The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania (DL)

February 4, 2019 updated by: Dr. Geofrey Makenga, National Institute for Medical Research, Tanzania

The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania: Cluster Randomized Trial

Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological parameters. Information on the relative cost-effectiveness estimates of DL and the community acceptability of DL will also be measured.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Vector control, together with prompt treatment with an artemisinin-based combination therapy (ACT) for individuals diagnosed with malaria and intermittent preventive treatment in pregnant women, is a critical component of malaria control in Africa. The two main vector control interventions used in Africa are long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS). LLINs are currently the mainstay of vector control and are believed to have contributed to the recent dramatic decline in malaria cases. However, resistance to the pyrethroid insecticides used in the bed nets has increased. The second main vector control method, IRS, has been an extremely effective adjunct to LLINs; its usefulness is threatened by the high cost of repeated applications and increasing mosquito resistance to insecticides used for spraying.

A new product, durable lining (DL) treated with non-pyrethroid insecticides, has been developed by Vestergaard, which theoretically mimics the effect of IRS but is designed to last for a minimum of three years. The product consists of a mixture of two non-pyrethroid insecticides incorporated into a polymer fabric that are designed to migrate differentially over the lifetime of the product to ensure sustained bioefficacy. The use of two agents may also decrease the risk of development of resistance. It is estimated that the cost of the insecticide treated wall liners (DL), which are installed on the indoor walls of houses, would be equal to 2-3 rounds of IRS.

To test the effectiveness of this new product, we will conduct a two-arm controlled randomized cluster trial to test the hypothesis that DL + LLINs are superior to LLINs alone. Over twelve (12) months (August 2015- Aug 2016), in an area with universal coverage (UC) of LLINs and where artemisinin combination therapies (ACT) are provided as the first-line treatment of malaria, we intend to evaluate the impact of DL on malaria transmission among children ages 6 months to 11 years as measured by the incidence of malaria parasitemia (symptomatic and asymptomatic), and the prevalence of moderate to severe anemia in under-fives. In addition, we will assess the effect of DL on entomological parameters, and measure the acceptability and a cost-effectiveness of the intervention. Stratified randomization based on malaria prevalence during the baseline survey will be used to select 22 clusters per arm in Muheza district.

Study Type

Interventional

Enrollment (Actual)

4917

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

  • Tanzania
    • Muheza
      • Tanga, Muheza, Tanzania, 255
        • Muheza

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

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Permanent residence in a selected household
  • Aged 6 months- 11years for cohort study
  • Informed parental consent
  • For children between 8-11 years old, written assent

Exclusion criteria:

  • Severely ill and unlikely to be able to complete the study
  • Family does not intend to remain in the study area during the study period, or through the long rains
  • Household does not accept intervention
  • Not living in the study area when interventions were implemented
  • enrolled in other interventional 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DL+LLINs
DL treated with abamectin and fenpyroximate
Drug: abamectin and fenpyroximate
No Intervention: LLINs
LLINs only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of malaria parasitemia
Time Frame: 1 year
The primary end point of the study is the cumulative incidence of malaria parasitaemia (asymptomatic or symptomatic) defined as the number of mRDT-confirmed episodes of parasitaemia per person-year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of DL on anemia
Time Frame: 1 year
change in mean haemoglobin in the intervention arm compared to the control
1 year

Collaborators and Investigators

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

Sponsor

National Institute for Medical Research, Tanzania

Collaborators

London School of Hygiene and Tropical Medicine
United States Agency for International Development (USAID)
Centers for Disease Control and Prevention
Kilimanjaro Christian Medical Centre, Tanzania
Brandeis University

Investigators

  • Principal Investigator: William N Kisinza, PhD, National Institute for Medical Research
  • Study Director: Joseph P Mugasa, PhD, National Institute for Medical Research

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 (Actual)

November 9, 2015

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

July 13, 2014

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DL Project in Tanzania

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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