Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk (R01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), through its National Institute of Allergy and Infectious Diseases (NIAID), has released a funding opportunity aimed at understanding the role of HIV-induced immunometabolic alterations in increasing the risk of tuberculosis (TB) and hepatitis B virus (HBV) in persons living with HIV. The initiative, titled "Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk (R01 Clinical Trial Not Allowed)," invites research proposals that investigate how combination antiretroviral therapy (cART)-suppressed HIV infection contributes to immune changes that may predispose individuals to TB and HBV progression. This R01 grant is positioned within the broader NIH objective of advancing biomedical research in infectious diseases and improving outcomes through deeper mechanistic understanding and translational application. This funding opportunity seeks to foster investigator-initiated research in immunometabolism—a field at the intersection of immune regulation and metabolic processes—by exploring how HIV reshapes the immune landscape and impacts the host response to co-infections. The initiative is rooted in epidemiological observations: people living with HIV are significantly more vulnerable to TB and HBV complications, even under effective viral suppression. Research is encouraged that examines multi-omic immune cell profiles, network-based analyses, and biomarker discovery related to co-infection risk. NIH emphasizes the importance of interdisciplinary approaches and suggests applicants consider including artificial intelligence or machine learning tools for data interpretation, and leveraging existing clinical samples where feasible. Award budgets under this opportunity are not capped but must be reasonable and commensurate with project needs. Each project can extend up to five years. Although no cost-sharing or matching is required, applicants requesting over $500,000 in direct costs in any year must contact the relevant NIH scientific officer at least six weeks before submission. Applications must be hypothesis-driven and supported by preliminary data. While clinical trials are not allowed under this specific R01 mechanism, laboratory-based studies that span from basic to translational research are eligible and encouraged. The application submission process must follow the NIH ASSIST system, Grants.gov Workspace, or institutional systems, all of which interface with eRA Commons for tracking. Proposals must conform strictly to both the NIH Application Guide and any program-specific requirements outlined in the NOFO. Submissions undergo peer review for significance, innovation, approach, and investigator qualifications, followed by council review. Applications that do not meet submission instructions may be delayed or rejected. Registration with SAM.gov, eRA Commons, and Grants.gov is mandatory for all applicants. This funding call has a recurring AIDS-specific submission cycle with deadlines on May 7, September 7, and January 7 annually, through 2028. The earliest submission date for the current round is April 7, 2025. Awards are expected to be issued starting December 2025 and through subsequent cycles. The updated expiration date for this opportunity is May 8, 2026, in accordance with NIH policy NOT-OD-26-029. The grant is open to a wide range of eligible entities, including higher education institutions, nonprofits, for-profit entities, government units, and foreign organizations, provided they meet all registration and eligibility requirements. Inquiries are encouraged and can be directed to scientific contact Dr. Josh Radke at josh.radke@nih.gov or grants management contact Robert Kirker at robert.kirker2@nih.gov. Technical support for submissions is available through eRA Commons and Grants.gov help desks. The NIH requires data management and sharing plans for all proposals and enforces strict compliance with human subjects, animal welfare, and biohazard regulations. Selected applicants will receive a Notice of Award upon approval, and awardees are subject to reporting requirements and NIH post-award monitoring policies.

Emphasize multidisciplinary collaboration, machine learning use, and robust immunometabolic models per NOFO guidance.