Implementation Research for Multi-morbidity Management in the Context of Non-communicable Diseases in Low- and Middle-Income Countries and US Tribal Populations (R61/R33 Clinical Trial Required)

The NIH’s "Implementation Research for Multi-morbidity Management in the Context of Non-communicable Diseases in Low- and Middle-Income Countries and US Tribal Populations" funding opportunity, with activity code R61/R33, supports implementation research to improve equitable, integrated, and effective care for people managing multiple long-term non-communicable diseases (NCDs) in low- and middle-income countries (LMICs) and American Indian/Alaska Native (AI/AN) communities in the U.S. This bi-phasic award structure is designed to support an initial one-year R61 phase to develop and finalize research and implementation protocols, with an optional transition to the R33 phase of up to four years for the broader study and scaling of implementation strategies. Applications must include both the R61 and R33 phases, with successful projects meeting R61 milestones required for R33 phase transition. The main goal of this funding is to encourage projects that develop patient-centered, culturally responsive interventions to address NCD multimorbidity, such as cardiovascular disease, diabetes, mental illness, and cancer, within LMIC and AI/AN populations. This NOFO places a strong emphasis on overcoming barriers to the widespread adoption and adaptation of evidence-based interventions and improving integrated, cost-effective care in resource-constrained settings. Responsive projects must address factors like health equity, stakeholder engagement, and context-specific adaptation to fit the unique social, political, and economic conditions of target populations. The program encourages the use of evidence-based frameworks, cultural sensitivity, and capacity-building for early-career researchers and local researchers in LMICs or AI/AN communities. Eligible applicants are U.S. and World Bank-defined LMIC institutions, with U.S.-based applicants required to include LMIC researchers as key personnel. The NIH strongly recommends that applicants form multidisciplinary teams, engage stakeholders, and prioritize partnerships with local governments, community leaders, and other relevant collaborators to ensure effective community engagement and support sustainable implementation. Applications should clearly outline how the research will address disparities in health outcomes, and equity-based adjustments in intervention delivery, and measure the interventions' effectiveness within the targeted populations. Applications are due on February 7, 2025, with additional submission windows in November 2025. Funding is contingent on NIH appropriations, with budgets based on project needs and no specified limit; however, requests over $500,000 in direct costs for any year require pre-application consultation with NIH contacts. NIH’s review criteria will assess the project’s significance, rigor, innovation, and feasibility. The scoring also considers the strength of partnerships, the equitable engagement plan, and the capacity-building components for both research staff and the targeted communities. For complete application preparation, applicants should follow specific NIH submission guidelines and include a milestone plan with well-defined, measurable outcomes for both project phases. Required documents include a detailed budget, data management and sharing plans, human subjects protection, and letters of support from collaborators. NIH contacts are available for applicant inquiries regarding eligibility, submission requirements, and program priorities, ensuring potential applicants can align their projects with the funding opportunity's scope and goals.