Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional)
Funding Agency:
- National Institutes of Health
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. As appropriate, studies are encouraged to explicitly examine whether the intervention mitigates differences in health outcomes between health disparity and non-health disparity populations. Given the 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. Research that directly tests the effectiveness of SDOH interventions in narrowing health gaps between health disparity and non-health disparity populations is also 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. Community partners can include, but are not limited to, those in the housing, transportation, food system, economic development, education, social services, and criminal legal system sectors. Applicants should provide details on the nature and extent of the partnerships by 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 group or cluster randomized controlled trial (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 rigorous 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 Existing or Upcoming Interventions may examine policies, programs, interventions, or environmental changes that are existing 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 strongly 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.
Application budgets cannot exceed $500,000 in direct costs per year and must reflect the actual needs of the proposed project.
March 22, 2024
Shalanda A. Bynum, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 301-755-4355
Email: shalanda.bynum@nih.gov
Sarah Mellam Steverman
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-5435
E-mail: sarah.steverman@nih.gov
Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov