Priority HIV/AIDS Research within the Mission of NIDDK (R01 Clinical Trial Optional)

The Priority HIV/AIDS Research within the Mission of NIDDK (R01 Clinical Trial Optional) grant, issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the National Institutes of Health (NIH), supports research aligned with NIH HIV/AIDS research priorities. This Notice of Funding Opportunity (NOFO), PAS-25-073, was developed to encourage new, renewal, resubmission, or revision applications that focus on understanding and addressing the systemic complications of HIV/AIDS within the scope of NIDDK's research mission. It reflects the ongoing commitment of NIH to integrate HIV/AIDS research across disciplines such as metabolic, endocrine, digestive, kidney, urologic, and hematologic diseases. The funding opportunity invites research that targets HIV-associated comorbidities, coinfections, and complications (CCCs) such as enteropathy, liver diseases, obesity, diabetes, and kidney issues. It emphasizes the importance of investigating pathophysiological mechanisms, interactions between HIV or its treatment and physiological processes, and the impact on the gastrointestinal and penile microbiomes. A particular focus is placed on understanding HIV reservoirs within NIDDK-relevant tissues, including gastrointestinal mucosa, the male genital tract, kidneys, and adipose tissue. These investigations are vital for developing strategies aimed at HIV cure or achieving sustained viral remission without lifelong antiretroviral therapy. The NOFO encourages both basic and applied research, including translational and clinical studies. Projects may explore how HIV affects gastrointestinal immunity and inflammation, metabolic/endocrine functions, and the impact of ART on relevant organ systems. It also supports studies on the biological, environmental, behavioral, and social factors that influence health outcomes in people with HIV. In particular, researchers are encouraged to investigate how social determinants of health—such as food insecurity, housing instability, discrimination, stigma, and inadequate access to care—exacerbate HIV-related complications or impact HIV reservoirs. Eligible applicants include a wide array of U.S.- and non-U.S.-based organizations, including higher education institutions, nonprofits, for-profits, tribal entities, local and state governments, and foreign organizations. There are no restrictions on the number of applications an institution may submit, provided each proposal is scientifically distinct. Projects proposing clinical trials are accepted but not required. Applicants requesting over $500,000 in direct costs in any year must contact NIH staff at least six weeks prior to submission. Applications must be submitted electronically via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. All proposals must adhere strictly to the NIH application guidelines, including the Research (R) Instructions, with additional specific requirements for data sharing and protection of human subjects when applicable. No pre-application materials (like LOIs) are required for this opportunity. Applications are accepted on a recurring cycle, with HIV/AIDS-related submissions due on May 7, September 7, and January 7 annually through January 2028. The earliest submission date is April 8, 2025, and the funding opportunity is set to expire on May 8, 2026. Scientific review and advisory council evaluations follow each deadline, with award announcements expected approximately six months after submission. Awards may be up to five years in length, with no preset budget ceiling, and a total estimated $2,000,000 allocated in fiscal year 2026 to fund approximately 3 to 5 awards.