Opportunity Information: Apply for RFA AI 21 013

The National Institutes of Health (NIH) funding opportunity titled "Understanding HIV Reservoir Dynamics (P01, Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-21-013) is a discretionary grant program designed to support large, multi-disciplinary Program Project (P01) applications focused on how the HIV reservoir changes over time. The central goal is to generate a clearer, more complete picture of the biological mechanisms that shape HIV persistence in the body, specifically looking across different cell types and tissues. By improving what is known about reservoir behavior and the factors that influence its stability, expansion, or decay, the program aims to lay practical scientific groundwork for future strategies that could either cure HIV or enable long-term control of infection without the burden of lifelong antiretroviral therapy.

This FOA is centered on reservoir dynamics, meaning it is not just about identifying where HIV persists, but about understanding how the reservoir evolves longitudinally. That includes studying how HIV-harboring cells may shift in frequency or characteristics over time, how different anatomical compartments contribute to persistence, and what host or viral mechanisms govern maintenance of infected cell populations. The emphasis on multiple cell types and tissues signals that applicants are expected to look beyond a single compartment (such as peripheral blood alone) and instead consider the complexity of HIV persistence across the body. The Program Project structure also implies the NIH is looking for coordinated research programs that connect complementary projects under a unified theme, typically bringing together expertise that could include virology, immunology, systems biology, clinical translational research, pathology, computational biology, and tissue-based sampling approaches, so long as the work stays within the non-clinical-trial scope.

A key constraint is stated directly in the title: clinical trials are not allowed under this announcement. In practical terms, that means the funded work should not involve prospective assignment of human participants to interventions to evaluate health-related outcomes. The research may still involve clinical samples, observational human studies, or analyses of existing cohorts and biospecimens, depending on NIH definitions and the specific study design, but it cannot be structured as an interventional clinical trial. The intent is to support foundational and mechanistic research that can later inform interventional studies and cure-focused clinical trials funded through other mechanisms.

The opportunity falls under NIH health research funding categories and lists CFDA numbers 93.242 and 93.855. While the summary information provided does not specify an institute or center beyond NIH overall, the FOA number prefix "AI" commonly indicates alignment with the National Institute of Allergy and Infectious Diseases (NIAID), which frequently supports HIV reservoir and cure-related research. The award ceiling is listed as $1,000,000, which signals that projects are expected to be substantial in scope and coordination, consistent with a P01 program structure. The original closing date was July 30, 2021, and the FOA creation date was April 7, 2021, indicating this was a time-limited call during that period; anyone interested now would typically look for reissued, related, or successor announcements if the original solicitation has closed.

Eligibility is broad and includes many types of organizations. Domestic applicants can include state, county, city or township governments, special district governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and a range of nonprofit organizations (both with and without 501(c)(3) status). It also includes for-profit organizations (other than small businesses) and small businesses, as well as public housing authorities and Indian housing authorities. Tribal eligibility is explicitly addressed, including Native American tribal governments that are federally recognized and Native American tribal organizations or governments that are not federally recognized. In addition, the FOA explicitly highlights a wide set of "other eligible applicants" that NIH wants to ensure are aware of the opportunity, including 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). It also allows eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations, reflecting an interest in broad participation and potentially international collaboration, which can be important in HIV research given global diversity in cohorts, viral subtypes, and clinical contexts.

Overall, this grant opportunity is aimed at accelerating progress toward HIV cure and durable remission by investing in coordinated research programs that can explain, in a detailed and tissue-aware way, how HIV reservoirs persist and change over time. The expected outcome is not an immediate clinical intervention, but the kind of mechanistic insight that helps the field decide where to target therapies, how to measure meaningful reservoir change, what biological pathways sustain persistence, and how reservoir behavior differs across cellular and anatomical niches.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding HIV Reservoir Dynamics (P01, 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 2021-04-07.
  • Applicants must submit their applications by 2021-07-30. (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.
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Frequently Asked Questions (FAQs)

What is the official title of this NIH funding opportunity?

The funding opportunity is titled "Understanding HIV Reservoir Dynamics (P01, Clinical Trial Not Allowed)."

What is the Funding Opportunity Number (FOA number)?

The FOA number is RFA-AI-21-013.

What type of funding mechanism is this?

This is a discretionary grant program supporting large, multi-disciplinary Program Project (P01) applications.

What is the overall scientific focus of this FOA?

The focus is on understanding how the HIV reservoir changes over time (reservoir dynamics), with the goal of developing a clearer picture of the biological mechanisms that shape HIV persistence in the body.

What does "reservoir dynamics" mean in the context of this opportunity?

In this FOA, reservoir dynamics means studying how HIV persistence evolves longitudinally, not just identifying where HIV persists at a single point in time. It includes examining how HIV-harboring cells change in frequency or characteristics over time, how different anatomical compartments contribute to persistence, and what host or viral mechanisms maintain infected cell populations.

Is this FOA limited to studying HIV persistence in blood?

No. The FOA emphasizes studying HIV persistence across multiple cell types and tissues. Applicants are expected to consider the complexity of HIV persistence across the body rather than focusing on a single compartment (such as peripheral blood alone).

What is the main goal of funding research on HIV reservoir dynamics?

The central goal is to generate a more complete understanding of the mechanisms driving HIV persistence, including factors influencing reservoir stability, expansion, or decay. This is intended to lay scientific groundwork for future strategies that could cure HIV or enable long-term control without lifelong antiretroviral therapy.

What kinds of research programs does NIH appear to be seeking under a P01 structure?

The P01 structure implies NIH is seeking coordinated, multi-project research programs in which complementary projects are connected under a unified theme related to HIV reservoir dynamics. These programs typically bring together multiple disciplines and approaches to address complex questions.

What disciplines or expertise are suggested as relevant for applications?

The FOA suggests coordinated expertise that could include virology, immunology, systems biology, clinical translational research, pathology, computational biology, and tissue-based sampling approaches, as long as the work stays within the non-clinical-trial scope.

Are clinical trials allowed under this FOA?

No. Clinical trials are not allowed under this announcement.

What does "Clinical Trial Not Allowed" mean in practical terms?

It means the funded work should not involve prospective assignment of human participants to interventions to evaluate health-related outcomes. The intent is to support foundational and mechanistic research rather than interventional clinical trial research.

Can the research involve human samples or observational studies?

Yes. The description indicates the research may still involve clinical samples, observational human studies, or analyses of existing cohorts and biospecimens, depending on NIH definitions and the specific study design, but it cannot be structured as an interventional clinical trial.

What is the intended outcome of the research funded through this FOA?

The expected outcome is mechanistic insight into where and how HIV persists and changes over time across cellular and anatomical niches. This includes informing where to target therapies in the future, how to measure meaningful reservoir change, what biological pathways sustain persistence, and how reservoir behavior differs across tissues and cell types.

Does the FOA aim to produce an immediate HIV cure intervention?

No. The FOA is aimed at foundational and mechanistic research intended to inform later interventional studies and cure-focused clinical trials funded through other mechanisms.

What is the award ceiling for this opportunity?

The award ceiling is listed as $1,000,000.

Which CFDA numbers are associated with this opportunity?

The opportunity lists CFDA numbers 93.242 and 93.855.

Which NIH institute or center is associated with this FOA?

The summary provided does not specify an institute or center beyond NIH overall. However, the FOA number prefix "AI" commonly indicates alignment with the National Institute of Allergy and Infectious Diseases (NIAID), which frequently supports HIV reservoir and cure-related research.

When was this FOA created?

The FOA creation date is April 7, 2021.

What was the original closing date?

The original closing date was July 30, 2021.

What should an applicant do if they are interested but the original closing date has passed?

Because this was a time-limited call during 2021, anyone interested now would typically look for reissued, related, or successor announcements if the original solicitation has closed.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic and non-domestic organizations, including government entities, higher education institutions, nonprofits, for-profits, small businesses, tribal entities, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations.

Are government entities eligible?

Yes. Eligible domestic applicants can include state, county, city or township governments, and special district governments.

Are public and state-controlled institutions of higher education eligible?

Yes. Public and state-controlled institutions of higher education are included in the eligibility list.

Are private institutions of higher education eligible?

Yes. Private institutions of higher education are included in the eligibility list.

Are nonprofit organizations eligible?

Yes. The eligibility list includes nonprofit organizations with 501(c)(3) status and nonprofits without 501(c)(3) status.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.

Are tribal governments and tribal organizations eligible?

Yes. Eligibility explicitly includes Native American tribal governments that are federally recognized, as well as Native American tribal organizations or governments that are not federally recognized.

Does NIH explicitly encourage applications from certain institution types?

Yes. The FOA highlights "other eligible applicants" NIH wants to ensure are aware of the opportunity, including 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).

Are faith-based or community-based organizations eligible?

Yes. The eligibility list includes faith-based or community-based organizations.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included as eligible applicants.

Are foreign organizations eligible to apply?

Yes. The FOA allows non-U.S. entities (foreign organizations) and regional organizations.

Are federal agencies eligible?

Yes. The FOA indicates eligible federal agencies may apply.

Why does the FOA emphasize multiple tissues and cell types?

The emphasis reflects the expectation that HIV persistence is distributed across the body, and understanding reservoir dynamics requires examining multiple anatomical compartments and infected cell populations over time rather than relying on a single source of data.

How does this FOA connect to HIV cure research?

By clarifying how reservoirs persist, expand, or decay and how they differ across tissues and cell types, the research is intended to provide practical scientific groundwork for future cure strategies or durable remission approaches that could reduce or eliminate the need for lifelong antiretroviral therapy.

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