Research on the Neuro-Immune Axis in the context of HIV and Substance Use (R01 Clinical Trial Not Allowed) | RFA DA 25 004

Opportunity Information: Apply for RFA DA 25 004

The NIH funding opportunity "Research on the Neuro-Immune Axis in the context of HIV and Substance Use (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-DA-25-004; CFDA 93.279) supports investigator-initiated research projects that clarify how the nervous and immune systems communicate with each other in ways that matter for HIV infection and substance use, especially where the two conditions overlap. The core idea is to move beyond studying the brain, the immune system, HIV, or substance use in isolation and instead map the specific neuroimmune networks and signaling routes (the "neuro-immune axis") that shape biology and disease outcomes when HIV and substance use disorder (SUD) co-occur. Projects are expected to identify, describe, and mechanistically characterize the cellular players, molecular signals, and communication pathways that link neurobiology and immune activity in this combined context.

A major emphasis is on discovering and defining neuroimmune communication pathways and targets that could explain comorbidity, meaning why and how HIV-related processes and substance use-related processes can amplify each other. This can include work that disentangles how immune activation, inflammation, viral factors, neuroinflammation, glial and neuronal signaling, peripheral immune signals, or immune-to-brain (and brain-to-immune) feedback loops contribute to changes in behavior, cognition, reward circuitry, susceptibility to infection, disease progression, treatment response, or other clinically relevant outcomes. The NOFO is also explicitly interested in studies that reveal the regulatory mechanisms by which neuroimmune interactions influence both HIV and substance use, which typically implies mechanistic approaches that can connect a pathway to a functional consequence rather than purely descriptive observations.

In addition to mapping pathways, the NOFO supports the discovery and development of novel modulatory probes and tools that help the field interrogate neuroimmune mechanisms more precisely. In practice, this could include creating or adapting chemical probes, biologic modulators, genetic or epigenetic tools, imaging approaches, biosensors, or other experimental reagents that allow researchers to selectively perturb or measure components of neuroimmune signaling relevant to HIV and substance use. The intent is not tool-building for its own sake, but tool-building that directly accelerates understanding of how neuroimmune circuits are regulated and how those regulatory features contribute to HIV/SUD comorbidity.

The activity mechanism is an R01 research project grant, and the opportunity specifies "Clinical Trial Not Allowed," which signals that the proposed work should not include a clinical trial as defined by NIH. That generally steers applicants toward basic, translational, and mechanistic studies that may use human samples, observational human data, or preclinical models, but do not prospectively assign human participants to an intervention to evaluate health-related outcomes. Applicants typically need to ensure that any human-related components remain non-interventional in the NIH clinical trial sense.

Eligibility is broad and includes many types of U.S.-based and non-U.S. organizations. Eligible applicants include state, county, and local governments; 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 (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The NOFO also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities/foreign organizations. This breadth is meant to encourage participation from diverse institutional settings and communities, including organizations positioned to address populations disproportionately affected by HIV and substance use.

Key administrative details included in the listing are that the sponsoring agency is the National Institutes of Health, the opportunity is categorized as discretionary, and the activity area is listed under education and health. The original closing date is 2024-11-13, and the record creation date is 2024-03-14. An award ceiling and expected number of awards are not specified in the provided source data, which usually means applicants should consult the full NOFO text and related NIH policy pages for any institute-specific budget expectations, project period norms, and application instructions.

Overall, this NOFO is aimed at strengthening the science of neuroimmune mechanisms at the intersection of HIV and substance use by funding R01-scale projects that can (1) uncover and validate neuroimmune networks and signaling pathways relevant to comorbidity and (2) generate or apply novel probes and tools that make those mechanisms measurable and testable in rigorous, hypothesis-driven ways, without proposing a clinical trial.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Research on the Neuro-Immune Axis in the context of HIV and Substance Use (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): 93.279.
• This funding opportunity was created on 2024-03-14.
• Applicants must submit their applications by 2024-11-13. (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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