Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria

NCT ID: NCT01043796

Last Updated: 2015-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1730 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Insecticide treated nets and wall liners

Group Type EXPERIMENTAL

Insecticide treated nets and wall liners

Intervention Type OTHER

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.

Insecticide treated nets alone

Group Type ACTIVE_COMPARATOR

Insecticide treated nets alone

Intervention Type OTHER

Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme

Interventions

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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.

Intervention Type OTHER

Insecticide treated nets alone

Participants will be provided with a long-lasting insecticide treated net recommended by the WHO Pesticide Evaluation Scheme

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John E Gimnig, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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Kenya Medical Research Institute

Kisumu, Nyanza, Kenya

Site Status

Countries

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Kenya

Other Identifiers

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CDC-NCZVED-5794

Identifier Type: -

Identifier Source: org_study_id

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