DeathCouponsNCT05766826
Coupons for Safe Water Project
A study testing Coupons for safe water program: Treatment in people with Death and Death, Infant, run by University of Chicago at 2 sites in Kenya.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Death, Death, Infant, Diarrhea
- What is being tested?
- Coupons for safe water program: Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,468 participants
- Where
- 2 sitesKenya
- Study dates
- 21 Feb 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently pregnant women
- Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.
Who cannot join
- Women who do not consent.
Trial locations and contacts
2 sites in 1 country.
Elisa M Maffioli, PhD contact
Kenya2 sites, 2 recruiting
- Recruiting
Health and Demographic Surveillance System (HDSS sites)
Kisumu
Sammy Khagayi, PhD, skhagayi@gmail.com
- Recruiting
Health and Demographic Surveillance System (HDSS) sites
Siaya
Sammy Khagayi, PhD, skhagayi@gmail.com
About this study
Official title: Scaling up Coupons for Safe Water Treatment in Kenya
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.
Read the 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.
- Conditions
- Death, Death, Infant, Diarrhea, Diarrhea, Infantile, Water-Borne Infectious Disease, Water-Related Diseases
- Being tested
- Coupons for safe water program: Treatment, Coupons for safe water program: Control
- Keywords
- Child health, Child mortality, Chlorine, Safe water, Targeting, Coupons, RCT, East Africa, Kenya
- Medical subject headings
- Death, Infant Death, Diarrhea, Diarrhea, Infantile, Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coupons for safe water program: TreatmentOther
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: ControlOther
Randomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | After enrollment over a phone call, they receive a SMS text message with an ID number to receive their coupons at the health facility. Those coupons can be used to redeem WaterGuard 150mL dilute chlorine. Participants in this group will receive a packet of coupons that ensure a monthly supply of a150ml bottle of dilute chlorine solution for at least the next 12 months. These coupons are redeemable in health facilities and other sites registered for the study. Receives: Other: Coupons for safe water program: Treatment |
| Control Arm | Experimental | After enrollment over a phone call, they will not be contacted. Receives: Other: Coupons for safe water program: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch.
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.
Measured: The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch.
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.
Measured: The study will measure the presence of free chlorine residual in drinking water 18 months after the program launch.
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.
Measured: The study will measure the presence of free chlorine residual in drinking water 24 months after the program launch.
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.
Measured: The study will measure the presence of free chlorine residual in drinking water 30 months after the program launch.
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.
Measured: The study will measure the presence of free chlorine residual in drinking water 36 months after the program launch.
Secondary outcomes (12)
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.
Measured: The study assesses child morbidity 6 months after the program launch.
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.
Measured: The study assesses child morbidity 12 months after the program launch.
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.
Measured: The study assesses child morbidity 18 months after the program launch.
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.
Measured: The study assesses child morbidity 24 months after the program launch.
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.
Measured: The study assesses child morbidity 30 months after the program launch.
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.
Measured: The study assesses child morbidity 36 months after the program launch.
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.
Measured: The study assesses the self-reported health facility attendance 6 months after the program launch.
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.
Measured: The study assesses the self-reported health facility attendance 12 months after the program launch.
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.
Measured: The study assesses the self-reported health facility attendance 18 months after the program launch.
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.
Measured: The study assesses the self-reported health facility attendance 24 months after the program launch.
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.
Measured: The study assesses the self-reported health facility attendance 30 months after the program launch.
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.
Measured: The study assesses the self-reported health facility attendance 36 months after the program launch.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start21 Feb 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 3,468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab, Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Michael Kremer, PhD, Principal investigator, University of ChicagoPascaline Dupas, PhD, Principal investigator, Stanford UniversityElisa M Maffioli, PhD, Principal investigator, University of MichiganAkito Kamei, PhD, Principal investigator, University of ChicagoSammy Khagayi, PhD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766826
- Sponsor's protocol ID
- DILChlorine Coupons Project
- Acronym
- Coupons
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the analysis is complete, the de-identified data will be deposited in the public server for replicability of the research analysis.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Coupons for Safe Water Treatment in Kenya
- ClinicalTrials.gov ID
- NCT05766826
- Acronym / sponsor ID
- Coupons / DILChlorine Coupons Project
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,468 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab, Kenya Medical Research Institute
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Coupons for safe water program: TreatmentAfter enrollment over a phone call, they receive a SMS text message with an ID number to receive their coupons at the health facility. Those coupons can be used to redeem WaterGuard 150mL dilute chlorine. Participants in this group will receive a packet of coupons that ensure a monthly supply of a150ml bottle of dilute chlorine solution for at least the next 12 months. These coupons are redeemable in health facilities and other sites registered for the study. |
| Control Arm | Experimental | Other: Coupons for safe water program: ControlAfter enrollment over a phone call, they will not be contacted. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Currently pregnant women
- Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.
Key exclusion criteria (1 listed)
- Women who do not consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coupons for safe water program: TreatmentRandomly selected women in the treatment group will receive coupons for free chlorine solutions to be redeemed at the health facility each month. | Other | Treatment Arm |
| Coupons for safe water program: ControlRandomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment. | Other | Control Arm |
Primary outcome
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.
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.
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.
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.
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.
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.
12 secondary outcomes
Child morbidity - 6 months
Time frame: The study assesses child morbidity 6 months after the program launch.
Child morbidity - 12 months
Time frame: The study assesses child morbidity 12 months after the program launch.
Child morbidity - 18 months
Time frame: The study assesses child morbidity 18 months after the program launch.
Child morbidity - 24 months
Time frame: The study assesses child morbidity 24 months after the program launch.
Child morbidity - 30 months
Time frame: The study assesses child morbidity 30 months after the program launch.
Child morbidity - 36 months
Time frame: The study assesses child morbidity 36 months after the program launch.
Self-reported health facility attendance - 6 months
Time frame: The study assesses the self-reported health facility attendance 6 months after the program launch.
Self-reported health facility attendance - 12 months
Time frame: The study assesses the self-reported health facility attendance 12 months after the program launch.
Self-reported health facility attendance - 18 months
Time frame: The study assesses the self-reported health facility attendance 18 months after the program launch.
Self-reported health facility attendance - 24 months
Time frame: The study assesses the self-reported health facility attendance 24 months after the program launch.
Self-reported health facility attendance - 30 months
Time frame: The study assesses the self-reported health facility attendance 30 months after the program launch.
Self-reported health facility attendance - 36 months
Time frame: The study assesses the self-reported health facility attendance 36 months after the program launch.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Yes. Once the analysis is complete, the de-identified data will be deposited in the public server for replicability of the research analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa M Maffioli, PhD contact
Michael Kremer, PhD principal investigator
University of Chicago
Pascaline Dupas, PhD principal investigator
Stanford University
Elisa M Maffioli, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coupons for safe water program: Treatment in people with Death and Death, Infant, run by University of Chicago at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akito Kamei, PhD (+12172006188, akamei@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.