Pilot Interventions to Integrate Social Care and Medical Care to Improve Health Equity (R01 Clinical Trial Required) | RFA DK 22 038

Opportunity Information: Apply for RFA DK 22 038

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), is funding R01 pilot and feasibility clinical trials that test practical ways to integrate social care into routine medical care in order to improve health equity. The central idea is to support interventions that happen during a health care visit and that both (1) screen patients for adverse social determinants of health (SDoH), also described as social risks, and (2) respond to identified social needs by connecting patients (or caregivers) to concrete services. These services may be delivered through community-based social service organizations outside the clinic or through programs that are co-located within a health system. The opportunity is explicitly focused on building real-world, implementable approaches that health care settings can use to reduce disparities and improve outcomes for conditions within NIDDKs mission.

The trials supported under this announcement are meant to answer two main questions. First, applicants must evaluate whether screening for social risks and then implementing a referral, navigation, or linkage process is feasible and acceptable in the flow of a health care visit. In practice, this means testing whether the screening process is workable for staff and patients, whether patients are willing to disclose needs, whether workflows and documentation are sustainable, and whether referral mechanisms actually function as intended. Second, the studies must look for early signals that the intervention may improve both the targeted social risk or need itself and health outcomes relevant to NIDDK diseases. Examples of social needs named in the announcement include transportation barriers, housing instability, and food insecurity. On the health side, outcomes should align with NIDDK-relevant prevention or treatment areas (for example, diabetes-related measures, kidney disease outcomes, obesity-related outcomes, digestive disease outcomes, or nutrition-related endpoints, depending on the study population and setting).

A key feature of this funding opportunity is that it is designed for pilot and feasibility work rather than fully powered effectiveness trials. Applicants are not required to provide preliminary evidence that their intervention works. Instead, NIDDK is looking for rigorous early-stage clinical trial designs that can establish the groundwork for a later, larger trial. Successful projects will do more than test an idea in a controlled environment; they should begin to clarify what promising, equitable, and scalable integration of social and medical care looks like in everyday practice. This includes generating useful lessons about implementation in diverse health care settings, such as staffing models for navigation, referral completion strategies, partnerships with community organizations, and ways to reduce drop-off between screening and service uptake.

Health equity is the organizing goal of the announcement. NIDDK expects applicants to focus on pragmatic approaches that can reduce health disparities for communities that are often underserved or face structural barriers to care. The announcement specifically highlights individuals from racial and ethnic minority groups, rural populations, sexual and gender minority groups, and other socioeconomically disadvantaged and medically underserved communities. In effect, the program is prioritizing interventions that are intentionally designed with equity in mind, including the choice of setting, population, screening approach, referral pathways, and outcome measures that reflect real barriers to achieving good health.

This is a discretionary grant opportunity with a clinical trial requirement, meaning the proposed work must meet NIHs definition of a clinical trial and include prospective assignment to an intervention in order to evaluate effects on outcomes. The funding opportunity title is Pilot Interventions to Integrate Social Care and Medical Care to Improve Health Equity (R01 Clinical Trial Required), and the opportunity number is RFA-DK-22-038. The activity category is listed under Food and Nutrition, Health, with CFDA number 93.847. While an award ceiling is not specified in the provided data, the mechanism being an R01 indicates NIDDK is supporting substantial but time-limited pilot work that is still expected to be clearly scoped, measurable, and informative for future scale-up.

Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other applicant types. The announcement also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, and U.S. territories or possessions, reflecting an emphasis on reaching and partnering with institutions connected to the communities most affected by disparities.

Foreign participation is restricted. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by NIH policy) are not allowed. In other words, the applicant organization and the work supported by the award must be fully domestic under NIH rules.

The original closing date listed for this opportunity was October 19, 2023, and the posting creation date is February 13, 2023. Overall, the announcement is aimed at accelerating practical, clinic-embedded strategies that identify social needs during care encounters and actively connect patients to services, while collecting the feasibility, acceptability, and early outcome data needed to justify and design larger trials that can meaningfully advance health equity in NIDDK-related diseases.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Pilot Interventions to Integrate Social Care and Medical Care to Improve Health Equity (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2023-02-13.
• Applicants must submit their applications by 2023-10-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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