PAR-22-132: Implementation Research to Reduce Noncommunicable Disease (NCD) Burden in Low- and Middle-Income Countries (LMICs) and Tribal Nations During Critical Life Stages and Key Transition Periods (R01 Clinical Trial Optional) – National Institutes of Health (.gov) – DC Initiative on Racial Equity
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Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)

National Eye Institute (NEI)

National Institute on Aging (NIA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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 Institute on Minority Health and Health Disparities (NIMHD)

National Cancer Institute (NCI)

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)

Funding Opportunity Title

Implementation Research to Reduce Noncommunicable Disease (NCD) Burden in Low- and Middle-Income Countries (LMICs) and Tribal Nations During Critical Life Stages and Key Transition Periods (R01 Clinical Trial Optional)

Activity Code

R01 Research Project Grant

Related Notices

NOT-TW-21-008 – Notice of Intent to Publish a Funding Opportunity Announcement for Implementation Research for Chronic Disease Prevention Across the Lifespan (R01 Clinical Trial Optional)

Funding Opportunity Announcement (FOA) Number

PAR-22-132

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.989, 93.399, 93.113, 93.866, 93.865, 93.867, 93.279, 93.307, 93.853, 93.242

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers (ICs), in collaboration with the Global Alliance for Chronic Diseases (GACD), invite applications for implementation research focused on addressing risk factors for common noncommunicable diseases (NCDs) in World Bank-defined low- and middle-income countries (LMICs) and American Indian/Alaska Native (AI/AN) Tribal Nation populations in the United States. This Funding Opportunity Announcement (FOA) supports innovative approaches to identifying, understanding, developing, and implementing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines. In addition, studies to advance dissemination and implementation research methods and measures into application are encouraged. Specifically, this FOA invites applications that propose interventions targeting critical life stages (e.g., infancy, childhood, adolescence, pregnancy, older adults) and key transitions between life stages to reduce health risk and/or enhance positive health and lifestyle behaviors.

All applications must be within the scope of the mission of one of the Institutes/Centers listed above (see “Components of Participating Organizations”). Applications will be accepted from US and World Bank-defined LMIC institutions only.

Posted Date

March 30, 2022

Open Date (Earliest Submission Date)

June 27, 2022

Letter of Intent Due Date(s)

30 days before receipt date.

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 27, 2022 Not Applicable August 10, 2022 November 2022 January 2023 April 2023

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.

Expiration Date

August 11, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Section I. Funding Opportunity Description

Purpose

The National Institutes of Health (NIH) participating Institutes and Centers (ICs), in collaboration with the Global Alliance for Chronic Diseases (GACD), invite applications for implementation research focused on addressing risk factors for common noncommunicable diseases (NCDs) in low- and middle-income countries (LMICs) and American Indian/Alaska Native (AI/AN) Tribal Nation populations in the United States. This Funding Opportunity Announcement (FOA) supports innovative approaches to identifying, understanding, developing, and implementing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines. In addition, studies to advance dissemination and implementation research methods and measures into application are encouraged. Specifically, this FOA invites applications that propose interventions targeting critical life stages (e.g., infancy, childhood, adolescence, pregnancy, older adults) and key transitions between life stages to reduce health risk and/or enhance positive health and lifestyle behaviors.

Applications will be accepted from US and LMIC institutions only. Eligible LMIC institutions are defined by the World Bank at the following link: datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups

Introduction

NCDs account for 60% of deaths globally where 8 in 10 deaths caused by NCDs occur in LMICs and marginalized communities. While NCDs account for the greatest loss of disability-adjusted life years (DALYs) around the world, research to study prevention and treatment are relatively under-resourced in LMICs and AI/AN Tribal Nation communities where the burden is increasing. The GACD was formed in 2010 in response to this concern and supports research and associated trainingto accelerate and improve prevention and treatment of NCDs in under-resourced environments.

The GACD represents 15 of the world’s largest funding agencies, including the NIH, and is the first alliance to specifically address NCDs. Collectively, GACD partner agencies provide over 80% of global public funding for health research and, since 2010, have supported 110 projects in the areas of hypertension, lung diseases, diabetes, mental health, cancer, stroke, and hypertension/diabetes intervention scale-up. GACD has supported 1,200 researchers at 300 institutions in 70 countries through investment of over US $220 million through its partner agencies. NIH has supported 11 GACD awards across these NCD domains and plans a new approach for cross-cutting, trans-NIH funding over the coming years.

This FOA is aligned with the overall GACD initiative to support implementation research to examine which interventions work, for whom, and under what circumstances. Projects may also address how interventions can be adapted and scaled up in ways that are feasible, acceptable, accessible, sustainable, and equitable in a given national context.

Implementation science is the study of the methods and strategies that enable research uptake into practice. Implementation science is especially relevant in LMICs, where it can help ensure that limited resources are invested in cost-effective interventions.

Implementation research is needed to account for the complexities of the systems in which interventions are implemented since other approaches often fail to address these. Results of implementation research support evidence-based policymaking that can build robust programs to improve public health. Additional information and resources on implementation research can be found on the GACD website.

Specific Challenge

Chronic NCDs, such as diabetes, cardiovascular disease, neurological disorders and stroke, respiratory diseases, certain cancers, and mental health disorders are the leading cause of morbidity and mortality in both LMICs and high-income countries (HICs), especially within AI/AN Tribal Nations. The COVID-19 pandemic has brought NCDs further into the spotlight, as the majority of those who have experienced severe illness and death have had one or more underlying NCDs. Reducing the burden of NCDs is therefore critical to building more resilient, equitable, and healthier societies.

The World Health Organization acknowledges the importance of adopting a life course approach as a conceptual framework when exploring the physical and social hazards that may impact health. A life course approach to NCDs may minimize the impact of exposure to known risk factors in early life through early adulthood and increase the likelihood of good health later in life, and potentially into the next generation, especially when considering maternal health during pregnancy.

A number of behavioral change interventions, as well as those that increase the health-promoting potential of environments and decrease risks associated with unhealthy environments, are effective in reducing, delaying, or preventing the risk of NCD onset or disease progression. However, research is lacking in how to integrate such interventions into communities and health systems, and/or how to target these interventions to specific life stages, especially in LMIC and other disadvantaged populations. Applicants responding to this FOA are invited to meet this challenge.

Research Objectives and Scope

Summary

The aim of this FOA is to invite applications for implementation research focused on addressing common NCD risk factors through interventions that improve health and/or enhance positive health and lifestyle behaviors at critical life stages (e.g., infancy,childhood, adolescence, pregnancy, older adults).

Responsive applications will:

  • build on a life course approach and focus on one or more critical life stage(s), or transitions between life stages;
  • focus on common NCD risk factors – exploring interventions known to prevent, or delay the onset or progression of, more than one NCD;
  • justify the choice of intervention(s) to be delivered during the selected life stage(s) and provide evidence of the intervention’s effectiveness and feasibility;
  • specifically address health equity, defined by the WHO as the absence of unfair, avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically or by other dimensions of inequality (e.g. sex, gender, ethnicity, disability, or sexual orientation);
  • address social determinants of NCDs in the relevant populations and assess culturally-tailored intervention strategies, including, for instance, studes that integrate Traditional ways of healing in AI/AN communities;
  • conduct research on multisectoral interventions that cut across health, environmental, social, and other sectors;
  • have an appropriate strategy for measuring implementation research and effectiveness outcomes, including stakeholder-relevant outcomes (e.g., functioning, health services use, and others);
  • demonstrate a commitment to stakeholder and community engagement;
  • provide opportunities for implementation research capacity building within project teams; and
  • demonstrate equitable partnerships and shared leadership between high-income country (HIC)/LMIC and/or non-Tribal Nation/Tribal Nation members of the project team, and between the project team and external stakeholders, including written letters of support from these groups and associated Institutional Review Boards (IRBs), as appropriate.

In addition, applicants are encouraged (though not required) to:

  • explore the implementation of interventions harnessing digital technology adaptations. [The GACD recently held a workshop focusing on best practices for planning and delivering sustainable and equitable digital health interventions for NCDs in LMICs and Indigenous communities. A summary report, which may assist with application planning, is available here].

NIH, through its partnership with GACD, is committed to supporting research undertaken through genuine multi-sectoral partnerships among diverse academics, policymakers, local authorities, for-profit institutions, non-profit organizations, and community groups from HICs, LMICs, and/or AI/AN Tribal Nations. Where possible, research questions should be driven by local stakeholders and other intended beneficiaries of the research project.

Applications proposing the following types of projects will NOT be considered responsive and will not be reviewed:

  • epidemiological cohort studies;
  • longitudinal studies that cannot feasibly be completed in the life cycle of the grant (limited to 5 years);
  • etiological work, mechanistic, or epidemiological research, unless an essential component of a focused study to develop implementation research approaches; and
  • clinical trials, validation studies, or intervention studies of the efficacy of a new pharmacological agent or behavioral intervention.

Study population and life course approach

The NIH, in partnership with the GACD, aims to improve health equity in LMICs or AI/AN Tribal Nation populations in the United States, with a focus on NCD prevention across the life course through targeted research during critical life stage(s) or transitions between life stages.

In all cases, the study population may include both people with existing NCDs, those without existing NCDs, or a combination of both, but the focus must be on addressing common NCD risk factors, such as depression, diabetes or impaired glucose tolerance, high cholesterol, high blood pressure, obesity, unhealthy diet, smoking, physical inactivity, and excess alcohol consumption. Applicants may propose implementation research focused on interventions that are implemented at the individual, family, community (e.g., work or school), population, and/or structural level. Applicants may also propose implementation research focused on NCD prevention in people living with HIV or other infectious disease comorbidities during critical life stages.

Evidence-based interventions

The research to be undertaken will focus on the implementation of one or more evidence-based interventions in preventing or reducing exposure to one or more common NCD risk factors.

Proposals might focus, for example, on the WHO Best Buys and/or other strategies and interventions (at a key life stage) that address: tobacco and nicotine avoidance; hypertension management, including reducing salt intake; limiting alcohol consumption, promoting regular physical activity, a healthy diet, and body weight; healthy sleeping patterns; clean air; and/or social and psychological well-being. Such strategies and interventions might focus on behavioral change and/or improving equitable access to resources necessary for health promotion.

Addressing health equity

Poverty, racism, ethnic discrimination, stigma, historical trauma, and other inequities are directly associated with detrimental health outcomes . All projects should consider the social determinants of health and discuss their potential impact on the effective implementation of the intervention(s). If there is a focus on a particular population (e.g. gender, race/ethnicity, Tribal Nation) then the reason for this should be justified.

In order to promote health equity, studies should aim to address differences in intervention access, uptake, and effectiveness in socially disadvantaged groups and develop strategies for reducing inequities. To facilitate this process at the data analysis stage, studies should be designed to address such differences (at a minimum, studies should capture sex/gender differences, though if feasible, a plan for capturing intersectional impacts on health outcomes should be included in the analysis strategy). Guidance for conducting sex/gender-responsive and intersectional research is available on the GACD call webpage.

Outcome measures

Inclusion of contextually-appropriate implementation research outcomes (e.g., uptake, acceptance, feasibility, cost, etc.) is key for driving appropriate assessment and potential scaling beyond the proposed research.

Where appropriate, outcomes should be measured in those targeted directly as well as others who are intended to benefit from the intervention (for example, the infants of mothers who received the intervention while pregnant, or the adult parents or grandparents of children who received the intervention).

Stakeholder and community engagement

For implementation research evidence to have a strong likelihood of being taken up into policy or practice and informing the scale up of effective interventions, it is vital that project teams engage the appropriate stakeholders, including decision makers such as policymakers, ministry officials, tribal leaders, IRBs, and non-governmental organization leaders, who can help sustain the project’s implementation, facilitate scale up, and use the knowledge generated from the project after the grant ends. Stakeholders also include end users and the direct beneficiaries of re


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