Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.

Study Overview
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Brief Summary
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This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.

Detailed Description
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Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding & Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes. The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated. The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class. Schools are randomly allocated to one of two arms: Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics Control schools: mass treatment with anthelminthics only Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.

Official Title
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Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya

Conditions
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Malaria, Falciparum

Intervention / Treatment
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* Drug: Intermittent preventive treatment (SP and amodiaquine)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in primary school, and attending regularly Enrolled in nursery or classes 1-7 Informed consent from parent or guardian Exclusion Criteria: Enrolled in primary class 8 Haemoglobin level below 70g/L at baseline History of reaction to sulfa drugs (e.g. fansidar, septrin) History of severe skin reaction to any drug Withdrawal criteria: Withdrawal of parental consent Haemoglobin level falling below 70g/L Severe adverse reaction to treatment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine) | Drug: Intermittent preventive treatment (SP and amodiaquine)<br>* Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.<br>|
| Placebo Comparator: 2<br>Dual placebo comparator | Other: Placebo<br>* Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anaemia (Hb <112g/L) |  | March 2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Plasmodium falciparum parasitaemia |  | March 2006 | 
| Sustained attention |  | March 2006 | 
| Mean haemoglobin |  | March 2006 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, anaemia, school performance, education, intermittent preventive treatment, schools