Novel Imaging Approaches for detection of Persistent HIV and Neuroimmune dysfunction associated with HIV In the Central Nervous System (CNS) (R21 Clinical Trial Not Allowed) | RFA MH 20 331

Opportunity Information: Apply for RFA MH 20 331

This grant opportunity, titled "Novel Imaging Approaches for detection of Persistent HIV and Neuroimmune dysfunction associated with HIV in the Central Nervous System (CNS) (R21 Clinical Trial Not Allowed)," is a National Institutes of Health (NIH) discretionary research grant solicitation (Funding Opportunity Number: RFA-MH-20-331; CFDA: 93.242) focused on advancing how researchers detect and understand HIV-related brain and immune effects in the era of effective antiretroviral therapy (ART). The central aim is to support exploratory, potentially high-risk but high-reward projects that use innovative imaging or neuroimaging tools to (1) clarify mechanisms driving neuroimmune dysfunction caused by HIV-1 and (2) identify persistent, latent, or reactivated HIV within the CNS of individuals whose virus is otherwise suppressed by ART. In plain terms, the FOA is interested in better ways to "see" what HIV is still doing in the brain and how it may be linked to ongoing immune activation or dysfunction, even when standard blood measures show successful suppression.

A major theme of the announcement is innovation in imaging as a pathway to breakthroughs. The FOA encourages development or application of new techniques, agents, methods, measures, models, or strategies that can improve detection sensitivity or biological specificity in the CNS context. Because it is an R21 mechanism, the expectation is often that projects will generate pilot data, feasibility evidence, or early proof-of-concept results that can later justify larger-scale studies. The FOA explicitly recognizes that these approaches may involve considerable risk, which is typical of R21-style funding when the science is promising but not yet fully validated. Importantly, clinical trials are not allowed under this announcement, meaning applicants should design studies that do not meet the NIH definition of a clinical trial (for example, they should avoid prospectively assigning human participants to an intervention to evaluate effects on health-related outcomes). However, the FOA still indicates interest in basic, preclinical, and clinical research, which typically allows observational human studies, studies using existing clinical imaging data, or research involving humans that does not constitute a clinical trial.

The scientific scope includes both mechanistic and detection-focused work. On the mechanistic side, the FOA seeks studies that help explain how HIV-1 contributes to neuroimmune dysfunction in the CNS, which can include persistent inflammation, immune activation, or other immune-brain interactions that may continue despite ART suppression. On the detection side, the emphasis is on locating or characterizing HIV persistence, latency, or reactivation in the brain and related CNS compartments using novel imaging or neuroimaging approaches. This can encompass imaging that targets immune processes, neuroinflammation, cellular activation states, or other biomarkers that could serve as indirect or direct signatures of viral persistence and its consequences.

The opportunity is open to a wide range of research environments and encourages multidisciplinary thinking. The FOA states that research may be conducted in both domestic and international settings, broadening the potential for collaborations, cohort access, or specialized imaging resources across countries. While multidisciplinary research teams and collaborative alliances are encouraged, they are not required, so single-institution applications can still be competitive if they have the needed expertise and infrastructure. The eligible applicant pool is broad and includes many organization types: state, county, city or township 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; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); small businesses; and other categories. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-domestic (non-U.S.) entities/foreign organizations, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. This breadth signals a strong interest in drawing ideas and capabilities from many sectors, including institutions that serve underrepresented communities and organizations outside the United States.

Administratively, this is an NIH grant under the "Health" activity category and uses the grant funding instrument. The source data lists an original closing date of March 11, 2020, and a creation date of December 16, 2019. The award ceiling and expected number of awards are not specified in the provided listing, which sometimes indicates that budgets and award counts depend on appropriations, scientific merit, and program priorities rather than a fixed published cap. Overall, the FOA is designed to spark early-stage, creative imaging-centered research that can reveal where HIV persists in the CNS and how that persistence may drive neuroimmune dysfunction, with the longer-term goal of enabling better measurement tools and, eventually, better strategies to address HIV-related CNS complications in ART-suppressed individuals.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Imaging Approaches for detection of Persistent HIV and Neuroimmune dysfunction associated with HIV In the Central Nervous System (CNS) (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 2019-12-16.
• Applicants must submit their applications by 2020-03-11. (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.

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