Coupons for Safe Water Project (Coupons)

Scaling up Coupons for Safe Water Treatment in Kenya

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.

Study Overview

• Status: Recruiting
• Conditions: Diarrhea; Death; Diarrhea, Infantile; Death, Infant; Water-Related Diseases; Water-Borne Infectious Disease
• Intervention / Treatment: Other: Coupons for safe water program: Treatment; Other: Coupons for safe water program: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3468
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akito Kamei, PhD; Phone Number: +12172006188; Email: akamei@uchicago.edu
• Study Contact Backup: Name: Elisa M Maffioli, PhD; Email: elisamaf@umich.edu

Study Locations

• Kenya
  • Kisumu, Kenya
    • Recruiting
    • Health and Demographic Surveillance System (HDSS sites)
    • Contact: Sammy Khagayi, PhD; Email: skhagayi@gmail.com
  • Siaya, Kenya
    • Recruiting
    • Health and Demographic Surveillance System (HDSS) sites
    • Contact: Sammy Khagayi, PhD; Email: skhagayi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Currently pregnant women
• Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.

Exclusion Criteria:

- Women who do not consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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.	Other: Coupons for safe water program: Treatment; Randomly selected women in the treatment group will receive coupons for free chlorine solutions to be redeemed at the health facility each month.
Experimental: Control Arm; After enrollment over a phone call, they will not be contacted.	Other: Coupons for safe water program: Control; Randomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch.
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.	The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch.
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.	The study will measure the presence of free chlorine residual in drinking water 18 months after the program launch.
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.	The study will measure the presence of free chlorine residual in drinking water 24 months after the program launch.
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.	The study will measure the presence of free chlorine residual in drinking water 30 months after the program launch.
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.	The study will measure the presence of free chlorine residual in drinking water 36 months after the program launch.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The study assesses child morbidity 6 months after the program launch.
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.	The study assesses child morbidity 12 months after the program launch.
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.	The study assesses child morbidity 18 months after the program launch.
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.	The study assesses child morbidity 24 months after the program launch.
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.	The study assesses child morbidity 30 months after the program launch.
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.	The study assesses child morbidity 36 months after the program launch.
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.	The study assesses the self-reported health facility attendance 6 months after the program launch.
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.	The study assesses the self-reported health facility attendance 12 months after the program launch.
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.	The study assesses the self-reported health facility attendance 18 months after the program launch.
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.	The study assesses the self-reported health facility attendance 24 months after the program launch.
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.	The study assesses the self-reported health facility attendance 30 months after the program launch.
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.	The study assesses the self-reported health facility attendance 36 months after the program launch.

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Abdul Latif Jameel Poverty Action Lab; Kenya Medical Research Institute
• Investigators: Principal Investigator: Michael Kremer, PhD, University of Chicago; Principal Investigator: Pascaline Dupas, PhD, Stanford University; Principal Investigator: Elisa M Maffioli, PhD, University of Michigan; Principal Investigator: Akito Kamei, PhD, University of Chicago; Principal Investigator: Sammy Khagayi, PhD, Kenya Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Anticipated): February 28, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Kenya; RCT; Targeting; Child mortality; Child health; East Africa; Chlorine; Safe water; Coupons
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Infections; Communicable Diseases; Death; Infant Death; Diarrhea; Diarrhea, Infantile; Waterborne Diseases
• Other Study ID Numbers: DILChlorine Coupons Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No