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

Malaria Clinical Trial

Official title:

Impact of a School-based Programme of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213211
• Other study ID #: QA475
• Secondary ID: 10576432
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: January 3, 2017
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2014
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3667
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artemether lumefantrine

Locations

Country	Name	City	State
Malawi	Malaria Alert Centre, College of Medicine	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Save the Children

Country where clinical trial is conducted

Malawi, 

References & Publications (2)

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):779-89. doi: 10.4269/ajt — View 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 us — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	School attendance	School attendance as assessed by class registers and independent spot-checks	1 year	No
Secondary	Plasmodium falciparum parasitaemia	Presence of malaria parasites in blood sample using microscopy	1 year	No
Secondary	Anaemia	Anaemia based on haemoglobin concentration assessed using Hemocue photometer	1 year	No
Secondary	Child wellbeing	Child-recorded wellbeing charts completed by each child three days per week between May and July 2015	1 year	No
Secondary	Cost effectiveness	Cost effectiveness analysis will consider reductions in absenteeism	1 year	No
Secondary	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	End of intervention period	No

External Links

•   Evaluating the Impact of a School-based Program of Malaria Diagnosis and Treatment on School Attendance in Southern Malawi
•   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