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Coupons for Safe Water Project (Coupons)

Primary Purpose

Death, Death, Infant, Diarrhea

Status
Recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Coupons for safe water program: Treatment
Coupons for safe water program: Control
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Death focused on measuring Child health, Child mortality, Chlorine, Safe water, Targeting, Coupons, RCT, East Africa, Kenya

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Currently pregnant women Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas. Exclusion Criteria: - Women who do not consent.

Sites / Locations

  • Health and Demographic Surveillance System (HDSS sites)Recruiting
  • Health and Demographic Surveillance System (HDSS) sitesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm

Control Arm

Arm Description

After enrollment over a phone call, they receive a SMS text message with an ID number to receive their coupons at the health facility. Those coupons can be used to redeem WaterGuard 150mL dilute chlorine. Participants in this group will receive a packet of coupons that ensure a monthly supply of a150ml bottle of dilute chlorine solution for at least the next 12 months. These coupons are redeemable in health facilities and other sites registered for the study.

After enrollment over a phone call, they will not be contacted.

Outcomes

Primary Outcome Measures

Verified chlorine usage - 6 months
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Verified chlorine usage - 12 months
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Verified chlorine usage - 18 months
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Verified chlorine usage - 24 months
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Verified chlorine usage - 30 months
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Verified chlorine usage - 36 months
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

Secondary Outcome Measures

Child morbidity - 6 months
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Child morbidity - 12 months
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Child morbidity - 18 months
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Child morbidity - 24 months
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Child morbidity - 30 months
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Child morbidity - 36 months
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Self-reported health facility attendance - 6 months
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Self-reported health facility attendance - 12 months
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Self-reported health facility attendance - 18 months
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Self-reported health facility attendance - 24 months
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Self-reported health facility attendance - 30 months
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Self-reported health facility attendance - 36 months
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.

Full Information

First Posted
February 2, 2023
Last Updated
March 10, 2023
Sponsor
University of Chicago
Collaborators
Abdul Latif Jameel Poverty Action Lab, Kenya Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05766826
Brief Title
Coupons for Safe Water Project
Acronym
Coupons
Official Title
Scaling up Coupons for Safe Water Treatment in Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Abdul Latif Jameel Poverty Action Lab, Kenya Medical Research Institute

4. Oversight

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

5. Study Description

Brief Summary
Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are a cost-effective and effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics.
Detailed Description
Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are (i) a cost-effective solution to targeting water treatment for households that need it and will use it and (ii) an effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further study the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. Investigators monitor the program's impact at Health and Demographic Surveillance Systems (HDSS) sites in collaboration with the Kenya Medical Research Institute (KEMRI). Data collection includes child mortality, as well as verbal autopsies for deceased children. Data on mortality will be useful for future meta-analyses that pool data from multiple studies in order to estimate the mortality impact of free chlorine distribution schemes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Death, Death, Infant, Diarrhea, Diarrhea, Infantile, Water-Borne Infectious Disease, Water-Related Diseases
Keywords
Child health, Child mortality, Chlorine, Safe water, Targeting, Coupons, RCT, East Africa, Kenya

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will conduct individual randomization, assigning half of the women to receive coupons and the other half to the control group as we enroll.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
After enrollment over a phone call, they receive a SMS text message with an ID number to receive their coupons at the health facility. Those coupons can be used to redeem WaterGuard 150mL dilute chlorine. Participants in this group will receive a packet of coupons that ensure a monthly supply of a150ml bottle of dilute chlorine solution for at least the next 12 months. These coupons are redeemable in health facilities and other sites registered for the study.
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
After enrollment over a phone call, they will not be contacted.
Intervention Type
Other
Intervention Name(s)
Coupons for safe water program: Treatment
Intervention Description
Randomly selected women in the treatment group will receive coupons for free chlorine solutions to be redeemed at the health facility each month.
Intervention Type
Other
Intervention Name(s)
Coupons for safe water program: Control
Intervention Description
Randomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment.
Primary Outcome Measure Information:
Title
Verified chlorine usage - 6 months
Description
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Time Frame
The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch.
Title
Verified chlorine usage - 12 months
Description
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Time Frame
The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch.
Title
Verified chlorine usage - 18 months
Description
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Time Frame
The study will measure the presence of free chlorine residual in drinking water 18 months after the program launch.
Title
Verified chlorine usage - 24 months
Description
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Time Frame
The study will measure the presence of free chlorine residual in drinking water 24 months after the program launch.
Title
Verified chlorine usage - 30 months
Description
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Time Frame
The study will measure the presence of free chlorine residual in drinking water 30 months after the program launch.
Title
Verified chlorine usage - 36 months
Description
Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.
Time Frame
The study will measure the presence of free chlorine residual in drinking water 36 months after the program launch.
Secondary Outcome Measure Information:
Title
Child morbidity - 6 months
Description
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Time Frame
The study assesses child morbidity 6 months after the program launch.
Title
Child morbidity - 12 months
Description
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Time Frame
The study assesses child morbidity 12 months after the program launch.
Title
Child morbidity - 18 months
Description
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Time Frame
The study assesses child morbidity 18 months after the program launch.
Title
Child morbidity - 24 months
Description
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Time Frame
The study assesses child morbidity 24 months after the program launch.
Title
Child morbidity - 30 months
Description
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Time Frame
The study assesses child morbidity 30 months after the program launch.
Title
Child morbidity - 36 months
Description
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents and cost related to sickness in the previous two weeks. This study will be underpowered to detect impacts on mortality, but investigators will collect data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
Time Frame
The study assesses child morbidity 36 months after the program launch.
Title
Self-reported health facility attendance - 6 months
Description
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Time Frame
The study assesses the self-reported health facility attendance 6 months after the program launch.
Title
Self-reported health facility attendance - 12 months
Description
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Time Frame
The study assesses the self-reported health facility attendance 12 months after the program launch.
Title
Self-reported health facility attendance - 18 months
Description
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Time Frame
The study assesses the self-reported health facility attendance 18 months after the program launch.
Title
Self-reported health facility attendance - 24 months
Description
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Time Frame
The study assesses the self-reported health facility attendance 24 months after the program launch.
Title
Self-reported health facility attendance - 30 months
Description
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Time Frame
The study assesses the self-reported health facility attendance 30 months after the program launch.
Title
Self-reported health facility attendance - 36 months
Description
Participants will be surveyed about recent visits to health facilities. For women who are currently pregnant or delivered a baby in the last 12 months, the study asks the number of antenatal care visits. For women who have children under age 5, we collect data on the number of postnatal care.
Time Frame
The study assesses the self-reported health facility attendance 36 months after the program launch.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The recruitment takes place at health facility targeting women visiting health facilities for antenatal care, postnatal care, and other reasons. This study recruits currently pregnant women.
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Currently pregnant women Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas. Exclusion Criteria: - Women who do not consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akito Kamei, PhD
Phone
+12172006188
Email
akamei@uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa M Maffioli, PhD
Email
elisamaf@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kremer, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascaline Dupas, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisa M Maffioli, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Akito Kamei, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sammy Khagayi, PhD
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Demographic Surveillance System (HDSS sites)
City
Kisumu
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sammy Khagayi, PhD
Email
skhagayi@gmail.com
Facility Name
Health and Demographic Surveillance System (HDSS) sites
City
Siaya
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sammy Khagayi, PhD
Email
skhagayi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the analysis is complete, the de-identified data will be deposited in the public server for replicability of the research analysis.
IPD Sharing Time Frame
After the completion of the whole study
IPD Sharing Access Criteria
The de-identified data will be deposited in the public server

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Coupons for Safe Water Project

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