School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Malaria is an important contributor to ill-health experienced by school-children and may have
      profound consequences for their learning and educational achievement, and there is a small,
      but growing, body of evidence that suggests malaria control can help improve educational
      outcomes. In Malawi, school-aged children are estimated to experience 0.59 clinical attacks
      of malaria each year, equivalent to 2.1 million attacks among Malawian school-aged children.
      To avert this health burden and potential education consequences, Save the Children in
      partnership with the Malawian Ministry of Health is providing treatment of symptomatic
      malaria cases in schools in southern Malawi, as part of the provision of first aid kits
      (known as Learner Treatment Kits, LTKs) in schools. To evaluate the impact of this
      intervention, a cluster randomised trial is being conducted among 58 schools in Traditional
      Area Chikowi in Malawi, over 12 months. Twenty nine schools are randomly selected to receive
      LTKs, which include malaria rapid diagnostic tests (RDTs) and artemisinin-based combination
      therapies (ACTs) to treat uncomplicated malaria, and 29 schools serve as the control group.
      The primary outcome is school attendance, with secondary outcomes of grade repetition, school
      drop-out and enrolment as well as morbidity, Plasmodium falciparum infection and anaemia. The
      study aims to conduct several quantitative and qualitative assessments to help evaluate the
      external validity of the findings.
    

Detailed description: 
      This study is a cluster-randomised trial with a comparison group to assess the impact of
      school-based malaria case management, with malaria rapid diagnostic tests (RDTs) for
      diagnosis and artemisinin-based combination therapy (ACT) for treatment of uncomplicated
      malaria incorporated into first aid kits (Learner Treatment Kits) also containing treatment
      and management for other common minor health issues. A seven day teacher training in the
      diagnosis and treatment of malaria, other contents of the kit and referral process is
      provided for the two teachers selected to act as the LTK dispensers in the school, as well as
      the head teacher. The target population in this study includes children attending the 58
      participating primary schools in Traditional Authority Chikowi, Zomba District, Malawi.
      Twenty nine schools are randomly selected to receive Learner Treatment Kits (LTKs) including
      RDTs and ACTs to treat uncomplicated malaria, and 29 schools serve as the control group. All
      children attending schools in the intervention arm have access to the LTK and are eligible
      for treatment on an opt-out basis, but the accessible study population includes the children
      randomly selected from classes 2, 4 and 6. The study hypothesis is that that school-based
      malaria case-management as part of LTKs will reduce rates of absenteeism in Malawian
      schoolchildren, when compared to those in control schools. The primary outcome is school
      attendance, with secondary outcomes of grade repetition, school drop-out and enrolment as
      well as morbidity, Plasmodium falciparum infection and anaemia. The study is designed to
      provide 80% power to detect a 16% reduction (53% relative reduction) in absenteeism in the
      intervention group compared to the control group at 5% level of significance. The unit of
      analysis is the school, but individual-level analysis using suitable generalised linear
      models, adjusted for clustering by school, will also be undertaken to explore differences in
      impact of the interventions according to child age, sex, home environment, school quality as
      well as differences in the uptake of the intervention.
    

Intervention name(s): Artemether lumefantrine
Intervention type(s): Drug
Other intervention name(s): artemisinin-based combination therapy (ACT); Coartem
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Artemisinins; Artemisinin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malawi; Case management; Rapid diagnostic tests; Artemether lumefantrine; School children; School health services; Attendance; Anaemia; Parasitic diseases