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), under the Department of Health and Human Services (HHS), is reissuing a Notice of Funding Opportunity (NOFO) PAR-25-068 to solicit pilot studies that investigate biological, behavioral, and social mechanisms contributing to HIV pathogenesis, particularly within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This initiative aims to support exploratory and developmental research aligned with NIH HIV/AIDS research priorities, which emphasize the elucidation of comorbidities, coinfections, and complications (CCCs) associated with HIV. These priorities were last formalized by the Office of AIDS Research (OAR) in NOT-OD-20-018. The scope of research encouraged by this NOFO includes investigations into how HIV and its treatment influence NIDDK-relevant organs and systems. These include the gastrointestinal tract, liver, pancreas, kidneys, urologic and hematologic systems, and adipose tissue. Furthermore, projects may explore how these processes contribute to systemic inflammation, HIV reservoirs, and the development of chronic conditions like obesity and diabetes. Applications may focus on biological mechanisms, environmental influences, social determinants of health (SDoH), and other factors that may exacerbate or mitigate HIV-related outcomes within these systems. Key funding considerations include an award budget not exceeding $275,000 in direct costs over a two-year period, with no more than $200,000 allowed in any single year. The program does not accept applications proposing clinical trials. Instead, it seeks pilot projects employing human subjects, animal models, or non-identifiable biospecimens and data. The opportunity supports new and resubmission applications. Applications must be submitted through approved electronic systems such as NIH ASSIST, Grants.gov Workspace, or institutional system-to-system platforms, and applicants must comply with NIH’s data management, registration, and sharing policies. Eligible applicants span a broad array of entities including higher education institutions (both public and private), nonprofits, small and large businesses, local and state governments, tribal governments and organizations, public housing authorities, and some foreign components of U.S. organizations. However, non-domestic (non-U.S.) entities and their components are not eligible to apply. Foreign components, if involved, must be justified in accordance with NIH policy. The application timeline follows NIH standard AIDS-related due dates. Upcoming deadlines include May 7, 2025; September 7, 2025; and January 7, 2026, with scientific merit reviews occurring about two months later and earliest start dates ranging from December 2025 to July 2026. The program is recurring, and the next expected cycle after January 2026 will be in May 2026, with future cycles continuing through at least November 2027 based on currently published due dates. The program is set to expire on November 17, 2027. Evaluation criteria for submitted applications include significance and innovation of the proposed research, the rigor and feasibility of the approach, and the expertise and resources of the investigator and institution. Applications not adhering to submission instructions or that fall outside the NOFO's defined mission and priority scope will be withdrawn without review. Contacts for scientific inquiries differ by NIDDK division, with separate liaisons available for digestive, metabolic, and kidney research areas.

Emphasize scientific rigor and feasibility; Align proposals tightly with NIDDK mission areas; Highlight relevance to HIV/AIDS comorbidities and social determinants of health