Intermittent preventive treatment to shrink the malaria reservoir and related morbidities by targeting school children in regions with different malaria endemicities (InSMART-school)

In endemic settings, among school aged children, malaria accounts for about 13-50% of all school absenteeism, causes anaemia and around 50% of the mortality and impairs the educational achievement of children. Intermittent preventive treatment (IPT) of pregnant women as well as seasonal malaria chemoprevention in children under the age of five have been implemented in several sub-Saharan countries and have proven to be very effective. However, none of these IPT strategies is targeting school children. 

A superiority, randomized, open label, controlled trial will enrol 3180 school children aged 5-15 years, who will receive either SP+AQ or SP+PPQ or control (no drug ), using a “balanced block design” with the “standard of care” arm as reference. The interventional treatments are given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects. All study-arms receive bed nets, early diagnosis and care for malaria, and praziquantel and albendazole as mass treatment for helminthiasis. The primary endpoint are change in mean haemoglobin concentration at months 4,8,16, 12 and 20 of follow-up, and prevalence of malaria asymptomatic infections at month 0, 12 and 20. Adverse events will be monitored throughout the study. Mixed design methods will be used to assess the acceptability, cost-effectiveness and feasibility of this IPTsc as part of a more comprehensive school children health package.

Clinical trial #NCT03640403

Clinical trial registration

Drug-based Strategies
Health Systems
Vulnerable Populations

Mar 2019 — Jun 2021

Tanzania

Novel uses of chemoprevention for malaria
Targeted Drug Administration (TDA) strategies