Opportunity Information: Apply for RFA DK 25 021
Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (R01 Clinical Trial Not Allowed) is an NIH research grant opportunity (Funding Opportunity Number RFA-DK-25-021) that supports projects aimed at building, refining, and applying advanced human-relevant cellular systems to better understand how HIV interacts with tissues and biological processes that fall under the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The central emphasis is on physiologically realistic models that capture key features of normal human biology, especially next-generation platforms such as microphysiological systems (often called "organ-on-a-chip" approaches), organoids, and other three-dimensional cellular or tissue models. The intent is to move beyond simplified culture systems and use models that can more faithfully reproduce tissue architecture, multicellular interactions, and functional biology relevant to HIV persistence and HIV-associated disease processes in NIDDK-related organ systems.
The scientific goals focus on HIV pathogenesis in contexts that matter to NIDDK, with projects expected to explore how HIV establishes and maintains persistence, how latency is created and sustained, what triggers reactivation, and what mechanisms might enable eradication or durable control. In addition to direct viral biology, the NOFO highlights interest in pathological processes that contribute to co-occurring conditions, meaning applicants can propose studies that link HIV infection or HIV-related inflammation and immune dysfunction to downstream tissue injury or chronic complications within NIDDK areas. In practice, this can include mechanistic work on how HIV or HIV-driven immune signaling affects metabolic pathways, gut and liver biology, pancreatic function, kidney tissue integrity, or other relevant physiological processes, as long as the proposal remains anchored in strong cellular modeling and clear relevance to NIDDK mission priorities.
This is an R01 mechanism, which typically supports substantial, hypothesis-driven or technology-enabling research programs, and it is explicitly "Clinical Trial Not Allowed," meaning the funded work must be non-clinical-trial research rather than interventional studies in human participants. The funding instrument type is a grant, categorized under discretionary funding, and the activity category is listed under food and nutrition and health. The opportunity references CFDA numbers 93.313 and 93.847, aligning it with NIH/NIDDK-related assistance listings. The posted award ceiling is $500,000, indicating an upper bound on the funding level anticipated per award under this announcement (with final budgets generally depending on NIH policies, project scope, and negotiated needs).
Eligibility is broad and includes many organization types across the public, private, nonprofit, and academic sectors. Eligible applicants include state, county, and city governments; 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other categories. The NOFO also explicitly calls out additional eligible applicants such as 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 non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility is meant to encourage participation from diverse institutions and communities with relevant expertise in HIV biology, tissue modeling, and NIDDK-related disease research.
Key dates and administrative details include a creation date of September 16, 2024, and an original application closing date of March 20, 2025. The sponsoring agency is the National Institutes of Health. While the posting lists "ExpectedAwards" without a specific number in the provided text, applicants should generally interpret that as meaning NIH anticipates making one or more awards depending on the quality of applications and availability of funds.
Overall, this NOFO is designed for researchers who can credibly recreate aspects of human tissue physiology in vitro and use those systems to answer hard questions about HIV persistence and HIV-driven pathology in organ systems relevant to diabetes, digestive diseases, nutrition, and kidney disease. Competitive applications will typically present a strong rationale for why the chosen cellular model is necessary and superior for the specific biological questions posed, a clear plan to validate that the model reflects meaningful features of human physiology, and well-defined mechanistic endpoints tied to viral persistence, latency, reactivation, eradication strategies, or the biology of HIV-associated comorbidities within NIDDK mission areas.Apply for RFA DK 25 021
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (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): 93.313, 93.847.
- This funding opportunity was created on 2024-09-16.
- Applicants must submit their applications by 2025-03-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- 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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Frequently Asked Questions (FAQs)
What is the name and funding opportunity number for this grant?
The opportunity is titled Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (R01 Clinical Trial Not Allowed). The Funding Opportunity Number is RFA-DK-25-021.
Which agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), with scientific relevance centered on the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What type of award mechanism is this?
This is an NIH R01 research grant mechanism, intended to support substantial research programs that are hypothesis-driven and/or technology-enabling.
Are clinical trials allowed under this NOFO?
No. The NOFO is explicitly designated as Clinical Trial Not Allowed, meaning the funded work must be non-clinical-trial research rather than interventional studies in human participants.
What is the central purpose of this funding opportunity?
The purpose is to support projects that build, refine, and apply advanced human-relevant cellular systems to understand how HIV interacts with tissues and biological processes that fall within NIDDK mission areas.
What kinds of cellular models are emphasized?
The emphasis is on physiologically realistic, next-generation in vitro platforms, including microphysiological systems (organ-on-a-chip), organoids, and other three-dimensional cellular or tissue models that better reproduce tissue architecture, multicellular interactions, and functional biology.
Does the NOFO encourage moving beyond traditional cell culture approaches?
Yes. The intent is to move beyond simplified culture systems and use models that can more faithfully reproduce key features of normal human biology relevant to HIV persistence and HIV-associated disease processes in NIDDK-related organ systems.
What scientific questions is this NOFO interested in addressing?
Projects are expected to address HIV pathogenesis questions relevant to NIDDK, such as how HIV establishes and maintains persistence, how latency is created and sustained, what triggers reactivation, and what mechanisms might enable eradication or durable control.
Is HIV-related inflammation and immune dysfunction within scope?
Yes. In addition to direct viral biology, the NOFO highlights interest in pathological processes that contribute to co-occurring conditions, including work linking HIV infection or HIV-driven inflammation/immune dysfunction to downstream tissue injury or chronic complications within NIDDK areas.
Which organ systems or biological areas are explicitly mentioned as examples of relevance to NIDDK?
Examples mentioned include mechanistic studies related to metabolic pathways, gut and liver biology, pancreatic function, and kidney tissue integrity, as long as the proposal is anchored in strong cellular modeling and clear relevance to NIDDK mission priorities.
What does “within NIDDK mission areas” mean in practical terms?
It means the proposed HIV pathogenesis research should focus on tissues, biology, and disease processes connected to NIDDK priorities, such as diabetes/metabolism, digestive and liver biology, nutrition-related biology, and kidney-related biology, using advanced cellular models to answer mechanistic questions.
What is the award ceiling for this opportunity?
The posted award ceiling is $500,000, which indicates an upper bound on the anticipated funding level per award under this announcement (with final budgets generally depending on NIH policies, project scope, and negotiated needs).
What kind of funding instrument is used?
The funding instrument type is a grant, categorized as discretionary funding.
What activity category is this opportunity listed under?
The activity category is listed under food and nutrition and health.
What CFDA numbers are associated with this opportunity?
The opportunity references CFDA 93.313 and CFDA 93.847, which align with NIH/NIDDK-related assistance listings.
Who is eligible to apply?
Eligibility is broad and includes many organization types across the public, private, nonprofit, and academic sectors, as well as U.S. and non-U.S. entities (foreign organizations).
Are higher education institutions eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are government entities eligible to apply?
Yes. Eligible applicants include state, county, and city governments, special district governments, and also eligible federal agencies.
Are Tribal entities eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized tribal governments.
Are nonprofits eligible?
Yes. Eligible applicants include nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (excluding institutions of higher education).
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations (other than small businesses) and small businesses.
Are community-based or faith-based organizations eligible?
Yes. The NOFO explicitly includes faith-based or community-based organizations among eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. The NOFO explicitly includes U.S. territories or possessions as eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The NOFO explicitly includes non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.
Does the NOFO encourage participation from specific institution types (MSIs and similar categories)?
Yes. The NOFO calls out additional eligible applicants including HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs, among others.
What are the key dates mentioned in the posting?
The posting lists a creation date of September 16, 2024 and an original application closing date of March 20, 2025.
How many awards does NIH expect to make?
The posting lists ExpectedAwards without a specific number in the provided text, which generally implies NIH anticipates making one or more awards depending on application quality and available funds.
What would a competitive application typically include, based on the description provided?
Based on the description, competitive applications will typically include: (1) a strong rationale for why the chosen advanced cellular model is necessary and superior for the questions posed, (2) a clear plan to validate that the model reflects meaningful features of human physiology, and (3) well-defined mechanistic endpoints tied to viral persistence, latency, reactivation, eradication strategies, or HIV-associated comorbidities within NIDDK mission areas.
Is the main emphasis technology development, biological discovery, or both?
Both are supported as described: projects may build/refine advanced cellular systems (platform-focused) and apply them to answer mechanistic questions about HIV persistence and HIV-driven pathology in NIDDK-relevant tissues (biology-focused).
Does the NOFO require that models be “human-relevant”?
Yes. The central emphasis is on advanced human-relevant cellular systems that capture key features of normal human biology.
What is meant by “physiologically realistic models” in this context?
In this context, it refers to in vitro systems designed to better reproduce tissue architecture, multicellular interactions, and functional biology compared to simplified culture systems, to make HIV pathogenesis findings more relevant to how tissues behave in humans.
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