Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria (MTC-ITWL)

February 2, 2015 updated by: Centers for Disease Control and Prevention

Malaria Transmission Consortium: The Added Effects of Insecticide Treated Materials, Artemisinin-containing Combination Treatments, and Larviciding on Malaria Transmission and Illness

The purpose of this study is to determine whether insecticide treated wall liners, in combination with insecticide treated nets, reduce the incidence of malaria infections compared to insecticide treated nets alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Insecticide treated nets (ITNs) have been shown to reduce malaria related morbidity and mortality and are increasingly being scaled up throughout sub-Saharan Africa. However, ITNs alone are unlikely to reduce transmission to zero in most settings and additional vector control tools are necessary. One new promising strategy is the use of insecticide treated wall liners (ITWLs). These are textiles treated with an insecticide that are used to line the inner walls of houses. The wall liners are considered a long-lasting alternative to indoor residual spraying which is also used for malaria vector control but is expensive to implement.

Within 6 pairs of villages, we plan to randomly allocate one village in each pair to receive either ITNs or ITNs plus ITWLs. Households will be randomly selected from each village and all children between the ages of 6 months and 11 years will be enrolled in a cohort study. The children will be cleared of existing infections and then followed monthly until they are found to be infected with malaria. The study will last for 6 months and will demonstrate whether the ITWLs provide additional protection against malaria over that provided by the use of ITNs.

Study Type

Interventional

Enrollment (Actual)

1730

Phase

  • Phase 3

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

  • Kenya
    • Nyanza
      • Kisumu, Nyanza, Kenya
        • Kenya Medical Research Institute

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 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 6 months up to 11 years
  • Living in the study area and remaining in the study area for the duration of the study
  • Informed consent provided by parents

Exclusion Criteria:

  • No informed consent
  • Living outside the study area, or likely to move outside study area
  • Severely ill and unlikely to be able to complete study

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Insecticide treated nets and wall liners
Other: Insecticide treated nets and wall liners
Participants will be provided a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme. Households where participants reside will be fitted with insecticide treated wall liners.
ACTIVE_COMPARATOR: Insecticide treated nets alone
Other: Insecticide treated nets alone
Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of new malaria infections
Time Frame: Monthly
Monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Bill and Melinda Gates Foundation
Kenya Medical Research Institute

Investigators

  • Principal Investigator: John E Gimnig, Ph.D., Centers for Disease Control and Prevention

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

May 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (ESTIMATE)

January 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCZVED-5794

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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