Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00878007|
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : February 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anaemia Malaria||Drug: Intermittent screening and treatment for malaria Behavioral: Teacher training on literacy instruction Other: IST plus literacy instruction programme||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5177 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Intermittent screening and treatment (IST) for malaria.
This intervention is a change from a previous intervention based on intermittent preventive treatment for malaria owning to the withdrawal of amodiaquine (one of the previous IPT drugs) in Kenya in 2009.
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.
Enhanced teacher training on literacy instruction.
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.
Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction
Other: IST plus literacy instruction programme
Schools will receive both IST and the literacy instruction programme
|No Intervention: 4|
- Anaemia [ Time Frame: 2 years ]
- Education achievement assessed by a battery of tests of reading, writing and arithmetic [ Time Frame: 2 years ]
- Prevalence of malaria parasitemia [ Time Frame: 2 years ]
- Concentration as assessed by classroom-based tests of sustained attention [ Time Frame: 2 years ]
- School attendance as assessed by class attendance registers [ Time Frame: 2 years ]
- Examination results as assessed by government examination scores [ Time Frame: 2 years ]
- Cost-effectiveness [ Time Frame: 2 years ]Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia
- Community acceptability [ Time Frame: 2 years ]A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878007
|KEMRI-Wellcome Trust Programme|
|Nairobi, Kenya, P.O. Box 43640 - 00100|
|Principal Investigator:||Simon Brooker, DPhil||London School of Hygiene and Tropical Medicine|