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

NCT04114305 | Completed

• 1 other identifier: IRB 6298
• Study Type: observational
• Target: 431
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Human Immunodeficiency Virus; HIV-Exposed Uninfected Children; Prevention of Mother to Child Transmission of HIV; Orphans and Vulnerable Children; Mentor Mothers; Swaziland; eSwatini

Outcome Measures

Primary Outcomes (2)

• Child development

  The primary outcome of childhood development was assessed when the children were 9 and 18 months of age using the Mullen Scales of Early Learning. Scores from each domain (Visual Reception, Fine Motor skills, Receptive Language, Expressive Language and Gross Motor skills) were analyzed separately.

  Through 18 months of age

• Maternal Psychosocial Well-being

  The primary maternal outcome of psychosocial well-being was assessed using the Edinburgh Postnatal Depression Scale (EPDS), categorized dichotomously as depressive symptoms present (EPDS score \>13) or absent (EPDS score ≤13). Parenting self-confidence was also assessed, using the Maternal Self-Report Inventory (Short Form) (MSRI). These instruments were administered to women at enrollment and at nine and 18 months postpartum.

  Assessed at 9 and 18 months postpartum

Secondary Outcomes (6)

• Maternal Retention in HIV care

  3, 6, 9 and 18 months postpartum

• Maternal CD4 count

  Through study completion, an average of 18 months postpartum

• Maternal HIV viral load

  Through study completion, an average of 18 months postpartum

• Child retention in well-child care

  3, 6, 9, 12-15 and 18 months after birth

• Pediatric hospitalizations

  3, 6, 9, 12-15 and 18 months after birth

Study Arms (2)

Intervention

HIV-infected pregnant women enrolled in ECD program implemented by m2m program; women followed during pregnancy and 18 months post-partum with their infants.

Behavioral: ECD Intervention

Control

HIV-infected pregnant women receiving routine care in clinics without ECD program; women followed during pregnancy and 18 months post-partum with their infants.

Interventions

ECD Intervention BEHAVIORAL

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.

Also known as: My Child, Our Child

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-infected pregnant women residing in Swaziland who were either being followed for antenatal care at clinics in which the m2m ECD intervention was being offered or at clinics where this intervention was not being offered.

You may qualify if:

• Age 18 years and over
• HIV+ woman with confirmed HIV status recorded on a clinic chart or register
• Visiting the PMTCT clinic in the 3rd trimester of pregnancy
• Verified resident within the clinic-defined catchment area

You may not qualify if:

• Age less than 18 years
• Reported specific plan to move outside catchment area or switch HIV care to another site
• Did not provide written consent to participate in the study or did not complete the enrollment questionnaire.
• Born to enrolled woman as a result of the pregnancy during which she was enrolled.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Andrea J Ruff, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Maureen Black, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: January 18, 2016
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anticipate data becoming available in early 2020. Duration of availability will be per sponsor requirements.