Malaria remains a major cause of illness among school-aged children in sub-Saharan Africa, many of whom carry asymptomatic Plasmodium falciparum infections that may contribute to anemia, inflammation, school absenteeism, and impaired cognitive performance. Intermittent preventive treatment in school-aged children (IPTsc) is recommended by the World Health Organization in settings with moderate-to-high malaria transmission, but the optimal dosing frequency remains uncertain. This cluster-randomized trial will compare monthly versus quarterly administration of dihydroartemisinin-piperaquine (DP) among 1,500 children aged 6-10 years attending six primary schools in Siaya County, Kenya. The primary objective is to determine whether monthly IPTsc results in greater improvements in executive functioning compared with quarterly IPTsc. Secondary objectives include evaluating effects on literacy, numeracy, school attendance, malaria infection, anemia, inflammatory and metabolic biomarkers, and molecular markers of antimalarial resistance.
Age 6 to 10 years at enrollment
Enrollment in a participating primary school in Siaya County, Kenya
Residence within the participating school's catchment area with no plans to relocate during the study period
Parent or legal guardian able and willing to provide informed consent
Known hypersensitivity or contraindication to dihydroartemisinin-piperaquine (DP)
Severe acute illness requiring urgent medical evaluation or hospitalization at enrollment
Known cardiac disease or history of conditions associated with increased risk of QT prolongation
Severe malnutrition requiring urgent referral or treatment
Parallel
Monthly DP
DrugAge- or weight-based dihydroartemisinin-piperaquine administered monthly for 24 months as intermittent preventive treatment in school-aged children (IPTsc).
Quarterly DP
DrugAge- or weight-based dihydroartemisinin-piperaquine administered every three months for 24 months as intermittent preventive treatment in school-aged children (IPTsc).
Change from baseline to 24 months in NeuroScreen Executive Function Composite z-score
Executive function will be assessed quarterly using tablet-based NeuroScreen tasks measuring working memory, inhibitory control/attention, and cognitive flexibility. The primary endpoint will be the adjusted change in the EF composite z-score from baseline to 24 months. Higher scores indicate better performance.
Change from baseline to 24 months in EGRA score
Literacy will be assessed using Early Grade Reading Assessment subtests adapted for the local language and educational context. Scores will be analyzed as standardized continuous outcomes; higher scores indicate better reading performance.
Change from baseline to 24 months in EGMA score
Numeracy will be assessed using Early Grade Mathematics Assessment subtests adapted for the local educational context. Scores will be analyzed as standardized continuous outcomes; higher scores indicate better mathematics performance.
Total School Absenteeism
Number and proportion of enrolled school days missed during the 24-month follow-up period, based on school registers and teacher confirmation.
Malaria-Associated School Absenteeism
Number of school days missed due to suspected or confirmed malaria illness, based on study assessments, clinic records when available, and caregiver/teacher illness reports.
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Indiana University
Lead sponsor
Jaramogi Oginga Odinga University of Science and Technology
Collaborator
Harvard School of Public Health (HSPH)
Collaborator
Broad Institute of MIT and Harvard
Collaborator
KEMRI Centre for Global Health Research (CGHR), Kisumu, Kenya
Collaborator
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