Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional)

Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional) is sponsored by National Institute of Nursing Research (NINR), National Institutes of Health (NIH).

This initiative solicits applications for 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 should demonstrate 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. It emphasizes community-engaged research and implementation science.

Expired RFA-NR-24-004: Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations 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 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 ) Funding Opportunity Title Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional) U01 Research Project – Cooperative Agreements December 11, 2024 - This RFA has been reissued as RFA-NR-25-003 .

January 30, 2024 - Pre-Application Webinar for RFA-NR-24-004: Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional). See Notice NOT-NR-24-006 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) 93.

361, 93. 853, 93. 233, 93.

837, 93. 838, 93. 839, 93.

840, 93. 121, 93. 866, 93.

313, 93. 242, 93. 213, 93.

846, 93. 113, 93. 279, 93.

273 Funding Opportunity Purpose The Transformative Research to Address Health Disparities and Advance Health Equity initiative is soliciting 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 should 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. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.

Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description This funding opportunity supports unusually innovative intervention research which, if successful, would have a major impact on preventing, reducing, or eliminating health disparities and advancing health equity.

Interventions addressing research questions that target social determinants of health (SDOH), which include structural factors and conditions of daily life, are required for this initiative (See NIH SDOH conceptualization here 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. Although a formative research phase may be necessary for some projects, an intervention research component is required for each proposed project.

Applicants may propose interventions addressing disparities in any health condition, disease, or health behavior that align with the priority research areas of listed NIH Institutes, Centers, and Offices. This initiative invites intervention research focused on transformative research ideas.

To be considered transformative, projects should reflect ideas substantially different from traditional concepts and have high potential to lead to major improvements in health through the development, implementation, or dissemination of innovative interventions to address health disparities and health inequities.

To accelerate progress in reducing health disparities, this funding opportunity seeks to support interventions that advance or solidify strategies, policies, programs, and environmental changes to address the Nation’s most pressing health challenges. Innovative interventions could take many forms depending on the population of interest and health disparity being addressed.

Note that "innovation" can include development and testing of an innovative intervention, new implementation and/or dissemination strategies for evidence-based interventions, and/or creative evaluation of a novel or unusual policy, program, or environmental change to provide insight into their health impacts.

Several key features of this funding opportunity are designed to emphasize that Transformative Research to Address Health Disparities and Advance Health Equity applications are different from conventional, investigator-initiated research applications.

These applications focus on the significance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on preliminary data or experimental details. No preliminary data are required for applications submitted in response to this funding opportunity, but could be included if available.

Applicants should keep the goal of the Transformative Research to Address Health Disparities and Advance Health Equity initiative in mind throughout the process – to develop, implement, disseminate, and/or evaluate innovative interventions and strategies that address health disparities and that seek to advance health equity.

To support the most innovative and impactful research, the NIH recognizes the need to promote a diverse research workforce (see NOT-OD-20-031 for NIH Interest in Diversity). Applications to this award program should reflect the full diversity of potential applicants and applicant institutions.

Applications from researchers with diverse backgrounds underrepresented across roles and positions in research, including underrepresented racial and ethnic groups, persons with disabilities, and women are strongly encouraged to apply. Outstanding research is conducted at a broad spectrum of institutions.

To support the highest quality research, this funding opportunity encourages applications from the full range of eligible institutions, including those that may serve primarily underrepresented groups, those that may be less research-intensive, and from all domestic geographic locations.

Key Definitions for this NOFO Social determinants of health (SDOH) are the conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life.

These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www. ninr.

nih. gov/researchandfunding/nih-sdohrcc for additional detail on the NIH SDOH Conceptualization. Despite scientific and technological discoveries that improved the health of the U.S. population overall, racial and ethnic minority populations and other populations marginalized by society continue to bear a disproportionate burden of disease and premature death.

The life expectancy at birth for Black/African American and American Indian/Alaska Native populations is 6 and 11 years lower than for the non-Hispanic White population. Across diseases and conditions, these disparities deepen with a large variance attributed to historical injustices and present social inequities that limit the opportunity of communities and populations to live and maintain lives that are health-promoting.

These factors are known as SDOH which shape individual, community, and population health across the life span. Populations that experience health disparities have higher levels of cumulative exposure to adverse SDOH such as concentrated poverty, lower-quality education and employment opportunities, poor housing affordability, and lower accessibility of healthy food.

Health disparity populations also have limited access to health-promoting social conditions, which further limits the optimization of health.

Structural factors, rooted in racism, sexism, classism, homophobia, and other discriminatory systems, shape the extent to which conditions of daily life are equitably distributed or unfairly distributed by race, ethnicity, sex, gender identity, socioeconomic position, sexual orientation, or geography, and their intersections.

Inequitable exposure to health-promoting or adverse conditions of daily life are underlying causes of persistent and pervasive health disparities. To make greater progress in fulfilling the NIH mission to enhance health, lengthen life, and reduce illness and disability, innovative and transformative approaches to addressing and removing longstanding barriers to advancing health equity are critical.

This requires a sustained focus on addressing adverse SDOH and expanding access to health-promoting SDOH among populations at a health disadvantage. To effectively accomplish this, strong community partnerships are necessary to ensure relevance and resonance of approaches to tackle and ultimately eliminate longstanding and pervasive issues that contribute to poor health outcomes.

Community partnerships are essential for developing feasible and acceptable approaches and achieving acceptance, uptake, and sustainability of proposed interventions and strategies.

Partnerships within and across sectors such as education, housing, transportation, commerce, agriculture, economic and urban development, justice, human and social services, and public health are critical to advancing the translation of findings into sustainable community- and system-level changes that will have lasting impacts on health and advance health equity.

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.

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: Randomization may not be possible for all intervention studies, e.g., where it is not possible to assign participants to high versus low discrimination conditions or in small sample sizes 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 or interrupted time series design. Also, hybrid effectiveness-implementation designs allow 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.

Non-Responsive Applications The following studies will be considered non-responsive for this announcement: Projects that do not address one or more SDOH as conceptualized as structural factors and conditions of daily life Projects that intervene solely at the individual/family level and not on SDOH as conceptualized by the NIH Intervention projects that do not include a community partnership Projects that do not focus on a population at higher risk of morbidity or mortality based on race, ethnicity, socioeconomic status, rurality, sexual orientation, and/or ability status Projects focusing on populations outside of the United States Projects that do not include a Plan for Enhancing Diverse Perspectives Construction and major renovations costs are unallowable through this RFA.

Applications that propose to use grant funds to support construction or major alteration and renovation projects will be considered non-responsive.

Areas of Interest of Participating Institutes, Centers, and Offices (ICOs) National Heart, Lung, and Blood Institute (NHLBI) The National Heart, Lung, and Blood Institute (NHLBI) provides national leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, blood and sleep disorders or conditions.

The NHLBI is interested in innovative applications for preventing, reducing, or eliminating health disparities of heart, lung, blood and sleep disorders/conditions in underserved communities through late-stage translation research, notably dissemination and implementation science. Investigators are required to meaningfully engage community partners at the onset and throughout their research project.

This engagement includes co-creation of research objectives, active community participation in the intervention, bi-directional communication, reasonable compensation for community partners, and shared leadership. Applicants are strongly encouraged to contact Scientific/Research staff noted in this RFA about proposed activities prior to submission.

National Institute on Aging (NIA) NIA supports mechanism-based intervention research to prevent, reduce, or eliminate health disparities and inequities over the life course, especially among older adults and people living with Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD), as well as their caregivers.

Applicants are encouraged to consider the priorities outlined in NIA’s strategic directions for health disparities research and in the AD+ADRD Research Implementation Milestones related to health disparities , and those reflected within NIA’s Health Disparities framework .

Similarly, NIA encourages applicants to draw upon the NIH Stage Model for Behavioral Intervention Development , which offers a framework to: (1) support development and testing of effective interventions that are defined by their principles and (2) ensure that efficacious interventions can be administered in the community or in health systems with fidelity to the intervention’s principles.

This includes the development, testing, and validation of scalable training materials and procedures so that these interventions can be delivered with fidelity in community settings or health systems. In keeping with the Stage Model, applications should propose contemporary analytic techniques to evaluate mechanisms by which the focal intervention impacts health and health disparities.

National Institute on Alcohol Abuse and Alcoholism (NIAAA) NIAAA is interested in supporting unusually innovative intervention research, which, if successful, would have a major impact on preventing, reducing, or eliminating health disparities and advancing health equity by addressing research questions that target social determinants of harmful drinking and alcohol use disorder.

While prior research on the impact of SDOH on the onset, progression, and recovery from alcohol use disorder (AUD) has primarily focused on SDOH at the individual level, more recent research examining community-level SDOH has found that communities with lower socioeconomic status experience more consequences from alcohol consumption, even though higher socioeconomic status communities consume more alcohol.

Lower socioeconomic status communities also have higher densities of alcohol outlets, which is associated with greater alcohol consumption and harms. Under this Initiative, NIAAA seeks to investigate strategies that address the social determinants of harmful drinking at all levels of influence, including at the individual, family, community, and government/policy levels.

Special emphasis will be placed on interventions to address the social determinants of harmful drinking, AUD onset and progression, and long-term recovery from AUD at higher levels of influence (e.g., communities, government) and on multi-level interventions.

Examples include but are not limited to strategies that address employment/income, housing, and access to mental health and primary care services among people who drink at harmful levels. Applications that include a partnership between Research Centers in Minority Institutions and other institutions with extensive programs in community-partnered alcohol prevention and treatment research are strongly encouraged.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases.

Research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine.

In the context of this NOFO, the NIAMS is particularly interested in innovative intervention research that integrates biomedical and behavioral mechanisms, on both individual and community levels, to reduce and encourage elimination of health disparities for patients with multiple chronic condition within the NIAMS mission relevant diseases, such as osteoarthritis (for specifics, please visit the website of the Health Disparities in Osteoarthritis Workshop ).

Clinical trial applications will only be supported by NIAMS if submitted to a NIAMS clinical trials specific NOFO. A current list of active NIAMS clinical trials NOFOs is available at https://www. niams.

nih. gov/grants-funding/conducting-clinical-research/investigator-clinical-trial-policies . Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Institute of Dental and Craniofacial Research (NIDCR) NIDCR is interested in supporting highly meritorious research that evaluates, implements, and or tests policies, programs, and/or interventions to promote equitable access to services, goods, and/or health care to help eliminate disparities in dental, oral, and craniofacial (DOC) diseases and conditions.

Applicants are encouraged to employ multi-sector collaboration and methodologies to elucidate mechanisms and solidify strategies for advancing DOC health equity by: Eliminating implementation barriers, unintended consequences, and enhancing facilitators Addressing social determinants of health, common risk factors, and structural/system barriers impacting co-morbidities of DOC diseases and conditions Enhancing acceptability/uptake, effectiveness, cost-saving, sustainability, and value Eliminating ineffective, low-value, and discriminatory practices, behaviors, and/or care National Institute on Drug Abuse (NIDA) NIDA is interested in innovative research determining the extent to which interventions at the policy, community, or organizational levels that address SDOH reduce health disparities and improve substance use and associated negative outcomes.

Specific outcomes of interest include: 1) preventing or reducing substance use risk, substance use initiation, substance misuse, and escalation from misuse to substance use disorder (SUD); 2) reducing health disparities and the severity of health, social, and criminal legal outcomes for people with SUD; and 3) improving access to, engagement with, and benefits from SUD treatment, harm reduction services, recovery support services, and efforts to prevent fatal and non-fatal overdose among populations who experience health disparities.

NIDA prioritizes research that examines the mechanisms through which addressing the SDOH will reduce health disparities and have an impact on substance use outcomes. Examples of research areas that would be of interest to NIDA include, but are not limited to: Policies and programs to improve the coordination of treatment/prevention of SUD with housing affordability, accessibility, and permanency.

Policies that enhance financial well-being within a population. Policy interventions may be implemented by multiple community-based organizations, and include efforts to provide direct cash payments, address food insecurity, promote workforce engagement, increase health insurance coverage, or other reforms to reduce economic insecurity.

Criminal and legal system policy and practice changes to address discrimination against racially and/or ethnically minoritized populations. Reforms may include efforts by criminal and legal system entities (i.e., law enforcement agencies, courts, community corrections), community empowerment organizations, crisis response providers, educational entities, and other sectors.

Policies or programs to prevent violence, including efforts by police, education, community groups, public health, and recreation organizations to reduce firearms access, increase availability of recreational opportunities for youth, or encourage healthy relationships.

Child welfare policies or programs intended to prevent child welfare system involvement and improve family functioning on substance use, adverse childhood experiences, family separation, and other negative outcomes for the family, parent(s), and/or child(ren). Interventions designed to reduce misinformation, stigma, and discrimination associated with substance use, SUD, and SUD services.

GED, high school completion, job-seeking support, or apprenticeship training program paired with mentorship for individuals aging out of child welfare, affected by regional job loss, in the criminal legal system, or experiencing multigenerational poverty. Policies or programs to improve equitable quality of, access to, and engagement in treatment and prevention services.

Efforts to coordinate SDOH-related programs and services across sectors/agencies and test the cost and public health impacts of those initiatives. Applicants may choose to study a single intervention or a combination of interventions.

To maximize the acceptability, feasibility, scalability, and sustainability of the SDOH intervention being studied, applicants are encouraged to engage relevant end users in study conceptualization, design, execution, and interpretation.

For the purpose of this NOFO, end user is broadly defined and may include policymakers, state and local level decision makers, practitioners, intervention implementers, families, youth, and community members, among others.

Studies supported by NIDA must include a substance use outcome, and applicants are encouraged to test the mediational processes by which addressing the SDOH reduces health disparities and improves substance use and related outcomes.

National Institute of Environmental Health Sciences (NIEHS) NIEHS’ mission is to discover how the environment affects people in order to promote healthier lives and has long worked to reduce environmental health disparities and promote environmental justice .

NIEHS is interested in innovative intervention research that addresses the interaction of SDOH with chemical and other environmental exposures that compromise health and contribute to health disparities.

Examples of environmental exposures which are considered of primary interest for NIEHS include but are not limited to: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates, or fibers, fungal, and bacterial or biologically derived toxins.

Applicants are strongly encouraged to reach out to the Scientific Contact in the NOFO to discuss if the application fits the NIEHS mission. Applications responsive to NIEHS are required to clearly identify the environmental exposure(s) of interest and describe the intersection of the exposure(s) with SDOH.

The use of a conceptual model demonstrating the relationship of SDOH with the environmental exposure(s) of interest is highly encouraged.

While the Transformative Research to Address Health Disparities and Advance Health Equity initiative supports the evaluation of existing or upcoming interventions, NIEHS is particularly interested in: 1) prospective interventions that develop and test interventions addressing the intersection of social and environmental determinants of health at multiple levels and 2) implementation research (including hybrid effectiveness-implementation studies) focused on strategies to adopt and integrate evidence-based interventions that eliminate environmental health disparities and advance environmental health equity.

For applications proposing prospective interventions and implementation research, the use of implementation science frameworks is strongly suggested to promote acceptability, scalability, and sustainability.

National Institute of Mental Health (NIMH) Develop and test new mental health preventive, treatment, and services interventions and/or strategies for implementing interventions with established effectiveness, with a focus on social determinants of health (SDOH) as primary mechanisms. Develop and test multi-level mental health interventions that target social and structural determinants of mental health disparities.

Identify SDOH that mediate or moderate intervention and/or implementation effectiveness. Identify risk and protective SDOH that drive disparities in intervention and/or implementation outcomes. Investigate whether and to what extent financing mechanisms, policies, regulations, and healthcare system rules optimize patient-level outcomes, and identify mutable factors and policy interventions that can improve mental health outcomes.

All applications that propose clinical trials should follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www. nimh. nih.

gov/funding/opportunities-announcements/clinical-trials-foas/index. shtml ). That is, the scope of work should include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes.

In this manner, the results of the trial will advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation. Depending on the research question, a variety of methodologically rigorous approaches may be indicated.

For example, for studies that involve testing and comparing alternative strategies, designs may include randomized controlled trials (RCTs) and variants (e.g., stepped wedge cluster randomized trial designs), quasi-experimental designs with non-randomized comparison groups, time-series designs, and other designs of equivalent rigor and relevance.

Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes.

Accordingly, this NOFO encourages research studies that examine approaches that can be used to reduce disparities for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons,