Water Filters and Improved Cookstoves in Western Rwanda

Not Applicable

Completed

• Conditions: Diarrhoeal Disease; Respiratory Infection; Pneumonia
• Interventions: Device: Water filter and cookstove

• Registration Number: NCT02239250
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Status Verified: 2015-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1582

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water filter and cookstove	Water filter and cookstove	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.

Primary Outcome Measures

Name	Time	Method
Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories	12 months	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	12 months	All types of diarrhoea (including severe, persistent, dysentery). This outcome measure will be assessed in the sector-level study.

Secondary Outcome Measures

Name	Time	Method
Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories	12 months	This outcome measure will be assessed in the nested village-level study.
All-cause mortality in children under 5 years of age in ubudehe 1 & categories	12 months	This outcome measure will be assessed in the sector-level study.
Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories	12 months	Incidence of maternal health outcomes including low birth weight, premature birth, and still birth
Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories	12 months	This outcome measure will be assessed in the nested village-level study.

Trial Locations

Locations (1)

Manna Energy Ltd.; 🇷🇼 Kigali, Rwanda