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DeathNCT04020965

Drinking Water Chlorination and Child Survival in Rural Kenya

A study testing Water Treatment, Sanitation and Handwashing in people with Death and Diarrhea, run by Tufts University at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Death, Diarrhea, Child Development
What is being tested?
Water Treatment, Sanitation and Handwashing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46,212 participants
Where
1 siteKenya
Study dates
26 Jul 2019to 26 May 2021
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 Up to 50 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Kenya1 site
  • REMIT Kenya

    Kisumu

Other trials in Kenya

About this study

Official title: Effect of Drinking Water Chlorination on 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.

Read the 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.

Being tested
Water Treatment, Sanitation, Handwashing, Nutrition
Medical subject headings
Death, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water TreatmentBehavioural

    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.

  • SanitationBehavioural

    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.

  • HandwashingBehavioural

    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.

  • NutritionDietary 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.

Study groups in NCT04020965
Study groupRoleWhat they receive
Control armNo interventionThis arm includes all households in villages randomized to the active control arm (double-sized) or passive control arm of the original trial. Village-level promoter visited households enrolled in the WASH Benefits Kenya study active control arm and strictly engaged in recording the child's MUAC and referring children identified as malnourished (MUAC<11.5 cm) to health clinics, for two years. These visits were also conducted in all active comparator arms. Households in active control and active comparator villages which were not enrolled in the original study did not receive such visits.
Water TreatmentExperimentalThis 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.
Receives: Behavioral: Water Treatment; Behavioral: Sanitation; Behavioral: Handwashing; Dietary Supplement: Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause under-five child mortality

    All-cause mortality for children who died under the age of 5 years.

    Measured: Measured 6 years after start of intervention (recall period from start of intervention to day of survey)

  2. Infectious disease related under-five child mortality

    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)

    Measured: Measured 6 years after start of intervention (recall period from start of intervention to day of survey)

Secondary outcomes (12)
  1. 7-day under-five child diarrhea prevalence

    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.

    Measured: Measured 6 years after intervention start

  2. All-cause under-two mortality

    All-cause mortality for children who died under the age of 2 years.

    Measured: Measured 6 years after intervention (recall period from start of intervention to day of survey)

  3. Diarrheal disease related under-five child mortality

    Mortality for children who died under the age of 5 years from diarrheal disease (ICD-10 code A09).

    Measured: Measured 6 years after intervention (recall period from start of intervention to day of survey)

  4. School attendance

    Mother-reported school attendance on the day of the survey

    Measured: Measured 6 years after intervention start

  5. School enrollment

    Mother-reported school enrollment at the time of the survey

    Measured: Measured 6 years after intervention start

  6. Motor development

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

    Measured: Measured 6 years after intervention start

  7. Emergent language and literacy

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

    Measured: Measured 6 years after intervention start

  8. Emergent math/numeracy

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

    Measured: Measured 6 years after intervention start

  9. Socio-emotional development

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

    Measured: Measured 6 years after intervention start

  10. All-cause under-six months mortality

    All-cause mortality for children who died under the age of 6 months.

    Measured: Measured 6 years after intervention (recall period from start of intervention to day of survey)

  11. All-cause neonatal mortality

    All-cause mortality for children who died under the age of 4 weeks.

    Measured: Measured 6 years after intervention (recall period from start of intervention to day of survey)

  12. Infectious disease related under-two mortality

    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):

    Measured: Measured 6 years after start of intervention (recall period from start of intervention to day of survey)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start26 Jul 2019
  3. Primary completion26 May 2021
  4. Study completion26 May 2021

Resources

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
Masking
None (open label)
Enrolment
46,212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020965
Sponsor's protocol ID
1903034
Status last verified
Sep 2022
First submitted
12 Jul 2019
Last updated
15 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • World Health Organization. Drinking-water. Available at: https://www.who.int/news-room/fact-sheets/detail/drinking-water. (Accessed: 20th February 2019)

  • Bhalotra, S. R., Díaz-Cayeros, A., Miller, G., Miranda, A. & Venkataramani, A. S. Urban Water Disinfection and Mortality Decline in Developing Countries.

  • Galiani, S., Gertler, P. & Schargrodsky, E. Water for Life: The Impact of the Privatization of Water Services on Child Mortality. J. Polit. Econ. 113, 83-120 (2005).

  • Cutler D, Miller G. The role of public health improvements in health advances: the twentieth-century United States. Demography. 2005 Feb;42(1):1-22. doi: 10.1353/dem.2005.0002.

    PubMed 15782893

Questions about this trial

What is this clinical trial studying?

A study testing Water Treatment, Sanitation and Handwashing in people with Death and Diarrhea, run by Tufts University at 1 site 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 0 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04020965, which also lists 4 linked publications.

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 15 Sep 2022.

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