Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
NCT ID: NCT06003816
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3140 participants
INTERVENTIONAL
2023-10-18
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
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.
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
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.
Standard Message Arm
Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution
Standard message
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Interventions
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Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
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.
Standard message
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Research Training and Management International (RTMI)
UNKNOWN
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Christine Marie George, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, , Bangladesh
Research Training and Management International
Dhaka, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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ASG Faruque, MBBS MPH
Role: primary
Other Identifiers
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IRB00009931
Identifier Type: -
Identifier Source: org_study_id
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