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Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic

Primary Purpose

Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Dominican Republic
Study Type
Interventional
Intervention
Installation of water filtration system for filtering existing water source
Sponsored by
Dordt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Lives in selected villages and has children that attend the local school

Exclusion Criteria:

  • No children attending the local school

Sites / Locations

  • Child Hope Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

School and village

School only

Village only

Control

Arm Description

Simultaneous installation of filters in schools and the village

Initial installation in school only

Initial installation in village only

Control group. No filter installation initially.

Outcomes

Primary Outcome Measures

Diarrhea
self-report of diarrhea

Secondary Outcome Measures

Full Information

First Posted
May 31, 2019
Last Updated
May 31, 2019
Sponsor
Dordt University
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1. Study Identification

Unique Protocol Identification Number
NCT03972618
Brief Title
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
Official Title
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 22, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dordt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 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 including schools, homes, simultaneous home/school and a control group
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
698 (Actual)

8. Arms, Groups, and Interventions

Arm Title
School and village
Arm Type
Experimental
Arm Description
Simultaneous installation of filters in schools and the village
Arm Title
School only
Arm Type
Experimental
Arm Description
Initial installation in school only
Arm Title
Village only
Arm Type
Experimental
Arm Description
Initial installation in village only
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group. No filter installation initially.
Intervention Type
Behavioral
Intervention Name(s)
Installation of water filtration system for filtering existing water source
Intervention Description
Installation of water filtration system and education on hand washing.
Primary Outcome Measure Information:
Title
Diarrhea
Description
self-report of diarrhea
Time Frame
2-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Lives in selected villages and has children that attend the local school Exclusion Criteria: No children attending the local school
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Tintle, Ph.D.
Organizational Affiliation
Dordt College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Hope Network
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Available upon reasonable request
Citations:
PubMed Identifier
33397511
Citation
Tintle N, Van De Griend K, Ulrich R, Wade RD, Baar TM, Boven E, Cooper CEA, Couch O, Eekhoff L, Fry B, Goszkowicz GK, Hecksel MA, Heynen A, Laughlin JA, Les SM, Lombard TR, Munson BD, Peterson JM, Schumann E, Settecerri DJ, Spry JE, Summerfield MJ, Sunder M, Wade DR, Zonnefeld CG, Brokus SA, Moen FS, Slater AD, Peterson JW, Pikaart MJ, Krueger BP, Best AA. Diarrhea prevalence in a randomized, controlled prospective trial of point-of-use water filters in homes and schools in the Dominican Republic. Trop Med Health. 2021 Jan 4;49(1):1. doi: 10.1186/s41182-020-00291-y.
Results Reference
derived

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Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic

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