Community Engaged Research on Pregnancy Related and Associated Infections and Sepsis Morbidity and Mortality (UG3/UH3 Clinical Trial Optional) | RFA HD 21 033

Opportunity Information: Apply for RFA HD 21 033

The National Institutes of Health (NIH) is soliciting applications under the funding opportunity titled "Community Engaged Research on Pregnancy Related and Associated Infections and Sepsis Morbidity and Mortality (UG3/UH3 Clinical Trial Optional)" (Funding Opportunity Number: RFA-HD-21-033; CFDA: 93.865). This opportunity uses a cooperative agreement mechanism, meaning NIH staff are expected to have substantial scientific and/or programmatic involvement during the project period rather than serving only as a pass-through funder. The overall aim is to support interdisciplinary, community-engaged research that can reduce or eliminate infections and sepsis as contributors to pregnancy-related and pregnancy-associated morbidity and mortality (PRAMM), with a strong emphasis on regions of the United States experiencing the highest maternal mortality and the most pronounced disparities.

At its core, the FOA is focused on health equity and on practical, real-world solutions that are shaped with communities rather than merely studied in them. It is intended to move beyond purely observational work by fostering collaborations across clinical care, public health, implementation science, social and behavioral science, and community partners who understand local barriers and needs. The target problem is specific: infections and sepsis that occur during pregnancy, delivery, and the postpartum period, and that lead to serious complications or death. Projects are expected to concentrate on places where maternal outcomes are worst and where disparities are most severe, which implicitly prioritizes work that addresses structural drivers of risk such as access to quality obstetric care, timely recognition and treatment of infection, racism and bias in healthcare settings, rurality, poverty, transportation barriers, and gaps in postpartum follow-up.

The UG3/UH3 structure signals a phased approach. In general terms, UG3 is commonly used as an initial, milestone-driven planning and preparatory phase, and UH3 is used to support the later implementation phase once feasibility and readiness criteria are met. This design is meant to help teams build durable community partnerships, refine protocols and workflows, establish data systems, and demonstrate that the proposed intervention or strategy can be executed effectively before expanding into a broader test or rollout. The label "Clinical Trial Optional" indicates that applicants may propose studies that do or do not meet NIH’s definition of a clinical trial, allowing flexibility for interventions, implementation strategies, quality improvement approaches, or other research designs as long as the work is rigorous and aligned with the FOA goals.

A wide range of domestic applicants are eligible, reflecting NIH’s intent to attract applicants that can authentically partner with affected communities and healthcare systems. 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/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 organizations. The FOA also explicitly calls out additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISI), along with faith-based and community-based organizations and regional organizations. This emphasis underscores that community-rooted institutions and minority-serving institutions are viewed as central partners in addressing PRAMM disparities.

There are clear restrictions on foreign involvement. Non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. In other words, the work is intended to be fully U.S.-based, aligning with the FOA’s focus on U.S. regions with high maternal mortality.

From a practical standpoint, competitive projects under this announcement would be expected to show strong community engagement, meaning community partners participate in shaping research questions, selecting outcomes that matter locally, designing and adapting interventions, and guiding dissemination of results. The research should be interdisciplinary and action-oriented, aiming to produce evidence that can be implemented in real clinical and public health settings to prevent infection, improve early detection of sepsis, standardize response protocols, and ultimately reduce severe maternal morbidity and mortality. While the FOA text provided does not list an award ceiling or the anticipated number of awards, it does specify the original closing date as May 20, 2021, and the opportunity was created on April 6, 2021, indicating it was a time-limited call rather than an open-ended, continuously available program announcement.

In summary, this NIH cooperative agreement opportunity is designed to fund community-centered, team-based research that tackles one of the most preventable contributors to maternal death and severe complications: pregnancy-related infections and sepsis. The funding structure encourages careful early-stage preparation followed by implementation, and the eligibility rules are broad within the United States to ensure that governments, health systems, universities, and community organizations can work together in the highest-need regions to reduce disparities and save lives.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Community Engaged Research on Pregnancy Related and Associated Infections and Sepsis Morbidity and Mortality (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2021-04-06.
• Applicants must submit their applications by 2021-05-20. (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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