Pragmatic Clinical Trials in Community Settings to Decrease or Prevent VCID Outcomes, Including in Populations that Experience Health Disparities (U01 Clinical Trial Required) | RFA NS 23 001

Opportunity Information: Apply for RFA NS 23 001

The NIH funding opportunity titled "Pragmatic Clinical Trials in Community Settings to Decrease or Prevent VCID Outcomes, Including in Populations that Experience Health Disparities (U01 Clinical Trial Required)" (RFA-NS-23-001) supports real-world, community-based clinical trials aimed at reducing or preventing harmful outcomes linked to vascular contributions to cognitive impairment and dementia (VCID). The central goal is to test practical interventions that can be implemented in everyday healthcare and community settings, rather than tightly controlled academic research environments, and to generate results that can translate quickly into routine practice. A major emphasis is placed on ensuring that trials include locally representative groups, particularly NIH-defined populations that experience health disparities in dementia, so that evidence produced is relevant to communities that are often underrepresented in research and disproportionately affected by dementia-related outcomes.

This FOA specifically calls for pragmatic clinical trials, meaning studies designed to evaluate interventions under typical conditions with broad eligibility criteria, operationally feasible workflows, and outcomes that matter clinically and to patients. Projects are expected to focus on strategies that reduce VCID risk or improve VCID-related outcomes through interventions that can realistically be delivered at scale in community settings such as primary care clinics, health systems, public health programs, senior centers, faith-based organizations, or other community-serving partners. Examples of responsive interventions named in the announcement include implementation approaches for blood pressure control, lifestyle modification programs that incorporate aerobic exercise, and efforts for early detection and treatment of VCID risk factors. The examples are not exhaustive, and applicants can propose other interventions as long as they have a clear, plausible pathway to decreasing or preventing negative clinical outcomes related to VCID.

The award mechanism is a U01 cooperative agreement, which indicates that NIH expects substantial involvement from program staff during the project. In practical terms, this typically means the research team will lead the work while NIH staff may collaborate on aspects such as study design refinement, milestone tracking, and coordination with broader NIH priorities in VCID research. Because this is a "Clinical Trial Required" opportunity, applications must include an actual clinical trial, not just planning activities or observational studies. The activity area is health, and the associated CFDA numbers listed are 93.853 and 93.866.

Eligibility is broad across U.S.-based organizations. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in that category); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types that align with community reach and equity-focused participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions.

At the same time, the FOA clearly limits foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible to apply. In addition, foreign components, as defined by the NIH Grants Policy Statement, are not allowed under this opportunity, which keeps the work fully within eligible U.S. organizational structures and locations.

Key administrative details from the source information include that the funding opportunity was created on 2022-06-16, with an original closing date of 2022-09-15. The listing does not provide an award ceiling or an expected number of awards in the provided text, but it does identify NIH as the sponsoring agency and confirms the discretionary nature of the program and the cooperative agreement funding instrument. Overall, the FOA is geared toward producing actionable, practice-ready evidence on interventions that reduce VCID burden in real community settings, with a strong and explicit focus on inclusion of populations experiencing dementia-related health disparities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pragmatic Clinical Trials in Community Settings to Decrease or Prevent VCID Outcomes, Including in Populations that Experience Health Disparities (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
• This funding opportunity was created on 2022-06-16.
• Applicants must submit their applications by 2022-09-15. (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.

Apply for RFA NS 23 001

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