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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodevelopment; Child Growth
• Intervention / Treatment: Behavioral: Friendship Bench; Behavioral: Infant and Young Child Feeding (IYCF) Curriculum; Behavioral: Play-Based Curriculum

Detailed Description

Prior to enrollment for the clinical trial, the three interventions will be culturally adapted and refined in Botswana and Kenya using a user-centered co-design approach. A 3-day participatory workshop will be held to select appropriate adaptations to the three interventions while maintaining core components. Following these adaptations, ~80 pregnant women/mother-infant pairs will be recruited for a formative pilot to further refine the three interventions. The workshop and pilot activities have already been completed in Zimbabwe under a different protocol.

Following the clinical trial, we will determine how the package of interventions works (or if it does not work, why) to improve child development. Hypothesized causal biological and behavioral pathways include maternal health, including mental health; infant health and nutrition; caregiving quality; and maternal-child interactions. Throughout the clinical trial, both quantitative and qualitative data will be collected to identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating the intervention package and neurodevelopmental evaluations into regular maternal and child health services across the three countries. Costing data will also be collected from time and motion cards and study budget records to determine the incremental costs of incorporating the intervention package and neurodevelopmental evaluations in the three participating countries.

• Study Type: Interventional
• Enrollment (Estimated): 1260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine McGrath; Phone Number: +1 206 619 8700; Email: mcgrathc@uw.edu
• Study Contact Backup: Name: Irene Nyambura Njuguna; Phone Number: +1-206-519-1275; Email: injugun@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BONDS Intervention; 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; 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.
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 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 12 months will be compared between the intervention and control arms.	Study midline (child age: 12 months)
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months	MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 24 months will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months	MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 24 months will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months	MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 24 months will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months	MDAT measures language development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT language domain z-score at 24 months will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist	The MacArthur Bates CDI uses caregiver-reported assessments of a child's language acquisition. Caregivers are provided a checklist of the ~100 most commonly spoken words in each language that their child speaks. Mean differences in the number of words spoken will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM)	The CFM assess functional difficulties across eight domains (vision, hearing, mobility, dexterity, communication, learning, playing, and controlling behavior), each assessed using 1-3 four-point Likert scales. The proportion of children with at least one functional difficulty across the eight domains will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Weight-for-age z-score (WAZ) at 24 months	WAZ will be calculated for each child at 24 months. Mean differences in WAZ will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Length-for-age z-score (LAZ) at 24 months	LAZ will be calculated for each child at 24 months. Mean differences in LAZ will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Weight-for-length z-score (WLZ) at 24 months	WLZ will be calculated for each child at 24 months. Mean differences in WLZ will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Head circumference-for-age z-score (HCAZ) at 24 months	HCAZ will be calculated for each child at 24 months. Mean differences in HCAZ will be compared between the intervention and control arms.	Study endline (child age: 24 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months	MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 12 months will be compared between the intervention and control arms.	Study midline (child age: 12 months)
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months	MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 12 months will be compared between the intervention and control arms.	Study midline (child age: 12 months)
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months	MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 12 months will be compared between the intervention and control arms.	Study midline (child age: 12 months)
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months	MDAT measures language development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT language domain z-score at 12 months will be compared between the intervention and control arms.	Study midline (child age: 12 months)
Proportion of children who are stunted	The proportion of children who are stunted will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Proportion of children who are wasted	The proportion of children who are wasted will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Proportion of children who are underweight	The proportion of children who are underweight will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Proportion of mothers with mental distress at 12 months	Mothers are considered to have mental distress if they have a positive screening for depression and/or anxiety. The proportion of mothers with mental distress will be compared between the intervention and control arms.	Study midline (child age: 12 months)
Proportion of mothers with mental distress at 24 months	Mothers are considered to have mental distress if they have a positive screening for depression and/or anxiety. The proportion of mothers with mental distress will be compared between the intervention and control arms.	Study endline (child age: 24 months)
Proportion of mothers who did early initiation of breastfeeding	Early initiation of breastfeeding (defined as mothers who put the baby to the breast within the first hour of birth) will be obtained via maternal self-report. The proportion of women who initiated breastfeeding within one hour of birth will be compared between the intervention and control arms.	First postnatal visit (0-2 weeks after delivery)
Proportion of infants who were exclusively breastfed through six months of age	Exclusive breastfeeding will be obtained via maternal self-report of breastfeeding through 6-months of age with no introduction of formula or complementary foods. The proportion of children who were exclusively breastfed for six months will be compared between the intervention and control arms.	First postnatal visit (0-2 weeks after delivery) through child age 6 months
Overall breastfeeding duration	Overall breastfeeding duration will be measured continuously for each child as the number of months they were breastfed. This will be obtained from maternal self-report. Mean differences in the overall duration of breastfeeding will be compared between the intervention and control arms.	First postnatal visit (0-2 weeks after delivery) through study endline (child age: 24 months)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: 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; Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Neurodevelopment; wasting; stunting; Maternal mental health; underweight; Breastfeeding initiation; Breastfeeding duration; Nurturing Care Framework; CHEU; CHU; Malawi Developmental Assessment Tool; vocabulary acquisition; functional difficulties
• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Body Weight Changes; Weight Loss; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Growth Disorders; Cachexia; Thinness
• Other Study ID Numbers: STUDY00022343; 1U19HD118601-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that is not directly identifiable will be shared.
• IPD Sharing 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.
• IPD Sharing Access Criteria: IPD will be available open access on NICHD DASH. Supporting information will be available open access on ct.gov.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No