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

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ClinicalTrials.gov Identifier: NCT02213211
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
Save the Children
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Artemether lumefantrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Diagnosis and treatment of malaria

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
Other Names:
  • artemisinin-based combination therapy (ACT)
  • Coartem

No Intervention: No intervention
No intervention provided



Primary Outcome Measures :
  1. School attendance [ Time Frame: 1 year ]
    School attendance as assessed by class registers and independent spot-checks


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213211


Locations
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Malawi
Malaria Alert Centre, College of Medicine
Blantyre, Malawi
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Save the Children
Investigators
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Principal Investigator: Don P Mathanga, MBBS Malaria Alert Centre, College of Medicine, Malawi
Principal Investigator: Katherine E Halliday, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Simon J Brooker, DPhil London School of Hygiene and Tropical Medicine

Additional Information:
Publications of Results:
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02213211     History of Changes
Other Study ID Numbers: QA475
1057 ( Other Identifier: National Health Sciences Research Committee (NHSRC) Malawi )
6432 ( Other Identifier: LSHTM ethics reference number )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: August 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In order to maximise the usefulness of the study results, it is intended that individual participant data (IPD) will be shared with the wider research community for scientific purposes only, as anonymized, non-personal, individual and summary information. The information will be shared in ways that do not reveal individual participant's identities or household location. The data will be available, on request, through The "Data Compass": the London School of Hygiene & Tropical Medicine (LSHTM) curated digital repository of research data. This will be made available at the stage of publication of the impact results in 2017.
Keywords provided by London School of Hygiene and Tropical Medicine:
Malawi
Case management
Rapid diagnostic tests
Artemether lumefantrine
School children
School health services
Attendance
Anaemia
Parasitic diseases
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Artemisinins
Artemisinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents