- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03972618
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College and Sawyer Products, Inc. to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms:
Arm 1: Simultaneous installation of filters in schools and the villages sending children to the school Arm 2: Initial installation of the water filters in a school, with later installation in the corresponding village Arm 3: Instillation of the water filters in villages, with later installation in the corresponding school Arm 4: Control arm. No filter installation initially but, ultimately, installation of filters in both the schools and villages.
Self-reported information on filter usage and health outcomes will be collected through surveys administered to parents (in the households in the villages), teachers (in the schools) and school administrators. Data collection will occur at baseline (when filters are installed), at 2 and 8 weeks post installation. The major goal of this project is to better understand the different health impacts of each different deployment strategy on child and family wellbeing. Better understanding of these filter installation strategies will help guide us as we make filter deployment decisions to provide access to clean drinking water.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Santo Domingo, Dominican Republic
- Child Hope Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lives in selected villages and has children that attend the local school
Exclusion Criteria:
- No children attending the local school
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: School and village
Simultaneous installation of filters in schools and the village
|
Installation of water filtration system and education on hand washing.
|
|
Experimental: School only
Initial installation in school only
|
Installation of water filtration system and education on hand washing.
|
|
Experimental: Village only
Initial installation in village only
|
Installation of water filtration system and education on hand washing.
|
|
No Intervention: Control
Control group.
No filter installation initially.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diarrhea
Time Frame: 2-weeks
|
self-report of diarrhea
|
2-weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathan Tintle, Ph.D., Dordt College
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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