Clinical trial NCT02213211: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Malawi
Case management
Rapid diagnostic tests
Artemether lumefantrine
School children
School health services
Attendance
Anaemia
Parasitic diseases
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Save the Children
First posted: 2014-08-11
Enrollment: 3667
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: School attendance
timeFrame: 1 year
Secondary outcomes:
measure: Plasmodium falciparum parasitaemia
timeFrame: 1 year
measure: Anaemia
timeFrame: 1 year
measure: Child wellbeing
timeFrame: 1 year
measure: Cost effectiveness
timeFrame: 1 year
measure: Stakeholder perceptions of LTK intervention
timeFrame: End of intervention period
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Malaria Alert Centre, College of Medicine
Study officials:
affiliation: Malaria Alert Centre, College of Medicine, Malawi
name: Don P Mathanga, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Katherine E Halliday, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Simon J Brooker, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.