Researching Interventions and Implementation Strategies to Evaluate the Health and Development of Children Affected by HIV

Over the past 5 years, NICHD has supported in-depth studies of CHEU through an R61/R33 mechanism in 5 programs. We propose to amplify the impact of the prior awards by collaborating in a multi-country application focused on CHEU research that involves prior R61/R33 awardees conducting studies in high HIV prevalence settings (Botswana, Kenya, and Zimbabwe). Our U19 application entitled “Researching Interventions and Implementation Strategies to Evaluate the Health and Development of Children Affected by HIV”, has the following Aims: To build a U19 structure that includes 34 Research Projects and 3 Cores as follows: Project 1 (Neuroanatomic pathways): Using existing cohorts, to compare brain structure in CHEU and CHU at 5-10 years and characterize longitudinal brain structural changes in Botswana and Kenya using low-field and high-field MRI; and determine associations between brain structure and neurodevelopment. Comparator groups include children and adolescents unexposed to HIV (CHU) and PrEP-exposed CHU. Project 2 (Intervention): Determine the impact of a combination intervention (which includes psychosocial support through problem-solving therapy [Friendship Bench]; counseling on optimal infant and young child feeding; child play/early learning to spur interaction and language/motor skills) on neurodevelopment in CHEU and CHU in an individual RCT across 3 countries. Project 3 (Implementation): To determine validity and feasibility of using a risk-score to identify and refer CHEU at most risk for neurodevelopmental delay; evaluate acceptability, feasibility and cost of Project 2 interventions; and to model cost-effectiveness and impact of risk-based screening/referral and interventions among CHEU and CHU. To implement a shared Scientific Administrative Core (SAC) to oversee scientific directions and implementation of the Research Projects and administrative, fiscal, and communication for the U19. To implement a shared Data Management and Analysis Core (DMAC) to oversee data management, standardization, quality control and analysis and to build capacity for in-country data analysis. To implement a shared Dissemination and Engagement Core (DEC) to develop materials and engage stakeholders at community, county/local, national, and global (WHO, UNICEF) levels in RISE U19 findings. Project Number: 3U19HD118601-01S1 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Grace John-Stewart (+4 co-PIs) | Institution: UNIVERSITY OF WASHINGTON, SEATTLE, WA | Award Amount: $939,977 | Activity Code: U19 | Study Section: ZHD1-DSR-B(50)R View on NIH RePORTER: https://reporter.nih.gov/project-details/3U19HD11860101S1