Harnessing Natural Killer (NK) Cells to Prevent, Control, or Eradicate HIV (R01 Clinical Trial Not Allowed) | RFA AI 20 016

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Harnessing Natural Killer (NK) Cells to Prevent, Control, or Eradicate HIV (R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number RFA-AI-20-016) focused on advancing HIV research by deepening what is known about NK cells and how they can be used, directly or indirectly, to stop HIV infection, keep the virus under control, or contribute to strategies aimed at eliminating persistent infection. The FOA emphasizes projects that move from fundamental discovery through translational work and into clinical research that is not a clinical trial, meaning applicants can use human samples, clinical cohorts, and other clinically grounded approaches, but cannot propose interventional studies that meet the definition of a clinical trial under NIH policy. The overall intent is to support studies that clarify NK cell effector functions (how NK cells kill infected targets or limit viral spread) as well as immunoregulatory functions (how NK cells shape broader immune responses), with the goal of identifying mechanisms and approaches that could be leveraged for prevention, durable viral suppression, or cure-directed interventions.

The scientific scope is broad but anchored to a clear theme: understanding and harnessing NK cell biology in the context of HIV. This can include basic research that dissects NK cell receptors, signaling pathways, activation states, memory-like features, trafficking, and interactions with infected cells and other immune populations. It can also include translational efforts aimed at defining which NK cell features correlate with protection or control, how HIV evades or suppresses NK activity, and what can be done to overcome those barriers. Clinically oriented research may involve careful characterization of NK cell responses in people living with HIV, in individuals exposed but uninfected, or in other relevant human settings, provided the work does not involve assigning participants to an intervention and measuring outcomes in a way that constitutes a clinical trial. Across these areas, the FOA is essentially looking for credible, mechanistic, and potentially actionable insights that could inform next-generation prevention tools, immune-based therapies, or eradication strategies.

The funding mechanism is an R01 research project grant, which typically supports hypothesis-driven projects of substantial scope and depth, often involving multidisciplinary teams and multi-aim research plans. While the source listing does not provide an award ceiling or the expected number of awards, the R01 format signals support for well-developed proposals with strong preliminary rationale, clear experimental plans, and meaningful potential impact on HIV immunology and intervention design. The program is categorized under the health funding activity area and is associated with CFDA numbers 93.242 and 93.855, consistent with NIH infectious disease and research infrastructure portfolios.

Eligibility is intentionally expansive. In addition to common NIH-eligible applicant organizations such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit entities (including small businesses), and a range of government bodies (state, county, city/township, special district governments, independent school districts, public housing authorities, and federally recognized tribal governments), the FOA explicitly highlights additional eligible applicants. These include 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); Indian/Native American Tribal Governments other than federally recognized; faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; and non-U.S. entities and regional organizations. This broad eligibility is designed to encourage wide participation, including institutions and communities that are often central to HIV prevention and care efforts, and to support collaborations that bring diverse scientific perspectives and populations into NK cell and HIV research.

Key administrative details in the provided source data include the original closing date of July 28, 2020, and a creation date of March 6, 2020. The opportunity is listed as a discretionary grant under NIH, and the title and description make the non-clinical-trial restriction explicit. In practical terms, applicants were expected to propose rigorous, ethically sound studies that could incorporate clinical samples and clinically relevant observations while staying within the boundaries of “clinical research” rather than interventional “clinical trials,” all in service of building a stronger, more useable evidence base for NK-cell-centered approaches to HIV prevention, control, and eradication.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Harnessing Natural Killer (NK) Cells to Prevent, Control, or Eradicate 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): 93.242, 93.855.
• This funding opportunity was created on 2020-03-06.
• Applicants must submit their applications by 2020-07-28. (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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