An interventional study of CHoBI7 health facility program and CHoBI7 mHealth program in Cholera, Diarrhea and Stunting, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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.
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.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 2,626 is above the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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:
Household members of the diarrhea patient will be eligible for the trial if:
Exclusion Criteria:
(1) Children in foster care will be excluded from all research study activities.
Participants received the standard recommendation on oral rehydration solution use
Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months
Behavioral: CHoBI7 health facility program · Behavioral: CHoBI7 mHealth program
Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months
Behavioral: CHoBI7 health facility program · Behavioral: CHoBI7 mHealth program · Behavioral: CHoBI7 home visit 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.
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).
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.
Diarrhea prevalence among children under 2 years of age
Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period
Time frame: 12 months
Diarrhea prevalence among children under 5 years of age
Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period
Time frame: 12 months
Diarrhea prevalence among all household members
Diarrhea prevalence among all household members assessed by self report over a 12-month period
Time frame: 12 months
Diarrhea prevalence among participants ages 5-9 years
Diarrhea prevalence among all household members ages 5-9 years assessed by self report over a 12-month period
Time frame: 12 months
Diarrhea prevalence among participants ages 10-18 years
Diarrhea prevalence among all household members ages 10-18 years assessed by self report over a 12-month period
Time frame: 12 months
Diarrhea prevalence among participants ages greater than 18 years
Diarrhea prevalence among all household members ages greater than 18 years assessed by self report over a 12-month period
Time frame: 12 months
Handwashing with soap
Household members handwashing with soap at food and stool related events assessed by 5-hour structured observation over a 12-month period
Time frame: 12 months
Household drinking water treatment
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
Time frame: 12 months
Height-for-age among children under 2 years of age
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
Time frame: 12 months
Height-for-age among children under 5 years of age
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
Time frame: 12 months
Weight-for-age among children under 2 years of age
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
Time frame: 12 months
Weight-for-age among children under 5 years of age
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
Time frame: 12 months
Weight-for-height among children under 2 years of age
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
Time frame: 12 months
Weight-for-height among children under 5 years of age
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
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
Ran from Dec 2016 to primary completion in Apr 2019, 28 months.
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