Drinking Water Chlorination and Child Survival in Rural Kenya

Not Applicable

Completed

• Conditions: Diarrhea; Child Development; Death
• Interventions: Behavioral: Water Treatment; Behavioral: Sanitation; Behavioral: Handwashing; Dietary Supplement: Nutrition

• Registration Number: NCT04020965
• Lead Sponsor: Tufts University

Brief Summary

The purpose of the study is to estimate the effect of community-wide provision of water treatment (chlorine) solution on all-cause child mortality and on infectious disease related child mortality. We will also examine effects on the following secondary outcomes: 7-day diarrhea prevalence, all-cause under-2 mortality, diarrheal disease related child mortality, school attendance, and school enrollment. In addition, and for a subsample of children, we will examine effects on motor development, emergent language and literacy, emergent math/numeracy, and socio-emotional development.

Detailed Description

The World Health Organization (WHO) estimates that in 2015 over 2 billion people consumed drinking water contaminated with feces and that approximately half a million people died from diarrheal disease associated with fecal contamination of water (1). Dilute chlorine solution is widely used to treat water as it is effective, safe, and low-cost. While nonexperimental studies suggest strong impacts of chlorine water treatment on child survival (2-4), there has been no previous randomized controlled trial of a water treatment intervention powered to evaluate effects on child survival.

We will examine the effect of community-wide provision of chlorine solution on child survival in rural Kenya, where a long-term village-wide chlorination randomized evaluation was implemented. The WASH Benefits Kenya trial was a randomized controlled trial of water treatment, sanitation, handwashing, and nutrition interventions in western Kenya. WASH Benefits Kenya enrolled pregnant women in their second or third gestational trimester between November 2012 and May 2014 and followed children for their first 2 years of life. In communities that were randomized to water treatment, chlorine solution dispensers were installed and refilled as needed. After the WASH Benefits Kenya trial ended, the NGO Evidence Action continued to refill most of the dispensers in the treatment villages.

We intend to re-visit all water treatment and control clusters in the trial approximately 6 years after the chlorination intervention was initiated to enroll all women 50 or younger, who had a child since January 1, 2008. We note that our target population includes both women (and children) who were and who were not "enrolled" in the original WASH Benefits Kenya study. The latter group is made up of women (and their children) who were pregnant before the study, women who were in their first trimester at the time of enrollment, and women who got pregnant after study enrollment. We expect to find approximately 22,000 such women. We will briefly survey these women to identify those that gave birth to a child who later died, and then conduct verbal autopsies to ascertain the cause of death. We will also perform free and total chlorine residual testing at households to assess current usage rates and collect GPS data on the location of houses and dispensers. We will estimate the intent-to-treat effect of the community-wide provision of chlorine solution on child survival by 1) comparing post-intervention mortality rates between water treatment and control areas; and 2) comparing changes in mortality rates (before and after the intervention) across treatment and control areas (a difference-in-difference analysis). The primary outcomes are all-cause child mortality and infectious disease related child mortality; secondary outcomes include: 7-day diarrhea prevalence, all-cause under-2 mortality, diarrheal disease related child mortality, school attendance, and school enrollment. In addition, for the subsample of children who were enrolled in the original WASH Benefits Kenya study, we will examine effects on motor development, emergent language and literacy, emergent math/numeracy, and socio-emotional development. Our findings will provide evidence on whether community-wide provision of chlorine reduces all-cause child mortality and infectious disease related child mortality.

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-16
• Study Start: 2019-07-26
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46212

Inclusion Criteria

1. Had one or more live births since January 1, 2008.
2. Live in a village which was randomized to water treatment or control arms during the WASH Benefits Kenya trial.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water Treatment	Handwashing	This arm includes all households in villages randomized in the original WASH Benefits trial to the water treatment arm, combined water treatment with handwashing and sanitation (WASH) arm, and combined WASH + nutrition arm. Village-level promoter visited households enrolled in the original trial to promote the interventions for approximately two years.
Water Treatment	Water Treatment	This arm includes all households in villages randomized in the original WASH Benefits trial to the water treatment arm, combined water treatment with handwashing and sanitation (WASH) arm, and combined WASH + nutrition arm. Village-level promoter visited households enrolled in the original trial to promote the interventions for approximately two years.
Water Treatment	Sanitation	This arm includes all households in villages randomized in the original WASH Benefits trial to the water treatment arm, combined water treatment with handwashing and sanitation (WASH) arm, and combined WASH + nutrition arm. Village-level promoter visited households enrolled in the original trial to promote the interventions for approximately two years.
Water Treatment	Nutrition	This arm includes all households in villages randomized in the original WASH Benefits trial to the water treatment arm, combined water treatment with handwashing and sanitation (WASH) arm, and combined WASH + nutrition arm. Village-level promoter visited households enrolled in the original trial to promote the interventions for approximately two years.

Primary Outcome Measures

Name	Time	Method
All-cause under-five child mortality	Measured 6 years after start of intervention (recall period from start of intervention to day of survey)	All-cause mortality for children who died under the age of 5 years.
Infectious disease related under-five child mortality	Measured 6 years after start of intervention (recall period from start of intervention to day of survey)	Mortality for children who died under the age of 5 years from infectious or parasitic diseases. Based on the 2016 WHO Verbal Autopsy instrument, the category of deaths by "infectious and parasitic diseases" include the following causes (ICD-10 codes in parenthesis): * Sepsis (A41); * Acute respiratory infection, including pneumonia (J22/J18); * HIV/AIDS related death (B24); * Diarrheal diseases (A09); * Malaria (B54); * Measles (B05); * Meningitis and encephalitis (G03; G04); * Tetanus, excluding neonatal tetanus (A35); * Pulmonary tuberculosis (A16); * Pertussis (A37); * Hemorrhagic fever (A99); * Dengue fever (A90; A91); * Unspecified infectious disease (B99)

Secondary Outcome Measures

Name	Time	Method
School attendance	Measured 6 years after intervention start	Mother-reported school attendance on the day of the survey
School enrollment	Measured 6 years after intervention start	Mother-reported school enrollment at the time of the survey
7-day under-five child diarrhea prevalence	Measured 6 years after intervention start	Diarrhea is defined as 3+ loose or watery stools in a 24 hour period. Data will be measured in interviews using mother-reported symptoms with a 7-day recall among children under 5 years.
All-cause under-two mortality	Measured 6 years after intervention (recall period from start of intervention to day of survey)	All-cause mortality for children who died under the age of 2 years.
Diarrheal disease related under-five child mortality	Measured 6 years after intervention (recall period from start of intervention to day of survey)	Mortality for children who died under the age of 5 years from diarrheal disease (ICD-10 code A09).
Motor development	Measured 6 years after intervention start	Motor development measured with the International Development and Early Learning Assessment tool.
Emergent language and literacy	Measured 6 years after intervention start	Emergent language and literacy measured with the International Development and Early Learning Assessment tool.
Emergent math/numeracy	Measured 6 years after intervention start	Emergent math/numeracy measured with the International Development and Early Learning Assessment tool.
Socio-emotional development	Measured 6 years after intervention start	Socio-emotional development measured with the International Development and Early Learning Assessment tool.
All-cause under-six months mortality	Measured 6 years after intervention (recall period from start of intervention to day of survey)	All-cause mortality for children who died under the age of 6 months.
All-cause neonatal mortality	Measured 6 years after intervention (recall period from start of intervention to day of survey)	All-cause mortality for children who died under the age of 4 weeks.
Infectious disease related under-two mortality	Measured 6 years after start of intervention (recall period from start of intervention to day of survey)	Mortality for children who died under the age of 2 years from infectious or parasitic diseases. Based on the 2016 WHO Verbal Autopsy instrument, the category of deaths by "infectious and parasitic diseases" include the following causes (ICD-10 codes in parenthesis):

Trial Locations

Locations (1)

REMIT Kenya; 🇰🇪 Kisumu, Kenya