Understanding Oral Human Papillomavirus (HPV) Infection, Acquisition, and Persistence in People Living with HIV (R01 Clinical Trial Not Allowed) | RFA DE 22 003

Opportunity Information: Apply for RFA DE 22 003

The National Institutes of Health (NIH) released the grant opportunity "Understanding Oral Human Papillomavirus (HPV) Infection, Acquisition, and Persistence in People Living with HIV (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-DE-22-003. It is a discretionary grant using the R01 research project mechanism, and it sits in the Education and Health activity areas (CFDA/Assistance Listing numbers 93.121 and 93.393). The application due date listed for the original closing was November 18, 2021, and the funding notice does not specify an award ceiling or the expected number of awards in the provided source details.

The central goal of this funding call is to support research that clarifies how oral HPV behaves in people living with HIV, with a specific focus on the epidemiology and biology of oral HPV infection, how it is acquired, and why it persists. The initiative is aimed at building a more complete picture of risk, transmission patterns, and biological factors that influence whether oral HPV clears or becomes chronic in the context of HIV infection. A major emphasis is also placed on early, initiating mechanisms that may connect oral HPV infection to downstream outcomes such as HPV-associated oral and oropharyngeal cancers and HPV-related warts, specifically as these processes may differ in people living with HIV due to immune dysregulation and other HIV-related factors.

Because this is an R01 "Clinical Trial Not Allowed" opportunity, the intent is to fund mechanistic, observational, and other non-trial human subjects research and related laboratory, translational, or population-based studies that do not meet the NIH definition of a clinical trial. In practice, that typically means the research can involve human participants, clinical samples, cohort analyses, molecular and microbiological work, and other approaches to understand acquisition and persistence, but it should not be designed to prospectively assign an intervention to participants to evaluate its effects on health-related outcomes. The scientific framing also makes clear that the research should be tailored to the HIV context, meaning applicants are expected to address how living with HIV shapes oral HPV dynamics and the early steps leading to cancerous or wart-related disease pathways.

Eligibility is broad and includes many standard applicant types, such as state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; and small businesses. The notice also explicitly highlights additional eligible applicant groups and institution types, 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and Indian/Native American tribal governments that are not federally recognized. It also allows non-domestic (non-U.S.) entities, meaning foreign organizations can apply, which can be important for international HIV and HPV research collaborations and for studying diverse populations where oral HPV and HIV epidemiology may differ.

Overall, this opportunity is designed to move the field toward a clearer understanding of why oral HPV infection may be more common, more persistent, or more clinically consequential in people living with HIV, and to identify early biological and epidemiologic signals that link infection to HPV-associated oral and oropharyngeal cancers and warts. The expected outcome is stronger foundational knowledge that can later inform prevention strategies, screening approaches, and future intervention development, while keeping the funded work within the bounds of non-clinical-trial research under the R01 mechanism.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Understanding Oral Human Papillomavirus (HPV) Infection, Acquisition, and Persistence in People Living with HIV (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 2021-06-29.
• Applicants must submit their applications by 2021-11-18. (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.

Apply for RFA DE 22 003

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