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

The National Institute on Deafness and Other Communication Disorders (NIDCD), part of the U.S. Department of Health and Human Services through the National Institutes of Health (NIH), is reissuing its funding opportunity titled "Advancing HIV/AIDS Research within the Mission of the NIDCD (R21 Clinical Trial Optional)" under Funding Opportunity Number PAR-25-318. This initiative reflects updated priorities as of March 31, 2025, and aims to stimulate HIV/AIDS-related research in scientific areas that align with the NIDCD’s mission. These areas include hearing, balance, taste, smell, voice, speech, and language, particularly in the context of populations living with HIV (PLWH). This Notice of Funding Opportunity (NOFO) supports exploratory and developmental research proposals, including low-risk clinical trials, to advance knowledge and interventions concerning communication disorders in individuals affected by HIV/AIDS. Applications should address research priorities set by the NIH Office of AIDS Research (OAR), which encompass topics such as reducing HIV incidence, developing new therapies, addressing comorbidities, and enhancing basic and implementation science. Studies supported may include research on the effects of HIV infection or HIV treatment on communication functions, identification of medication side effects impacting sensory functions, or development of intervention strategies to mitigate communication disorders in PLWH. Eligible projects must be hypothesis-driven and may include basic, epidemiological, translational, or clinical research. Clinical trials supported by this NOFO must be low-risk, defined as trials not requiring FDA oversight and presenting minimal risk to participants. Trials that require Investigational New Drug or Device exemptions, or those that aim to change healthcare policy or standards, are not eligible under this R21 mechanism and should apply to a companion U01 opportunity. Multidisciplinary collaborations and leveraging of existing HIV/AIDS cohorts or clinical trials are encouraged to enhance the impact and feasibility of research proposals. The total allowable direct costs for the two-year project period cannot exceed $275,000, with a maximum of $200,000 in any one year. The project period must not exceed two years. Applications will follow NIH's standard submission and review cycles, with the earliest start date after peer and advisory council review being approximately six to seven months after submission. This opportunity is open to a wide range of applicants, including higher education institutions, nonprofit and for-profit organizations, small businesses, tribal governments, and foreign organizations. All applicants must complete specific registrations, including SAM, Grants.gov, and eRA Commons, before submitting an application. Key deadlines follow NIH’s AIDS-specific submission dates, with the next due dates falling on May 7, 2025; September 7, 2025; January 7, 2026; and continuing through November 16, 2027, before the opportunity’s expiration on November 17, 2027. Applications are submitted via ASSIST, Grants.gov Workspace, or institutional systems, and applicants must conform strictly to all requirements in the Application Guide and the NOFO itself. Non-compliant applications may be rejected. Evaluation criteria include scientific significance, innovation, feasibility of the approach, investigator qualifications, and institutional resources. Proposals must describe how they will impact the health of PLWH and address communication disorders. Applications undergo NIH's peer review system and must comply with data sharing, human subjects, and clinical trial registration policies. Contact information for scientific, financial, and technical assistance is provided, with designated contacts at NIDCD and NIH support desks available to assist applicants throughout the process.

Emphasize conceptual innovation and strong alignment with NIH HIV/AIDS priorities; focus on feasibility and investigator expertise.