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Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7)

Primary Purpose

Cholera, Diarrhea, Stunting

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHoBI7 health facility program
CHoBI7 mHealth program
CHoBI7 home visit program
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholera focused on measuring handwashing with soap, water treatment, behavior change, water, sanitation and hygiene

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Standard recommendation (ORS)

    mHealth with no home visits

    mHealth with home visits

    Arm Description

    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

    Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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

    Full Information

    First Posted
    July 2, 2019
    Last Updated
    January 27, 2022
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    International Centre for Diarrhoeal Disease Research, Bangladesh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04008134
    Brief Title
    Cholera-Hospital-Based-Intervention-for-7-days
    Acronym
    CHoBI7
    Official Title
    CHoBI7 Trial: A Hospital Based Water, Sanitation and Hygiene Intervention for Households of Diarrheal Patients in Bangladesh
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 4, 2016 (Actual)
    Primary Completion Date
    April 26, 2019 (Actual)
    Study Completion Date
    April 26, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    International Centre for Diarrhoeal Disease Research, Bangladesh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholera, Diarrhea, Stunting
    Keywords
    handwashing with soap, water treatment, behavior change, water, sanitation and hygiene

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    Masking was not possible because the intervention included visible components including a handwashing station and a covered drinking water storage vessel.
    Allocation
    Randomized
    Enrollment
    2626 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard recommendation (ORS)
    Arm Type
    No Intervention
    Arm Description
    Participants received the standard recommendation on oral rehydration solution use
    Arm Title
    mHealth with no home visits
    Arm Type
    Experimental
    Arm Description
    Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months
    Arm Title
    mHealth with home visits
    Arm Type
    Experimental
    Arm Description
    Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months
    Intervention Type
    Behavioral
    Intervention Name(s)
    CHoBI7 health facility program
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CHoBI7 mHealth program
    Intervention Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    CHoBI7 home visit program
    Intervention Description
    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 Outcome Measure Information:
    Title
    Diarrhea prevalence among children under 2 years of age
    Description
    Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period
    Time Frame
    12 months
    Title
    Diarrhea prevalence among children under 5 years of age
    Description
    Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period
    Time Frame
    12 months
    Title
    Diarrhea prevalence among all household members
    Description
    Diarrhea prevalence among all household members assessed by self report over a 12-month period
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Diarrhea prevalence among participants ages 5-9 years
    Description
    Diarrhea prevalence among all household members ages 5-9 years assessed by self report over a 12-month period
    Time Frame
    12 months
    Title
    Diarrhea prevalence among participants ages 10-18 years
    Description
    Diarrhea prevalence among all household members ages 10-18 years assessed by self report over a 12-month period
    Time Frame
    12 months
    Title
    Diarrhea prevalence among participants ages greater than 18 years
    Description
    Diarrhea prevalence among all household members ages greater than 18 years assessed by self report over a 12-month period
    Time Frame
    12 months
    Title
    Handwashing with soap
    Description
    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
    Title
    Household drinking water treatment
    Description
    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
    Title
    Height-for-age among children under 2 years of age
    Description
    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
    Title
    Height-for-age among children under 5 years of age
    Description
    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
    Title
    Weight-for-age among children under 2 years of age
    Description
    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
    Title
    Weight-for-age among children under 5 years of age
    Description
    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
    Title
    Weight-for-height among children under 2 years of age
    Description
    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
    Title
    Weight-for-height among children under 5 years of age
    Description
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christine Marie George, PhD
    Organizational Affiliation
    Johns Hopkins Bloomberg School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32761174
    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, Sack DA, Perin J, Alam M. Effects of a Water, Sanitation, and Hygiene Mobile Health Program on Diarrhea and Child Growth in Bangladesh: A Cluster-randomized Controlled Trial of the Cholera Hospital-based Intervention for 7 Days (CHoBI7) Mobile Health Program. Clin Infect Dis. 2021 Nov 2;73(9):e2560-e2568. doi: 10.1093/cid/ciaa754.
    Results Reference
    result
    PubMed Identifier
    33949243
    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 Quality: A Randomized Controlled Trial. Health Educ Behav. 2022 Apr;49(2):326-339. doi: 10.1177/1090198120987134. Epub 2021 May 5.
    Results Reference
    result
    PubMed Identifier
    31366398
    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, sanitation, and hygiene mobile health program: CHoBI7 mobile health program. BMC Public Health. 2019 Jul 31;19(1):1028. doi: 10.1186/s12889-019-7144-z. Erratum In: BMC Public Health. 2019 Aug 19;19(1):1134.
    Results Reference
    result
    PubMed Identifier
    32487209
    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 water treatment intervention for household members of diarrhea patients in health facilities in Dhaka, Bangladesh (CHoBI7 program). BMC Public Health. 2020 Jun 1;20(1):831. doi: 10.1186/s12889-020-08727-0.
    Results Reference
    result
    PubMed Identifier
    32406989
    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-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health program. Trop Med Int Health. 2020 Aug;25(8):996-1007. doi: 10.1111/tmi.13415. Epub 2020 Jul 21.
    Results Reference
    result
    PubMed Identifier
    32406965
    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 evaluation for the delivery of a water, sanitation and hygiene mobile health program: findings from the randomised controlled trial of the CHoBI7 mobile health program. Trop Med Int Health. 2020 Aug;25(8):985-995. doi: 10.1111/tmi.13414. Epub 2020 Jul 18.
    Results Reference
    result
    PubMed Identifier
    32406581
    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 diarrhoea patients in healthcare facilities in Bangladesh: a cluster-randomised controlled trial of the CHoBI7 mobile health program. Trop Med Int Health. 2020 Aug;25(8):1008-1015. doi: 10.1111/tmi.13416. Epub 2020 Jul 14.
    Results Reference
    result
    PubMed Identifier
    35008045
    Citation
    George CM, Perin J, Parvin T, Bhuyian S, Thomas ED, 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 Mobile Health Program. Am J Trop Med Hyg. 2022 Jan 10;106(3):979-984. doi: 10.4269/ajtmh.21-0679.
    Results Reference
    result

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