NCT02213211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,667

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 4, 2017

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

April 7, 2014

Last Update Submit

January 3, 2017

Conditions

Malaria

Keywords

MalawiCase managementRapid diagnostic testsArtemether lumefantrineSchool childrenSchool health servicesAttendanceAnaemiaParasitic diseases

Outcome Measures

Primary Outcomes (1)

  • School attendance

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

    1 year

Secondary Outcomes (5)

  • Plasmodium falciparum parasitaemia

    1 year

  • Anaemia

    1 year

  • Child wellbeing

    1 year

  • Cost effectiveness

    1 year

  • Stakeholder perceptions of LTK intervention

    End of intervention period

Study Arms (2)

Diagnosis and treatment of malaria

EXPERIMENTAL

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

No intervention

NO INTERVENTION

No intervention provided

Interventions

Artemether lumefantrineDRUG
Also known as: artemisinin-based combination therapy (ACT), Coartem
Diagnosis and treatment of malaria

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Student enrolled at participating schools in standards 2, 4 and 6
  • Provision of informed consent from parent or guardian
  • Provision of assent by student

You may not qualify if:

  • Student unwilling to participate in the study
  • Student known to have a chronic medical condition, which will affect their school attendance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Alert Centre, College of Medicine

Blantyre, Malawi

Location

Related Publications (3)

  • 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.

    PMID: 26283750RESULT

  • 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.

    PMID: 26377070RESULT

  • 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.

    PMID: 32133163DERIVED

Related Links

MeSH Terms

Conditions

MalariaAnemiaParasitic Diseases

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

August 11, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 4, 2017

Record last verified: 2014-08

Data Sharing

IPD Sharing
Will share

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.

Locations

MA(1)