Evaluation of an Early Childhood Development Intervention Among Children Born to HIV-Infected Women in Eswatini

NCT04114305 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 431

Last updated 2020-04-29

No results posted yet for this study

Summary

With increased use of effective strategies to prevent HIV transmission from women to their infants, the number of HIV infected children has dramatically decreased. This has led to an increased number of children who have been exposed to HIV, but who are not themselves infected. There is concern that exposure to HIV can lead to poorer health outcomes, including less optimal neurodevelopment. Because of this possibility in a growing population of HIV-exposed, but uninfected (HEU) children, there is a need to identify interventions to optimize their growth and development. This study was undertaken to evaluate the impact of a two-generation intervention, jointly targeting child neurodevelopment and maternal psychosocial wellbeing, integrated into antenatal care/prevention of maternal to child transmission (ANC/PMTCT) clinics.

The intervention was implemented by mothers2mothers (m2m), an organization based in South Africa with a long-standing program using peer mentors (Mentor Mothers) to support HIV-infected women and their families. The m2m ECD intervention provided by specially trained Mentor Mothers included home- and community based activities meant to assist mothers and other caregivers in building resilience and gaining skills to support their children's development. The primary intervention was an intensive program of home visits beginning during pregnancy and continuing until the child reached two years of age, with up to 46 home visits. At each visit, the ECD Mentor Mothers helped parents/caregivers to learn about ages and stages of growth (including pre-birth), and to facilitate responsive parenting and early learning opportunities for their children. Mentor Mothers also conducted parenting information play groups (PIPs) in each community for ECD clients and ECD information was integrated into the existing facility support groups provided at each health clinic. The intervention covered general areas of maternal and child health, nutrition, social services, support for primary caregivers and stimulation for early learning.

Since the intervention was targeted at two generations, the primary aims were two-fold: to assess the impact on pediatric neurodevelopment and on maternal psychosocial function. Secondary aims included assessment of maternal and child retention in care, maternal HIV outcomes and child mortality, health, growth and nutrition. Children were enrolled into one of two study arms: 1) the intervention arm included children from clinics where the m2m ECD program was being implemented, and 2) the comparison arm included children from government clinics that offered standard of care services but no m2m or ECD program.

Mothers were enrolled during antenatal care, in the third trimester of pregnancy. Children and their mothers were followed though 18 months of age and their evaluation included an assessment of development (Mullen Scale of Early Learning) at 9 and 18 months, as well as assessments of child growth, maternal psychosocial well-being, parenting practices and retention in care.

Conditions

  • Early Childhood Development (ECD)

Interventions

BEHAVIORAL

ECD Intervention

Modeled on the Early Learning Resource Unit's Family \& Community Motivator home visiting program and Philani Mentor Mothers home visiting program in South Africa. Program provided stimulation in 5 domains: cognitive, receptive and expressive language, gross and fine motor skills, also covered topics in maternal and child health, nutrition and social services. Comprised primarily of home visits beginning during pregnancy and continuing until the child was 18 months. ECD MM taught the parent/caregiver about ages and stages of growth, helped facilitate responsive parenting and early learning opportunities for their children, demonstrated use of toys and books to stimulate the child, provided families with picture books, and taught caregivers to create toys and books for their child. Community parenting information play groups and educational talks on ECD at the clinic supplemented home visits.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Andrea J Ruff, MD · Johns Hopkins Bloomberg School of Public Health

  • Maureen Black, PhD · University of Maryland, College Park

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-18
Primary Completion
2018-04-27
Completion
2018-04-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114305 on ClinicalTrials.gov