PROJECT 2
BACKGROUND
Two-thirds of all children across Eastern and Southern Africa (ESA) fail to achieve their developmental potential.1 There is strong evidence that children exposed to HIV but uninfected (CHEU) have an increased risk of suboptimal neurodevelopment compared to children who are HIV-unexposed (CHU).2–4 Despite strong evidence of adverse outcomes among CHEU and high risk of poor development among all children, there is scant research on interventions to improve outcomes and close the gap between CHEU and CHU.
Poor neurodevelopmental outcomes in CHEU are related to HIV-specific risk factors, as well as social/universal risk factors that disproportionately affect CHEU.5 These social and universal risk factors could be comprehensively addressed through the World Health Organization (WHO) Nurturing Care Framework (NCF), with its five interrelated components (good health, nutrition, safety/security, early learning, responsive caregiving).6
Few studies have developed comprehensive, scalable, and sustainable models to support child development. For example, in two recent meta-analysis7,8 only 10% of the RCTs reviewed were conducted in Africa.Most interventions in this review were community-based curriculum models that had efficacy in improving cognitive development; however, few addressed more than 1 or 2 NCF components and none of those in Africa began in pregnancy, missing a critical period for interventions to promote healthy brain development. Even fewer studies have examined the efficacy of interventions in CHEU, a missed opportunity as CHEU are known to be at elevated risk and appear to be more responsive to early-life interventions than CHU.9,10
OBJECTIVES
The overarching goal of BONDS is to determine whether a scalable, community health worker-administered package of evidence-based interventions improves neurodevelopment for all children and closes the developmental gap between children who are exposed or not exposed to HIV. The intervention package will include caregiver problem-solving therapy (Friendship Bench), a curriculum-based infant and young child feeding program, and a play-based early learning curriculum, administered from pregnancy to 2-years of age. We will also provide a large multi-country data repository for future studies on mechanisms of child development.
The specific aims include:
1) To culturally adapt and refine three interventions to create a maternal-child package aligned with all five components of the NCF.
2) To determine the efficacy of the BONDS intervention to improve neurodevelopment among CHEU and CHU in an individually randomized clinical trial in Kenya, Botswana, and Zimbabwe.
3) To evaluate mechanisms of action of the BONDS intervention package, including maternal health, infant nutrition, and caregiving quality.
4) To identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating neurodevelopmental evaluations and the BONDS intervention components into routine maternal and child health care settings.
STUDY TEAM
MULTIPLE PRINCIPAL INVESTIGATOR AND SENIOR ADVISOR
Department of Paediatrics and Child Health
University of Nairobi
PROJECT DIRECTORS
Queen Mary University of London; Zvitambo Institute for Maternal and Child Health
School of Nursing,
Emory University;
Department of Global Health, University of Washington
Department of
Psychiatry and Psychology,
Mayo Clinic
Department of
Global Health,
University of
Washington
CO-INVESTIGATORS
Department of Research and Programs,
Kenyatta National Hospital
Diagnostic Services and Health Information, Kenyatta National Hospital
Department of Paediatrics and Child Health, Faculty of Health Sciences,
University of Nairobi
Kenya Medical Research Institute,
Centre for Clinical Research
Botswana Harvard
Health Partnership
Botswana Harvard
Health Partnership
Botswana Harvard
Health Partnership
Zvitambo Institute for Maternal and Child Health Research
Institute of Infection, University of Liverpool;
Zvitambo Institute for Maternal and Child Health Research
Department of
Global Health,
University of Washington
Department of Global Health, University of Washington
STUDY COORDINATORS
Department of Global Health, University of Washington
Botswana Harvard
Health Partnership
Zvitambo Institute for Maternal and Child Health Research
Division of Pediatric Global Health,
Mass General Hospital
Rise Consortium 