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Completed

NCT Number: NCT04020965

Drinking Water Chlorination and Child Survival in Rural Kenya

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.

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Key information

Age range

Up to 50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

REMIT Kenya

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Treatment and study plan

Water Treatment

Behavioral

Hardware: Chlorine dispensers provided for free at communal water sources, available to households in intervention arm who were and who were not enrolled in the WASH Benefits Kenya study.

Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on the treatment of drinking water for all children living in the household. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits. After the completion of the WASH Benefits Kenya study, the NGO Evidence Action conducted educational campaigns to promote the use of dispensers.

Sanitation

Behavioral

Only households enrolled in the original WASH Benefits study and assigned to the combined WASH and combined WASH + nutrition arms received this intervention.

Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, and new or upgraded pit latrine for each household enrolled in the WASH Benefits Kenya study. Upgrades included structural improvements, plastic slabs, and superstructure improvements. Households in intervention villages not enrolled in the original trial did not receive any hardware.

Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on handwashing with soap at critical times around food preparation, defecation, and contact with feces. Compounds in intervention villages that were not enrolled in the original trial did not receive such visits.

Handwashing

Behavioral

Only households enrolled in the original WASH Benefits study and assigned to the combined WASH and combined WASH + nutrition arms received this intervention.

Hardware: Handwashing "dual tippy tap" stations, including jugs for clean and for soapy water, for each compound. Handwashing stations were stocked with soap for the duration of the WASH Benefits Kenya study. Compounds in intervention villages who were not enrolled in the WASH Benefits Kenya study did not receive any hardware.

Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on the use of latrines for defecation and the removal of human and animal feces from the compound. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits.

Nutrition

Dietary Supplement

Supplement: Lipid-based Nutrient Supplement (LNS) twice daily from ages 6 to 24 months, among children enrolled in the WASH Benefits Kenya study and for the duration of that study. Children in intervention villages who were not enrolled in the WASH Benefits Kenya study did not receive any supplements.

Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver the following behavior change messages: (1) practice exclusive breastfeeding from birth to 6 months of age; (2) continue breast feeding with the introduction of LNS; (3) provide your child micronutrient-rich foods and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits.

Primary outcomes

  1. All-cause under-five child mortality

    Time frame: 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.

  2. Infectious disease related under-five child mortality

    Time frame: 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 outcomes

  1. 7-day under-five child diarrhea prevalence

    Time frame: 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.

  2. All-cause under-two mortality

    Time frame: 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.

  3. Diarrheal disease related under-five child mortality

    Time frame: 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).

  4. School attendance

    Time frame: Measured 6 years after intervention start

    Mother-reported school attendance on the day of the survey

  5. School enrollment

    Time frame: Measured 6 years after intervention start

    Mother-reported school enrollment at the time of the survey

  6. Motor development

    Time frame: Measured 6 years after intervention start

    Motor development measured with the International Development and Early Learning Assessment tool.

  7. Emergent language and literacy

    Time frame: Measured 6 years after intervention start

    Emergent language and literacy measured with the International Development and Early Learning Assessment tool.

  8. Emergent math/numeracy

    Time frame: Measured 6 years after intervention start

    Emergent math/numeracy measured with the International Development and Early Learning Assessment tool.

  9. Socio-emotional development

    Time frame: Measured 6 years after intervention start

    Socio-emotional development measured with the International Development and Early Learning Assessment tool.

  10. All-cause under-six months mortality

    Time frame: 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.

  11. All-cause neonatal mortality

    Time frame: 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.

  12. Infectious disease related under-two mortality

    Time frame: 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):

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • University of California, Berkeley
  • University of Chicago

Registry information

Official study title

Effect of Drinking Water Chlorination on Child Survival in Rural Kenya

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2019
Registry last updated
Sep 15, 2022

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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