Coupons for Safe Water Project

Diarrhea Clinical Trial

— Coupons  

Official title:

Scaling up Coupons for Safe Water Treatment in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766826
• Other study ID #: DILChlorine Coupons Project
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2023
• Source: University of Chicago
• Contact: Akito Kamei, PhD
• Phone: +12172006188
• Email: akamei[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3468
• Est. completion date: October 1, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently pregnant women

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

Exclusion Criteria:

• Women who do not consent.

Related Conditions & MeSH terms

• Communicable Diseases
• Death
• Death, Infant
• Diarrhea
• Diarrhea, Infantile
• Infant Death
• Infections
• Water-Related Diseases
• Waterborne Diseases

Intervention

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.
• Coupons for safe water program: Control
Randomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment.

Locations

Country	Name	City	State
Kenya	Health and Demographic Surveillance System (HDSS sites)	Kisumu
Kenya	Health and Demographic Surveillance System (HDSS) sites	Siaya

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Abdul Latif Jameel Poverty Action Lab, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.