Understanding the Mechanisms of Neuropsychiatric Side Effects and Neurological Toxicities of HIV Medicines (R21 Clinical Trial Not Allowed) | RFA MH 20 115

Opportunity Information: Apply for RFA MH 20 115

The National Institutes of Health (NIH) announced this discretionary grant opportunity, RFA-MH-20-115, titled "Understanding the Mechanisms of Neuropsychiatric Side Effects and Neurological Toxicities of HIV Medicines (R21 Clinical Trial Not Allowed)." It uses the R21 mechanism, which is designed for exploratory, early-stage, or high-risk/high-reward work. The central goal is to support innovative research that clarifies why some people living with HIV experience neuropsychiatric symptoms (for example, mood, sleep, anxiety, or cognitive changes) and other neurological toxicities that appear to be associated with HIV medications. The emphasis is on uncovering mechanisms and risk factors that could ultimately point to better prevention, safer prescribing, targeted interventions, or more personalized HIV treatment strategies.

Projects supported under this FOA are expected to be primarily basic or preclinical in nature, rather than clinical trials. The "Clinical Trial Not Allowed" designation means applicants should not propose studies that meet the NIH definition of a clinical trial (for instance, prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes). Instead, the opportunity is geared toward mechanistic, translationally oriented research that could include laboratory-based investigations, preclinical model systems, and other approaches that build credible biological or behavioral explanations for observed side effects and toxicities. Research may be conducted in domestic or international settings, reflecting NIH interest in findings that can generalize across different populations and treatment contexts.

A key theme of the FOA is identifying underlying mechanisms and risk factors. Mechanisms can include, for example, drug effects on central nervous system pathways, neuroinflammation, neurotransmitter systems, mitochondrial function, blood-brain barrier transport, or other biological processes that might plausibly link specific antiretroviral agents or regimens to neuropsychiatric outcomes. Risk factors may involve host characteristics (such as genetics, age, sex, comorbid mental health conditions, substance use, or co-infections), treatment-related variables (dose, combinations, drug-drug interactions), and contextual factors that influence vulnerability. The FOA signals particular interest in work that can move beyond documenting associations to explaining why they occur, and in doing so, reveal actionable targets for therapeutic intervention or precision medicine approaches (for example, predictors that could guide regimen selection for individuals more likely to experience adverse neuropsychiatric effects).

The program encourages innovative, multidisciplinary thinking. While not mandatory, collaborative alliances and teams that span relevant expertise areas are welcomed, such as neuropharmacology, psychiatry, neurology, virology, immunology, genetics, computational biology, toxicology, and behavioral science. The intent is to foster creative projects that might be too early or too unconventional for larger confirmatory grants, but that have a clear rationale and a plausible path toward generating decisive preliminary findings.

From an administrative standpoint, this is a grant in the health activity category (CFDA 93.242) administered by NIH. The original closing date listed is May 2, 2019, and the award ceiling noted is $200,000. While the number of expected awards is not specified in the provided excerpt, the R21 format typically supports smaller, focused studies intended to generate proof-of-concept data, develop new methods, or test novel hypotheses that can later be scaled into larger projects.

Eligibility is broad. In addition to standard eligible applicants such as state, county, and local governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, the FOA explicitly notes additional eligible categories. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), tribal governments and tribal organizations (including those other than federally recognized), faith-based or community-based organizations, U.S. territories or possessions, eligible federal agencies, and non-U.S. entities (foreign organizations) as well as regional organizations. This breadth is consistent with NIH interest in drawing from diverse institutional perspectives and ensuring that research on HIV treatment-related neuropsychiatric and neurological harms can be informed by varied populations, settings, and scientific approaches.

Overall, the opportunity is best understood as a targeted call for creative, mechanism-driven research that explains neuropsychiatric side effects and neurological toxicities linked to HIV medications, with the practical long-term aim of improving tolerability, safety, and individualized treatment decisions, while staying firmly outside the boundaries of proposing a clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding the Mechanisms of Neuropsychiatric Side Effects and Neurological Toxicities of HIV Medicines (R21 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.
• This funding opportunity was created on 2019-02-27.
• Applicants must submit their applications by 2019-05-02. (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 $200,000.00 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.

Apply for RFA MH 20 115

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