HIV/AIDS and the Tumor Niche (U54 Clinical Trial Not Allowed) | RFA CA 20 016

Opportunity Information: Apply for RFA CA 20 016

The NIH grant opportunity "HIV/AIDS and the Tumor Niche (U54 Clinical Trial Not Allowed)" (RFA-CA-20-016) is a cooperative agreement designed to push forward research on how HIV infection and AIDS shape the tumor niche, also called the tumor microenvironment, and how that niche influences cancer risk, cancer development, disease progression, and even cancer detection and diagnosis in people living with HIV. The central idea is that cancers arising in the setting of HIV are not driven only by tumor cell genetics, but also by the surrounding biological environment that supports or restrains tumor growth, including immune cells, stromal cells, blood vessels, inflammatory signals, and virus-related factors. This FOA aims to deepen the field's understanding of what is different about the tumor microenvironment when the underlying host is HIV-infected, and how those differences translate into real-world cancer outcomes.

The research focus is organized around two broad, controlling forces thought to be key to establishing and maintaining the tumor niche in the HIV/AIDS setting. First is the role of the AIDS retrovirus itself, meaning direct or indirect effects of HIV (and potentially HIV-related viral products) on tissues, immune regulation, inflammation, and cellular interactions that can shape a pro-tumor or anti-tumor environment. Second is the host response to HIV infection, which includes chronic immune activation, immune suppression or dysfunction, altered cytokine and chemokine signaling, changes in immune cell composition and trafficking, and longer-term consequences of persistent infection and treatment. By targeting these two areas, the FOA is seeking mechanistic and systems-level insight into how HIV-associated biology influences the microenvironments in which tumors start, evolve, and are recognized clinically.

This opportunity uses the U54 mechanism, which is typically associated with larger, multi-component or center-like efforts where NIH staff have substantial programmatic involvement compared to standard research grants. Because it is a cooperative agreement, awardees should expect more active coordination with NIH on key aspects such as milestones, collaboration expectations, data/resource sharing, and overall program direction. The FOA is explicitly "Clinical Trial Not Allowed," meaning applicants must propose research that does not meet NIH's definition of a clinical trial; the work can still be human-focused (for example, using biospecimens, observational analyses, or mechanistic studies) so long as it does not prospectively assign humans to interventions to evaluate health-related outcomes.

Eligibility is broad and includes many types of domestic organizations and government entities. Eligible applicants listed include 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 and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, the FOA places firm limits on foreign participation at the applicant level. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed, which typically means a U.S. applicant can include certain well-justified foreign collaborations or performance sites as components of the project, subject to NIH rules and approval.

Administratively, the opportunity is offered by the National Institutes of Health under the Health and Education activity categories and is associated with CFDA number 93.396. The original closing date listed is July 15, 2020, and the maximum award amount (award ceiling) is stated as $1,000,000. The posting indicates it is a discretionary funding opportunity and reiterates the overall purpose: advancing understanding of the HIV/AIDS context in shaping the tumor microenvironment, with the goal of improving knowledge that could ultimately inform better strategies for cancer risk assessment, diagnosis, and management for people living with HIV, even though the proposed projects themselves cannot be clinical trials.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HIV/AIDS and the Tumor Niche (U54 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): 93.396.
• This funding opportunity was created on 2020-01-23.
• Applicants must submit their applications by 2020-07-15. (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 $1,000,000.00 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.

Apply for RFA CA 20 016

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