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Neurodevelopmental Assessment of Early-treated HIV-infected Children

Neurodevelopmental Assessment of Early-treated HIV-infected Children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201801002967587
Enrollment
220
Registered
2018-01-11
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Paediatrics Early Childhood Development

Interventions

None
Early Childhood Developmental Stimulation Box

Sponsors

Empilweni Services and Research Unit (ESRU)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: POC or laboratory-based infant diagnostic test positive on a sample collected within 48 hours of birth, the mother willing and able to provide informed consent.

Exclusion criteria

Exclusion criteria: Expressed intention to leave the Johannesburg area permanently, co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life, active (uncontrolled) maternal psychiatric illness.

Design outcomes

Primary

MeasureTime frame
To compare the neurodevelopment of a cohort of early-treated HIV positive children receiving an early childhood stimulation intervention with a cohort of early-treated HIV positive children and HIV-exposed uninfected children not having received the intervention.

Secondary

MeasureTime frame
To describe the neurodevelopment of a cohort of perinatally-infected HIV positive children initiated on antiretroviral treatment in infancy.;To compare the neurodevelopment of a cohort of early-treated HIV positive children with a control group of HIV-exposed uninfected children;To investigate associations between neurodevelopmental outcomes and environmental factors using the Household Survey and Parenting Stress Index-SF, in early treated perinatally-infected HIV positive children and HIV-exposed uninfected children.

Countries

South Africa

Contacts

Public ContactRenate Strehlau

Deputy Director ESRU

renate.strehlau@wits.ac.za+27114709214

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026