Multidisciplinary Studies of HIV/AIDS and Aging (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), under the U.S. Department of Health and Human Services, has issued a Notice of Funding Opportunity (NOFO) titled "Multidisciplinary Studies of HIV/AIDS and Aging (R01 Clinical Trial Optional)" aimed at supporting research at the intersection of HIV and aging. The initiative is driven by the increasing number of individuals living with HIV who are aged 50 and above, projected to exceed 70% of HIV-positive adults by 2030. This demographic shift is largely due to the success of antiretroviral therapy (ART), which has extended the lifespan of HIV-positive individuals, and new infections among older adults. The initiative is supported by numerous NIH Institutes and Centers, such as the National Institute on Aging (NIA), National Institute of Mental Health (NIMH), National Cancer Institute (NCI), among others, with co-funding potential from the Office of Research on Women’s Health (ORWH). The purpose of this NOFO is to advance the understanding of biological, clinical, and socio-behavioral aspects of aging within the context of HIV infection and treatment. It also seeks to improve strategies for the prevention, testing, treatment, and management of HIV-related comorbidities, co-infections, and complications. Proposals must align with the Office of AIDS Research (OAR) priorities as detailed in NOT-OD-20-018. The funding supports multidisciplinary research including human studies, animal models, and in vitro work that demonstrate relevance to clinical features of HIV/AIDS and aging. A special emphasis is placed on including older participants, particularly those aged 70 and above, and on addressing outcomes meaningful in geriatric care, such as physical function, cognitive decline, and quality of life. Applicants are encouraged to utilize existing NIH-supported resources such as observational studies, clinical networks, and research centers. The NOFO emphasizes robust control selection, characterization of phenotypes in aging HIV populations, and exploration of innovative approaches even in the absence of preliminary data. The participating NIH components each outline specific areas of interest, such as alcohol use among people living with HIV (PLWH) (NIAAA), oral health complications (NIDCR), comorbidities and organ-specific effects (NIDDK), and neurological impacts (NINDS), among others. The NOFO allows for new, renewal, resubmission, and revision applications, with a maximum project duration of five years. Budgets are not capped but must be justified by the scope of the project. While clinical trials are optional, specific institutes like NIAMS and NIDCR will not support them under this announcement and direct investigators to institute-specific funding opportunities. Applications involving human subjects must meet strict NIH protocols, including data safety monitoring and appropriate Institutional Review Board approvals. The opportunity was posted on January 8, 2025, and opened for submission on April 7, 2025. Due dates for AIDS-related applications fall on May 7, September 7, and January 7 annually, with the earliest potential start date ranging from December 2025 to July 2027, depending on the cycle. Though the NOFO originally had an expiration date of January 8, 2027, it was shortened to January 8, 2026, per NOT-AG-26-002. Despite the expiration, late or continuous submissions may still be accepted on a case-by-case basis under NIH policies. Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution, with tracking managed via eRA Commons. Registrations for SAM, UEI, eRA Commons, and Grants.gov are mandatory. Contacts for program and financial inquiries span the involved NIH Institutes, with lead contacts including Candice Beaubien at NIA for scientific questions and Mitchell Whitfield for financial inquiries. Applications must comply with NIH’s data management and sharing policy, and those exceeding $500,000 in direct costs per year must coordinate with NIH staff at least six weeks prior to submission.