Focus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne PathogensNCT01998282
Evaluation of a Project to Distribute Water Filters and Cook Stoves in Western Rwanda--Phase 1B
An observational study of Focus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne Pathogens, run by London School of Hygiene and Tropical Medicine at 1 site in Rwanda.
Trial summary
DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Focus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne Pathogens
- How many people
- 1,035 participants
- Where
- 1 siteRwanda
- Study dates
- Oct 2013to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lower income (ubudehe groups 1 and 2) householders from 18 villages (9 intervention and matched controls) in 11 designated Districts in Rwanda: Rutsiro, Karongi, Ngororero, Nyamasheke, Nyabihu Districts of Western Province (excluding part of the district to the north of the Ruhengeri road); Rubuvu District (excluding part of the district to the north of the Ruhengeri road); Nyaruguru, Nyamagabe, Muhanga, and Ruhango Districts in Southern Province; Gakenke District in Northern Province.
Households will be eligible to participate in the study if they reside in selected villages and are willing to participate after receiving complete details regarding the study. Intervention households must have a functioning stove and water filter in order to participate, though they do not need to be in regular use. We will enroll all households with a child under 5 years of age if they are in Ubudehe groups 1 or 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of Water Filters and Improved Cook Stoves on Drinking Water and Quality and Indoor Air Pollution: A Matched Cohort Study in Rwanda
DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda. Prior to the full roll out of the campaign, the implementers are conducting research in connection with a distribution among 2000 households in western Rwanda. The objective of this matched cohort study (Phase 1B)are to investigate whether the filters and stoves delivered in October 2012 are still performing and in use, to determine whether they are associated with reductions in exposure to pathogens from drinking water and stoves, and to assembly information on health and other conditions necessary for the design of a large scale health impact evaluation.
- Keywords
- Focus of study is to assess filter/stove use and efficacy in reducing exposure to waterborne and airborne pathogens.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Household water filter and improved cook stove | Vestergaard-Frandsen LifeStraw Family 2.0 filter and Ecozoom stove | |
| Control | Traditional water management practices and cooking stoves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal exposure to PM2.5 and CO (mg/m3)
PM2.5 and CO concentrations will be measure in mg/m3 and reported as the mean concentration over 48 hours.
Measured: 10 months
Secondary outcomes (1)
Thermotolerant coliforms (TTC) in colony forming units (CFU) per 100ml of sample water
TTC will be measured as the total number of colony forming units (CFU) of TTC in the water sample and will be reported as number of CFU per 100ml of sample water.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne PathogensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Rwanda, DelAgua, Portland State University, University of Colorado, Boulder
- Responsible party
- Principal investigator, Thomas Clasen, London School of Hygiene and Tropical Medicine
- Investigators
- Thomas F Clasen, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998282
- Sponsor's protocol ID
- 6457
- Status last verified
- Mar 2017
- First submitted
- 8 Nov 2013
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Water Filters and Improved Cook Stoves on Drinking Water and Quality and Indoor Air Pollution: A Matched Cohort Study in Rwanda
- ClinicalTrials.gov ID
- NCT01998282
- Acronym / sponsor ID
- 6457
- Keywords
- Focus of study is to assess filter/stove use and efficacy in reducing exposure to waterborne and airborne pathogens.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Ministry of Health, Rwanda, DelAgua, Portland State University, University of Colorado, Boulder
- Study start
- Oct 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda. Prior to the full roll out of the campaign, the implementers are conducting research in connection with a distribution among 2000 households in western Rwanda. The objective of this matched cohort study (Phase 1B)are to investigate whether the filters and stoves delivered in October 2012 are still performing and in use, to determine whether they are associated with reductions in exposure to pathogens from drinking water and stoves, and to assembly information on health and other conditions necessary for the design of a large scale health impact evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Household water filter and improved cook stove | – | –Vestergaard-Frandsen LifeStraw Family 2.0 filter and Ecozoom stove |
| Control | – | –Traditional water management practices and cooking stoves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lower income (ubudehe groups 1 and 2) householders from 18 villages (9 intervention and matched controls) in 11 designated Districts in Rwanda: Rutsiro, Karongi, Ngororero, Nyamasheke, Nyabihu Districts of Western Province (excluding part of the district to the north of the Ruhengeri road); Rubuvu District (excluding part of the district to the north of the Ruhengeri road); Nyaruguru, Nyamagabe, Muhanga, and Ruhango Districts in Southern Province; Gakenke District in Northern Province.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Personal exposure to PM2.5 and CO (mg/m3)
Time frame: 10 months
PM2.5 and CO concentrations will be measure in mg/m3 and reported as the mean concentration over 48 hours.
1 secondary outcome
Thermotolerant coliforms (TTC) in colony forming units (CFU) per 100ml of sample water
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F Clasen, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne Pathogens, run by London School of Hygiene and Tropical Medicine at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal exposure to PM2.5 and CO (mg/m3) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.