NCT04114305

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

Completed Last updated 29 April 2020

What this trial tests

trial testing ECD Intervention in Early Childhood Development (ECD) in 431 participants. Completed in 27 April 2018.

Timeline

18 January 2016

Primary endpoint
27 April 2018

27 April 2018

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	431
Start date	18 January 2016
Primary completion	27 April 2018
Estimated completion	27 April 2018

Drugs / interventions tested

• ECD Intervention

Conditions studied

• Early Childhood Development (ECD) — all drugs for Early Childhood Development (ECD) →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

18 and older, female only, with Early Childhood Development (ECD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A trial of nurturing care among children who are HIV-exposed and uninfected in eSwatini.
   Ruff A, Dlamini X, Nonyane BA, Simmons N, et al · · 2023 · cited 6× · PMID 37909213 · DOI 10.1002/jia2.26158