Pilot Studies of Biological, Behavioral and Social Mechanisms Contributing to HIV Pathogenesis Within the Mission of NIDDK (R21 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is inviting applications for the reissued funding opportunity titled "Pilot Studies of Biological, Behavioral and Social Mechanisms Contributing to HIV Pathogenesis Within the Mission of NIDDK (R21 Clinical Trial Not Allowed)." This Notice of Funding Opportunity (NOFO), numbered PAR-25-068, supports exploratory and developmental research projects aligned with NIDDK’s mission areas, such as diabetes, digestive diseases, kidney disorders, nutrition, and obesity, within the context of HIV/AIDS. The research must also align with the NIH Office of AIDS Research (OAR) priorities as outlined in NOT-OD-20-018. The primary aim of this opportunity is to foster pilot studies that enhance understanding of HIV pathogenesis and related complications within tissues and systems relevant to the NIDDK. Areas of interest include comorbidities and complications (CCCs) such as gastrointestinal issues, liver disease, obesity, and kidney conditions, particularly how these are influenced by HIV or its treatments. Special attention is given to mechanisms driving HIV-related inflammation and reservoir persistence within relevant tissues, including the gastrointestinal tract, male genital tract, adipose tissue, and kidney. Additionally, the NOFO emphasizes the investigation of health-impeding social determinants of health (SDoH), such as food insecurity, discrimination, and poor access to care, which may exacerbate HIV-related health outcomes and affect reservoir dynamics. Eligible projects may be basic or translational in nature and can include human subjects research, animal models, or studies using non-identifiable biospecimens. Clinical trials are not permitted under this NOFO. Applicants considering clinical trials should consult PAS-25-102 instead. The scope of funding includes studies related to immunology, microbiome research, viral co-infections, and behavioral or environmental factors influencing HIV outcomes within the NIDDK domain. This opportunity is open to a wide range of U.S.-based entities, including higher education institutions, nonprofit organizations, government bodies at all levels (local, state, tribal, and federal), and for-profit entities, including small businesses. Foreign institutions are not eligible to apply, although foreign components of U.S. organizations may be included. Applicants must complete all necessary registrations (e.g., SAM, eRA Commons, Grants.gov) well in advance of submission. Applications are due on standard NIH AIDS application dates, starting May 7, 2025, and repeating on a set annual schedule through at least November 2027. The earliest date to submit an application is April 7, 2025. All applications must be submitted electronically using one of the NIH-supported systems such as ASSIST or Grants.gov Workspace. Applications must comply with standard NIH formatting and submission protocols, and incomplete or noncompliant submissions will not be reviewed. The total project budget cannot exceed $275,000 in direct costs over a two-year period, with no more than $200,000 allocated in any one year. Cost sharing is not required. The review process will evaluate the importance of the proposed research, scientific rigor, feasibility, investigator expertise, and resource adequacy. Applications will undergo a two-level peer review process, and awards will be contingent on NIH appropriations and the availability of meritorious applications. For program-specific questions, applicants may contact division-specific program officers listed in the NOFO.

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