School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi

Conditions
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Malaria

Intervention / Treatment
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* Drug: Artemether lumefantrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Student enrolled at participating schools in standards 2, 4 and 6 Provision of informed consent from parent or guardian Provision of assent by student Exclusion Criteria: Student unwilling to participate in the study Student known to have a chronic medical condition, which will affect their school attendance

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnosis and treatment of malaria<br>School-based diagnosis and treatment of uncomplicated malaria using malaria RDTs and Artemether lumefantrine as part of Learner Treatment Kits (LTK) used by teachers. Drug: Artemether lumefantrine (artemisinin-based combination therapy [ACT], Coartem). Three-day doses of 20mg/120mg, 40mg/240mg, 60mg/360mg and 80mg/480mg Coartem are provided, according to weight, upon a positive rapid diagnostic test (RDT) result. | Drug: Artemether lumefantrine<br> <br> * Other names: Coartem;|
| No Intervention: No intervention<br>No intervention provided | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| School attendance | School attendance as assessed by class registers and independent spot-checks | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmodium falciparum parasitaemia | Presence of malaria parasites in blood sample using microscopy | 1 year | 
| Anaemia | Anaemia based on haemoglobin concentration assessed using Hemocue photometer | 1 year | 
| Child wellbeing | Child-recorded wellbeing charts completed by each child three days per week between May and July 2015 | 1 year | 
| Cost effectiveness | Cost effectiveness analysis will consider reductions in absenteeism | 1 year | 
| Stakeholder perceptions of LTK intervention | Perceptions of intervention from teachers, school children and healthcare workers as well as key policy makers obtained through focus group discussions and in-depth interviews | End of intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malawi, Case management, Rapid diagnostic tests, Artemether lumefantrine, School children, School health services, Attendance, Anaemia, Parasitic diseases