The Combined Use of Indoor Residual Spraying (IRS) and Long-lasting Insecticidal Nets (LLINs) for Malaria Prevention
October 2, 2012 updated by: London School of Hygiene and Tropical Medicine
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
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
22300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kagera
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Muleba, Kagera, Tanzania
- Recruiting
- PAMVERC office
-
Contact:
- Natacha Protopopoff, PHD
- Email: nprotopopoff@gmail.com
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Principal Investigator:
- Natacha Protopopoff, PHD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- resident in selected cluster (village)
Exclusion Criteria:
- Not resident in selected cluster (village)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LLIN plus IRS
LLIN by universal coverage campaign 2 rounds of indoor residual spraying with bendiocarb insecticide
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2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
Other Names:
Long lasting Insecticide treated mosquito net
Other Names:
|
|
Active Comparator: LLIN only
LLIN by universal coverage campaign
|
Long lasting Insecticide treated mosquito net
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prevalence of malarial infection in children 6 months to 10 years
Time Frame: 9 months post randomisation
|
9 months post randomisation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Moderate to severe anaemia in children under 5 years
Time Frame: 9 months post randomisation
|
9 months post randomisation
|
|
Post-spraying prevalence of infection with malarial parasites in children 6 months to 10 years
Time Frame: 6 months post randomisation
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6 months post randomisation
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Entomological Innoculation Rate
Time Frame: Malaria season post randomisation(Average value during 6 months after randomisation)
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Malaria season post randomisation(Average value during 6 months after randomisation)
|
|
Relative abundance of adult Anopheles mosquitoes by species
Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation)
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Malaria season post randomisation (Average value during 6 months after randomisation)
|
|
genotypic markers of insecticide resistance in malaria vector mosquitoes
Time Frame: Malaria season post randomisation (Average value during 6 months after randomisation)
|
Malaria season post randomisation (Average value during 6 months after randomisation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark Rowland, Phd, London School of Hygiene and Tropical Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kleinschmidt I, Schwabe C, Shiva M, Segura JL, Sima V, Mabunda SJ, Coleman M. Combining indoor residual spraying and insecticide-treated net interventions. Am J Trop Med Hyg. 2009 Sep;81(3):519-24.
- West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.
- West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Enhanced protection against malaria by indoor residual spraying in addition to insecticide treated nets: is it dependent on transmission intensity or net usage? PLoS One. 2015 Mar 26;10(3):e0115661. doi: 10.1371/journal.pone.0115661. eCollection 2015.
- West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
September 21, 2012
First Submitted That Met QC Criteria
September 27, 2012
First Posted (Estimate)
October 2, 2012
Study Record Updates
Last Update Posted (Estimate)
October 3, 2012
Last Update Submitted That Met QC Criteria
October 2, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITDCVP54
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.