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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05766826
Other study ID # DILChlorine Coupons Project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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