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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant woman attending participating clinics

≥15 years of age

Willing to disclose a known positive HIV status or undergo HIV testing if serostatus is unknown or negative

Willing to attend follow up visits

Disqualifiers

Incarcerated individuals

Pregnant women and mothers who participated in the Aim 1 pilot of the BONDS interventions or has previously participated in the BONDS interventions during the trial

Any pregnant women and mothers who live in a home in which a BONDS participant has already been enrolled

Pregnant women, mothers, and babies who have any acute or chronic condition which, in the opinion of the study team, means enrollment in the trial would not be advisable

Trial design

Treatments tested in this trial

  • Friendship Bench
  • Infant and Young Child Feeding (IYCF) Curriculum
  • Play-Based Curriculum

Treatment groups

1,260 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Washington

Lead sponsor

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

Collaborator