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

NCT07430826 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY000223431U19HD118601-01
• Study Type: interventional
• Target: 1,260
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Nurturing Care Framework; CHEU; CHU; Neurodevelopment; Malawi Developmental Assessment Tool; HIV; vocabulary acquisition; functional difficulties; Breastfeeding duration; Breastfeeding initiation; Maternal mental health; stunting; wasting; underweight

Outcome Measures

Primary Outcomes (1)

• Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months

  MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 24 months will be compared between the intervention and control arms.

  Study endline (child age: 24 months)

Secondary Outcomes (11)

• Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months

  Study midline (child age: 12 months)

• Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months

  Study endline (child age: 24 months)

• Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months

  Study endline (child age: 24 months)

• Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months

  Study endline (child age: 24 months)

• Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months

  Study endline (child age: 24 months)

Other Outcomes (12)

• Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months

  Study midline (child age: 12 months)

• Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months

  Study midline (child age: 12 months)

• Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months

  Study midline (child age: 12 months)

Study Arms (2)

BONDS Intervention

EXPERIMENTAL

The intervention arm will combine three evidence-based interventions (Friendship Bench, infant and young child feeding curriculum, play-based learning curriculum) in a country-adapted package delivered by CHWs to participants starting in pregnancy and continuing through a child's second year of life. The intervention will be delivered at home, in the community, in a government clinic, or study clinic in the context of ongoing antenatal care and maternal and child health services for pregnant women, mothers, and children.

Behavioral: Friendship Bench; Behavioral: Infant and Young Child Feeding (IYCF) Curriculum; Behavioral: Play-Based Curriculum

Standard of Care

NO INTERVENTION

The standard of care arm includes regular antenatal care and maternal and child health services. These services across the three countries include recommended antenatal care visits during which maternal/fetal health is assessed, antenatal tests are conducted, nutrition supplements and disease prophylaxis are provided, and basic education on danger signs, breastfeeding and nutrition are provided. Postnatal and infant care include family planning, growth monitoring, immunization, and assessment of child development.

Interventions

Friendship Bench BEHAVIORAL

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.

BONDS Intervention

Infant and Young Child Feeding (IYCF) Curriculum BEHAVIORAL

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.

BONDS Intervention

Play-Based Curriculum BEHAVIORAL

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.

BONDS Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Resides inside of the study catchment area and does not plan to move within the next 2 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Related Publications (6)

• World Health Organization. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential [Internet]. Geneva: World Health Organization; 2018. 55 p. Available from: iris.who.int/handle/10665/272603

  BACKGROUND

• Wedderburn CJ, Evans C, Yeung S, Gibb DM, Donald KA, Prendergast AJ. Growth and Neurodevelopment of HIV-Exposed Uninfected Children: a Conceptual Framework. Curr HIV/AIDS Rep. 2019 Dec;16(6):501-513. doi: 10.1007/s11904-019-00459-0.

  PMID: 31732866 BACKGROUND

• Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4.

  PMID: 27717632 BACKGROUND

• Evans C, Chasekwa B, Ntozini R, Majo FD, Mutasa K, Tavengwa N, Mutasa B, Mbuya MNN, Smith LE, Stoltzfus RJ, Moulton LH, Humphrey JH, Prendergast AJ; Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial Team. Mortality, Human Immunodeficiency Virus (HIV) Transmission, and Growth in Children Exposed to HIV in Rural Zimbabwe. Clin Infect Dis. 2021 Feb 16;72(4):586-594. doi: 10.1093/cid/ciaa076.

  PMID: 31974572 BACKGROUND

• Jeong J, Franchett EE, Ramos de Oliveira CV, Rehmani K, Yousafzai AK. Parenting interventions to promote early child development in the first three years of life: A global systematic review and meta-analysis. PLoS Med. 2021 May 10;18(5):e1003602. doi: 10.1371/journal.pmed.1003602. eCollection 2021 May.

  PMID: 33970913 BACKGROUND

• Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102.

  PMID: 28027368 BACKGROUND

MeSH Terms

Conditions

Growth Disorders; Cachexia; Thinness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms

Study Officials

• Grace John-Stewart, Md, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Andrew Prendergast

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• Kathleen Powis

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Dalton Wamalwa

  University of Nairobi / Kenyatta National Hospital

  PRINCIPAL INVESTIGATOR

• Irene Njuguna

  Emory University

  STUDY DIRECTOR

• Christine McGrath

  University of Washington

  STUDY DIRECTOR

• Andrew Prendergast

  Queen Mary University of London

  STUDY DIRECTOR

• Adam Cassidy

  Mayo Clinic

  STUDY DIRECTOR

Central Study Contacts

Irene Nyambura Njuguna

CONTACT

+1-206-519-1275; injugun@emory.edu

Christine McGrath

CONTACT

+1 206 619 8700; mcgrathc@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analysts will also be blinded to arm allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine, Global Health

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available on NICHD DASH 12 months after the end of participant follow-up, which is anticipated to be December 2029. Supporting information (protocol, ICFs, SAPs) is anticipated to be available on ct.gov by May 2027.
• Access Criteria: IPD will be available open access on NICHD DASH. Supporting information will be available open access on ct.gov.