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OPTIMAL LEAP: Optimizing Dihydroartemisinin-Piperaquine IPTsc Intervals to Advance Learning, Executive Function, Attendance, and Antimalarial Resistance Surveillance in Kenyan Schoolchildren

Study acronym: Optimal LEAP
StatusNot Yet Recruiting
PhasePhase 3
Started2028-01-01
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07798583
Lead Sponsor Indiana University
Collaborators: Jaramogi Oginga Odinga University of Science and Technology, Harvard School of Public Health (HSPH), Broad Institute of MIT and Harvard, KEMRI Centre for Global Health Research (CGHR), Kisumu, Kenya
Conditions Malaria, Asymptomatic Malaria, Intermittent Preventive Treatment
Enrollment 1,500 participants
Start Date 2028-01-01
Primary Completion 2030-01-01 (estimated)
Study Completion 2033-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-01