Advancing Understanding, Prevention, and Management of Infections Transmitted from Women to their Infants (R01 Clinical Trial Optional) | PA 18 031

Opportunity Information: Apply for PA 18 031

The grant opportunity titled "Advancing Understanding, Prevention, and Management of Infections Transmitted from Women to their Infants (R01 Clinical Trial Optional)" (Funding Opportunity Number PA-18-031) is a National Institutes of Health (NIH) discretionary grant aimed at strengthening research on perinatal infections that pass from women to their babies. The central focus is on non-HIV infectious diseases transmitted during pregnancy, labor and delivery, and breastfeeding. The overall intent is to move the field forward by encouraging studies that clarify how these infections are transmitted, how they can be prevented, and how clinical care can be improved to produce better outcomes for both mothers and infants. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the NIH institute specifically highlighted as committed to supporting this work, reflecting the agency's broader mission around maternal and child health.

This FOA is designed to stimulate a wide range of research approaches, spanning translational science, epidemiology, and clinical research, including clinical trials when appropriate. "Translational" here generally means work that bridges basic discoveries and real-world clinical or public health applications, such as turning laboratory findings into diagnostic tools, prevention strategies, or treatment approaches. Epidemiologic studies can include population-level investigations that identify risk factors, transmission patterns, or disparities in infection rates and outcomes. Clinical studies and trials can test interventions, care strategies, diagnostics, therapeutics, or management approaches that could directly improve maternal and neonatal health. The "Clinical Trial Optional" designation indicates applicants may propose a clinical trial, but they are not required to; strong non-trial studies that address the FOA goals are also within scope.

The project theme is intentionally centered on infections transmitted from women to infants during key exposure windows, including in utero transmission during pregnancy, exposure during the intrapartum period (labor and delivery), and postnatal transmission via breastfeeding. The FOA emphasizes improvement in understanding, prevention, and clinical outcomes, which can include reducing transmission, mitigating disease severity, improving early detection, refining treatment regimens, or strengthening management guidelines for pregnant and postpartum women and their infants. Because the announcement explicitly targets non-HIV infections, proposals should align with other pathogens or syndromes affecting maternal-infant health rather than HIV-focused transmission research.

Funding is provided through the NIH R01 mechanism, which is the standard research project grant used to support discrete, specified projects led by an investigator or team. The activity category listed is Health, Income Security and Social Services, and the CFDA (now commonly referenced as Assistance Listing) number provided is 93.865, which aligns with NICHD research support. The source data lists the award ceiling and expected awards fields as blank, meaning applicants typically need to rely on the FOA details and NIH standard R01 budgeting rules rather than a fixed published cap in this summary. The original closing date in the provided record is 2019-09-07, and the creation date is 2017-11-02, which helps place the opportunity historically, though applicants would normally confirm current submission windows, active dates, and any reissued versions of the announcement in NIH systems.

Eligibility is broad and reflects NIH's typical openness to multiple institution types, including governmental entities, academic institutions, nonprofits, and certain for-profit organizations. Eligible applicants listed include state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Higher education eligibility includes public and state-controlled institutions of higher education as well as private institutions of higher education. Tribal eligibility is also included, covering federally recognized Native American tribal governments and other Native American tribal organizations that are not federally recognized governments. Both 501(c)(3) nonprofits and nonprofits without 501(c)(3) status are eligible (in both cases, other than institutions of higher education), along with for-profit organizations other than small businesses and small businesses. The listing also includes an "Others" category, signaling that additional entity types may be permitted depending on NIH rules and FOA-specific language.

The FOA also explicitly highlights additional eligible applicant groups to encourage participation from diverse and historically underrepresented or mission-specific institutions and organizations. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs). It also includes eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). That explicit inclusion matters because it signals that NICHD is open to a wide range of settings and populations, including research conducted outside the United States when scientifically justified, and collaborations that connect academic research with community implementation environments.

In practical terms, a competitive proposal under this FOA would be expected to present a clear scientific rationale tied to perinatal transmission of a non-HIV infection, define the maternal and infant populations of interest, and articulate how the project will generate actionable knowledge or improved care. Strong applications generally align study design with the transmission window (pregnancy, delivery, breastfeeding), specify measurable outcomes relevant to prevention or clinical management, and explain how findings could translate into improved guidelines, interventions, or health outcomes. Because the FOA welcomes translational, epidemiologic, and clinical studies (with trials optional), applicants have flexibility in methodology as long as the work directly supports the overarching goal: advancing understanding, preventing transmission, and improving outcomes for infections passed from women to their infants.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Advancing Understanding, Prevention, and Management of Infections Transmitted from Women to their Infants (R01 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 2017-11-02.
• Applicants must submit their applications by 2019-09-07. (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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