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Completed

NCT Number: NCT04008134

Cholera-Hospital-Based-Intervention-for-7-days

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.

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Key information

Conditions

Cholera Bacterial Infections Bacterial Infections and Mycoses Diarrhea Gram-Negative Bacterial Infections Growth Disorders Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stunting Vibrio Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

CHoBI7 health facility program

Behavioral

The CHoBI7 health facility program focuses on promoting handwashing with soap and water treatment to diarrhea patients and their household members during the one-week period after the patient is admitted to the health facility, when their household is at highest risk for diarrheal diseases. The CHoBI7 program includes: (1) a WASH pictorial module delivered by a health worker bedside to diarrhea patient and their household members in a health facility on handwashing with soap, water treatment, and safe water storage; and (2) a diarrhea prevention package containing chlorine tablets for water treatment, a soapy water bottle (water and detergent powder), a handwashing station, and a water vessel with a lid and tap for safe drinking water storage. Households are instructed to boil their water once their supply of chlorine tablets is completed.

CHoBI7 mHealth program

Behavioral

The CHoBI7 mHealth (mobile health) program targets five key behaviors: (1) preparing soapy water using water and detergent powder; (2) handwashing with soap at food and stool related events; (3) treating household drinking water using chlorine tablets during the one week high risk period after the diarrhea patient in the household was admitted to the health facility; (4) safe drinking water storage in a water vessel with a lid and tap; and (5) heating of household drinking water until it reaches a rolling boil after the one week high risk period. Participant households receive bi-weekly voice and text messages from the CHoBI7 mHealth program over a 12-month period. These mobile messages are sent using the VIAMO platform (www.viamo.io).

CHoBI7 home visit program

Behavioral

The CHoBI7 home visit program involves two, 30-minute home visits conducted during the week after the index diarrhea patient was recruited at the health facility. A health worker reinforces the content of the CHoBI7 health facility program in the participant's home.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Diarrhea prevalence among participants ages 5-9 years

    Time frame: 12 months

    Diarrhea prevalence among all household members ages 5-9 years assessed by self report over a 12-month period

  2. Diarrhea prevalence among participants ages 10-18 years

    Time frame: 12 months

    Diarrhea prevalence among all household members ages 10-18 years assessed by self report over a 12-month period

  3. Diarrhea prevalence among participants ages greater than 18 years

    Time frame: 12 months

    Diarrhea prevalence among all household members ages greater than 18 years assessed by self report over a 12-month period

  4. Handwashing with soap

    Time frame: 12 months

    Household members handwashing with soap at food and stool related events assessed by 5-hour structured observation over a 12-month period

  5. Household drinking water treatment

    Time frame: 12 months

    Households with stored drinking water samples without detectable E.coli (<1 colony forming units / 100 ml) assessed by unannounced household visits for sample collection of household stored drinking water over a 12-month period

  6. Height-for-age among children under 2 years of age

    Time frame: 12 months

    Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards

  7. Height-for-age among children under 5 years of age

    Time frame: 12 months

    Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards

  8. Weight-for-age among children under 2 years of age

    Time frame: 12 months

    Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards

  9. Weight-for-age among children under 5 years of age

    Time frame: 12 months

    Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards

  10. Weight-for-height among children under 2 years of age

    Time frame: 12 months

    Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards

  11. Weight-for-height among children under 5 years of age

    Time frame: 12 months

    Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study title

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

Acronym: CHoBI7

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Feb 10, 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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