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

Primary Purpose

Malaria

Status
Terminated
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
abamectin and fenpyroximate
Sponsored by
National Institute for Medical Research, Tanzania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria control, Insecticide treated durable Wall Liners, Malaria incidence, Randomized Trial

Eligibility Criteria

6 Months - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muheza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DL+LLINs

LLINs

Arm Description

DL treated with abamectin and fenpyroximate

LLINs only

Outcomes

Primary Outcome Measures

Incidence of malaria parasitemia
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

Secondary Outcome Measures

Effectiveness of DL on anemia
change in mean haemoglobin in the intervention arm compared to the control

Full Information

First Posted
July 13, 2014
Last Updated
February 4, 2019
Sponsor
National Institute for Medical Research, Tanzania
Collaborators
Kilimanjaro Christian Medical Centre, Tanzania, London School of Hygiene and Tropical Medicine, Centers for Disease Control and Prevention, Brandeis University, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02533336
Brief Title
The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania
Acronym
DL
Official Title
The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania: Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
futility ground
Study Start Date
November 9, 2015 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute for Medical Research, Tanzania
Collaborators
Kilimanjaro Christian Medical Centre, Tanzania, London School of Hygiene and Tropical Medicine, Centers for Disease Control and Prevention, Brandeis University, United States Agency for International Development (USAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria control, Insecticide treated durable Wall Liners, Malaria incidence, Randomized Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4917 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DL+LLINs
Arm Type
Experimental
Arm Description
DL treated with abamectin and fenpyroximate
Arm Title
LLINs
Arm Type
No Intervention
Arm Description
LLINs only
Intervention Type
Drug
Intervention Name(s)
abamectin and fenpyroximate
Primary Outcome Measure Information:
Title
Incidence of malaria parasitemia
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effectiveness of DL on anemia
Description
change in mean haemoglobin in the intervention arm compared to the control
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William N Kisinza, PhD
Organizational Affiliation
National Institute for Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph P Mugasa, PhD
Organizational Affiliation
National Institute for Medical Research
Official's Role
Study Director
Facility Information:
Facility Name
Muheza
City
Tanga
State/Province
Muheza
ZIP/Postal Code
255
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
34521374
Citation
Mpangala KR, Halasa-Rappel YA, Mohamed MS, Mnzava RC, Mkuza KJ, Mangesho PE, Kisinza WN, Mugasa JP, Messenger LA, Mtove G, Kihombo AR, Shepard DS. On the cost-effectiveness of insecticide-treated wall liner and indoor residual spraying as additions to insecticide treated bed nets to prevent malaria: findings from cluster randomized trials in Tanzania. BMC Public Health. 2021 Sep 14;21(1):1666. doi: 10.1186/s12889-021-11671-2.
Results Reference
derived
PubMed Identifier
27456339
Citation
Mtove G, Mugasa JP, Messenger LA, Malima RC, Mangesho P, Magogo F, Plucinski M, Hashimu R, Matowo J, Shepard D, Batengana B, Cook J, Emidi B, Halasa Y, Kaaya R, Kihombo A, Lindblade KA, Makenga G, Mpangala R, Mwambuli A, Mzava R, Mziray A, Olang G, Oxborough RM, Seif M, Sambu E, Samuels A, Sudi W, Thomas J, Weston S, Alilio M, Binkin N, Gimnig J, Kleinschmidt I, McElroy P, Moulton LH, Norris L, Ruebush T, Venkatesan M, Rowland M, Mosha FW, Kisinza WN. The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: study protocol for a two-armed cluster randomized trial. BMC Public Health. 2016 Jul 25;16:633. doi: 10.1186/s12889-016-3287-3. Erratum In: BMC Public Health. 2016 Nov 25;16(1):1195.
Results Reference
derived

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

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