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

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.

Conditions

• Malaria
• Asymptomatic Malaria
• Intermittent Preventive Treatment

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).

Sponsors & Collaborators

• Jaramogi Oginga Odinga University of Science and Technology

  collaborator UNKNOWN

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Broad Institute of MIT and Harvard

  collaborator OTHER

• KEMRI Centre for Global Health Research (CGHR), Kisumu, Kenya

  collaborator UNKNOWN

• Indiana University

  lead OTHER

Principal Investigators

• Megan S McHenry, MD, MS · Indiana University

• Eren Oyungu, MBChB, MMED · Moi University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2028-01-01

Primary Completion

2030-01-01

Completion

2033-01-01