Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa

Summary

The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. The main objectives of this study are to:

* Determine whether the adapted package of interventions improves neurodevelopment among children with and without in utero HIV exposure
* Identify why the intervention does or does not impact children's neurodevelopment.

Researchers will compare children who receive the intervention package and those who do not to see if the interventions improve child neurodevelopment and growth. Researchers will also compare children with and without HIV exposure to see if there are improvements in neurodevelopment and growth for children who were exposed to HIV.

All participants will attend regular prenatal and postnatal care appointments. Participants who are randomized to receive the package of interventions will attend regularly scheduled visits where they will discuss problem-solving strategies, receive information on healthy foods for children, and learn about how to play with their children. Mothers receiving the intervention package will also have the opportunity to meet with other mothers and babies in small groups where their children can play together.

Conditions

• Neurodevelopment
• Child Growth

Interventions

BEHAVIORAL

Friendship Bench

After enrollment, participants randomized to BONDS will be linked to a community health worker (CHW) who will arrange Friendship Bench (FB) sessions. During the sessions, participants identify their current stressors, and work with CHWs to consider solutions and select and implement practical solutions.

BEHAVIORAL

Infant and Young Child Feeding (IYCF) Curriculum

Community health workers will deliver the infant and young child feeding (IYCF) curriculum between pregnancy and 2 years. Modules in pregnancy will focus on early breastfeeding initiation, exclusive breastfeeding (EBF), how to breastfeed and challenges with breastfeeding. Following birth, modules will reinforce education and support EBF through 6 months and then transition to the introduction of other foods and food preparation demonstrations with continued breastfeeding.

BEHAVIORAL

Play-Based Curriculum

This parent-focused, play-based intervention addresses responsive caregiving and opportunities for early learning. The intervention will emphasize the importance of early learning experiences and adopting a growth mindset, with common themes including the use of scaffolding and "serve and return" activities.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Grace John-Stewart, Md, PhD · University of Washington

• Andrew Prendergast · Queen Mary University of London

• Kathleen Powis · Massachusetts General Hospital

• Dalton Wamalwa · University of Nairobi / Kenyatta National Hospital

• Irene Njuguna · Emory University

• Christine McGrath · University of Washington

• Andrew Prendergast · Queen Mary University of London

• Adam Cassidy · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-11-30

Primary Completion

2029-12-31

Completion

2029-12-31