Understanding Persistent Oral Human Papillomavirus and Human Immunodeficiency Virus Co-infection and Its Role with Oropharyngeal Cancer Induction (R01 Clinical Trial Not Allowed) | RFA DE 24 001

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The grant opportunity "Understanding Persistent Oral Human Papillomavirus and Human Immunodeficiency Virus Co-infection and Its Role with Oropharyngeal Cancer Induction (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-DE-24-001) is a National Institutes of Health (NIH) discretionary research grant that seeks to fund mechanistic studies focused on why oral HPV infection becomes persistent in the context of HIV, and how that persistent co-infection contributes to the initiation and biological development (pathogenesis) of HPV-associated oropharyngeal cancers (HPV-OPC). The core scientific goal is to move beyond general associations and dig into the underlying biology of co-infection, including the factors that allow HPV to evade clearance in the oral cavity and the ways HIV-related immune changes may shape HPV persistence and cancer-relevant processes in oropharyngeal tissues.

This is an R01 mechanism, meaning it is geared toward substantial, hypothesis-driven research projects with clearly defined aims and a strong rationale, typically involving multi-year, multidisciplinary work. The NOFO explicitly states "Clinical Trial Not Allowed," which generally means the funding is intended for preclinical, translational, observational, or mechanistic research that does not meet NIH's definition of a clinical trial (for example, not prospectively assigning human participants to interventions to evaluate health-related outcomes). In practice, applicants would be expected to propose studies that might include laboratory-based experiments, analyses of clinical specimens, computational or immunologic profiling, or well-designed human subject research that remains non-interventional, as long as it directly targets the biological mechanisms behind persistent oral HPV in people with HIV and links those mechanisms to cancer induction.

The scientific focus is specifically on persistent oral HPV and HIV co-infection and its role in HPV-OPC. That emphasis signals interest in questions such as how immune suppression or immune dysregulation associated with HIV affects HPV infection dynamics in the oral/oropharyngeal environment, what viral or host factors predict persistence versus clearance, how co-infection influences local inflammation and immune surveillance, and what molecular events in infected epithelial cells might push tissue toward malignant transformation. Because the endpoint is "induction and pathogenesis" of HPV-associated oropharyngeal cancers, proposals would be expected to connect persistence to oncogenic progression, for example through pathways involving viral oncogene expression, host genomic instability, epithelial differentiation changes, or microenvironmental shifts that permit tumor initiation and progression.

The opportunity falls under the broad activity areas of education and health and is linked to CFDA numbers 93.121 and 93.393, indicating alignment with NIH-supported oral health/dental research and broader cancer or related biomedical research portfolios. While the notice does not list a specific award ceiling or number of expected awards in the provided data, it is structured as a competitive NIH research grant with the typical expectations of rigorous preliminary data (when appropriate), strong methodological detail, and a clear plan for how the proposed experiments will yield mechanistic insight rather than purely descriptive findings.

A wide range of organizations are eligible to apply. In addition to standard eligible applicant types such as state, county, city/township, and special district governments, public and private institutions of higher education, and independent school districts, eligibility includes federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations that are not federally recognized governments; nonprofits both with and without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional eligible applicant categories that NIH often calls out to encourage broad participation and inclusion, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; regional organizations; and non-U.S. entities (foreign organizations). This broad eligibility suggests NIH is open to domestic and international teams with the expertise and resources to study HIV/HPV co-infection and HPV-related oropharyngeal carcinogenesis, including settings where HIV burden is substantial and where persistent HPV infections may be more readily studied.

Key administrative details in the provided source data include the original application closing date of 2023-07-24 and a creation date of 2023-04-07. The sponsoring agency is the National Institutes of Health. Overall, the opportunity is centered on generating actionable biological understanding of why persistent oral HPV is more likely or more consequential in people living with HIV, and how that persistence contributes to the earliest steps and ongoing mechanisms of HPV-driven oropharyngeal cancer development, with the explicit boundary that funded projects must not be designed as clinical trials.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Understanding Persistent Oral Human Papillomavirus and Human Immunodeficiency Virus Co-infection and Its Role with Oropharyngeal Cancer Induction (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.393.
• This funding opportunity was created on 2023-04-07.
• Applicants must submit their applications by 2023-07-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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