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NCT Number: NCT05766826

Coupons for Safe Water Project

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.

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Key information

Conditions

Death Death, Infant Diarrhea Diarrhea, Infantile Infant Death Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Water-Borne Infectious Disease Water-Related Diseases Waterborne Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women who do not consent.

Treatment and study plan

Coupons for safe water program: Treatment

Other

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

Other

Randomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment.

Primary outcomes

  1. Verified chlorine usage - 6 months

    Time frame: 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.

  2. Verified chlorine usage - 12 months

    Time frame: 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.

  3. Verified chlorine usage - 18 months

    Time frame: 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.

  4. Verified chlorine usage - 24 months

    Time frame: 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.

  5. Verified chlorine usage - 30 months

    Time frame: 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.

  6. Verified chlorine usage - 36 months

    Time frame: 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.

Secondary outcomes

  1. Child morbidity - 6 months

    Time frame: 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.

  2. Child morbidity - 12 months

    Time frame: 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.

  3. Child morbidity - 18 months

    Time frame: 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.

  4. Child morbidity - 24 months

    Time frame: 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.

  5. Child morbidity - 30 months

    Time frame: 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.

  6. Child morbidity - 36 months

    Time frame: 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.

  7. Self-reported health facility attendance - 6 months

    Time frame: 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.

  8. Self-reported health facility attendance - 12 months

    Time frame: 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.

  9. Self-reported health facility attendance - 18 months

    Time frame: 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.

  10. Self-reported health facility attendance - 24 months

    Time frame: 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.

  11. Self-reported health facility attendance - 30 months

    Time frame: 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.

  12. Self-reported health facility attendance - 36 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Akito Kamei, PhD

CONTACT

[email protected]

+12172006188

Elisa M Maffioli, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Abdul Latif Jameel Poverty Action Lab
  • Kenya Medical Research Institute

Registry information

Official study title

Scaling up Coupons for Safe Water Treatment in Kenya

Acronym: Coupons

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2023
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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