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NOT YET RECRUITING
NCT07798583
PHASE3

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

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

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.

Official title: OPTIMAL LEAP: Optimizing Preventive Treatment Intervals for Malaria to Advance Longitudinal Learning, Executive Function, Attendance, and Pathways

Key Details

Gender

All

Age Range

6 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2028-01-01

Completion Date

2033-01-01

Last Updated

2026-09-01

Healthy Volunteers

Yes

Interventions

DRUG

Monthly DP

Age- or weight-based dihydroartemisinin-piperaquine administered monthly for 24 months as intermittent preventive treatment in school-aged children (IPTsc).

DRUG

Quarterly DP

Age- or weight-based dihydroartemisinin-piperaquine administered every three months for 24 months as intermittent preventive treatment in school-aged children (IPTsc).