[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626068":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":58,"locations":20,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":20,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":109,"whyStopped":20,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":20},{"fullName":5,"class":6},"University of Washington","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15],"Behavioral: Friendship Bench","Behavioral: Infant and Young Child Feeding (IYCF) Curriculum","Behavioral: Play-Based Curriculum",{"label":17,"type":18,"description":19,"interventionNames":20},"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\u002Ffetal 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.",null,[22,27,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"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.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":20},"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.",[9],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":20},"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.",[9],[36,39,42,45,48,52,54,55],{"name":37,"affiliation":5,"role":38},"Grace John-Stewart, Md, PhD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Andrew Prendergast","Queen Mary University of London",{"name":43,"affiliation":44,"role":38},"Kathleen Powis","Massachusetts General Hospital",{"name":46,"affiliation":47,"role":38},"Dalton Wamalwa","University of Nairobi \u002F Kenyatta National Hospital",{"name":49,"affiliation":50,"role":51},"Irene Njuguna","Emory University","STUDY_DIRECTOR",{"name":53,"affiliation":5,"role":51},"Christine McGrath",{"name":40,"affiliation":41,"role":51},{"name":56,"affiliation":57,"role":51},"Adam Cassidy","Mayo Clinic",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":20,"email":63},"Irene Nyambura Njuguna","CONTACT","+1-206-519-1275","injugun@emory.edu",{"name":53,"role":61,"phone":65,"phoneExt":20,"email":66},"+1 206 619 8700","mcgrathc@uw.edu",{"type":38,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Grace John-Stewart","Professor: School of Medicine, Global Health",[71],{"name":72,"class":73},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100626068","building-opportunities-for-nurturing-care-to-enhance-child-development-in-eastern-and-southern-africa-100626068",false,"NCT07430826","Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa","Building Opportunities for Nurturing Care to Enhance Development in Eastern and Southern Africa","BONDS","Inclusion Criteria:\n\n* Pregnant woman attending participating clinics\n* ≥15 years of age\n* Willing to disclose a known positive HIV status or undergo HIV testing if serostatus is unknown or negative\n* Willing to attend follow up visits\n* Resides inside of the study catchment area and does not plan to move within the next 2 years\n\nExclusion Criteria:\n\n* Incarcerated individuals\n* 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\n* Any pregnant women and mothers who live in a home in which a BONDS participant has already been enrolled\n* 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",true,"FEMALE","15 Years",{"count":86,"type":87},1260,"ESTIMATED","INTERVENTIONAL",[90],"NA","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:\n\n* Determine whether the adapted package of interventions improves neurodevelopment among children with and without in utero HIV exposure\n* Identify why the intervention does or does not impact children's neurodevelopment.\n\nResearchers 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.\n\nAll 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.",[93,94],"Neurodevelopment","Child Growth",[96,97,98,93,99,100,101,102,103,104,105,106,107,108],"Nurturing Care Framework","CHEU","CHU","Malawi Developmental Assessment Tool","HIV","vocabulary acquisition","functional difficulties","Breastfeeding duration","Breastfeeding initiation","Maternal mental health","stunting","wasting","underweight","NOT_YET_RECRUITING","2026-02-27",{"date":112,"type":113},"2026-03-03","ACTUAL",{"date":115,"type":87},"2026-11",{"date":117,"type":87},"2029-12",{"name":5,"class":6}]