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Clinical Trials/NCT04008134
NCT04008134CompletedNot Applicable

CHoBI7 Trial: A Hospital Based Water, Sanitation and Hygiene Intervention for Households of Diarrheal Patients in Bangladesh

Johns Hopkins Bloomberg School of Public Health0 sites2,626 target enrollmentStarted: December 4, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,626
Primary Endpoint
Diarrhea prevalence among children under 2 years of age

Study Overview

Brief Summary

The Cholera Hospital Based Intervention for 7 Days (CHoBI7) randomized controlled trial for transition to scale aimed to: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

Detailed Description

The findings from the recent randomized controlled trial of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections in intervention households, and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention. Next steps to transition to scale were: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Masking Description

Masking was not possible because the intervention included visible components including a handwashing station and a covered drinking water storage vessel.

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Diarrhea patients will be defined as patients having acute watery diarrhea three or more loose stools over a 24-hour period in the past three days. Diarrhea patients admitted to ICDDRB Dhaka Hospital or Mugda General Hospital will be eligible for the trial if:
  • have had 3 or more loose stools over the past 24 hours
  • plan to reside in Dhaka for the next 12 months
  • have no basin for running water in their home
  • have a child under five years of age in their household (including themselves) that produced a stool sample at baseline
  • have a working mobile phone in the household.
  • Household members of the diarrhea patient will be eligible for the trial if:
  • they have shared the same cooking pot and resided in the same home with the diarrhea patient for the last three days
  • plan to reside in their current household with the diarrhea patient for the next 12 months

Exclusion Criteria

  • (1) Children in foster care will be excluded from all research study activities.

Outcomes

Primary Outcomes

Diarrhea prevalence among children under 2 years of age

Time Frame: 12 months

Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period

Diarrhea prevalence among all household members

Time Frame: 12 months

Diarrhea prevalence among all household members assessed by self report over a 12-month period

Diarrhea prevalence among children under 5 years of age

Time Frame: 12 months

Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period

Secondary Outcomes

  • Weight-for-age among children under 5 years of age(12 months)
  • Weight-for-height among children under 5 years of age(12 months)
  • Diarrhea prevalence among participants ages 10-18 years(12 months)
  • Handwashing with soap(12 months)
  • Diarrhea prevalence among participants ages 5-9 years(12 months)
  • Weight-for-age among children under 2 years of age(12 months)
  • Diarrhea prevalence among participants ages greater than 18 years(12 months)
  • Household drinking water treatment(12 months)
  • Height-for-age among children under 2 years of age(12 months)
  • Height-for-age among children under 5 years of age(12 months)
  • Weight-for-height among children under 2 years of age(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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