Implementation Research on Noncommunicable Disease Risk Factors among Low- and Middle-Income Country and Tribal Populations Living in City Environments (R01 Clinical Trial Optional) | PAR 23 042

FAQs: NIH PAR 23-042 (GACD) - Urban NCD Risk Factor Implementation Research (R01)

1) What is NIH PAR 23-042 trying to fund?

PAR 23-042 supports R01 grant applications focused on implementation research that reduces risk factors for common noncommunicable diseases (NCDs). The main goal is to generate practical, decision-ready evidence that helps policymakers, public health leaders, health systems, and community organizations prevent and manage NCDs in real-world urban settings.

2) Is this opportunity about inventing new clinical interventions?

No. The emphasis is not on creating entirely new clinical interventions. The focus is on improving the adoption and effective real-world use of proven, evidence-based interventions, tools, policies, and guidelines.

3) What types of populations are prioritized?

The FOA centers on disadvantaged populations living in city environments, specifically: (1) people in World Bank-defined low- and middle-income countries (LMICs) and/or (2) American Indian and Alaska Native (AI/AN) Tribal Nation populations living in cities within the United States.

4) How does the FOA define "cities" or "urban environments"?

"Cities" is defined broadly. It includes formal urban centers as well as informal settlements, slums, and periurban areas. This reflects that infrastructure, health systems, and living conditions vary widely across urban settings.

5) What is the main research focus: clinical outcomes or implementation outcomes?

The FOA emphasizes dissemination and implementation (D and I) research. While projects should aim to reduce NCD risk factors in practice, a major theme is understanding and improving how evidence-based approaches are adopted, integrated, scaled, and sustained. This includes measuring and improving implementation outcomes such as reach, fidelity, acceptability, feasibility, equity, cost, penetration, and sustainability.

6) What does "implementation research" mean in this program?

In this context, implementation research means studying how to get evidence-based interventions, tools, policies, and guidelines used effectively in real-world settings. Projects are expected to address the practical challenges that prevent proven approaches from working at population scale in urban environments.

7) What kinds of barriers or "last mile" problems should applicants address?

The FOA highlights common barriers in urban settings such as limited access to primary care, fragmented services, affordability challenges, supply chain problems, workforce constraints, cultural and linguistic mismatches, stigma, competing policy priorities, and weak governance or data systems.

8) What stage of implementation is the FOA most interested in?

Applicants are expected to examine the difficult, real-world steps of moving from "what works" to what works at scale, including adoption, adaptation to local context, integration into existing services, scale-up beyond a pilot site, and sustainability after the study ends.

9) What is meant by "decision-ready evidence"?

"Decision-ready evidence" refers to results that are practical and actionable for real-world use, especially by policymakers, public health leaders, health systems, and community organizations who need clear guidance on what implementation approaches work, for whom, and under what conditions in urban settings.

10) What research approaches or strategies are encouraged?

The FOA encourages applicants to test strategies that improve uptake and long-term use of evidence-based approaches. Examples mentioned include task-sharing, training models, audit and feedback, decision support tools, community health worker integration, policy enforcement approaches, and financing and incentive models.

11) Does the FOA encourage work on dissemination and implementation methods and measurement?

Yes. A major theme is strengthening D and I methods and measurement. This can include studying which implementation strategies are most effective, how to measure key implementation outcomes, and how local context influences success or failure.

12) What implementation outcomes are specifically called out?

The FOA explicitly references outcomes such as reach, fidelity, acceptability, feasibility, equity, cost, penetration, and sustainability.

13) Are projects expected to be generalizable beyond a single city or site?

The FOA signals interest in projects that are locally useful while also being generalizable enough to inform future implementation efforts in other urban settings facing similar constraints.

14) What is the grant mechanism used for this opportunity?

This announcement is structured as an NIH R01 mechanism.

15) What does "Clinical Trial Optional" mean here?

"Clinical Trial Optional" means the project may include a clinical trial component, but it is not required. This is intended to fit implementation research, where the most appropriate design depends on the setting and the question.

16) What study designs are compatible with this FOA?

The FOA notes that implementation research designs can include pragmatic trials, cluster randomized studies, stepped-wedge designs, mixed-methods evaluations, and quasi-experimental approaches, depending on what is realistic and informative in the target setting.

17) What is the expected end result or payoff of funded projects?

The intended payoff is evidence that guides real-world policy and practice to improve prevention and management of NCDs by reducing exposure to key risk factors and strengthening the systems that deliver effective interventions in disadvantaged urban settings.

18) Who can apply (in general terms)?

Eligibility is broad and includes many organization types positioned to do community- and system-focused work, including government entities, higher education institutions, tribal governments and organizations, housing authorities, nonprofits, for-profits (other than small businesses), small businesses, and other entities.

19) What government entities are listed as eligible applicants?

Eligible government applicants include state, county, and city or township governments, as well as special district governments and independent school districts.

20) Are universities and colleges eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible. The FOA also highlights several categories of serving institutions (for example, HBCUs, TCCUs, and Hispanic-serving Institutions).

21) Are Tribal Nations and Tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are eligible, as are tribal organizations other than federally recognized tribal governments. The FOA also highlights Tribally Controlled Colleges and Universities (TCCUs).

22) Are community-based or faith-based organizations eligible?

Yes. The FOA explicitly highlights faith-based or community-based organizations as additional eligible applicants.

23) Are nonprofits eligible even if they do not have 501(c)(3) status?

Yes. The eligible applicant list includes nonprofits with or without 501(c)(3) status.

24) Are for-profit organizations or small businesses eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.

25) Are non-U.S. organizations allowed to apply?

Yes. The FOA explicitly highlights non-U.S. entities (foreign organizations) as eligible applicants.

26) Are U.S. territories or possessions included?

Yes. The FOA explicitly highlights U.S. territories or possessions as additional eligible applicants.

27) Why does this FOA emphasize partnerships across sectors?

The FOA reflects that implementation research in cities often requires partnerships across universities, health systems, public agencies, and trusted community organizations, including organizations rooted in Tribal and underserved communities.

28) What role does context play in projects funded under this FOA?

Context is central. The FOA encourages studying how local conditions influence implementation success or failure, and how interventions can be adapted to fit local systems, cultures, languages, governance realities, and resource constraints.

29) What kinds of urban health system challenges does the FOA want projects to tackle?

The FOA points to challenges such as fragmented services, limited access to primary care, affordability barriers, supply chain weaknesses, workforce constraints, and weak governance or data systems.

30) What is the connection to the Global Alliance for Chronic Diseases (GACD)?

This NIH Funding Opportunity Announcement (PAR 23-042) was developed in collaboration with the Global Alliance for Chronic Diseases (GACD) and aligns with a focus on implementation research to reduce NCD risk factors.