The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention

Study Overview
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Brief Summary
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The study is a cluster randomised trial to compare the effectiveness of indoor residual spraying (IRS) combined with the use of long lasting insecticidal nets (LLINs) with the effectiveness of LLINs alone for preventing malaria infection and morbidity. The primary outcome measure is prevalence of parasitaemia and anaemia in children aged 0.5-10 years, measured in cross sectional surveys. Secondary outcomes include relative population density for each mosquito vector species, malaria transmission as measured by entomological inoculation rates (EIR) by mosquito vector species, monitoring of resistance markers including kdr, and user acceptability of LLINs compared with IRS. Findings from this study are expected to inform decision making so that resource utilization can be optimised.

Official Title
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Cluster Randomised Trial to Compare Effectiveness of the Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) to LLINs Alone for Malaria Prevention in Muleba District, Kagera Region, Tanzania

Conditions
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Malaria

Intervention / Treatment
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* Other: Indoor residual spraying with bendiocarb
* Other: LLIN by universal coverage campaign


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: resident in selected cluster (village) Exclusion Criteria: Not resident in selected cluster (village)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LLIN plus IRS<br>LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide | Other: Indoor residual spraying with bendiocarb<br>* 2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart<br>* Other names: Ficam;Other: LLIN by universal coverage campaign<br>* Long lasting Insecticide treated mosquito net<br>* Other names: Olyset nets;|
| Active Comparator: LLIN only<br>LLIN by universal coverage campaign | Other: LLIN by universal coverage campaign<br>* Long lasting Insecticide treated mosquito net<br>* Other names: Olyset nets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of malarial infection in children 6 months to 10 years |  | 9 months post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate to severe anaemia in children under 5 years |  | 9 months post randomisation | 
| Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years |  | 6 months post randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vector control, LLIN, IRS