Medication Adherence Clinical Trial
Official title:
Neuropsychiatric Adverse Effects of Efavirenz in Children Living With HIV in Kilimanjaro, Tanzania
Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing
evidence shows that central nervous system side-effects in adults are more common than
previously thought. Still, reliable data in children are lacking. As HIV-infected children
nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential
long-term central nervous system side-effects, interfering with neurodevelopment and
psychosocial maturation. Using validated tools, we assessed (1) competence
(social/activities/school) and psychopathology (internalizing/externalizing problems), (2)
cognitive performance (intelligence and working memory), and (3) adherence in Tanzanian
children on an efavirenz or non-efavirenz based regimen
In this cross-sectional observational study the investigators will examine neuropsychiatric
and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination
antiretroviral therapy (cART) with or without efavirenz.
In this cross-sectional observational study, we include HIV-infected children (6-12 years) on cART for ≥ 6 months, with viral loads ≤ 1000 copies/ml in Kilimanjaro Region, Tanzania. Psychopathology and competence will be assessed using the Child Behaviour Checklist. Cognitive performance will be assessed using the Raven's Coloured Progressive Matrices and the digit span test. Non-adherence is defined as any reported missed doses over the previous 3 days or <100% adherence since the last clinical visit. Analysis of covariance and logistic regression models will be used to assess differences between groups. . ;
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