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Water Filters and Improved Cookstoves in Western Rwanda

Primary Purpose

Diarrhoeal Disease, Respiratory Infection, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Rwanda
Study Type
Interventional
Intervention
Water filter and cookstove
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhoeal Disease focused on measuring Child health, Pneumonia, Diarrhoea, Household air pollution, PM2.5, Stove intervention, Biomass fuel, Monitoring and evaluation, Water filter, Compliance, Thermotolerant coliforms, Rwanda

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For Sector-level study:
  • All households shown on updated 2012 government registers to be members of ubudehe 1 and 2 in Western Province, Rwanda will be eligible to participate in the study.
  • For nested village-level study:
  • All villages from all sectors in Western province, according to official Government lists will be eligible for participation with the exception of those villages that were selected for participation in Phase 1.
  • At the village-level, all households that are classified as ubudehe 1 & 2 according to updated 2012 government registers, are part of the village, are able to provide informed consent, and that have at least one child under 4 years of age at the time of enrollment will be eligible for participation. Presence of a child under 4 years of age will be assessed by checking dates of birth or recorded age in months in the CHW register of children <5 years (Igitabo Cy'Ibikorwa Byo Gukurikirana), which are maintained at the village by CHW (though occasionally these are transferred to health centers). If this data is missing will be assesses based on CHW's report. In those cases where a village has more than the required number of participating households (10 household), a random selection of 10 households will be drawn.
  • For the assessment of personal exposure to HAP a stricter set of eligibility criteria will be applied. Households that comply with the following eligibility criteria will be eligible for the exposure to HAP sub-study.

    • Have a child 1.5-4 year old,
    • Have a child healthy enough to wear the monitoring equipment (as perceived by the mother),
    • Have a non-smoking primary cook,
    • Have a primary cook that is currently not pregnant (as far as she is aware of), and
    • Have a primary cook that is in a healthy state to wear the monitoring equipment
  • The first two households identified from a randomised list will be invited to participate.
  • For the biomarker sub-studies, both the primary cook and the child under 4 years of age from households undergoing HAP exposure assessment will be eligible for the inflammatory cytokine biomarker study. For the enteric seroconversion study, all children aged 6 to 12 months will be eligible for participation.

Sites / Locations

  • Manna Energy Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Water filter and cookstove

Control

Arm Description

All household that appear on Government approved lists as belonging to ubudehe 1 & 2 categories in the 72 sectors randomised as intervention sectors will be eligible to receive one free water filtering device and one free cookstove. All households will be given instructions of how to use the intervention.

All household that appear on Government approved lists as belonging to ubudehe 1 & 2 categories in the 24 sectors randomised as control sectors will continue with their traditional cooking methods and drinking practices.

Outcomes

Primary Outcome Measures

Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
All types of pneumonia (severe, non severe). This outcome measure will be assessed in the sector-level study.
Incidence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
All types of diarrhoea (including severe, persistent, dysentery). This outcome measure will be assessed in the sector-level study.

Secondary Outcome Measures

All-cause mortality in children under 5 years of age in ubudehe 1 & categories
This outcome measure will be assessed in the sector-level study.
Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories
Incidence of maternal health outcomes including low birth weight, premature birth, and still birth
Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
This outcome measure will be assessed in the nested village-level study.
Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
This outcome measure will be assessed in the nested village-level study.

Full Information

First Posted
September 9, 2014
Last Updated
September 9, 2016
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
DelAgua, Emory University, Portland State University, University of Colorado, Boulder, Oregon Health and Science University, Ministry of Health, Rwanda, National University, Rwanda
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1. Study Identification

Unique Protocol Identification Number
NCT02239250
Brief Title
Water Filters and Improved Cookstoves in Western Rwanda
Official Title
Assessing the Health Impact of Advance Water Filters and Improved Cookstoves in Western Province, Rwanda: A Cluster-randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
DelAgua, Emory University, Portland State University, University of Colorado, Boulder, Oregon Health and Science University, Ministry of Health, Rwanda, National University, Rwanda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
DelAgua Health Rwanda (Implementation) Ltd. together with Rwanda Ministry of Health (MoH) are delivering an intervention, consisting on the free distribution of one advance water filter and one improved cookstove to all household classified as ubudehe 1 and 2 according to government approved registers (poorest tertile), in Western Province. The aim of this intervention is to reduce the morbidity and mortality associated with diarrhoeal diseases and pneumonia in Rwanda. The London School of Hygiene and Tropical Medicine (LSHTM) will be undertaking an independent evaluation of this large-scale intervention to assess its impact on health. The trial will evaluate whether the provision of improved cookstoves and advance water filters can reduce pneumonia and diarrhoea disease in children under 5 years of age. A cluster randomized controlled trial (CRCT) with two arms of unequal size (3:1 ratio) will be use to answer this question. The 96 sectors in Western Province, Rwanda, will be randomised to either receive the intervention or the control. Each eligible household in intervention sectors will receive one EcoZoom™ Spartan and one Vestergaard Frandsen Lifestraw Family™ 2.1 water filter free of charge. Eligible households in control sectors will continue with their traditional cooking and drinking practices. Health data on children under 5 years of age will be collected from community health worker (CHW) and health facility records all across Western Province to evaluate the health impact of the intervention. The study will encompass 12 months of follow-up. After this time the control sectors will receive the intervention. This independent evaluation will also include a nested village-level study within the larger sector-level study, with the aim to evaluate uptake, consistent use and acceptability of the intervention, as well as to assess the impact on environmental exposures and health outcomes. 174 villages (74 controls and 74 intervention) will be selected for participation. Household surveys will be used to collect data on intervention use and acceptability as well as on self-reported health data. Water samples will be collected and monitoring of exposure to Households Air Pollution (HAP) will be undertaken. Measurements of blood pressure, expirated Carbon monoxide (CO) and pulse CO-oximetry will be undertake in primary cooks and or children under 5 years of age. Additionally, as part of this nested study, two exploratory studies will also be conducted. One will be focused on assessing the potential of biomarkers as indicators of environmental exposures (mainly HAP and water quality) and health status, while the other exploratory sub-study will assess the reactivity of participants to the use of remotely reporting electronic sensors to measure target behaviours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoeal Disease, Respiratory Infection, Pneumonia
Keywords
Child health, Pneumonia, Diarrhoea, Household air pollution, PM2.5, Stove intervention, Biomass fuel, Monitoring and evaluation, Water filter, Compliance, Thermotolerant coliforms, Rwanda

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water filter and cookstove
Arm Type
Experimental
Arm Description
All household that appear on Government approved lists as belonging to ubudehe 1 & 2 categories in the 72 sectors randomised as intervention sectors will be eligible to receive one free water filtering device and one free cookstove. All households will be given instructions of how to use the intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
All household that appear on Government approved lists as belonging to ubudehe 1 & 2 categories in the 24 sectors randomised as control sectors will continue with their traditional cooking methods and drinking practices.
Intervention Type
Device
Intervention Name(s)
Water filter and cookstove
Other Intervention Name(s)
Vestergaard Frandsen Lifestraw Family™ 2.1, EcoZoom™ Spartan
Intervention Description
The Vestergaard Frandsen Lifestraw Family™ 2.1 is a point-of-use water treatment system.Water is poured through a 20 micron pre-filter into a 6L influent water tank.This water then filters through a 0.20 micron hollow-fiber ultrafiltration membrane into a 5.5L storage container.Water is then poured through a plastic tap, which prevents re-contamination.This system filters up to 18,000L of water.The system exceeds the WHO's "highly protective" standard for household water treatment technologies.The EcoZoom™ Spartan stove concentrates the combustion process while channeling airflow to completely burn the fuel provided.The stove has a ceramic combustion chamber within a steel housing, which is topped with a cast iron stove.The stove includes a rack for placing firewood and a pot skirt that improves the thermal efficiency.The cookstoves and filters will be delivered together at no cost to participating households.Households will receive instructions on how to operate these devices.
Primary Outcome Measure Information:
Title
Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
Description
All types of pneumonia (severe, non severe). This outcome measure will be assessed in the sector-level study.
Time Frame
12 months
Title
Incidence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
Description
All types of diarrhoea (including severe, persistent, dysentery). This outcome measure will be assessed in the sector-level study.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All-cause mortality in children under 5 years of age in ubudehe 1 & categories
Description
This outcome measure will be assessed in the sector-level study.
Time Frame
12 months
Title
Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories
Description
Incidence of maternal health outcomes including low birth weight, premature birth, and still birth
Time Frame
12 months
Title
Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Prevalence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Prevalence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 &2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Prevalence of self-reported diarrhoea among primary cooks
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Prevalence of self-reported respiratory conditions among primary cooks in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Mena difference in blood pressure in primary cooks in ubudehe 1 and 2 categories
Description
Mean difference of systolic and diastolic measured separately. This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Mean difference in levels of expirated CO in children under 5 years of age and primary cooks in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Mean difference levels of Carboxyhaemoglobin in children under 5 years of age and primary cooks in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Percentage seroconversion against enteric pathogens in children 6-12 months of age at enrolment in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Mean difference in inflammatory cytokines in children under 5 years of age in unudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Median difference in 48-h personal exposure to PM2.5 in children under 5 years of age and primary cooks in ubudehe 1 & 2 categories
Description
This outcome measure will be assessed in the nested village-level study.
Time Frame
12 months
Title
Levels of faecal contamination in drinking water
Description
This outcome measure will be assessed in the nested village-level study. Proportion of water samples samples free of faecal contamination.
Time Frame
12 months
Title
Levels of consistent use of the intervention
Description
This outcome measure will be assessed in the intervention group only of the nested village-level study. Percentage of households reporting the use of the stove as their primary stove in all follow-up visits. Percentage of households reporting their current drinking water was treated by the intervention filter in all follow-up visits.
Time Frame
12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For Sector-level study: All households shown on updated 2012 government registers to be members of ubudehe 1 and 2 in Western Province, Rwanda will be eligible to participate in the study. For nested village-level study: All villages from all sectors in Western province, according to official Government lists will be eligible for participation with the exception of those villages that were selected for participation in Phase 1. At the village-level, all households that are classified as ubudehe 1 & 2 according to updated 2012 government registers, are part of the village, are able to provide informed consent, and that have at least one child under 4 years of age at the time of enrollment will be eligible for participation. Presence of a child under 4 years of age will be assessed by checking dates of birth or recorded age in months in the CHW register of children <5 years (Igitabo Cy'Ibikorwa Byo Gukurikirana), which are maintained at the village by CHW (though occasionally these are transferred to health centers). If this data is missing will be assesses based on CHW's report. In those cases where a village has more than the required number of participating households (10 household), a random selection of 10 households will be drawn. For the assessment of personal exposure to HAP a stricter set of eligibility criteria will be applied. Households that comply with the following eligibility criteria will be eligible for the exposure to HAP sub-study. Have a child 1.5-4 year old, Have a child healthy enough to wear the monitoring equipment (as perceived by the mother), Have a non-smoking primary cook, Have a primary cook that is currently not pregnant (as far as she is aware of), and Have a primary cook that is in a healthy state to wear the monitoring equipment The first two households identified from a randomised list will be invited to participate. For the biomarker sub-studies, both the primary cook and the child under 4 years of age from households undergoing HAP exposure assessment will be eligible for the inflammatory cytokine biomarker study. For the enteric seroconversion study, all children aged 6 to 12 months will be eligible for participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Clasen, JD MSc PhD
Organizational Affiliation
LSHTM & Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manna Energy Ltd.
City
Kigali
ZIP/Postal Code
PO Box 1594
Country
Rwanda

12. IPD Sharing Statement

Citations:
PubMed Identifier
31158266
Citation
Kirby MA, Nagel CL, Rosa G, Zambrano LD, Musafiri S, Ngirabega JD, Thomas EA, Clasen T. Effects of a large-scale distribution of water filters and natural draft rocket-style cookstoves on diarrhea and acute respiratory infection: A cluster-randomized controlled trial in Western Province, Rwanda. PLoS Med. 2019 Jun 3;16(6):e1002812. doi: 10.1371/journal.pmed.1002812. eCollection 2019 Jun.
Results Reference
derived
PubMed Identifier
29736475
Citation
Nagel CL, Kirby MA, Zambrano LD, Rosa G, Barstow CK, Thomas EA, Clasen TF. Study design of a cluster-randomized controlled trial to evaluate a large-scale distribution of cook stoves and water filters in Western Province, Rwanda. Contemp Clin Trials Commun. 2016 Aug 2;4:124-135. doi: 10.1016/j.conctc.2016.07.003. eCollection 2016 Dec 15.
Results Reference
derived

Learn more about this trial

Water Filters and Improved Cookstoves in Western Rwanda

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