The Department of Health and Human Services, through the NIH, has issued a funding opportunity titled "Early Stage Investigator HIV/AIDS Research Using Nonhuman Primate (NHP) Models (R21 Clinical Trial Not Allowed)." This initiative, reissued as PAR-25-165, seeks to support Early Stage Investigators (ESIs) who are within ten years of obtaining their terminal degree or completing residency and have at least two years of postdoctoral experience. The goal is to promote preclinical HIV/AIDS research utilizing NHP models, enabling ESIs to develop independent research directions and position themselves for subsequent funding opportunities such as R01 grants. This opportunity aligns with the NIH’s FY 2021–2025 Strategic Plan for HIV and HIV-Related Research, targeting priorities such as reducing HIV incidence, developing next-generation therapies, researching cures, addressing comorbidities, and advancing cross-disciplinary research.

This grant emphasizes the use of NHPs due to their physiological similarities to humans, making them ideal for HIV/AIDS research. Applicants are encouraged to propose projects with direct translational potential to human studies. Examples include research on vaccines, therapeutic agents, biomarkers, and interventions targeting viral reservoirs. NIMH is particularly interested in studies addressing HIV-associated CNS diseases, biomarkers of CNS complications, and eradication strategies for CNS viral reservoirs. Applications focusing on peripheral reservoirs or outside the scope of antiretroviral therapy are deemed non-responsive.

Eligible applicants include U.S.-based higher education institutions, nonprofits, and for-profit organizations. Foreign organizations are ineligible. Applicants must have an appointment at or documented collaboration with an NHP research facility capable of providing the required animals, facilities, and resources. Each proposal must clearly describe the relevance of the research to preclinical HIV/AIDS translational goals and detail the resources and expertise supporting the project.

The funding allows a maximum budget of $200,000 in direct costs annually, with a total cap of $400,000 for up to two years. Preliminary data are not required for R21 applications, but strong conceptual frameworks and innovative approaches are emphasized. Applications will be evaluated on factors including significance, innovation, approach, and investigator qualifications. Institutional support and resource availability will also be assessed, especially for proposals involving complex NHP research.

Key dates for submission include an opening date of April 7, 2025, with the first due date for applications being May 7, 2025. Subsequent deadlines follow NIH’s AIDS application cycle. Applicants must ensure registrations with required systems such as SAM, Grants.gov, and eRA Commons are completed well in advance. Applications must comply with NIH policy requirements, including those for data sharing and vertebrate animal research.

This funding opportunity aims to bridge gaps for ESIs in the HIV/AIDS field, enabling impactful research that leverages the unique capabilities of NHP models. Interested applicants are advised to review the full NOFO and consult NIH contacts for programmatic and administrative guidance.