The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is inviting research applications under the program titled “Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (R01 Clinical Trial Not Allowed).” This funding opportunity encourages research using advanced cellular models, including microphysiological systems, organoids, and other 3D cell models, to study HIV interactions with tissues relevant to NIDDK’s mission. The aim is to understand mechanisms of HIV persistence, latency, reactivation, and related pathologies in co-occurring conditions, enhancing knowledge in areas such as viral reservoirs, inflammatory processes, and tissue damage across organ systems affected by HIV.

Research proposals should focus on HIV/AIDS within the scope of NIDDK’s research areas, emphasizing HIV cure research, HIV comorbidities, and the specific biological challenges posed by HIV in organs like the gastrointestinal tract, liver, kidneys, and adipose tissue. The funding opportunity invites exploration of topics such as tissue-specific pathophysiological processes, unique drug targets, and interactions between organ systems influenced by conditions like obesity or antiretroviral-induced liver disease. The Office of Research on Women's Health (ORWH) may co-fund projects that focus on women’s health in relation to HIV, particularly research that enables sex or gender analyses or investigates the female genital tract using models like organ-on-a-chip.

The budget for this award allows up to $500,000 per year in direct costs, with a maximum project duration of five years. NIDDK expects to commit $3 million to fund approximately four awards in fiscal year 2026. Eligible applicants include higher education institutions, non-profit organizations, for-profit entities, local and federal government bodies, and foreign organizations. Submissions must comply with registration requirements in the System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code, eRA Commons, and Grants.gov, as well as NIH-specific mandates like the use of Data Management and Sharing Plans.

Applications must be submitted through ASSIST or Grants.gov by March 20, 2025, and must strictly follow the NIH Application Guide instructions. Letters of intent, while not mandatory, are requested by February 20, 2025, and should include essential project information and contact details for the principal investigator. Applications will undergo scientific merit review based on factors such as the significance, innovation, rigor, and feasibility of the research plan, as well as the expertise and resources available to the research team. Additional review will assess protections for human subjects, animal welfare, and biohazards if relevant.

Non-responsive applications, such as those focusing on areas outside NIDDK’s mission or relying solely on 2D culture models, will be administratively withdrawn. The review process includes initial peer review and a second level of review by an NIDDK Advisory Council. Successful projects will be subject to NIH award conditions, including adherence to NIH policies on data sharing, human subjects protection, and other regulatory guidelines.

Contact points for inquiries include program-specific scientific contacts for digestive diseases, kidney and urologic diseases, and metabolic diseases, as well as financial and submission support services. Recipients are expected to comply with all reporting and administrative requirements and must submit annual progress reports and financial statements, including final reports at project close.