The Office of the Director of the National Institutes of Health (NIH) announces the opportunity for investigators with relevant active NIH-supported grants from the participating Institutes listed above to address the scientific priorities that will lay the foundation for the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE), which is in development.

An estimated 700 women die each year in the U.S. from conditions related to or associated with pregnancy or childbirth (the highest rate among developed nations), and over 50,000 women experience severe maternal morbidity (SMM). In response to the rising maternal mortality (MM) in the United States (U.S.), the IMPROVE initiative will support research on how to mitigate preventable MM, decrease SMM, and promote health equity in the U.S. IMPROVE will aim to use an integrated approach to understand biological, behavioral, sociocultural, and structural factors contributing to MM/SMM by building an evidence base for improved care and outcomes in specific populations and regions of the country. IMPROVE will be a multipronged, innovative research initiative designed to target health disparities and populations disproportionately affected by MM/SMM, including African American (AA), American Indian/Alaskan Native (AI/AN), Asian Pacific Islander, Hispanic/Latina, very young women and women of advanced maternal age, and people with disabilities. Geographical disparities and social determinants of health (SDoH), including education, racism, and socioeconomic standing will also be addressed by the IMPROVE approach.

Causes of SMM and MM are multifaceted. In the U.S., the leading causes are cardiovascular disease, hemorrhage, and infection. Significant contributing factors include comorbid conditions (e.g., diabetes, obesity, mental health issues, substance use disorders) and structural and health care system factors. Therefore, it is necessary to implement comprehensive strategies to address preventable contributors to SMM/MM in disproportionately affected populations.

In order to rapidly improve our understanding of the leading causes of pregnancy-related and pregnancy-associated morbidity, including SMM, and MM during pregnancy, at delivery, and up to one year post-partum and to expand research and development of risk stratification approaches and mitigation strategies, NIH is soliciting the submission of applications for Administrative Supplements to active social, biobehavioral, and fundamental science awards.

Applicants are encouraged to incorporate where appropriate community partnerships and focus on disparities by race or ethnicity, age, disability status, and geographic region within the overarching research areas. Projects may involve secondary analysis of existing data or collection of new data.

Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3, NIH Strategic Plan For Data Science).

Applications in response to this NOSI should be aligned with one or more of these equally significant goal

• Goal 1: Incorporate community partnerships and participation in domestic MM and pregnancy-related and pregnancy-associated morbidity research to resolve health disparities and attain equity in maternal health.
• Goal 2: Expand research on the leading causes of MM and pregnancy-related and pregnancy-associated morbidity in the U.S. to strengthen evidence-based care and prevention strategies and improve outcomes.
• Goal 3: Develop an integrated understanding of pregnancy-related and pregnancy-associated morbidity and MM causes, including underlying comorbidities, and mechanisms to identify preventable risk factors and develop early effective interventions.

Areas of research interests include but are not limited to the following:

• Identify determinants of risk or protection to detect the most vulnerable populations and provide points of intervention in cardiovascular, stroke, abnormal placentation, hemorrhage, gestational diabetes, infection and immunity, mental health, and substance abuse research areas.
• Determine how factors related to race, ethnicity, and age affect the underlying leading causes, contributors, and mechanisms of MM/pregnancy-related and pregnancy-associated morbidity.
• Identify multi-level (individual, interpersonal, community, and sociocultural) determinants of maternal health disparities, as well as factors that contribute to optimal maternal outcomes in high risk communities.

• Use omics and other novel technologies in existing well-characterized cohorts or in clinical trials of pregnant women to accelerate identification of diagnostic, predictive, or therapeutic biomarkers (including brain structure and function alterations) for pregnancy-related adverse maternal health outcomes.
• Determine the contribution of immune system dysregulation and autoimmunity during pregnancy and the postpartum period leading to poor pregnancy and maternal health outcomes.

• Identify predictors and contribution to maternal mortality of postpartum anxiety and depression or harmful substance use and drug overdoses, including relevant environmental and social factors (e.g., institutional racism, access to care, intimate partner violence, etc.) that affect them.

• Develop and/or test interventions addressing stress, perinatal and postpartum depression and harmful substance use (e.g., peer support, complementary health approaches, strategies to coordinate or integrate OB/GYN and mental health and substance use treatment services) and assess their impact on maternal health outcomes.

• Develop approaches or interventions that target pregnancy-related cardiovascular disease and/or underlying cardiovascular risk factors during the perinatal and postnatal periods and assess their impact on maternal health status.
• Identify barriers and opportunities and design strategies for implementing clinical guidelines on blood pressure management, physical activity, and diet tailored to high risk communities.
• Link or establish the feasibility of linking existing MM/pregnancy-related and pregnancy-associated morbidity datasets, electronic health records, and clinical and biomarker data from existing national cohorts, biobank data, national surveys and registries.
• Develop tools or modify existing tools (e.g. Smartwatch with ECG, blood pressure, sleep monitor and heart rate monitor, devices to measure real-time stress level, wearable devices to detect postpartum depression, predictive modeling tools, etc.) to recognize pregnancy related warning signs.
• Identify, monitor, or target pregnancy-related and pregnancy-associated morbidity/MM-related ischemic stroke (arterial and venous), intra-cerebral hemorrhage, epilepsy, migraine, nervous system infections, headache, encephalopathy syndromes, or cognitive impairment.
• Develop strategies for enhancing community partnerships that engages women and their families, community healthcare providers and systems, and local governments to identify barriers to and community-specific opportunities for optimal maternal health equity.
• Design and test strategies to improve interdisciplinary coordinated care, particularly during transition periods, from prenatal to one year postpartum to prevent mortality and adverse health outcomes.

Applications that incorporate community partnerships and interdisciplinary research are strongly encouraged.

As administrative supplements extend the work as awarded in the parent grant, the proposal needs to be within the scope of the project that is already supported. Supplements to awards to clinical trials are allowed. Supplement applicants must demonstrate how the additional NIH funding will advance science and/or medicine above their current funding level.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent:

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional

All instructions in the SF424 (R&R) Application Guide and PA-18-591 (or its reissue) must be followed, with the following additions:

• Application Due Date(s) June 22, 2020 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-OD-20-104 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

• The project and budget periods must be within the currently approved project period for the existing parent award.

• Individual requests can be no more than $150,000 in direct costs for the entire project period.
• The project period will be limited to 1 year.
• The Research Strategy section of the application is limited to 6 pages and should include the following information
• • • Discussion of the scientific rationale and relevance to maternal mortality.

• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-E-ADMINSUPP . This FOA will be reissued with application form packages containing FORMS-F-ADMINSUPP on May 25, 2020. Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice. The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request

Review Process

Each IC will conduct administrative reviews of applications that will then be prioritized by NIH staff on the Maternal Mortality Task Force.

Criteria:

Priority will be given to projects that incorporate community needs and perspectives or that focus on a population disproportionately affected by MM/SMM. NIH staff will review the following:

• Does the work proposed address one or more of the goals as defined earlier in this notice (NOT-OD-20-104)?
• Is the project designed to advance our understanding of the mechanisms, interventions, or risk profiles of pregnancy-related and pregnancy-associated morbidity/MM in the U.S.?
• Does the supplement propose to address one or more of the leading preventable causes of pregnancy-related and pregnancy-associated morbidity/MM in the U.S. as outlined in this notice (NOT-OD-20-104)? If not, is there strong justification for addressing other preventable causes?
• Will the proposal address pregnancy-related and pregnancy-associated morbidity/MM in one or more high risk populations based on race/ethnicity, age, or geographic region?
• Is the work proposed within the scope of the active parent award?
• Is the parent award progressing satisfactorily/according to planned timeline and milestones?
• Is the proposed project technically feasible within the supplement budget and funding period?
• Is the overall strategy, methodology, and analyses proposed in the supplement application well-reasoned and appropriate to accomplish the activities in the proposed project period?