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

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Artemether lumefantrine
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malawi, Case management, Rapid diagnostic tests, Artemether lumefantrine, School children, School health services, Attendance, Anaemia, Parasitic diseases

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Malaria Alert Centre, College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diagnosis and treatment of malaria

No intervention

Arm Description

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.

No intervention provided

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasmodium falciparum parasitaemia
Presence of malaria parasites in blood sample using microscopy
Anaemia
Anaemia based on haemoglobin concentration assessed using Hemocue photometer
Child wellbeing
Child-recorded wellbeing charts completed by each child three days per week between May and July 2015
Cost effectiveness
Cost effectiveness analysis will consider reductions in absenteeism
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

Full Information

First Posted
April 7, 2014
Last Updated
January 3, 2017
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Save the Children
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1. Study Identification

Unique Protocol Identification Number
NCT02213211
Brief Title
School-based Programme of Malaria Diagnosis and Treatment in Southern Malawi
Official Title
Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Save the Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malawi, Case management, Rapid diagnostic tests, Artemether lumefantrine, School children, School health services, Attendance, Anaemia, Parasitic diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnosis and treatment of malaria
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention provided
Intervention Type
Drug
Intervention Name(s)
Artemether lumefantrine
Other Intervention Name(s)
artemisinin-based combination therapy (ACT), Coartem
Primary Outcome Measure Information:
Title
School attendance
Description
School attendance as assessed by class registers and independent spot-checks
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Plasmodium falciparum parasitaemia
Description
Presence of malaria parasites in blood sample using microscopy
Time Frame
1 year
Title
Anaemia
Description
Anaemia based on haemoglobin concentration assessed using Hemocue photometer
Time Frame
1 year
Title
Child wellbeing
Description
Child-recorded wellbeing charts completed by each child three days per week between May and July 2015
Time Frame
1 year
Title
Cost effectiveness
Description
Cost effectiveness analysis will consider reductions in absenteeism
Time Frame
1 year
Title
Stakeholder perceptions of LTK intervention
Description
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
Time Frame
End of intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don P Mathanga, MBBS
Organizational Affiliation
Malaria Alert Centre, College of Medicine, Malawi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine E Halliday, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon J Brooker, DPhil
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaria Alert Centre, College of Medicine
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
26283750
Citation
Mathanga DP, Halliday KE, Jawati M, Verney A, Bauleni A, Sande J, Ali D, Jones R, Witek-McManus S, Roschnik N, Brooker SJ. The High Burden of Malaria in Primary School Children in Southern Malawi. Am J Trop Med Hyg. 2015 Oct;93(4):779-789. doi: 10.4269/ajtmh.14-0618. Epub 2015 Aug 17.
Results Reference
result
PubMed Identifier
26377070
Citation
Witek-McManus S, Mathanga DP, Verney A, Mtali A, Ali D, Sande J, Mwenda R, Ndau S, Mazinga C, Phondiwa E, Chimuna T, Melody D, Roschnik N, Brooker SJ, Halliday KE. Design, implementation and evaluation of a training programme for school teachers in the use of malaria rapid diagnostic tests as part of a basic first aid kit in southern Malawi. BMC Public Health. 2015 Sep 17;15:904. doi: 10.1186/s12889-015-2228-x.
Results Reference
result
PubMed Identifier
32133163
Citation
Halliday KE, Witek-McManus SS, Opondo C, Mtali A, Allen E, Bauleni A, Ndau S, Phondiwa E, Ali D, Kachigunda V, Sande JH, Jawati M, Verney A, Chimuna T, Melody D, Moestue H, Roschnik N, Brooker SJ, Mathanga DP. Impact of school-based malaria case management on school attendance, health and education outcomes: a cluster randomised trial in southern Malawi. BMJ Glob Health. 2020 Jan 14;5(1):e001666. doi: 10.1136/bmjgh-2019-001666. eCollection 2020.
Results Reference
derived
Links:
URL
http://www.youtube.com/watch?v=MBVzoIk7cFY
Description
Social Innovation in Health Initiative (SIHI). This short film forms part of the SIHI case series, showcasing selected social innovations improving healthcare delivery from Africa, Asia and Latin America

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

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