (e.g., Psychological First Aid or Skills for Psychological Recovery)
• Promoting self-management of pre-existing chronic physical or mental health conditions and appropriate linkage to healthcare services
• Practice-based research on state and community interventions to prevent suicide and suicide attempts
  

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Prospective Interventions: Investigators who wish to evaluate the effect of a community-based intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

The following types of projects would not be responsive to this NOSI: 1) projects without a focus on one or more NIH-designated health disparity populations or COVID-19 vulnerable populations, 2) projects that do not test intervention effects on behavioral and/or health outcomes, 3) prospective intervention projects that involve testing interventions outside of the US, and 4) projects that are exclusively qualitative.

To maximize comparisons across datasets or studies, and facilitate data integration and collaboration, researchers funded through this NOSI are encouraged to use the following resources:

• Data Harmonization for Social Determinants of Health via the PhenX Toolkit: NIMHD strongly encourages investigators involved in human-subject studies 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, human-subject studies should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).
• A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing 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, if consensus-based measures (e.g., https://www.phenxtoolkit.org/collections/view/1) are not available.
  

Additionally, researchers with funding through this NOSI will be strongly encouraged to share their survey items to make them public for other researchers to consider by submitting their surveys to [email protected].

Application and Submission Information

Applications in response to this NOSI must be submitted using one of the following target opportunities or subsequent reissued equivalent.

• PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) is intended to provide funds for NIH grantees where the work proposed in the supplement is within the scope of the ongoing grant.
• PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant
• The funding instrument, or activity code, will be the same as the parent award.
  

ORWH reminds applicants that the appropriate consideration of sex and gender as described in NOT-OD-15-102is NIH policy and a consideration for NIH support.

All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-18-591 or PA-18-935) must be followed, with the following additions:

• Individual requests can be no more than $250,000 in direct costs per year.
• The project period will generally be limited to one year and must reflect the needs of the project. A second year of support may be awarded with strong justification.
• The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.
• The Research Strategy section of the application is limited to 6 pages.
• Applicants should address whether ongoing or potential future public health restrictions (e.g., closures, physical distancing) might affect the research approach and, if so, include a plan to prevent or mitigate any effect on the proposed study.
• Applications will be accepted on a rolling basis from June 10, 2020 through December 15, 2020 by 5:00 PM local time of the applicant organization. This NOSI expires on December 30, 2020.
• Applications submitted before July 15, 2020 will be considered for funding in in Fiscal Year 2020. Applications received after July 16, 2020 may be held for consideration in Fiscal Year 2021 and not be eligible for funding until October 2020.

• Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-F-ADMINSUPP . In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Competitive revision applications to PA-18-935 must use the application form package with the Competition ID that contains FORMS-F-COMP-REV .
• IMPORTANT: For funding consideration, all applicants must designate NOT-MD-20-022 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.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package.
  

Investigators are strongly encouraged to contact and discuss their proposed research/aims with the Scientific/Research Contacts listed on this NOSI well in advance of submission to better determine appropriateness and interest of the relevant Institute or Center.

Inquiries

Scientific/Research Contact(s)

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: [email protected]

Cheri Wiggs, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email:[email protected]

Luke Stoeckel, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Kathy Jung, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-8744
Email: [email protected]

Sonia Lee, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: [email protected]

Kelly King, AuD, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: [email protected]

Darien Weatherspoon, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5394
Email: [email protected]

Mary Evans, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578
Email: [email protected]

Will M. Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5909
Email: [email protected]

Julia Zur, PhD
National Institute on Drug Addiction (NIDA)
Telephone: 301-443-2261
Email: [email protected]

Lindsey Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4036
Email:[email protected]

Denise Juliano-Bult, MSW.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1638
Email: [email protected]

Wendy Weber, ND, PhD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email:[email protected]

Erica Rosemond, PhD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8927
Email: [email protected]

Jacqueline Lloyd, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-5559
Email: [email protected]

Karen Parker, PhD
Sexual and Gender Minority Research Office (SGMRO)
Telephone: 301-451-2055
Email: [email protected]

Erica Spotts, PhD
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-594-2105
Email:[email protected]

Damiya E. Whitaker, PsyD
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-8206
Email: [email protected]

Financial/Grants Management Contact(s)

Priscilla Grant, JD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

E.C. Melvin
National Institute on Aging (NIA)
Telephone: 301-480-8991
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301- 443-4704
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: [email protected]

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Sharon Bourque
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8846
Email: [email protected]

Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

Irene Haas
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0836
Email: [email protected]