Understanding HIV Reservoir Dynamics (P01, Clinical Trial Not Allowed) | RFA AI 21 013

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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