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Neurodevelopmental assessment of HIV-exposed uninfected and early-treated HIV-infected children: study protocol
Renate Strehlau1, Tamryn van Aswegen2, Joanne Potterton2,3
1Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. renate.strehlau@wits.ac.za.
Insights
Early childhood stimulation programs combined with antiretroviral treatment (ART) show promise in improving neurodevelopmental outcomes for infants born with HIV in Sub-Saharan Africa.
Area of Science:
- Global child development
- Pediatric infectious diseases
- Public health interventions
Background:
- Sub-Saharan Africa faces a high burden of developmental delays in children, exacerbated by HIV and environmental challenges.
- Early childhood developmental stimulation programs offer a potential strategy to improve outcomes for at-risk children.
Purpose of the Study:
- To evaluate the impact of an early childhood stimulation program combined with antiretroviral treatment (ART) on neurodevelopmental outcomes in HIV-infected neonates.
- To compare neurodevelopmental outcomes between HIV-infected infants receiving the intervention and those not receiving it.
- To explore associations between neurodevelopment, environmental factors, and parental stress.
Main Methods:
- A non-randomized controlled intervention study conducted in Johannesburg, South Africa.
- HIV-positive neonates received ART and a tailored stimulation program throughout their first year.
- Neurodevelopment was assessed at 12 months using the Bayley Scales of Infant and Toddler Development (BSID-III).
Main Results:
- (Results not yet available as study is ongoing/recently initiated)
Conclusions:
- The study aims to determine if early intervention with ART and stimulation can positively influence neurodevelopment in HIV-infected infants.
- Findings will inform the development of targeted interventions to mitigate developmental risks associated with pediatric HIV in resource-limited settings.
Objective:
Sub-Saharan Africa has the highest prevalence of children at risk of not achieving their developmental potential, attributable largely to the human immunodeficiency virus (HIV) pandemic coupled with negative environmental factors. Childhood developmental stimulation programmes can mitigate adverse outcomes.
Methods:
Neonates testing HIV positive at birth will be initiated on antiretroviral treatment (ART) and receive an age-appropriate stimulation program, updated at 3 monthly intervals through the first year of life. Neurodevelopment at 12 months of age will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Outcomes will be compared with HIV-infected and HIV-exposed uninfected children (HEU) not having received the stimulatory intervention. Associations between neurodevelopmental outcomes, environmental factors, and parental stress will be investigated. The study will take place at a single site in Johannesburg, South Africa. This non-randomised controlled intervention study, with a single non-blinded comparative intervention group, aims to investigate whether an early childhood stimulation programme used in conjunction with ART initiated at birth can positively impact neurodevelopmental outcomes at 1 year of age in children infected with HIV. Trial registration 15 January 2018, Pan African Clinical Trial Registry PACTR201801002967587.
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