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Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)

Primary Purpose

Cholera, Diarrhea

Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
Standard message
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 randomized controlled trial, water, sanitation, hygiene, case area targeted intervention, Bangladesh

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Index cholera patient have no running water inside of their home Exclusion Criteria: No one will be excluded because of age, sex, religion, or sexual preference

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, BangladeshRecruiting
  • Research Training and Management InternationalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI

Standard Message Arm

Arm Description

The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors.

Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution

Outcomes

Primary Outcome Measures

Number of non-baseline cholera infections among individuals residing in a ring around cholera patients
cholera infection assessed by bacterial culture and/or vibriocidal antibody titer

Secondary Outcome Measures

Diarrhea among individuals residing in a ring around cholera patients
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Rate of Handwashing with soap at stool and food related events
Rate of patient household members handwashing with soap at stool and food related events
Free chlorine concentration (mg/L) in stored drinking water
Free chlorine concentration (mg/L) in stored drinking water
Presence of Vibrio cholerae and E. coli in stored drinking water
E.coli and Vibrio cholerae measured by bacterial culture
Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire which involves both multiple choice questions and spot checks
Height-for-age measurements among children under 2 years of age
Height 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 measurements among children under 5 years of age
Height 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 measurements among children under 2 years of age
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 measurements among children under 5 years of age
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 measurements 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 measurements 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
August 16, 2023
Last Updated
October 20, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Research Training and Management International (RTMI), International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT06003816
Brief Title
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
Official Title
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Research Training and Management International (RTMI), International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.
Detailed Description
Background: Worldwide there are estimated to be 2.9 million cholera cases annually. Effective targeted water, sanitation, and hygiene (WASH) interventions are urgently needed to reduce cholera globally. The investigators study in Bangladesh found that individuals living within 50 meters of a cholera patient were at 30 times higher risk of developing cholera than the general population during the first week after the index patient sought care at a health facility. However, there has been little work done to develop and evaluate interventions for this high risk population. Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted WASH intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases. Previous studies: The investigators research group developed the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), a WASH intervention delivered to cholera patients and the participants household members in a health facility. the investigators randomized controlled trial (RCT) in Bangladesh of CHoBI7 demonstrated this intervention was effective in significantly reducing cholera, and led to sustained increases in handwashing with soap and improved drinking water quality 12 months post-intervention in cholera patient households. This intervention, however, solely focused on cholera patients households. There are no studies to date that have evaluated the impact on reducing cholera of delivering a ring WASH intervention to households living near cholera patients. Design and Setting: The Director of Disease Control at the Bangladesh Ministry of Health and Family Welfare would like to take CHoBI7 to scale across Bangladesh, and has requested the investigators build evidence on scalable approaches for delivering CHoBI7 as a CATI in a ring around cholera patient households. This study will have 3 phases. During the formative research and planning phase the investigators will develop a scalable, theory and evidence based ring WASH intervention through in-depth interviews, focus group discussions, workshops, and a pilot. During the intervention implementation and evaluation phase the investigators will conduct a RCT to prospectively follow 3120 participants from 1040 households living in 40 rings around cholera cases to evaluate the effectiveness of the intervention in: (1) reducing cholera infections during the first week after the index patient in the ring seeks care at a health facility; and (2) increasing handwashing with soap and stored water quality over a 12 month period. The first arm will receive the standard recommendation given in Bangladesh during diarrhea outbreaks on oral rehydration solution use and a leaflet on WASH practices during a single visit. The second arm will receive this message and the ring WASH intervention which includes group sessions and home visits and mobile health messages. Whole genome sequencing will be performed on water and clinical Vibrio cholerae strains collected to investigate spatiotemporal transmission dynamics of V. cholerae in hotspots. During the dissemination and policy planning phase, the investigators will partner with the Director of Disease Control to disseminate study findings and inform cholera control policies. Significance: This will be the first RCT of a CATI WASH program to evaluate whether this intervention approach can reduce cholera.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera, Diarrhea
Keywords
randomized controlled trial, water, sanitation, hygiene, case area targeted intervention, Bangladesh

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
Arm Type
Experimental
Arm Description
The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors.
Arm Title
Standard Message Arm
Arm Type
Active Comparator
Arm Description
Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution
Intervention Type
Behavioral
Intervention Name(s)
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
Intervention Description
The CHoBI7 program is during group sessions by a health promoter to those residing in a ring around a cholera patient reinforced through weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended water, sanitation, and hygiene behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Standard message
Intervention Description
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Primary Outcome Measure Information:
Title
Number of non-baseline cholera infections among individuals residing in a ring around cholera patients
Description
cholera infection assessed by bacterial culture and/or vibriocidal antibody titer
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Diarrhea among individuals residing in a ring around cholera patients
Description
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Time Frame
12 months
Title
Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Description
Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Time Frame
12 Months
Title
Rate of Handwashing with soap at stool and food related events
Description
Rate of patient household members handwashing with soap at stool and food related events
Time Frame
12 Months
Title
Free chlorine concentration (mg/L) in stored drinking water
Description
Free chlorine concentration (mg/L) in stored drinking water
Time Frame
12 months
Title
Presence of Vibrio cholerae and E. coli in stored drinking water
Description
E.coli and Vibrio cholerae measured by bacterial culture
Time Frame
12 months
Title
Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire
Description
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire which involves both multiple choice questions and spot checks
Time Frame
12 months
Title
Height-for-age measurements among children under 2 years of age
Description
Height 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 measurements among children under 5 years of age
Description
Height 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 measurements among children under 2 years of age
Description
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 measurements among children under 5 years of age
Description
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 measurements 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 measurements 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
No
Eligibility Criteria
Inclusion Criteria: Index cholera patient have no running water inside of their home Exclusion Criteria: No one will be excluded because of age, sex, religion, or sexual preference
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Marie George, PhD
Phone
(202) 657-5798
Email
cmgeorge@jhu.edu
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
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ASG Faruque, MBBS MPH
First Name & Middle Initial & Last Name & Degree
ASG Faruque
Email
gfaruque@icddrb.org
Facility Name
Research Training and Management International
City
Dhaka
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tahmina Parvin
Email
tahminaph14@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tahmina Parvin

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data will be de-identified and available to our collaborators

Learn more about this trial

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)

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