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

The Priority HIV/AIDS Research within the Mission of NIDDK funding opportunity supports research aligned with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the overarching priorities set by the NIH Office of AIDS Research. This opportunity, funded through the National Institutes of Health (NIH), specifically invites research projects exploring HIV/AIDS-related topics that intersect with NIDDK's scope, including diabetes, digestive diseases, kidney and urologic conditions, nutritional disorders, and obesity. This initiative, cataloged under PAS-25-073, aims to advance scientific understanding and treatment of systemic complications of HIV and their effects on critical organ systems relevant to the NIDDK mission. The grant encourages proposals that investigate the mechanistic links between HIV infection and co-occurring conditions such as enteropathy, liver disease, diabetes, obesity, kidney and hematologic conditions, and complications arising from antiretroviral therapy. Projects are expected to delve into how HIV exacerbates or contributes to these conditions, exploring both the physiological and socio-environmental factors involved. For example, the impact of HIV-associated gastrointestinal dysfunction on systemic inflammation, and how this may lead to chronic diseases such as liver or metabolic disorders, is within scope. Additionally, researchers may explore how social determinants of health (SDoH)—such as food insecurity, stigma, and limited healthcare access—contribute to HIV-related comorbidities and influence disease progression or treatment outcomes. The funding opportunity welcomes basic, translational, and clinical research that enhances understanding of the interaction between HIV and NIDDK-relevant tissues and organ systems. Notably, it encourages studies targeting viral reservoirs in organs such as the gastrointestinal mucosa, male genital tract, kidney, and adipose tissue, with the goal of contributing to long-term HIV cure strategies. Investigations into the microbiome, mucosal immunity, metabolic/endocrine disruptions, and social/behavioral influences on health outcomes are also encouraged. The initiative supports diverse methodologies and interdisciplinary approaches that align with NIH’s HIV/AIDS research priorities, as outlined in NOT-OD-20-018. Applications proposing clinical trials are optional and may be included but are not required. The scope of the award allows for new applications, renewals, resubmissions, and revisions, with a maximum project period of five years. While application budgets are not limited, they must align with the actual needs of the proposed research. For FY2026, the NIDDK anticipates funding between three to five awards with a total program funding of $2 million. Projects with direct costs exceeding $500,000 in any one year must contact a program official at least six weeks before submission. The application process follows standard NIH submission protocols and can be completed via the NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution. All applicants must comply with the instructions in the SF424 (R&R) Application Guide. Required registrations include SAM.gov, eRA Commons, and Grants.gov, and the applicant institution must have appropriate accounts in place prior to submission. Applications are due by 5:00 PM local time of the applicant organization and will undergo NIH peer review procedures, with review dates and award cycles occurring three times annually through 2028. This Notice of Funding Opportunity remains open with recurring deadlines tied to the NIH’s AIDS submission calendar, with the next due date on May 7, 2025. The program is set to expire on November 6, 2027, unless reissued. The earliest project start dates range from December 2025 to April 2028, depending on the submission cycle. Investigators are encouraged to contact program officials in the relevant NIDDK divisions for guidance and are reminded to align proposals with the stated research priorities. Primary contacts include Khoa Dinhdang Nguyen (Digestive Diseases and Nutrition), Deepak Nihalani (Kidney, Urologic, and Hematologic Diseases), and Saul Malozowski (Diabetes, Endocrinology, and Metabolic Diseases).

Applicants are strongly encouraged to confirm project alignment with NIDDK mission early; Nonresponsive projects will be withdrawn without review.