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 Contact

Study Contact Backup

Study Locations

  • Tanzania
    • Kagera
      • Muleba, Kagera, Tanzania
        • Recruiting
        • PAMVERC office
        • Contact:
        • 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
Other: Indoor residual spraying with bendiocarb
2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
Other Names:
  • Ficam
Other: LLIN by universal coverage campaign
Long lasting Insecticide treated mosquito net
Other Names:
  • Olyset nets
Active Comparator: LLIN only
LLIN by universal coverage campaign
Other: LLIN by universal coverage campaign
Long lasting Insecticide treated mosquito net
Other Names:
  • Olyset nets

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
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)
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)
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.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

National Institute for Medical Research, Tanzania
Kilimanjaro Christian Medical Centre, Tanzania

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

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.

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