An interventional study of Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI and Standard message in Cholera and Diarrhea, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 2 sites in Bangladesh. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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.
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.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's planned enrollment of 3,140 is above the median of 262 across 72 interventional studies indexed under Cholera.
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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.
Behavioral: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution
Behavioral: Standard message
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 given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
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
Time frame: 1 month
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)
Time frame: 12 months
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)
Time frame: 12 Months
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
Time frame: 12 Months
Free chlorine concentration (mg/L) in stored drinking water
Free chlorine concentration (mg/L) in stored drinking water
Time frame: 12 months
Presence of Vibrio cholerae and E. coli in stored drinking water
E.coli and Vibrio cholerae measured by bacterial culture
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
Plan to share: No — All data will be de-identified and available to our collaborators
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Started Oct 2023 (actual). Primary completion is estimated for Nov 2027, 49 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Nov 2026 → Nov 2027 and completion Nov 2026 → Nov 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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