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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04008134
Acronym
CHoBI7
Enrollment
2626
Registered
2019-07-05
Start date
2016-12-04
Completion date
2019-04-26
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholera, Diarrhea, Stunting

Keywords

handwashing with soap, water treatment, behavior change, water, sanitation and hygiene

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.

Interventions

BEHAVIORALCHoBI7 health facility program

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.

BEHAVIORALCHoBI7 mHealth program

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).

BEHAVIORALCHoBI7 home visit program

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.

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

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

Sex/Gender
ALL
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: 1. have had 3 or more loose stools over the past 24 hours 2. plan to reside in Dhaka for the next 12 months 3. have no basin for running water in their home 4. have a child under five years of age in their household (including themselves) that produced a stool sample at baseline 5. have a working mobile phone in the household. Household members of the diarrhea patient will be eligible for the trial if: 1. they have shared the same cooking pot and resided in the same home with the diarrhea patient for the last three days 2. 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.

Design outcomes

Primary

MeasureTime frameDescription
Diarrhea prevalence among children under 2 years of age12 monthsDiarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period
Diarrhea prevalence among children under 5 years of age12 monthsDiarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period
Diarrhea prevalence among all household members12 monthsDiarrhea prevalence among all household members assessed by self report over a 12-month period

Secondary

MeasureTime frameDescription
Handwashing with soap12 monthsHousehold members handwashing with soap at food and stool related events assessed by 5-hour structured observation over a 12-month period
Household drinking water treatment12 monthsHouseholds 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
Height-for-age among children under 2 years of age12 monthsHeight, 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
Height-for-age among children under 5 years of age12 monthsHeight, 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
Diarrhea prevalence among participants ages 5-9 years12 monthsDiarrhea prevalence among all household members ages 5-9 years assessed by self report over a 12-month period
Weight-for-age among children under 5 years of age12 monthsHeight, 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
Weight-for-height among children under 2 years of age12 monthsHeight, 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
Weight-for-height among children under 5 years of age12 monthsHeight, 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
Weight-for-age among children under 2 years of age12 monthsHeight, 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
Diarrhea prevalence among participants ages 10-18 years12 monthsDiarrhea prevalence among all household members ages 10-18 years assessed by self report over a 12-month period
Diarrhea prevalence among participants ages greater than 18 years12 monthsDiarrhea prevalence among all household members ages greater than 18 years assessed by self report over a 12-month period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026