Intervention Research to Improve Native American Health (R01 Clinical Trial Optional)

The Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) is a reissued funding opportunity from the National Institutes of Health (NIH), under Funding Opportunity Number PAR-25-379. It is supported by numerous NIH Institutes and Centers including, but not limited to, the National Institute on Drug Abuse (NIDA), National Institute on Aging (NIA), National Cancer Institute (NCI), and others. The primary aim of this initiative is to support research on culturally appropriate interventions that improve health outcomes in Native American, Alaska Native, and Native Hawaiian communities. The grant encourages etiologic research that informs interventions, development and testing of health-related interventions, and dissemination and implementation research for scaling effective practices. This opportunity seeks to address longstanding health disparities within Native communities by funding research that acknowledges and incorporates Indigenous Knowledge, community values, and resilience. Applicants are expected to engage communities throughout the research process, ensuring cultural relevance and sustainability. Proposals may address a wide range of health outcomes including chronic disease, addiction, mental health, and infectious diseases, with an emphasis on adaptability for scale-up in other tribal communities. Applicants must demonstrate clear community engagement, including evidence of support from tribal organizations or communities, and must detail collaborative structures such as community advisory boards. Intervention designs should be scalable and sustainable, ideally aligning with existing programmatic infrastructure like Medicaid or Indian Health Services. Qualitative methods and mixed-methods approaches are encouraged to capture culturally significant factors and contextual influences. Applications must follow the NIH standard submission process via ASSIST, Grants.gov Workspace, or institutional systems, and adhere strictly to NIH application instructions. Application budgets are not capped but must reflect project needs. Projects may span up to five years. If direct costs exceed $500,000 in any year, applicants must contact NIH at least six weeks in advance. Clinical trials are optional but must meet NIH rigor standards if proposed. Key dates include an open date of September 21, 2025, with recurring application deadlines on October 21 annually through 2026. Applications undergo NIH’s two-level review process, and awards will be made contingent on merit and appropriations. Scientific inquiries can be directed to NIH contacts specific to each participating institute listed in the NOFO. The funding initiative also has a companion planning grant under PAR-25-378. Additional application components include a required Data Management and Sharing Plan and, if applicable, community and tribal resolutions of support.

Engage community partners early Include culturally appropriate and Indigenous Knowledge-based components Justify intervention and comparison group design in community context Review critical considerations document for Native research