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Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health

Primary Purpose

Helminthiasis, Diarrhea, Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Combined water, sanitation, and hygiene
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Helminthiasis focused on measuring Chlorine water treatment, Point-of-use water treatment, Household water treatment with safe storage, Handwashing with soap, Hand hygiene, Latrines, Child potties, Intestinal parasitic infection, Soil-transmitted helminths, Water, Sanitation, Handwashing, Diarrhea, Herd immunity, Helminths

Eligibility Criteria

undefined - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children not enrolled in WASH Benefits who live in a compound within 120 steps (2 minutes walking time) of a compound enrolled in WASH Benefits (combined WSH or control arms) and are 0-60 months 24 months after intervention

Exclusion Criteria:

  • Children enrolled in WASH Benefits
  • Children who live in compounds (baris) that share a courtyard with a compound enrolled in the WASH Benefits study
  • Children who live in compounds (baris) that share a latrine or handwashing station with a compound enrolled in the WASH Benefits study

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Combined water, sanitation, and hygiene

Non-intervention arm

Arm Description

Water quality, Sanitation, Handwashing

None. Households will continue their usual practices.

Outcomes

Primary Outcome Measures

Prevalence of soil-transmitted helminths (Ascaris, hookworm, Trichuris)
Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Stool samples with any ova will be considered positive.
Intensity of soil-transmitted helminth infections (Ascaris, hookworm, Trichuris)
Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Intensity will be measured using WHO cutoffs based on the number of eggs per gram of stool (>=5,000 eggs/gram for Ascaris, >=1,000 eggs/gram for hookworm, and >=2,000 eggs/gram for Trichuris).

Secondary Outcome Measures

Diarrhea prevalence
Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention.
Respiratory illness prevalence
Respiratory illness is defined as a persistent cough or difficulty breathing in the 7 days before the interview. Respiratory illness will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention.

Full Information

First Posted
March 18, 2015
Last Updated
October 25, 2016
Sponsor
University of California, Berkeley
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Stanford University, Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02396407
Brief Title
Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health
Official Title
Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Stanford University, Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to measure whether a combined water, sanitation, and hygiene intervention leads to improved health of children who did not receive the intervention themselves and who live within a close vicinity of intervention recipients.
Detailed Description
Almost 90% of diarrhea cases and 15% of under-5 diarrhea deaths worldwide could be prevented through improved water, sanitation, and hygiene. Sanitation interventions are also important for the prevention of soil-transmitted helminths, which infect 21 million children under five each year. Infection with soil-transmitted helminths and repeated episodes of diarrhea early in life can compromise physical and cognitive growth and development, resulting in poorer school performance later in life. Thus, water, sanitation, and hygiene (WASH) interventions are important not only for reducing child mortality, but also for preventing cycles of poverty and poor health. It is possible that WASH interventions affect not only those who receive them but also those who are geographically proximate or connected socially to those receiving the intervention. Indeed, there is a large infectious disease modeling literature based on this premise. Investigators define intervention effects on non-recipients "spillovers", and they are often referred to as "herd effects" or "indirect effects". Most studies that have empirically measured spillovers of child health interventions with an experimental design have focused on vaccines and deworming, and no studies have measured spillovers from WASH interventions. The development and application of methodology for measuring spillovers of community interventions empirically would make a valuable contribution to fields including epidemiology, economics, political science, and social welfare, all of which are concerned with measuring the impact of programs and interventions which may spill over. The presence and magnitude of positive spillovers are important; if spillovers are present and are in the same direction as treatment effects but are not accounted for when estimating treatment effects, estimates will be biased towards the null. As a result, both the efficacy and cost effectiveness of the intervention will be underestimated. In this study, investigators will measure spillovers of water, sanitation, and hygiene interventions in an existing, large, rigorously designed trial: the WASH Benefits trial (https://clinicaltrials.gov/ct2/show/NCT01590095). Funded by the Bill & Melinda Gates Foundation, this trial aims to measure the individual and combined effects of water, sanitation, and hygiene interventions on child health and development. It is a cluster-randomized, controlled trial with six treatment arms and a double-sized control arm carried out in rural Bangladesh. This add-on study is funded by the National Institute for Child Health and Human Development (1R21HD076216-01A1). Investigators hypothesize that children who live in close proximity to compounds that receive a combined sanitation, handwashing, and water treatment intervention--compared to children who live in close proximity to control compounds (no intervention)--will have: 1) lower prevalence of diarrhea, 2) lower prevalence and intensity of infection of soil transmitted helminths, and 3) lower prevalence of respiratory illness. Investigators will collect additional data from the existing combined intervention (sanitation+handwashing+water) and control arms of the WASH Benefits trial. For each WASH Benefits household, investigators will locate the nearest household with children 0-59 months of age that are not enrolled in WASH Benefits and collect data in that household. Our primary outcomes are soil transmitted helminth infection among children 0-59 months, caregiver-reported 7-day diarrhea, and respiratory illness among children 0-59 months (the same age as the WASH Benefits cohort). Our findings will document either the presence or absence of spillovers of the combined sanitation+handwashing+water intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminthiasis, Diarrhea, Respiratory Infection
Keywords
Chlorine water treatment, Point-of-use water treatment, Household water treatment with safe storage, Handwashing with soap, Hand hygiene, Latrines, Child potties, Intestinal parasitic infection, Soil-transmitted helminths, Water, Sanitation, Handwashing, Diarrhea, Herd immunity, Helminths

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1789 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined water, sanitation, and hygiene
Arm Type
Active Comparator
Arm Description
Water quality, Sanitation, Handwashing
Arm Title
Non-intervention arm
Arm Type
No Intervention
Arm Description
None. Households will continue their usual practices.
Intervention Type
Behavioral
Intervention Name(s)
Combined water, sanitation, and hygiene
Intervention Description
Water: Free chlorine tablets (Aquatabs; NaDCC) and safe storage vessel to treat and store drinking water. Sanitation: Free child potties, sani-scoop hoes to remove feces from household, and latrine upgrades to a dual pit latrine for all households in study compounds. Handwashing: Handwashing stations including soapy water bottles and detergent soap. Local promoters visit study compounds at least monthly to deliver behavior change messages that focus on (1) treating drinking water for children < 36 months of age, (2) use of latrines for defecation and the removal of human and animal feces from the compound, and (3) handwashing with soap at critical times around food preparation, defecation, and contact with feces.
Primary Outcome Measure Information:
Title
Prevalence of soil-transmitted helminths (Ascaris, hookworm, Trichuris)
Description
Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Stool samples with any ova will be considered positive.
Time Frame
Measured approximately 24 months after intervention
Title
Intensity of soil-transmitted helminth infections (Ascaris, hookworm, Trichuris)
Description
Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Intensity will be measured using WHO cutoffs based on the number of eggs per gram of stool (>=5,000 eggs/gram for Ascaris, >=1,000 eggs/gram for hookworm, and >=2,000 eggs/gram for Trichuris).
Time Frame
Measured approximately 24 months after intervention
Secondary Outcome Measure Information:
Title
Diarrhea prevalence
Description
Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention.
Time Frame
Measured approximately 24 months after intervention
Title
Respiratory illness prevalence
Description
Respiratory illness is defined as a persistent cough or difficulty breathing in the 7 days before the interview. Respiratory illness will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention.
Time Frame
Measured approximately 24 months after intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children not enrolled in WASH Benefits who live in a compound within 120 steps (2 minutes walking time) of a compound enrolled in WASH Benefits (combined WSH or control arms) and are 0-60 months 24 months after intervention Exclusion Criteria: Children enrolled in WASH Benefits Children who live in compounds (baris) that share a courtyard with a compound enrolled in the WASH Benefits study Children who live in compounds (baris) that share a latrine or handwashing station with a compound enrolled in the WASH Benefits study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Colford, Jr., MD PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
23996605
Citation
Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476.
Results Reference
background
PubMed Identifier
23629931
Citation
Lin A, Arnold BF, Afreen S, Goto R, Huda TMN, Haque R, Raqib R, Unicomb L, Ahmed T, Colford JM, Luby SP. Household environmental conditions are associated with enteropathy and impaired growth in rural Bangladesh. Am J Trop Med Hyg. 2013 Jul;89(1):130-137. doi: 10.4269/ajtmh.12-0629. Epub 2013 Apr 29.
Results Reference
background
PubMed Identifier
23557125
Citation
Sultana R, Mondal UK, Rimi NA, Unicomb L, Winch PJ, Nahar N, Luby SP. An improved tool for household faeces management in rural Bangladeshi communities. Trop Med Int Health. 2013 Jul;18(7):854-60. doi: 10.1111/tmi.12103. Epub 2013 Apr 5.
Results Reference
background
PubMed Identifier
24060247
Citation
Hulland KR, Leontsini E, Dreibelbis R, Unicomb L, Afroz A, Dutta NC, Nizame FA, Luby SP, Ram PK, Winch PJ. Designing a handwashing station for infrastructure-restricted communities in Bangladesh using the integrated behavioural model for water, sanitation and hygiene interventions (IBM-WASH). BMC Public Health. 2013 Sep 23;13:877. doi: 10.1186/1471-2458-13-877.
Results Reference
background
PubMed Identifier
24160869
Citation
Dreibelbis R, Winch PJ, Leontsini E, Hulland KR, Ram PK, Unicomb L, Luby SP. The Integrated Behavioural Model for Water, Sanitation, and Hygiene: a systematic review of behavioural models and a framework for designing and evaluating behaviour change interventions in infrastructure-restricted settings. BMC Public Health. 2013 Oct 26;13:1015. doi: 10.1186/1471-2458-13-1015.
Results Reference
background
PubMed Identifier
24645919
Citation
Vujcic J, Ram PK, Hussain F, Unicomb L, Gope PS, Abedin J, Mahmud ZH, Islam MS, Luby SP. Toys and toilets: cross-sectional study using children's toys to evaluate environmental faecal contamination in rural Bangladeshi households with different sanitation facilities and practices. Trop Med Int Health. 2014 May;19(5):528-36. doi: 10.1111/tmi.12292. Epub 2014 Mar 19.
Results Reference
background
PubMed Identifier
25816342
Citation
Ercumen A, Naser AM, Unicomb L, Arnold BF, Colford JM Jr, Luby SP. Effects of source- versus household contamination of tubewell water on child diarrhea in rural Bangladesh: a randomized controlled trial. PLoS One. 2015 Mar 27;10(3):e0121907. doi: 10.1371/journal.pone.0121907. eCollection 2015.
Results Reference
background
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT01590095
Description
WASH Benefits Bangladesh ClinicalTrials.gov Registration
URL
http://bmjopen.bmj.com/content/3/8/e003476.full
Description
Description of the design and rationale for WASH Benefits (open access article)

Learn more about this trial

Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health

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