Neurodevelopmental assessment of HIV-exposed uninfected and early-treated HIV-infected children: study protocol.
Renate StrehlauTamryn van AswegenJoanne PottertonPublished in: BMC research notes (2018)
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.
Keyphrases
- hiv infected
- antiretroviral therapy
- hiv positive
- study protocol
- randomized controlled trial
- human immunodeficiency virus
- south africa
- hiv infected patients
- hiv aids
- clinical trial
- young adults
- men who have sex with men
- open label
- phase ii
- mass spectrometry
- insulin resistance
- heat stress
- stress induced
- adipose tissue
- atomic force microscopy
- single molecule
- placebo controlled
- low birth weight