Clinical trial NCT02239250: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: DelAgua
name: Emory University
name: Portland State University
name: University of Colorado, Boulder
name: Oregon Health and Science University
name: Ministry of Health, Rwanda
name: National University, Rwanda
First posted: 2014-09-12
Enrollment: 1582
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Incidence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality in children under 5 years of age in ubudehe 1 & categories
timeFrame: 12 months
measure: Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
timeFrame: 12 months
Other outcomes:
measure: Prevalence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Prevalence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 &2 categories
timeFrame: 12 months
measure: Prevalence of self-reported diarrhoea among primary cooks
timeFrame: 12 months
measure: Prevalence of self-reported respiratory conditions among primary cooks in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Mena difference in blood pressure in primary cooks in ubudehe 1 and 2 categories
timeFrame: 12 months
measure: Mean difference in levels of expirated CO in children under 5 years of age and primary cooks in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Mean difference levels of Carboxyhaemoglobin in children under 5 years of age and primary cooks in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Percentage seroconversion against enteric pathogens in children 6-12 months of age at enrolment in ubudehe 1 & 2 categories
timeFrame: 12 months
measure: Mean difference in inflammatory cytokines in children under 5 years of age in unudehe 1 & 2 categories
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Levels of faecal contamination in drinking water
timeFrame: 12 months
measure: Levels of consistent use of the intervention
timeFrame: 12 months
Locations:
city: Kigali
country: Rwanda
facility: Manna Energy Ltd.
Study officials:
affiliation: LSHTM & Emory University
name: Thomas Clasen, JD MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.