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
Locations
Sponsors and collaborators
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator