Biotypes of CNS Complications in People Living with HIV (P01 Clinical Trial Not Allowed) | RFA MH 24 235

Opportunity Information: Apply for RFA MH 24 235

The National Institutes of Health (NIH) funding opportunity titled "Biotypes of CNS Complications in People Living with HIV (P01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-MH-24-235) supports large, multi-project research programs aimed at understanding why central nervous system (CNS) complications still occur in people living with HIV even when the virus is well controlled with suppressive antiretroviral therapy. The premise behind the announcement is that HIV can enter the CNS very early, as soon as about eight days after infection, and that this early and persistent interaction between HIV, the brain, and the immune system can lead to a wide range of long-term outcomes. These outcomes can include cognitive problems (such as memory or attention changes), neurological issues, and mental health related complications. While the field has accumulated substantial data on HIV-related CNS pathology, the opportunity highlights that clear, targetable cause-and-effect mechanisms remain difficult to pin down, which is one reason effective therapies to slow, stop, or reverse these CNS effects are still lacking.

A central goal of this initiative is to move beyond one-size-fits-all descriptions of HIV-associated CNS complications and instead define "actionable biotypes" based on underlying biological mechanisms. In this context, a biotype can be understood as a biologically grounded subgroup of people who share a similar mechanistic pathway leading to CNS complications, even if their outward symptoms overlap with those of other subgroups. The emphasis on actionable biotypes signals that NIH is looking for research that does more than classify patients; the classification should be tied to mechanistic drivers that can realistically inform prevention strategies, clinical monitoring, or future therapeutic development. The opportunity also underscores heterogeneity: people living with HIV can experience very different CNS trajectories, and teasing apart that diversity is viewed as essential for developing precision approaches that match interventions to the specific biology driving an individual's symptoms.

The award mechanism is a P01 program project grant, which typically supports a coordinated set of interrelated projects organized around a unifying scientific theme. This format is meant to encourage interdisciplinary teams to tackle complex problems from multiple angles, for example by integrating clinical characterization with neuroimaging, immunology, virology, neuropathology, genetics, biomarkers, and computational or systems biology approaches, as long as everything is tied together by a shared framework focused on mechanistic biotypes. The notice explicitly states "Clinical Trial Not Allowed," meaning the supported research should not include prospective assignment of human participants to an intervention to evaluate effects on health-related outcomes. Applicants can still generally propose many types of human-focused clinical research, observational studies, biospecimen analyses, and data-driven subtype discovery, but they must avoid designs that meet the NIH definition of a clinical trial for this specific announcement.

Eligibility is broad and includes many types of institutions and 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education, since higher-ed entities have their own category); for-profit organizations (other than small businesses); and small businesses. The announcement also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility reflects an interest in drawing on diverse scientific and community strengths, including institutions serving populations disproportionately affected by HIV and organizations positioned to support meaningful engagement with people living with HIV.

From an administrative standpoint, this is a discretionary grant opportunity issued by NIH in the health and education funding activity categories, with CFDA (Assistance Listing) numbers 93.242, 93.279, and 93.853. The posting lists an original closing date of 2023-12-11 and a creation date of 2023-08-29. The award ceiling and expected number of awards are not specified in the provided source data, which usually means applicants need to consult the full funding announcement and NIH budget guidance for allowable project periods, budget structure, and any institute- or program-specific expectations.

Overall, the opportunity is designed to accelerate progress on HIV-associated CNS complications by supporting integrated research programs that can identify biologically meaningful subgroups and link them to clear mechanisms. The intended payoff is a stronger foundation for precision medicine approaches, where future diagnostics, monitoring tools, or treatments can be tailored to the specific pathways driving CNS complications in different groups of people living with HIV, rather than treating these complications as a single uniform condition.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Biotypes of CNS Complications in People Living with HIV (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, 93.279, 93.853.
• This funding opportunity was created on 2023-08-29.
• Applicants must submit their applications by 2023-12-11. (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.

Apply for RFA MH 24 235

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