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Completed

NCT Number: NCT02213211

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaria Alert Centre, College of Medicine

Blantyre, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemether Lumefantrine

Drug

Other names: artemisinin-based combination therapy (ACT), Coartem

Primary outcomes

  1. School attendance

    Time frame: 1 year

    School attendance as assessed by class registers and independent spot-checks

Secondary outcomes

  1. Plasmodium falciparum parasitaemia

    Time frame: 1 year

    Presence of malaria parasites in blood sample using microscopy

  2. Anaemia

    Time frame: 1 year

    Anaemia based on haemoglobin concentration assessed using Hemocue photometer

  3. Child wellbeing

    Time frame: 1 year

    Child-recorded wellbeing charts completed by each child three days per week between May and July 2015

  4. Cost effectiveness

    Time frame: 1 year

    Cost effectiveness analysis will consider reductions in absenteeism

  5. Stakeholder perceptions of LTK intervention

    Time frame: End of intervention period

    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

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Save the Children

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2014
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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