Notice of Intent to Publish a Funding Opportunity Announcement for Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional)

Key Dates

None

National Institute of Nursing Research (NINR)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

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)

Office of Research on Women's Health (ORWH)

The purpose of this notice is to inform the research community of the National Institute of Nursing Research (NINR), with other NIH Institutes, Centers, and Offices (ICOs) listed above, intends to publish a notice of funding opportunity (NOFO), Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional).

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

This NOFO will utilize the U01 activity code. Details of the planned NOFO are provided below.

The Transformative Research to Address Health Disparities and Advance Health Equity initiative will solicit applications to support unusually innovative intervention research addressing social determinants of health (SDOH) which, if successful, would have a major impact on preventing, reducing, or eliminating health disparities and advancing health equity. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact on advancing NIH’s commitment to addressing SDOH to accelerate progress in improving health for all. Preliminary data are not required for this initiative.

Projects are expected to propose exceptionally innovative and transformative activities that are urgently needed to prevent, reduce, or eliminate health disparities and advance health equity. Projects may prospectively test new or adapted interventions (referred to as prospective interventions), evaluate existing or upcoming novel or unusual policy, programmatic, or environmental changes to generate significantly novel insights, or conduct innovative dissemination and implementation research. Research projects must address one or more SDOH as conceptualized by the NIH (https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc#tabs2). SDOH can be addressed alone or in combination with other determinants of health and as part of a single or multilevel intervention approach. Studies should be guided by a conceptual framework identifying hypothesized pathways between the intervention or program and outcome(s). All projects should examine the mechanisms by which the intervention alters health and health disparities.

Projects must include a focus on one or more NIH-designated populations that experience health disparities in the US, which includes racial and ethnic minority populations, people with lower socioeconomic status, underserved rural populations, sexual and gender minority populations, people with disabilities, and any subpopulations that can be characterized by the intersection of two or more of these descriptors. Encouraged are studies designed to explicitly examine whether the intervention mitigates differences in health outcomes between health disparity and non-health disparity populations. Given heterogeneity within health disparity populations, within-group comparisons of intervention effects that allow for discovery of health risk and resilience factors are also encouraged.

Innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines are of interest. Projects that focus on elimination of interventions that are ineffective, unproven, low-value, or harmful in advancing health equity are also invited. Implementation research aims should be guided by equity-oriented theoretical models and frameworks. Modeling studies that evaluate the impact of specific interventions and implementation strategies to identify leverage points on costs and prioritizing strategies, particularly across the broad multi-sector nature of SDOH to inform scale up of interventions across communities and contexts, would also be responsive. Additionally, research that directly tests the effectiveness of interventions on narrowing health gaps between health disparity and non-health disparity populations is strongly encouraged.

Community Partnerships: Projects must document or demonstrate throughout the research process meaningful community partnerships to foster the development of feasible and acceptable approaches as well as acceptance, uptake, and sustainability of proposed interventions and strategies. Applicants should provide details on the nature and extent of the partnerships, including clearly describing the roles of partners and providing evidence of support from partners.

Prospective Interventions to Address SDOH may develop and test the effectiveness of new or adapted interventions in a variety of settings in the U.S., such as neighborhoods, 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, healthcare systems, and recreational settings. Approaches may include randomized control trials (RCTs) (e.g., individual-level RCT, group or cluster RCT, stepped wedge RCT, stepped wedge group or cluster RCT pragmatic RCT), pragmatic trials, adaptive designs (e.g., multiphase optimization strategy (MOST), sequential multiple assignment randomized trials [SMART]), implementation trials (including hybrid effectiveness/implementation designs), and quasi-experimental designs.

Examples of projects supported in this category include, but are not limited to, studies that develop and evaluate the effectiveness of interventions to improve health or reduce health disparities by:

• Improving community conditions through community revitalization investment projects
• Improving economic stability, such as through increased job opportunities or quality employment
• Improving housing access, quality, or affordability
• Improving education quality
• Reducing community-level violence, including firearm violence
• Improving the availability or quality of green spaces or recreational spaces
• Improving community childcare availability together with providing access to parental support groups
• Improving nutritious food availability in the community in addition to providing primary care-based nutritional counseling to individuals

Evaluation of Ongoing or Upcoming Interventions may examine policies, programs, interventions, or environmental changes that are ongoing or upcoming in the U.S. to address SDOH (structural factors or conditions of daily life) (regardless of NIH funding) by states/territories, cities, counties, tribal communities, healthcare systems, public health departments, school systems, employers, or other organizations. Projects including multiple sites, locations, or settings are encouraged to allow for the analysis of variability across and within settings. Studies that compare outcomes across populations in the U.S. with other countries are also allowed, if the comparison elucidates intervention mechanisms to reduce health disparities in the U.S. In addition to examination of individual level impacts as primary outcomes, examination of secondary outcomes that address unintended consequences of a policy or program, degree of implementation (including acceptance, uptake, spread, and sustainability), and implementation barriers and facilitators, are encouraged.

Examples of projects supported in this category include, but are not limited to studies that evaluate impacts on health and health disparities of:

• Federal, tribal, state, local, or organizational demonstration projects aimed at addressing SDOH
• Tribal policies or programs aimed to address SDOH among American Indian/Alaska Native populations
• New standards of care, changes in health insurance coverage, expansion of access to social services, and other factors that influence SDOH
• Programs or policies designed to improve access, quality, or affordability of housing, transportation, and food on health within communities
• Infrastructure changes related to housing, transportation, the food environment, or the built environment
• Programs, policies, or environmental changes targeting SDOH in addition to factors targeting individual or family circumstances such as housing instability, transportation access, nutrition insecurity
• Community economic development policy or program in addition to job training for individuals
• Program or policy to increase community availability of affordable housing, while also implementing screening and referrals for housing insecurity in healthcare settings

Study Designs: Randomized controlled trials may not be possible in all innovative research designs, e.g., where it is not possible to assign participants to high versus low discrimination conditions or in communities where cross intervention contamination is likely to occur or be a problem. Alternative rigorous research designs that provide robust evidence of intervention effectiveness include quasi-experimental designs, such as multiple baseline or repeated measures design, interrupted timeseries design, or stepped-wedge cluster randomized designs in which all subjects receive the intervention. Further, hybrid effectiveness-implementation designs allow early observational investigation of implementation processes while also testing intervention effectiveness. Investigators should justify their research and analytic design selection and provide adequate evidence of their ability to execute a rigorous and appropriate analysis of randomized or non-randomized study data.
 

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Shalanda A. Bynum, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 301-755-4355
Email: [email protected]