Abstract:
Introduction For the growing number of children
with in utero and postpartum exposure to HIV and/
or antiretrovirals, it is unclear which exposures or
risk factors play a significant role in predicting worse
neurodevelopmental outcomes. This protocol describes
a prospective longitudinal cohort study of infants born
to mothers living with HIV and those born to mothers
without HIV. We will determine which risk factors are
most predictive of child neurodevelopment at 24 months.
We aim to create a risk assessment tool to help predict
which children are at risk for worse neurodevelopment
outcomes.
Methods and analysis This study leverages an existing
Kenyan cohort to prospectively enrol 500 children born
to mothers living with HIV and 500 to those without
HIV (n=1000 total) and follow them from birth to age
24 months. The following factors will be measured
every 6 months: infectious morbidity and biological/
sociodemographic/psychosocial risk factors. We will
compare these factors between the two groups. We will
then measure and compare neurodevelopment within
children in both groups at 24 months of age using the
Child Behaviour Checklist and the Bayley Scales of Infant
and Toddler Development, third edition. Finally, we will use
generalised linear mixed modelling to quantify associations
with neurodevelopment and create a risk assessment tool
for children ≤24 months.
Ethics and dissemination The study is approved by
the Moi University’s Institutional Research and Ethics
Committee (IREC/2021/55; Approval #0003892), Kenya’s
National Commission for Science, Technology and
Innovation (NACOSTI, Reference #700244) and Indiana
University’s Institutional Review Board (IRB Protocol
#110990). This study carries minimal risk to the children
and their mothers, and all mothers will provide written
consent for participation in the study. Results will be
disseminated to maternal child health clinics within
Uasin Gishu County, Kenya and via papers submitted to
peer-reviewed journals and presentation at international
conferences.
