Water Filters and Improved Cookstoves in Western Rwanda

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02239250
• Date of registration: 09/09/2014
• Prospective Registration: No
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Water Filters and Improved Cookstoves in Western Rwanda
• Scientific title: Assessing the Health Impact of Advance Water Filters and Improved Cookstoves in Western Province, Rwanda: A Cluster-randomised Controlled Trial
• Date of first enrolment: August 2014
• Target sample size: 1582
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02239250
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Rwanda

Contacts

• Name: Thomas Clasen, JD MSc PhD
• Affiliation: LSHTM & Emory University

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 5 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diarrhoeal Disease

Pneumonia

Respiratory Infection

Intervention(s)

Device: Water filter and cookstove

Primary Outcome(s)

Incidence of IMCI defined pneumonia in children under 5 years of age in ubudehe 1 & 2 categories [Time Frame: 12 months]

Incidence of IMCI defined diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories [Time Frame: 12 months]

Secondary Outcome(s)

Prevalence of self-reported diarrhoea in children under 5 years of age in ubudehe 1 & 2 categories [Time Frame: 12 months]

Incidence of maternal health outcomes among women un ubudehe 1 & 2 categories [Time Frame: 12 months]

All-cause mortality in children under 5 years of age in ubudehe 1 & categories [Time Frame: 12 months]

Prevalence of pneumonia in children under 5 years of age in ubudehe 1 & 2 categories [Time Frame: 12 months]

Secondary ID(s)

NCT01882777_2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DelAgua

University of Colorado, Boulder

Portland State University

Ministry of Health, Rwanda

National University, Rwanda

Emory University

Oregon Health and Science University