Novel Preclinical Models of NeuroHIV in the cART Era (R61/R33 - Clinical Trial Not Allowed) | RFA NS 24 035

Opportunity Information: Apply for RFA NS 24 035

The NIH funding opportunity "Novel Preclinical Models of NeuroHIV in the cART Era (R61/R33 - Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-NS-24-035) supports projects aimed at building and testing next-generation laboratory models that better mirror how HIV affects the central nervous system (CNS) in the current treatment landscape. The central scientific goal is to improve the translational relevance of NeuroHIV research tools by focusing on chronic HIV infection in the CNS during the modern combination antiretroviral therapy (ART/cART) era, particularly under conditions where systemic virus is suppressed. In practical terms, NIH is looking for proposals that create models capable of capturing the persistent, hard-to-study aspects of HIV in the brain and related tissues despite effective ART, which is a major gap in many older or less human-relevant systems.

This opportunity specifically solicits two broad types of model platforms. One is next-generation humanized small animal models, meaning animal systems engineered or reconstituted with human cells and/or tissues to more faithfully replicate human immune and CNS interactions relevant to HIV. The other is human cellular microphysiological systems, which generally refers to advanced in vitro human-based platforms such as organ-on-chip or complex 3D tissue systems that recreate key features of human CNS biology, immune responses, and viral persistence in a controlled setting. Across both model types, the emphasis is not simply on building a model, but on early-stage validation to demonstrate that the model behaves in ways that are meaningful for the real-world scenario of long-term treated HIV infection, including the biological consequences of viral suppression and potential reservoirs or ongoing inflammatory processes in the CNS.

The funding mechanism is an R61/R33 phased innovation-style grant. The R61 phase typically supports the initial development work and feasibility milestones, while the R33 phase supports expansion and further validation once the early go/no-go criteria are met. This structure is designed to push model development forward with clear performance expectations, encouraging applicants to define measurable milestones and demonstrate progress toward a model that the broader NeuroHIV field can use. The announcement explicitly states "Clinical Trial Not Allowed," meaning the supported work must be preclinical and mechanistic, focused on model development and validation rather than interventional studies in human participants.

From an administrative standpoint, this is a discretionary NIH grant opportunity within the education and health activity category, with CFDA numbers 93.242, 93.279, and 93.853 listed in the source data. The award ceiling is $600,000. The original closing date is December 2, 2024, and the opportunity was created on June 25, 2024. While the expected number of awards is not specified in the provided source text, the intent is clearly to spur multiple efforts that can collectively modernize the preclinical toolkit for NeuroHIV research under contemporary ART conditions.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Standard 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; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories as specified); for-profit organizations other than small businesses; and small businesses. The notice also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities/foreign organizations, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions. This breadth signals NIH interest in drawing on diverse institutional strengths, including organizations with strong community, clinical, engineering, or translational neuroscience capacity that can contribute to better NeuroHIV modeling.

Overall, the opportunity is best understood as an investment in better research infrastructure for NeuroHIV: model systems that reflect the realities of the cART era, where many people living with HIV have suppressed viral loads but may still experience CNS-related complications, persistent inflammation, or reservoir-related biology that remains difficult to interrogate. Competitive applications will likely be those that clearly justify what is missing from current models, present a credible engineering/biological strategy to address those gaps, and lay out concrete validation plans showing how the new model will be used to study chronic treated HIV in the CNS in a way that is directly relevant to human disease biology.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Novel Preclinical Models of NeuroHIV in the cART Era (R61/R33 - 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, 93.279, 93.853.
• This funding opportunity was created on 2024-06-25.
• Applicants must submit their applications by 2024-12-02. (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 $600,000.00 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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