Coupons for Safe Water Project

Not Applicable

Recruiting

• Conditions: Death, Infant; Water-Borne Infectious Disease; Diarrhea; Death; Diarrhea, Infantile; Water-Related Diseases

• Registration Number: NCT05766826
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2023-02-02
• Study Start: 2023-02-21
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Primary Completion: 2026-02-28
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3468

Inclusion Criteria

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

Exclusion Criteria

• Women who do not consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Verified chlorine usage - 18 months	The study will measure the presence of free chlorine residual in drinking water 18 months after the program launch.	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	The study will measure the presence of free chlorine residual in drinking water 24 months after the program launch.	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	The study will measure the presence of free chlorine residual in drinking water 36 months after the program launch.	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 - 6 months	The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch.	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	The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch.	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	The study will measure the presence of free chlorine residual in drinking water 30 months after the program launch.	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

Name	Time	Method
Child morbidity - 6 months	The study assesses child morbidity 6 months after the program launch.	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	The study assesses child morbidity 30 months after the program launch.	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	The study assesses child morbidity 36 months after the program launch.	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 - 24 months	The study assesses the self-reported health facility attendance 24 months after the program launch.	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.
Child morbidity - 12 months	The study assesses child morbidity 12 months after the program launch.	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	The study assesses the self-reported health facility attendance 6 months after the program launch.	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	The study assesses the self-reported health facility attendance 36 months after the program launch.	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.
Child morbidity - 18 months	The study assesses child morbidity 18 months after the program launch.	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	The study assesses child morbidity 24 months after the program launch.	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 - 12 months	The study assesses the self-reported health facility attendance 12 months after the program launch.	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	The study assesses the self-reported health facility attendance 18 months after the program launch.	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	The study assesses the self-reported health facility attendance 30 months after the program launch.	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.

Trial Locations

Locations (2)

Health and Demographic Surveillance System (HDSS sites); 🇰🇪 Kisumu, Kenya

Health and Demographic Surveillance System (HDSS) sites; 🇰🇪 Siaya, Kenya