Overview

This trial is active, not recruiting.

Condition malaria
Treatment artemether lumefantrine
Sponsor London School of Hygiene and Tropical Medicine
Collaborator Save the Children
Start date April 2014
End date April 2015
Trial size 3480 participants
Trial identifier NCT02213211, 1057, 6432, QA475

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 mRDTs and 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Drug: Artemether lumefantrine School-based diagnosis and treatment of uncomplicated malaria using malaria rapid diagnostic tests (mRDTs) and Artemether lumefantrine as part of Learner Treatment Kits (LTK) used by teachers.
artemether lumefantrine Artemisinin Combination Treatment
School-based diagnosis and treatment of uncomplicated malaria using malaria rapid diagnostic tests (mRDTs) and Artemether lumefantrine as part of Learner Treatment Kits (LTK) used by teachers. All children in the school have access to the service.
(No Intervention)
No intervention provided

Primary Outcomes

Measure
School attendance
time frame: 1 year

Secondary Outcomes

Measure
Plasmodium falciparum parasitaemia
time frame: 1 year
Anaemia
time frame: 1 year
Cost effectiveness
time frame: 1 year

Eligibility Criteria

Male or female participants from 5 years up to 18 years old.

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

Additional Information

Official title Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi
Principal investigator Don P Mathanga, MBBS
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 for diagnosis and Artemisinin Combination Treatment 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 mRDTs 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.