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

Diarrhea Clinical Trial

— CHoBI7  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008134
• Other study ID #: IRB00006785
• Secondary ID: PR-15133
• Status: Completed
• Phase: N/A
• Start date: December 4, 2016
• Est. completion date: April 26, 2019

Study information

• Verified date: January 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2626
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholera
• Diarrhea
• Stunting

Intervention

Behavioral:
• CHoBI7 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.
• CHoBI7 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).
• CHoBI7 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (8)

George C, Perin J, Parvin T, Bhuyian S, Thomas E, Monira S, Zohura F, Hasan T, Sack D, Alam M. Effects of a Water, Sanitation and Hygiene Mobile Health Program on Respiratory Illness in Bangladesh: A Cluster-Randomized Controlled Trial of the CHoBI7 Mobil — View Citation

George CM, Bhuyian MSI, Thomas ED, Parvin T, Monira S, Zohura F, Hasan MT, Tahmina S, Munmun F, Sack DA, Perin J, Alam M. Psychosocial Factors Mediating the Effect of the CHoBI7 Mobile Health Program on Handwashing With Soap and Household Stored Water Qua — View Citation

George CM, Monira S, Zohura F, Thomas ED, Hasan MT, Parvin T, Hasan K, Rashid MU, Papri N, Islam A, Rahman Z, Rafique R, Islam Bhuyian MS, Saxton R, Labrique A, Alland K, Barman I, Jubyda FT, Afroze F, Sultana M, Johura FT, Khan MAH, Tahmina S, Munmun F, — View Citation

George CM, Zohura F, Teman A, Thomas E, Hasan T, Rana S, Parvin T, Sack DA, Bhuyian SI, Labrique A, Masud J, Winch P, Leontsini E, Zeller K, Begum F, Khan AH, Tahmina S, Munum F, Monira S, Alam M. Formative research for the design of a scalable water, san — View Citation

Islam Bhuyian MS, Saxton R, Hasan K, Masud J, Zohura F, Monira S, Kumar Biswas S, Tasdik Hasan M, Parvin T, Minhaj I, Md Zillur Rahman K, Papri N, Rashid MU, Sharin L, Teman A, Thomas ED, Alland K, Labrique A, Sack DA, Perin J, Alam M, George CM. Process — View Citation

Masud J, Islam Bhuyian MS, Kumar Biswas S, Zohura F, Perin J, Papri N, Dil Farzana F, Parvin T, Monira S, Alam M, George CM. Diarrhoeal disease knowledge among diarrhoea patient housholds: findings from the randomised controlled trial of the Cholera-Hospi — View Citation

Thomas ED, Zohura F, Hasan MT, Rana MS, Teman A, Parvin T, Masud J, Bhuyian MSI, Hossain MK, Hasan M, Tahmina S, Munmun F, Khan MAH, Monira S, Sack DA, Leontsini E, Winch PJ, Alam M, George CM. Formative research to scale up a handwashing with soap and wa — View Citation

Zohura F, Bhuyian MSI, Saxton RE, Parvin T, Monira S, Biswas SK, Masud J, Nuzhat S, Papri N, Hasan MT, Thomas ED, Sack D, Perin J, Alam M, George CM. Effect of a water, sanitation and hygiene program on handwashing with soap among household members of dia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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	12 months
Primary	Diarrhea prevalence among all household members	Diarrhea prevalence among all household members assessed by self report over a 12-month period	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months