The National Institute of Diabetes and Digestive and Kidney Diseases invites research applications addressing HIV/AIDS-related topics within its mission under the Priority HIV/AIDS Research within the Mission of NIDDK (R01 Clinical Trial Optional) funding opportunity. This initiative supports research aligned with the NIH Office of AIDS Research priorities. It aims to address HIV/AIDS-related complications, co-infections, and comorbidities affecting organ systems such as the gastrointestinal tract, liver, pancreas, kidneys, and adipose tissue, as well as metabolic and endocrine functions. Basic, translational, and clinical research is encouraged, with a focus on mechanistic studies, interactions of HIV or its treatments with physiological processes, and the impacts of health-impeding social determinants of health on disease development and viral reservoirs.

Research projects may explore the pathophysiological pathways through which HIV or its treatments contribute to comorbidities, including metabolic and endocrine dysfunction, gastrointestinal immunity, viral reservoirs in tissues, and the role of social determinants of health in health outcomes. Topics of interest include interactions with the microbiome, co-infections such as hepatitis viruses, and obesity-related metabolic complications. Applications that focus on non-NIDDK-related organ systems, prioritize viral hepatitis over its pathogenic effects, or do not align with NIH HIV/AIDS priorities are deemed non-responsive and will not be reviewed.

Eligible applicants include higher education institutions, nonprofits, for-profit entities, government agencies, and foreign organizations. Both new and renewal applications are accepted, with budgets reflecting project needs. Funding is anticipated for three to five awards, totaling approximately $2 million in fiscal year 2026. The maximum project period is five years, with a flexible timeline depending on the scope of the proposed research.

Applications may include clinical trials, but trials are not required. Proposals must include plans for data sharing and management, as well as the use of common data elements to facilitate standardization and integration of research data. Applicants are encouraged to consult NIDDK staff early to ensure alignment with the institute's mission and research priorities.

Key submission dates include an open application date of April 8, 2025, with the first application deadline on May 7, 2025. Future deadlines follow NIH standard due dates. Applications must be submitted electronically via ASSIST, Grants.gov, or institutional systems. Compliance with all NIH policies and submission guidelines is mandatory, including the NIH Data Management and Sharing Policy.

The review process will evaluate significance, innovation, rigor, feasibility, investigator expertise, and resource adequacy. Additional considerations include protections for human subjects, budget justification, and the inclusion of diverse populations. For assistance, applicants can contact scientific or grants management officials listed in the funding announcement.