Back to results

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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 3

Locations

Kenya

Study Type

Interventional

Intervention

Insecticide treated nets and wall liners

Insecticide treated nets alone

About this trial

This is an interventional prevention trial for Malaria focused on measuring Insecticide treated wall liners, Insecticide treated nets, Incidence cohort

Eligibility Criteria

6 Months - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kenya Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insecticide treated nets and wall liners

Insecticide treated nets alone

Arm Description

Outcomes

Primary Outcome Measures

Incidence of new malaria infections

Secondary Outcome Measures

Full Information

NCT ID

NCT01043796

First Posted

January 6, 2010

Last Updated

February 2, 2015

Sponsor

Centers for Disease Control and Prevention

Collaborators

Kenya Medical Research Institute, Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01043796

Brief Title

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

Acronym

MTC-ITWL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

Kenya Medical Research Institute, Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Insecticide treated wall liners, Insecticide treated nets, Incidence cohort

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1730 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insecticide treated nets and wall liners

Arm Type

Experimental

Arm Title

Insecticide treated nets alone

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Insecticide treated nets and wall liners

Intervention Description

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

Intervention Name(s)

Insecticide treated nets alone

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of new malaria infections

Time Frame

Monthly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John E Gimnig, Ph.D.

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kenya Medical Research Institute

City

Kisumu

State/Province

Nyanza

Country

Kenya

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs