The Role of Exosomes in HIV Neuropathogenesis (R01) | Apply Online

Opportunity Summary:

The grant opportunity titled "The Role of Exosomes in HIV Neuropathogenesis (R01)" (Funding Opportunity Number RFA-MH-16-100) was a National Institutes of Health (NIH) discretionary research funding announcement that supported R01 grant applications focused on how exosomes contribute to HIV-related brain disease. The scientific emphasis was on HIV-1 Associated Neurocognitive Disorders (HAND), a spectrum of cognitive, behavioral, and motor impairments that can occur in people living with HIV, including in the era of antiretroviral therapy. The FOA centered on the idea that exosomes, which are small extracellular vesicles released by many cell types and capable of carrying proteins, lipids, and nucleic acids, may be key players in how HIV affects the central nervous system (CNS). Applicants were invited to propose studies that clarify whether and how exosomes drive neurological injury, neuroinflammation, viral persistence effects, or other mechanisms relevant to HAND.

A major goal of the announcement was to define the "central role" of exosomes in HIV neuropathogenesis, meaning the research should go beyond simply observing that exosomes change during infection and instead test mechanistic links. Projects could include basic research aimed at identifying the cellular sources of exosomes in the CNS or periphery, characterizing exosome cargo in the context of HIV infection, and determining how exosome-mediated communication alters neurons, glia, the blood-brain barrier, or immune trafficking in ways that contribute to cognitive impairment. At the same time, the FOA also emphasized translational directions, specifically encouraging proposals that evaluate exosomes as practical tools for clinical impact, either as biomarkers for diagnosing or monitoring HAND or as delivery vehicles for CNS-targeted therapeutics. That translational angle implies interest in questions like whether exosomal markers in blood or cerebrospinal fluid correlate with HAND severity, predict progression, reflect treatment response, or provide a minimally invasive readout of CNS processes.

The opportunity explicitly welcomed both domestic and international research settings, which is important because HAND burdens and comorbidities can vary across regions and because global cohorts may provide access to diverse viral subtypes, treatment patterns, and demographic factors. The FOA also encouraged, but did not require, multidisciplinary teams and collaborative alliances. In practice, that means NIH was signaling that competitive applications could integrate expertise across fields such as virology, neuroscience, extracellular vesicle biology, immunology, neuroimaging, clinical neurology, biomarker development, and drug delivery. Even so, single-investigator or single-institution projects were not excluded as long as the science was strong and feasible.

Administratively, this was an NIH grant mechanism using the R01 funding instrument, under the broad activity category of Health. The announcement referenced CFDA numbers 93.242 (Mental Health Research Grants) and 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), reflecting the intersection of neuroHIV, mental health and cognitive outcomes, and neuroscience research priorities. The FOA did not require cost sharing or matching funds, which typically reduces barriers for applicants by allowing the proposed research to be supported without institutional matching commitments.

Eligibility was broad and included many types of U.S. organizations and governments, such as public and private institutions of higher education, nonprofits with or without 501(c)(3) status (with the caveat of NIH rules for specific organizational types), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities (state, county, city or township, special district governments, and certain housing authorities). The FOA also made clear that additional eligible applicants included minority-serving institutions (for example HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities, and AANAPISIs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and importantly, non-U.S. entities (foreign organizations) and regional organizations. That last point underscores that NIH was open to supporting research led or conducted outside the United States when scientifically justified.

In terms of timing, the FOA was posted and created on March 20, 2015, with an original and final application due date of September 2, 2015. The archive date was October 3, 2015, meaning the announcement is no longer active for new submissions under that specific solicitation, though similar research topics may appear in later NIH notices or parent announcements. The official NIH listing included an additional information link to the full FOA text hosted on the NIH grants site, and the contact listed for access or technical linking issues was the NIH Office of Extramural Research (OER) webmaster email.

Overall, the core purpose of this R01 opportunity was to push the field toward a clearer, testable understanding of exosomes in the biology of HAND while simultaneously advancing the possibility that exosomes could be leveraged in real-world clinical approaches, either by serving as accessible biomarkers of CNS disease in HIV or by acting as engineered or naturally derived carriers to deliver therapeutics across or within the CNS.

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