NCT01998282

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,035

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

November 8, 2013

Last Update Submit

March 9, 2017

Conditions

Focus of Study is to Assess Filter and Stove Use and Efficacy in Reducing Exposure to Waterborne and Airborne Pathogens

Keywords

Focus of study is to assess filter/stove use and efficacy in reducing exposure to waterborne and airborne pathogens.

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 months

Secondary Outcomes (1)

  • Thermotolerant coliforms (TTC) in colony forming units (CFU) per 100ml of sample water

    10 months

Other Outcomes (4)

  • Blood pressure

    10 months

  • Blood pressure covariates

    10 months

  • Use of filter and stove

    10 months

  • +1 more other outcomes

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

DelAgua Health Rwanda

Kigali, PO Box 1594, Rwanda

Location

Study Officials

  • Thomas F Clasen, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Water, Sanitation and Health

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 28, 2013

Study Start

October 1, 2013

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

RW(1)