Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

Malaria Clinical Trial

Official title:

Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878007
• Other study ID #: 5503
• Status: Completed
• Phase: N/A
• First received: April 7, 2009
• Last updated: February 14, 2014
• Start date: January 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2014
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial Summary

While malaria represents one of the main health problems afflicting schoolchildren, the evidence base for policy development and programme implementation for school-based malaria control remains inadequate. A recent study in western Kenya showed that delivering intermittent preventive treatment (IPT) to schoolchildren improved rates of anaemia and classroom concentration, but did not improve school performance. This study aims to (i) investigate the impact of malaria prevention using a strategy of periodic screening using malaria rapid diagnostic tests and treatment positives using artemether-lumefantrine (AL) on health and education among schoolchildren and (ii) determine the interaction between health and improved literacy instruction. The study hypothesis is that that school-based malaria prevention will reduce rates of anaemia or improve educational outcomes in Kenyan schoolchildren, when compared to comparison schools. In addition, a programme of training for primary school teachers to improve literacy instruction will improve literacy rates and there will be no interaction between the malaria intervention and the education intervention, such that learning will not be improved when teaching is effective and children are healthy. The study will be undertaken in 101 randomly selected primary schools in Kwale District. The malaria intervention consists of screening all children using rapid diagnostic tests (RDTs) for malaria. Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with AL according to national guidelines. Screening and treatment will be administered by district public health staff once a school term, observed by the evaluation research team. This intervention has been changed from IPT due to the withdrawal of amodiaquine in Kenya. The education intervention includes a programme of training for primary school teachers to improve literacy instruction. The study is designed to detect a 25% reduction in anaemia and an improvement of 0.2 standard deviations in mathematics and literacy tests. Additional outcomes will also be measured including malaria parasitaemia, classroom attention and school attendance. Cost-effectiveness and community acceptability of the interventions will be assessed. Anaemia and educational outcomes will be assessed before interventions and 12 and 24 months later. Malaria parasitaemia using blood slides will only be assessed at follow-up.

Description:

This study will be a factorial-design, cluster-randomised trial with a comparison group to assess the impact of (i) malaria prevention, based on screening and treatment, and (ii) enhanced literacy instruction by teachers on the health and educational achievement of healthy schoolchildren.

The target population in this study includes children attending primary schools in Kenya. The accessible population includes the children attending the participating primary schools in classes 1 and 5 in Kwale district. Schools will be randomized to one of four groups, receiving either the screening and treatment intervention alone, the education intervention alone, the malaria and education interventions combined, or neither intervention. 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 each intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5177
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Pupil enrolled at participating schools in classes 1 and 5;

• Provision of informed consent from parent or guardian;

• Provision of assent by student

Exclusion Criteria:

• Pupils unwilling to participate in the study;

• Known allergy or history of adverse reaction to study medications;

• Known or suspected sickle-cell trait

Study Design

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

Related Conditions & MeSH terms

• Anaemia
• Malaria

Intervention

Drug:
• Intermittent screening and treatment for malaria
All children will be screened for malaria using rapid diagnostic tests (RDTs) once a term (thrice yearly). Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with artemether-lumefantrine according to national guidelines. Screening and treatment will be administered by district public health staff once a school term, observed by the evaluation research team.

Behavioral:
• Teacher training on literacy instruction
Education intervention designed to improved early grade literacy instruction, focusing on phonological awareness & vocabulary and relationship between letters and sounds in a systematic and explicit fashion. Specific interventions will include training on (i) how to monitor students' progress in large classes (ii) developing and using instructional materials for reading (iii) lesson planning for explicit teaching of letter-sound relationships (iv) instructional techniques for large classes.

Other:
• IST plus literacy instruction programme
Schools will receive both IST and the literacy instruction programme

Locations

Country	Name	City	State
Kenya	KEMRI-Wellcome Trust Programme	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	World Bank

Country where clinical trial is conducted

Kenya, 

References & Publications (6)

Brooker S, Okello G, Njagi K, Dubeck MM, Halliday KE, Inyega H, Jukes MC. Improving educational achievement and anaemia of school children: design of a cluster randomised trial of school-based malaria prevention and enhanced literacy instruction in Kenya. Trials. 2010 Oct 7;11:93. doi: 10.1186/1745-6215-11-93. — View Citation

Drake TL, Okello G, Njagi K, Halliday KE, Jukes MCh, Mangham L, Brooker S. Cost analysis of school-based intermittent screening and treatment of malaria in Kenya. Malar J. 2011 Sep 20;10:273. doi: 10.1186/1475-2875-10-273. — View Citation

Halliday KE, Karanja P, Turner EL, Okello G, Njagi K, Dubeck MM, Allen E, Jukes MC, Brooker SJ. Plasmodium falciparum, anaemia and cognitive and educational performance among school children in an area of moderate malaria transmission: baseline results of — View Citation

Halliday KE, Okello G, Turner EL, Njagi K, Mcharo C, Kengo J, Allen E, Dubeck MM, Jukes MC, Brooker SJ. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial. PLoS Med. 2014 Jan 28;11(1):e100 — View Citation

Okello G, Jones C, Bonareri M, Ndegwa SN, McHaro C, Kengo J, Kinyua K, Dubeck MM, Halliday KE, Jukes MC, Molyneux S, Brooker SJ. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya. Trials. 2013 May 16;14:142. doi: 10.1186/1745-6215-14-142. — View Citation

Okello G, Ndegwa SN, Halliday KE, Hanson K, Brooker SJ, Jones C. Local perceptions of intermittent screening and treatment for malaria in school children on the south coast of Kenya. Malar J. 2012 Jun 8;11:185. doi: 10.1186/1475-2875-11-185. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaemia		2 years	No
Primary	Education achievement assessed by a battery of tests of reading, writing and arithmetic		2 years	No
Secondary	Prevalence of malaria parasitemia		2 years	No
Secondary	Concentration as assessed by classroom-based tests of sustained attention		2 years	No
Secondary	School attendance as assessed by class attendance registers		2 years	No
Secondary	Examination results as assessed by government examination scores		2 years	No
Secondary	Cost-effectiveness	Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia	2 years	No
Secondary	Community acceptability	A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.	2 years	No