Clinical trial NCT05766826: Coupons for Safe Water Project
Official title: Scaling up Coupons for Safe Water Treatment in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Abdul Latif Jameel Poverty Action Lab
name: Kenya Medical Research Institute
First posted: 2023-03-13
Enrollment: 3468
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Verified chlorine usage - 6 months
timeFrame: The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch.
measure: Verified chlorine usage - 12 months
timeFrame: The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch.
measure: Verified chlorine usage - 18 months
timeFrame: The study will measure the presence of free chlorine residual in drinking water 18 months after the program launch.
measure: Verified chlorine usage - 24 months
timeFrame: The study will measure the presence of free chlorine residual in drinking water 24 months after the program launch.
measure: Verified chlorine usage - 30 months
timeFrame: The study will measure the presence of free chlorine residual in drinking water 30 months after the program launch.
measure: Verified chlorine usage - 36 months
timeFrame: The study will measure the presence of free chlorine residual in drinking water 36 months after the program launch.
Secondary outcomes:
measure: Child morbidity - 6 months
timeFrame: The study assesses child morbidity 6 months after the program launch.
measure: Child morbidity - 12 months
timeFrame: The study assesses child morbidity 12 months after the program launch.
measure: Child morbidity - 18 months
timeFrame: The study assesses child morbidity 18 months after the program launch.
measure: Child morbidity - 24 months
timeFrame: The study assesses child morbidity 24 months after the program launch.
measure: Child morbidity - 30 months
timeFrame: The study assesses child morbidity 30 months after the program launch.
measure: Child morbidity - 36 months
timeFrame: The study assesses child morbidity 36 months after the program launch.
measure: Self-reported health facility attendance - 6 months
timeFrame: The study assesses the self-reported health facility attendance 6 months after the program launch.
measure: Self-reported health facility attendance - 12 months
timeFrame: The study assesses the self-reported health facility attendance 12 months after the program launch.
measure: Self-reported health facility attendance - 18 months
timeFrame: The study assesses the self-reported health facility attendance 18 months after the program launch.
measure: Self-reported health facility attendance - 24 months
timeFrame: The study assesses the self-reported health facility attendance 24 months after the program launch.
measure: Self-reported health facility attendance - 30 months
timeFrame: The study assesses the self-reported health facility attendance 30 months after the program launch.
measure: Self-reported health facility attendance - 36 months
timeFrame: The study assesses the self-reported health facility attendance 36 months after the program launch.
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Health and Demographic Surveillance System (HDSS sites)
city: Siaya
country: Kenya
facility: Health and Demographic Surveillance System (HDSS) sites
Study officials:
affiliation: University of Chicago
name: Michael Kremer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Pascaline Dupas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Elisa M Maffioli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Akito Kamei, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Sammy Khagayi, PhD
role: PRINCIPAL_INVESTIGATOR
References: