R01HD104552
Project Grant
Overview
Grant Description
Predicting Neurodevelopmental Risk in Children Born to Mothers Living with HIV in Kenya - Project Summary
Children who are HIV-exposed but uninfected (HEU) may have worse neurodevelopmental outcomes compared to their HIV-unexposed and uninfected (HUU) peers. However, the etiology of this potential association is unclear. With a growing population of children who are HIV-exposed, making up over 15% of children in some countries, there is a critical need to identify evidence-based risk factors associated with poor neurodevelopment to appropriately target interventions.
The specific objectives of this application are: (1) to evaluate potential risk factors longitudinally over the first 2 years of life in children who are HEU and HUU and define those associated with worse neurodevelopmental outcomes at 24 months, and (2) to create a risk assessment tool to predict which children will have worse neurodevelopmental outcomes.
The central hypothesis is that children who are HEU and HUU will have different neurodevelopmental outcomes, and that we can use risk factors to predict which children are at risk for worse outcomes before 2 years of age. The rationale for developing this tool is to identify children at risk for worse neurodevelopmental outcomes earlier to allow for targeted intervention.
In Aim 1, we will evaluate the potential risk factors for poor neurodevelopment in young children. In Aim 2, we will compare neurodevelopmental outcomes between 24-month-old children who are HEU and those who are HUU in Kenya. In Aim 3, we will create a risk assessment tool to predict which children are at risk for worse neurodevelopmental outcomes at 24 months of age.
This study will leverage an existing cohort to prospectively enroll 500 children who are HEU and 500 who are HUU and longitudinally follow them from birth to 24 months of age. Within the first aim, the following factors will be measured every 6 months: infectious morbidity, biological risk factors, and social risk factors (both sociodemographic and psychosocial). We will then compare these factors between children who are HEU and HUU.
Within the second aim, we will measure neurodevelopment (cognition, language, motor, and behavior) in children at 24 months of age using the Child Behavior Checklist and the Bayley Scales of Infant and Toddler Development, 3rd Edition, which our team has culturally adapted and internally validated for use in Kenya. We will then compare neurodevelopmental outcomes between children who are HEU and HUU, providing well-powered data to determine whether differences truly exist between the groups.
Finally, within the third aim, we will use generalized linear mixed modeling to quantify associations among multiple factors on child neurodevelopment and create a risk assessment tool for use in children under 24 months.
The proposed study is significant, as we will determine interconnected factors associated with worse neurodevelopmental outcomes in children who are HEU and HUU in Kenya. The resulting risk assessment tool will allow clinical providers to institute interventions for children at risk for worse neurodevelopmental outcomes earlier. This work will also create a longitudinal cohort of children exposed to antiretroviral therapy and HIV that may be monitored for future studies.
Children who are HIV-exposed but uninfected (HEU) may have worse neurodevelopmental outcomes compared to their HIV-unexposed and uninfected (HUU) peers. However, the etiology of this potential association is unclear. With a growing population of children who are HIV-exposed, making up over 15% of children in some countries, there is a critical need to identify evidence-based risk factors associated with poor neurodevelopment to appropriately target interventions.
The specific objectives of this application are: (1) to evaluate potential risk factors longitudinally over the first 2 years of life in children who are HEU and HUU and define those associated with worse neurodevelopmental outcomes at 24 months, and (2) to create a risk assessment tool to predict which children will have worse neurodevelopmental outcomes.
The central hypothesis is that children who are HEU and HUU will have different neurodevelopmental outcomes, and that we can use risk factors to predict which children are at risk for worse outcomes before 2 years of age. The rationale for developing this tool is to identify children at risk for worse neurodevelopmental outcomes earlier to allow for targeted intervention.
In Aim 1, we will evaluate the potential risk factors for poor neurodevelopment in young children. In Aim 2, we will compare neurodevelopmental outcomes between 24-month-old children who are HEU and those who are HUU in Kenya. In Aim 3, we will create a risk assessment tool to predict which children are at risk for worse neurodevelopmental outcomes at 24 months of age.
This study will leverage an existing cohort to prospectively enroll 500 children who are HEU and 500 who are HUU and longitudinally follow them from birth to 24 months of age. Within the first aim, the following factors will be measured every 6 months: infectious morbidity, biological risk factors, and social risk factors (both sociodemographic and psychosocial). We will then compare these factors between children who are HEU and HUU.
Within the second aim, we will measure neurodevelopment (cognition, language, motor, and behavior) in children at 24 months of age using the Child Behavior Checklist and the Bayley Scales of Infant and Toddler Development, 3rd Edition, which our team has culturally adapted and internally validated for use in Kenya. We will then compare neurodevelopmental outcomes between children who are HEU and HUU, providing well-powered data to determine whether differences truly exist between the groups.
Finally, within the third aim, we will use generalized linear mixed modeling to quantify associations among multiple factors on child neurodevelopment and create a risk assessment tool for use in children under 24 months.
The proposed study is significant, as we will determine interconnected factors associated with worse neurodevelopmental outcomes in children who are HEU and HUU in Kenya. The resulting risk assessment tool will allow clinical providers to institute interventions for children at risk for worse neurodevelopmental outcomes earlier. This work will also create a longitudinal cohort of children exposed to antiretroviral therapy and HIV that may be monitored for future studies.
Awardee
Funding Goals
TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. 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. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Indiana
United States
Geographic Scope
State-Wide
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 431% from $671,758 to $3,564,109.
Trustees Of Indiana University was awarded
Neurodevelopmental Risk in HEU Children in Kenya
Project Grant R01HD104552
worth $3,564,109
from the National Institute of Child Health and Human Development in April 2021 with work to be completed primarily in Indiana United States.
The grant
has a duration of 4 years 9 months and
was awarded through assistance program 93.865 Child Health and Human Development Extramural Research.
The Project Grant was awarded through grant opportunity Promoting NICHD Areas of Research for HIV/AIDS in Maternal and Child Health (R01).
Status
(Ongoing)
Last Modified 1/21/25
Period of Performance
4/9/21
Start Date
1/31/26
End Date
Funding Split
$3.6M
Federal Obligation
$0.0
Non-Federal Obligation
$3.6M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for R01HD104552
Transaction History
Modifications to R01HD104552
Additional Detail
Award ID FAIN
R01HD104552
SAI Number
R01HD104552-3806904193
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NT00 NIH EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
Funding Office
75NT00 NIH EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
Awardee UEI
SHHBRBAPSM35
Awardee CAGE
434D9
Performance District
IN-90
Senators
Todd Young
Mike Braun
Mike Braun
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute of Child Health and Human Development, National Institutes of Health, Health and Human Services (075-0844) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,580,917 | 100% |
Modified: 1/21/25