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
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 22,300
- Locations
- 1
- Primary Endpoint
- Prevalence of malarial infection in children 6 months to 10 years
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •resident in selected cluster (village)
Exclusion Criteria
- •Not resident in selected cluster (village)
Outcomes
Primary Outcomes
Prevalence of malarial infection in children 6 months to 10 years
Time Frame: 9 months post randomisation
Secondary Outcomes
- 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)