Advancing HIV/AIDS Research within the Mission of the NIDCD (R21 Clinical Trial Optional)

The Advancing HIV/AIDS Research within the Mission of the NIDCD (R21 Clinical Trial Optional) grant, reissued under funding opportunity number PAR-25-318, is offered by the U.S. Department of Health and Human Services through the National Institutes of Health (NIH) and specifically managed by the National Institute on Deafness and Other Communication Disorders (NIDCD). The R21 mechanism supports early-stage, exploratory, and developmental research projects and offers a unique opportunity to stimulate high-priority HIV/AIDS research in relation to communication disorders, including hearing, balance, taste, smell, voice, speech, and language. This initiative reflects the NIH Office of AIDS Research’s strategic priorities and is open to projects that align both with these and NIDCD's scientific mission. The overarching purpose of this opportunity is to expand understanding of how HIV/AIDS and its treatment impact communication disorders, with the ultimate goal of informing treatment and prevention strategies for people living with HIV (PLWH). The scope of this research includes studies of the effects of HIV infection, treatment regimens, and co-infections on sensory and communication processes across the lifespan. Specific areas of inquiry might include pathophysiological pathways, medication side effects, and epidemiological trends among affected populations. Multidisciplinary collaboration and leveraging of existing HIV/AIDS research cohorts and clinical trials are strongly encouraged. For applications proposing clinical trials, only those deemed "low risk" are permissible under this announcement. These trials must not require FDA oversight (i.e., no Investigational New Drug or Device Exemptions) and should pose minimal physical or psychological risk to participants. The intent of such trials should be to inform future research directions rather than directly alter standard care or policy. Studies not meeting this low-risk definition must instead apply through the U01 NOFO PAR-25-319. Funding under this program may not exceed $275,000 in direct costs over a two-year project period, with no more than $200,000 allowed in a single year. NIH grants policy applies to all awards, and applications may be submitted as new, renewal, resubmission, or revision projects. The total number of awards is contingent on the availability of funds and the quality of submissions received. Eligible applicants include a broad range of U.S.- and foreign-based entities, such as higher education institutions, nonprofits, small and large businesses, state and local governments, tribal organizations, and certain international organizations. All applicants must be appropriately registered with systems such as SAM, eRA Commons, and Grants.gov before submission. Principal Investigators must also have eRA Commons credentials. The application process includes submission through NIH ASSIST, Grants.gov Workspace, or institutional S2S systems. No pre-application is required. Applications are accepted only for AIDS-related research on standard NIH AIDS deadlines, with the next due date being May 7, 2026. The funding opportunity is recurring, with additional cycles through January 2028. Review and award cycles follow standard NIH timelines, and the earliest possible award start date is approximately seven months after submission. Specific questions may be directed to Trinh T. Ly, MD ([email protected]) for scientific inquiries, or Samantha Tempchin ([email protected]) for financial matters.

Demonstrate alignment with both NIDCD mission and OAR HIV/AIDS research priorities; collaborative approaches are encouraged.