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. .
Study Type
OBSERVATIONAL
Enrollment
144
Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
Kilimanjaro Christian Medical Centre
Moshi, Kilimanjaro, Tanzania
Mawenzi Regional Hospital
Moshi, Kilimanjaro, Tanzania
Kibosho Hospital
Kibosho, Tanzania
Kiboroloni Dispensary
Moshi, Tanzania
Majengo Health Centre
Moshi, Tanzania
Pasua Health Centre
Moshi, Tanzania
Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms)
Neuropsychological symptoms will be assessed using the Swahili version of the Child Behavior Checklist for 6-18 years (CBCL6-18)
Time frame: At day of inclusion
Cognitive functioning - non-verbal cognitive ability (general intelligence)
Non-verbal cognitive ability will be assessed using the Raven's Progressive Matrices
Time frame: At day of inclusion
Cognitive functioning - working memory
Working memory will be assessed using the Wechsler Intelligence Scale for Children (WISC-III) Digit Span Test
Time frame: At day of inclusion
Treatment adherence
Treatment adherence will be measured using an adherence questionnaire, adapted from the PENTA 16 trial (permission obtained from the author prof. Giaquinto)
Time frame: At day of inclusion
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