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Field
Trial Status
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Before
in_development
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After
on_going
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Field
Abstract
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Before
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, we conduct a randomized controlled trial (RCT) 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. We further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. We 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.
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After
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, we conduct a randomized controlled trial (RCT) 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. We further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics. We monitor the program's impact at Health and Demographic Surveillance Systems (HDSS) sites in collaboration with the Kenya Medical Research Institute (KEMRI). We collect similar household data in the study areas outside the HDSS site to monitor the program's impact. 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.
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Field
Last Published
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Before
January 23, 2023 06:36 AM
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After
July 13, 2023 02:50 PM
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Intervention (Public)
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Before
Our study proposes to conduct a coupon program for free chlorine. The research activities include:
Enrollment:
Pregnant women and women with children under age two that visit health facilities will be eligible to receive coupons for free chlorine at the health facility.
Randomization:
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.
Treatment:
Households with women in the treatment group will receive a monthly supply of coupons for chlorine products until the end of the program. The program will be set up so that coupon redemption can be monitored in real-time using digital redemption records. The incoming data allows the program implementer to identify individuals with low redemption rates and potentially target those for information interventions.
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After
Our study proposes to conduct a coupon program for free chlorine. The research activities include:
Enrollment:
Pregnant women that visit health facilities will be eligible to receive coupons for free chlorine at the registered facility.
Randomization:
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.
Treatment:
Households with women in the treatment group will receive a monthly supply of coupons for chlorine products until the end of the program. The program will be set up so that coupon redemption can be monitored in real-time using digital redemption records. The incoming data allows the program implementer to identify individuals with low redemption rates and potentially target those for information interventions.
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Intervention Start Date
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Before
February 01, 2023
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After
February 21, 2023
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Primary Outcomes (End Points)
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Before
Verified chlorine usage, Child morbidity.
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After
Redemption, Verified chlorine usage, Child morbidity.
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Field
Primary Outcomes (Explanation)
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Before
Verified chlorine usage: 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.
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents in the previous two weeks.
The data will be collected every six months by HDSS household survey. Note: This study will be underpowered to detect impacts on mortality, but we will be collecting data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
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After
Redemption: Redemption of the coupon is voluntary. The program will be set up so that coupon redemption can be monitored using digital redemption records.
Verified chlorine usage: 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.
Child morbidity will include caregiver-reported diarrhea, fever, and cough incidents in the previous two weeks.
The data will be collected every six months by the household survey. Note: This study will be underpowered to detect impacts on mortality, but we will be collecting data on mortality in any case as this study will contribute to a meta-analysis conducted in the future.
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Experimental Design (Public)
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Before
Women enrolled in the study will be randomly assigned to receive free chlorine coupons (“Treatment”) or not (“Control”).
Enrollment
Any pregnant woman or woman with children under two years old visiting the health facility will be enrolled in the program. The inclusion criteria of this study are “any pregnant women or women with children under age two who visit our partner health facilities who reside in HDSS catchment areas.” There are no exclusion criteria except for women who did not consent to the study. A list of eligible women, including names or phone numbers and other information in the health facility registry, will be compiled based on health facility registers on a daily or weekly basis. The list will be sent to the research team using an encrypted data collection system. Trained enumerators will make phone calls to eligible women to enroll them in the program if they consent to participation.
Randomization and treatment
We will conduct household-level randomization. Randomly selected women in the treatment group will receive coupons for free chlorine solutions to be redeemed at the health facility each month.
Redemption
Each coupon can be redeemed at the health facility each month for a one-month supply of chlorine products. Whether women or other household members will come to health facilities to redeem coupons or not receive chlorine solutions is voluntary. When the coupon is redeemed, the health facilities workers will submit a digital redemption record. Coupons in a packet will be signed to confirm the monthly redemption to the beneficiary. With the data gathered, it will be possible to compare how many products are procured in each health facility and how many are given to households.
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After
Women enrolled in the study will be randomly assigned to receive free chlorine coupons (“Treatment”) or not (“Control”).
Enrollment
Any pregnant woman visiting the health facility will be enrolled in the program. The inclusion criteria of this study are “any pregnant women who visit our partner health facilities who reside in catchment areas.” There are no exclusion criteria except for women who did not consent to the study. A list of eligible women, including names or phone numbers and other information in the health facility registry, will be compiled based on health facility registers on a daily or weekly basis. The list will be sent to the research team using an encrypted data collection system. Trained enumerators will make phone calls to eligible women to enroll them in the program if they consent to participation.
Randomization and treatment
We will conduct household-level randomization. Randomly selected women in the treatment group will receive coupons for free chlorine solutions to be redeemed at the registered facility each month.
Redemption
Each coupon can be redeemed at the registered facility each month for a one-month supply of chlorine products. Whether women or other household members will come to registered facilities to redeem coupons or not receive chlorine solutions is voluntary. When the coupon is redeemed, a digital redemption record will be submitted. Coupons in a packet will be signed to confirm the monthly redemption to the beneficiary. With the data gathered, it will be possible to compare how many products are procured in each registered facility and how many are given to households.
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Planned Number of Clusters
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Before
We expect about 16,000 households with children under age two or pregnant mothers in HDSS sites.
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After
We expect about 6,000 households with pregnant mothers
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Planned Number of Observations
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Before
Although our enrollment criteria target children under age 2 at the time of the enrollment (given that the oldest children become age 5 at the end of the three years program), we will collect the morbidity information of any children under age 5 when the household is interviewed.
We expect about 1.3 eligible children from the average household. Therefore, there are around 20,800 children under the age of 5 at HDSS sites. The final sample size for the analysis depends on how many women come to the health facility during our enrollment period. We aim to have a sample of at least 3,468 under the age 5 children to be sufficient for the analysis.
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After
Although our enrollment criteria target pregnant mothers at the time of the enrollment, we will collect the morbidity information of any children under age 5 who reside in the households enrolled in the study.
The final sample size for the analysis depends on how many women come to the health facility during our enrollment period. We aim to have a sample of at least 3,468 under the age 5 children to be sufficient for the analysis.
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Field
Intervention (Hidden)
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Before
Our study proposes to conduct a coupon program for free chlorine. The research activities include:
Enrollment:
Pregnant women and women with children under age two that visit health facilities will be eligible to receive coupons for free chlorine at the health facility.
Randomization:
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.
Treatment:
Households with women in the treatment group will receive a monthly supply of coupons for chlorine products until the end of the program. The program will be set up so that coupon redemption can be monitored in real-time using digital redemption records. The incoming data allows the program implementer to identify individuals with low redemption rates and potentially target those for information interventions.
|
After
Our study proposes to conduct a coupon program for free chlorine. The research activities include:
Enrollment:
Pregnant women that visit health facilities will be eligible to receive coupons for free chlorine at the registered facility.
Randomization:
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.
Treatment:
Households with women in the treatment group will receive a monthly supply of coupons for chlorine products until the end of the program. The program will be set up so that coupon redemption can be monitored in real-time using digital redemption records. The incoming data allows the program implementer to identify individuals with low redemption rates and potentially target those for information interventions.
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Secondary Outcomes (Explanation)
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Before
The HDSS household survey will ask households whether their current drinking water was treated with chlorine. We will also analyze other health behaviors to understand the pathway of the health impact.
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After
The household survey will ask households whether their current drinking water was treated with chlorine. We will also analyze other health behaviors to understand the pathway of the health impact.
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