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

NCT ID: NCT02213211

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3667 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Artemether lumefantrine

Intervention Type: DRUG

No intervention

No intervention provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Artemether lumefantrine

Intervention Type: DRUG

Other Intervention Names

artemisinin-based combination therapy (ACT); Coartem

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Save the Children

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Don P Mathanga, MBBS

Role: PRINCIPAL_INVESTIGATOR

Malaria Alert Centre, College of Medicine, Malawi

Katherine E Halliday, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Simon J Brooker, DPhil

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Malaria Alert Centre, College of Medicine

Blantyre, , Malawi

Countries

Malawi

References

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.

Reference Type: RESULT

PMID: 26283750 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26377070 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32133163 (View on PubMed)

Related Links

http://www.youtube.com/watch?v=MBVzoIk7cFY

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

Other Identifiers

1057

Identifier Type: OTHER

Identifier Source: secondary_id

6432

Identifier Type: OTHER

Identifier Source: secondary_id

QA475

Identifier Type: -

Identifier Source: org_study_id