Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The purpose of this announcement is to alert the research community of the upcoming publication of a Notice of Funding Opportunity (NOFO) for NICHD Program Project Grants for HIV Research. These Program Project (P01) applications will support integrated, multi-project research programs to address HIV scientific areas relevant to the NICHD mission as a well-defined, central research focus or objective.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The new NOFO will use the NIH Program Project (P01) to conduct and support laboratory research, clinical trials, and studies that explore health processes in HIV scientific areas. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people; and to examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury.
The NOFO is expected to be published in early 2025 with an expected application due date in Spring 2025.
Background
The mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. NICHD supports and conducts domestic and international research and NIH research training and career development programs related to the epidemiology, diagnosis, clinical manifestations, pathogenesis, transmission, treatment, and prevention of HIV infection and its complications in infants, children, adolescents, and women (including pregnant and lactating). In all studies the inclusion of populations disproportionately affected by incidence and prevalence of HIV including racial and ethnic minority groups is expected.
NICHD wants to strengthen both existing collaborations and foster new ones in different areas of HIV research, that will benefit from enhanced multidisciplinary approaches.
The goal of this initiative is to encourage collaborations and stimulate collaborators with a combination of skills ideas, and resources to use multi-project research programs that address NICHD HIV scientific areas as the central research focus and that through synergy among projects, will yield more robust outcomes than would be expected from a single study or multiple isolated studies.
The intention is to encourage participation from a combination of early career HIV investigators, those who have not traditionally engaged in HIV research and more established HIV researchers, with leadership fairly distributed among the groups.
This NOFO supports multi-project applications. In multi-project applications, synergy includes enhancement of scientific knowledge, ideas, and outcomes obtained through the interactions of the individual projects and cores. The proposed combination of skills, ideas, and resources will potentially yield greater outcomes than from conducting HIV research activities as single project applications. Examples of synergy within the program could include sharing data and methods, technologies, samples, reagents, human subject population(s), mathematical modeling, new epidemiological methods, GPS modeling, and use of large data sets, complementary research approaches, data management/analytical tools, and model organisms, which may impact the direction and outcomes of the science and research. The component research projects must share a common central theme, focus, or objective if it contributes to the common overall theme or objective of the program project.
Objectives
This HIV/AIDS P01 NOFO aims to strengthen existing and foster new collaborations in areas of HIV research that could benefit from enhanced multidisciplinary approaches. The work will include NICHD populations of interest including infants, children, adolescents, and women (including pregnant and lactating).
The topics proposed should be in alignment with the NICHD Strategic Plan and the NIH/OAR HIV/AIDS research priorities: https://www.oar.nih.gov/hiv-policy-and-research/research-priorities.
The areas of interest include topics in the following themes:
1) Research to understand changes in immune status and inflammation in HIV exposure or infection and co-infection in the maternal fetal/dyad, during pregnancy including metabolic, hormonal, gut microbiome and virome changes on brain and organ development . Understanding the role that innate immunity plays in the immune response early in life and in response to vaccines and immune based therapies.
2)The use of new technologies from different fields including advanced statistical modeling, Artificial Intelligence (AI) to better track NICHD priority populations in the HIV epidemic and its evolution and co-occurrence in other epidemics/pandemics is encouraged.
3) Development and validation of methods to predict outcomes and inform intervention strategies for HIV prenatal and pregnancy testing, linkage to care, and treatment (i.e., antiretrovirals, contraceptives and multipurpose-prevention technologies, immune-prophylaxis) to improve reproductive health.
4) Basic, biobehavioral, and translational HIV science research to understand altered immune crosstalk in pregnancy, placenta, and fetus, including interaction with environment, biome, nutrition, co-infections, and co-morbidities on the development of the immune system.
5) Research on the effects of HIV and HIV treatment on fertility, pregnancy and post-partum outcomes, complications, co-morbidities, and co-infections including sexually transmitted infections (STI's) (for example syphilis, chlamydia, gonorrhea, HPV, trichomoniasis and CMV).
6) Research on the effects of HIV and HIV treatment on reproductive system pathology, male and female urogenital system conditions, fertility, sexual maturation, nutrition, growth, endocrine, and bone development .
7) The study of adverse outcomes related to antiretroviral medications, HIV and co-infections and co-morbidities. While perinatal HIV transmission rates have declined, concerns remain that the use of different antiretroviral medications over time including long acting injectables may increase adverse pregnancy and infant outcomes (e.g., preterm birth, metabolic including obesity).
8) Research on different approaches to vaccine development and HIV cure may be needed for individuals with evolving immune status. Research on the establishment of HIV reservoirs in different developmental stages, acute vs chronic infection and the type, quality, durability, vulnerability, and preferred cell type (stem cells) of the reservoirs needs further elucidation, especially in understudied populations such as pregnant women and infants.
9) Research on HIV and the many elements including infection, inflammation, cellular, molecular, and paternal factors that influence development of the immune system in utero and during the postnatal period.
P01 Program Project
The P01 application must include:
The P01 application can include:
The P01 team must include
Applicants are encouraged to contact the program official listed under Scientific/Research Contact(s) listed in Section VII to discuss their applications prior to submission to ensure that they will be responsive.
NICHD/NIH intends to commit $3M total cost in each of FY 2026, 2027, and 2028.
NICHD intends to fund up to 2 awards.
Application budgets are limited to $1M per year in direct costs and should reflect the actual needs of the proposed program.
93.865
Applications are not being solicited at this time.
Please direct all inquiries to:
Denise Russo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
Email: [email protected]