Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
14 febbraio 2014 aggiornato da: London School of Hygiene and Tropical Medicine
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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
5177
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Nairobi, Kenya, P.O. Box 43640 - 00100
- Kemri-Wellcome Trust Programme
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 5 anni a 18 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: 4
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Sperimentale: 1
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. |
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.
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Sperimentale: 2
Enhanced teacher training on literacy instruction.
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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.
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Sperimentale: 3
Intermittent screening and treatment (IST) for malaria and enhanced teacher training on literacy instruction
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Schools will receive both IST and the literacy instruction programme
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Anaemia
Lasso di tempo: 2 years
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2 years
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Education achievement assessed by a battery of tests of reading, writing and arithmetic
Lasso di tempo: 2 years
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2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Prevalence of malaria parasitemia
Lasso di tempo: 2 years
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2 years
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Concentration as assessed by classroom-based tests of sustained attention
Lasso di tempo: 2 years
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2 years
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School attendance as assessed by class attendance registers
Lasso di tempo: 2 years
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2 years
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Examination results as assessed by government examination scores
Lasso di tempo: 2 years
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2 years
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Cost-effectiveness
Lasso di tempo: 2 years
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Cost-effectiveness analysis will consider improvements in educational achievement and reductions in anaemia
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2 years
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Community acceptability
Lasso di tempo: 2 years
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A modified stakeholder analysis will assess key people's views on the implementation and longer-term sustainability of the programme.
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2 years
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Simon Brooker, DPhil, London School of Hygiene and Tropical Medicine
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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):e1001594. doi: 10.1371/journal.pmed.1001594. eCollection 2014 Jan.
- 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 a cluster randomized trial on the coast of Kenya. Trop Med Int Health. 2012 May;17(5):532-49. doi: 10.1111/j.1365-3156.2012.02971.x.
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2010
Completamento primario (Effettivo)
1 aprile 2012
Completamento dello studio (Effettivo)
1 aprile 2012
Date di iscrizione allo studio
Primo inviato
7 aprile 2009
Primo inviato che soddisfa i criteri di controllo qualità
7 aprile 2009
Primo Inserito (Stima)
8 aprile 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
17 febbraio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 febbraio 2014
Ultimo verificato
1 febbraio 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 5503
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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