CholeraNCT06003816
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
A study testing Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI and Standard message in people with Cholera and Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI and Standard message
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,140 participants
- Where
- 2 sitesBangladesh
- Study dates
- 18 Oct 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Index cholera patient have no running water inside of their home
Who cannot join
- No one will be excluded because of age, sex, religion, or sexual preference
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh2 sites, 2 recruiting
- Recruiting
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
ASG Faruque, MBBS MPH
ASG Faruque, gfaruque@icddrb.org
- Recruiting
Research Training and Management International
Dhaka
Tahmina Parvin, tahminaph14@yahoo.com
Tahmina Parvin
About this study
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.
Read the 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.
- Being tested
- Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI, Standard message
- Keywords
- randomized controlled trial, water, sanitation, hygiene, case area targeted intervention, Bangladesh
- Medical subject headings
- Cholera, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATIBehavioural
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 messageBehavioural
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
| Study group | Role | What they receive |
|---|---|---|
| Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI | Experimental | 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. Receives: Behavioral: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI |
| Standard Message Arm | Active comparator | Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution Receives: Behavioral: Standard message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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
Measured: 12 Months
Free chlorine concentration (mg/L) in stored drinking water
Free chlorine concentration (mg/L) in stored drinking water
Measured: 12 months
Presence of Vibrio cholerae and E. coli in stored drinking water
E.coli and Vibrio cholerae measured by bacterial culture
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start18 Oct 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholeraStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Research Training and Management International (RTMI), International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Christine Marie George, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003816
- Sponsor's protocol ID
- IRB00009931
- Other IDs
- 1R01AI148332-01
- Status last verified
- Dec 2025
- First submitted
- 16 Aug 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified and available to our collaborators
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
- ClinicalTrials.gov ID
- NCT06003816
- Acronym / sponsor ID
- IRB00009931
- Keywords
- randomized controlled trial, water, sanitation, hygiene, case area targeted intervention, Bangladesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,140 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Research Training and Management International (RTMI), International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI | Experimental | Behavioral: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATIThe 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 Arm | Active comparator | Behavioral: Standard messageStandard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Index cholera patient have no running water inside of their home
Key exclusion criteria (1 listed)
- No one will be excluded because of age, sex, religion, or sexual preference
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATIThe 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. | Behavioural | Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI |
| Standard messageStandard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution | Behavioural | Standard Message Arm |
Primary outcome
Number of non-baseline cholera infections among individuals residing in a ring around cholera patients
Time frame: 1 month
cholera infection assessed by bacterial culture and/or vibriocidal antibody titer
12 secondary outcomes
Diarrhea among individuals residing in a ring around cholera patients
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)
Time frame: 12 Months
Rate of Handwashing with soap at stool and food related events
Time frame: 12 Months
Free chlorine concentration (mg/L) in stored drinking water
Time frame: 12 months
Presence of Vibrio cholerae and E. coli in stored drinking water
Time frame: 12 months
Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire
Time frame: 12 months
Height-for-age measurements among children under 2 years of age
Time frame: 12 months
Height-for-age measurements among children under 5 years of age
Time frame: 12 months
Weight-for-age measurements among children under 2 years of age
Time frame: 12 months
Weight-for-age measurements among children under 5 years of age
Time frame: 12 months
Weight-for-height measurements among children under 2 years of age
Time frame: 12 months
Weight-for-height measurements among children under 5 years of age
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. All data will be de-identified and available to our collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Marie George, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI and Standard message in people with Cholera and Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Marie George, PhD ((202) 657-5798, cmgeorge@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of non-baseline cholera infections among individuals residing in a ring around cholera patients (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.