Advancing HIV/AIDS Research within the Mission of the NIDCD (R01 Clinical Trial Optional)

The "Advancing HIV/AIDS Research within the Mission of the NIDCD (R01 Clinical Trial Optional)" grant opportunity represents a targeted initiative by the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the U.S. Department of Health and Human Services' National Institutes of Health (NIH). This funding mechanism, under announcement number PAR-25-319, seeks to stimulate research that intersects high-priority HIV/AIDS investigations with the scientific mission areas of the NIDCD. It specifically encourages exploration into how HIV/AIDS affects hearing, balance, taste, smell, voice, speech, and language. This grant is a reissue of PAR-23-099 and aligns with the latest strategic directions of the NIH Office of AIDS Research. This NOFO is open to a broad range of research types, including hypothesis-driven epidemiological, basic, translational, and clinical studies. It supports projects that examine the impact of HIV/AIDS and related treatments on communication disorders in populations living with HIV (PLWH). Investigators are encouraged to focus on research related to the acute and chronic effects of HIV and its treatments on communication mechanisms, including both sensory and expressive aspects. Only low-risk clinical trials that do not require FDA oversight, carry minimal risk, and are not designed to change standard of care policies are permitted under this opportunity. Applications for clinical trials exceeding these parameters will be considered non-responsive and directed to a separate cooperative agreement mechanism (PAR-25-318). Eligible entities for this funding include a wide array of domestic and foreign organizations, such as higher education institutions (both public and private), non-profits, small and large businesses, state and local governments, tribal entities, school districts, housing authorities, and international applicants. Applicants must complete registrations with SAM.gov, eRA Commons, and Grants.gov, among others. Principal Investigators must also have eRA Commons accounts. Applications may be submitted via NIH ASSIST, institutional systems, or Grants.gov Workspace. The application process officially opens on April 7, 2025. For the HIV/AIDS cycle, applications are due on a recurring basis: May 7 and September 7 in 2025, and continuing in January, May, and September through January 2028. All submissions must be made by 5:00 PM local time of the applicant organization. The current expiration date for this NOFO is May 8, 2026, in accordance with recent NIH notice NOT-OD-26-029. Submitted applications will undergo peer review to assess significance, innovation, rigor, feasibility, and investigator qualifications. Criteria specific to this NOFO include the project’s potential impact on the health and well-being of PLWH. The award budget is capped at $499,999 in direct costs per year, with a maximum project period of five years. The number of awards made depends on NIH appropriations and the quality of applications received. Cost sharing is not required. Applications must comply with all requirements outlined in the NOFO and the NIH Application Guide, and must include a Data Management and Sharing Plan in accordance with NIH policy. Upon selection, recipients will be issued Notices of Award outlining expectations, which include data and safety monitoring for clinical trials and adherence to relevant human subjects and biohazards policies. Questions about the funding opportunity should be directed to Dr. Trinh T. Ly (trinh.ly@nih.gov, 301-435-4085) for scientific matters, and to Samantha Tempchin (samantha.tempchin@nih.gov, 301-435-1404) for financial or grants management issues. Additional support contacts include Grants.gov and the eRA Service Desk. This funding opportunity plays a critical role in advancing the understanding and treatment of communication disorders in people affected by HIV/AIDS, with the ultimate aim of improving quality of life and public health outcomes.