Diarrhea InfectiousCHoBI7NCT06498817
Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
A study testing Standard Recommendation and CHoBI7 Scale-Up Program in people with Diarrhea Infectious and Cholera, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial summary
The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Infectious, Cholera
- What is being tested?
- Standard Recommendation and CHoBI7 Scale-Up Program
- 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
- 1,600 participants
- Where
- 1 siteBangladesh
- Study dates
- 19 Aug 2024to 31 Dec 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diarrhea patients presenting with three or more loose stools over a 24h period
- Having no running water inside of the patient's home
- Plan to reside in current residence for the next 3 months
- Have a child <5 years in the patient's household
- Have a working mobile phone in the household
Who cannot join
- No one will be excluded because of age, sex, religion, or sexual preference
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tahmina Parvin, MS contact
Bangladesh1 site, 1 recruiting
- Recruiting
Manikganjg Sadar (District) Hospital
Mānikganj, 1800
About this study
The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and had significant sustained impacts on handwashing with soap behaviors and improved water quality 12 months post intervention. Therefore, the investigators next step in the transition to scale is to: (1) To tailor the CHoBI7 program for delivery in rural health facilities and market test the CHoBI7 Program to determine the feasibility of providing a modified water, sanitation, and hygiene (WASH) package with only a soapy water bottle and chlorine tablets in both urban and rural settings through formative research and engagement of key stakeholders (Formative Research Phase); and (2) To evaluate the effectiveness of delivering the CHoBI7 program in district hospitals and sub-district health complexes in rural areas in terms of increases in WASH behaviors and decreases in diarrheal disease by conducting a randomized controlled trial (RCT) (Intervention Implementation and Evaluation Phase).
Read the detailed description
Diarrhea is the second leading cause of death in children under 5 years of age globally, causing an estimated 800,000 deaths annually. Previous studies have identified lack of caregiver hand washing with soap and treatment of household drinking water, poor water storage practices, and lack of caregiver knowledge of diarrhea prevention as important risk factors for diarrheal disease in pediatric populations. Water, sanitation, and hygiene (WASH) interventions promoting household chlorination of drinking water and hand washing with soap have the potential to reduce diarrheal disease incidence in children less than five years of age an estimated 30 to 40%. However, there has been limited success in encouraging households to sustain these behaviors over time. Furthermore, community-based WASH interventions are expensive and often difficult to implement in an urban context in low resource settings.
Previous studies have found that at the time of a severe illness such as cholera outbreaks, households have higher perceived severity and benefits of water treatment. In Madagascar an intervention which promoted the use of chlorine and 20 liter jerry cans reached peak sales during the high season for cholera. Consistent findings were observed in Zambia where sales of a water treatment product called Clorin significantly increased during a cholera epidemic. Furthermore in Dhaka, Bangladesh, the use of a community level point of use chlorine dispenser peaked after cholera deaths in a slum area of the city. Therefore admission at a health care facility for the treatment of severe diarrhea could potentially serve as an ideal opportunity to promote WASH interventions on improved water treatment and hygiene practices
The research team developed a Hospital Based WASH intervention which is entitled CHoBI7 (Cholera Hospital-Based Intervention for 7 days). Chobi means "picture" in Bangla for the pictorial WASH module delivered as part of the program. The CHoBI7 intervention was initially designed to reduce cholera infection among family members of hospitalized cholera cases during the one week high risk period after the case presents at the hospital. This Hospital Based WASH intervention is disseminated by health facility based promoters to hospitalized diarrhea patients and the family members and includes: (1) A pictorial module on diarrhea transmission and prevention, and (2) A diarrhea prevention package which contains chlorine tablets for water treatment, a soapy water bottle and a hand washing station, and a sealed water vessel to ensure safe water storage. The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention.
In an effort to build evidence to take the CHoBI7 intervention to scale in Bangladesh, the investigators partnered with the Bangladesh Ministry of Health and Family Welfare (MoHFW) to develop and evaluate scalable approaches for CHoBI7 intervention delivery. The CHoBI7 intervention was broaden during this time to include diarrhea patients of all etiology not just cholera. In addition, the investigators developed the CHoBI7 WASH mobile health (mHealth) program, to serve as a low cost scalable approach to reinforce the CHoBI7 WASH pictorial module delivered in the health facility without the need for home visits. After health facility delivery of the CHoBI7 pictorial module by a health worker, diarrhea patient households receive weekly voice and text messages from the CHoBI7 mHealth program over a 12 month period. The CHoBI7 WASH mHealth program significantly decreased diarrhea and stunting among young children, and lead to sustained handwashing with soap practices and improved stored drinking water quality during the 12 month surveillance period in an urban setting in Dhaka, Bangladesh during the investigators recent randomized controlled trial.
The investigators goal for this study is to develop a scalable version of the CHoBI7 program that can be delivered in district hospitals and sub-district health complexes in rural and urban Bangladesh. This scalable version of the CHoBI7 program will provide only a soapy water bottle and chlorine tablets, and encourage households to construct a handwashing station themselves using items in the homes
- Conditions
- Diarrhea Infectious, Cholera
- Being tested
- Standard Recommendation, CHoBI7 Scale-Up Program
- Keywords
- randomized controlled trial, Bangladesh, cholera, diarrheal diseases, water, sanitation, and hygiene, healthcare facilities, mobile health, child health
- Medical subject headings
- Dysentery, Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard RecommendationBehavioural
Standard recommendation given by government of Bangladesh on the use of oral rehydration solution (ORS) and a flyer on water treatment and handwashing with soap given at the health facility during the time of diarrhea patient treatment.
CHoBI7 Scale-Up ProgramBehavioural
Health promoter delivery of handwashing with soap, water treatment, and safe water storage module in the health facility to diarrhea patients and the patient's household members during the time of treatment. This module includes video testimonials from diarrhea patient households on how the patient benefits from adhering to the promoted behaviors, and a demonstration on how to construct homemade handwashing washing stations. This in-person module is reinforced by weekly voice, interactive voice response, and text messages for three months sent to the mobile phones of diarrhea patient household members from a doctor at diarrhea ward at local hospital.
| Study group | Role | What they receive |
|---|---|---|
| Standard Recommendation | Active comparator | Standard recommendation given by government of Bangladesh on the use of oral rehydration solution (ORS) and a flyer on water treatment and handwashing with soap given at the health facility during the time of diarrhea patient treatment. Receives: Behavioral: Standard Recommendation |
| CHoBI7 Scale-Up Program | Experimental | Health promoter delivery of handwashing with soap, water treatment, and safe water storage module in the health facility to diarrhea patients and the patient's household members during the time of treatment. This module includes video testimonials from diarrhea patient households on how the patient benefits from adhering to the promoted behaviors, and a demonstration on how to construct homemade handwashing washing stations. This in-person module is reinforced by weekly voice, interactive voice response, and text messages for three months sent to the mobile phones of diarrhea patient household members from a doctor at diarrhea ward at local hospital. Receives: Behavioral: Standard Recommendation; Behavioral: CHoBI7 Scale-Up Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 measured using a 5 hour structured observation tool in the household using form developed by the investigators.
Measured: 3 months
Number of constructed homemade handwashing stations
Household construction of homemade handwashing station
Measured: 3 months
Secondary outcomes (4)
Number of participants with diarrhea
Number of participants with self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Measured: 3 months
Amount of free chlorine concentration in stored drinking water
mg/Liter
Measured: 3 months
Number of stored drinking water samples with E. coli
Number of stored drinking water samples with E. coli
Measured: 3 months
Water, sanitation, and hygiene (WASH) psychosocial factors
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire. 5-point scale (0 = [almost] never/0-1 times out of 10-1 = [almost] always/9-10 times out of 10). with higher scores indicating higher handwashing frequency.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start19 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea InfectiousStudies 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
- 1,600 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), United States Agency for International Development (USAID), GiveWell
- Responsible party
- Sponsor
- Investigators
- Christine Marie George, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498817
- Sponsor's protocol ID
- IRB00015070
- Acronym
- CHoBI7
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
- ClinicalTrials.gov ID
- NCT06498817
- Acronym / sponsor ID
- CHoBI7 / IRB00015070
- Conditions
- Diarrhea Infectious, Cholera
- Keywords
- randomized controlled trial, Bangladesh, cholera, diarrheal diseases, water, sanitation, and hygiene, healthcare facilities, mobile health, child health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Research Training and Management International (RTMI), United States Agency for International Development (USAID), GiveWell
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jul 2024 (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.
The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and had significant sustained impacts on handwashing with soap behaviors and improved water quality 12 months post intervention. Therefore, the investigators next step in the transition to scale is to: (1) To tailor the CHoBI7 program for delivery in rural health facilities and market test the CHoBI7 Program to determine the feasibility of providing a modified water, sanitation, and hygiene (WASH) package with only a soapy water bottle and chlorine tablets in both urban and rural settings through formative research and engagement of key stakeholders (Formative Research Phase); and (2) To evaluate the effectiveness of delivering the CHoBI7 program in district hospitals and sub-district health complexes in rural areas in terms of increases in WASH behaviors and decreases in diarrheal disease by conducting a randomized controlled trial (RCT) (Intervention Implementation and Evaluation Phase).
Detailed description
Diarrhea is the second leading cause of death in children under 5 years of age globally, causing an estimated 800,000 deaths annually. Previous studies have identified lack of caregiver hand washing with soap and treatment of household drinking water, poor water storage practices, and lack of caregiver knowledge of diarrhea prevention as important risk factors for diarrheal disease in pediatric populations. Water, sanitation, and hygiene (WASH) interventions promoting household chlorination of drinking water and hand washing with soap have the potential to reduce diarrheal disease incidence in children less than five years of age an estimated 30 to 40%. However, there has been limited success in encouraging households to sustain these behaviors over time. Furthermore, community-based WASH interventions are expensive and often difficult to implement in an urban context in low resource settings.
Previous studies have found that at the time of a severe illness such as cholera outbreaks, households have higher perceived severity and benefits of water treatment. In Madagascar an intervention which promoted the use of chlorine and 20 liter jerry cans reached peak sales during the high season for cholera. Consistent findings were observed in Zambia where sales of a water treatment product called Clorin significantly increased during a cholera epidemic. Furthermore in Dhaka, Bangladesh, the use of a community level point of use chlorine dispenser peaked after cholera deaths in a slum area of the city. Therefore admission at a health care facility for the treatment of severe diarrhea could potentially serve as an ideal opportunity to promote WASH interventions on improved water treatment and hygiene practices
The research team developed a Hospital Based WASH intervention which is entitled CHoBI7 (Cholera Hospital-Based Intervention for 7 days). Chobi means "picture" in Bangla for the pictorial WASH module delivered as part of the program. The CHoBI7 intervention was initially designed to reduce cholera infection among family members of hospitalized cholera cases during the one week high risk period after the case presents at the hospital. This Hospital Based WASH intervention is disseminated by health facility based promoters to hospitalized diarrhea patients and the family members and includes: (1) A pictorial module on diarrhea transmission and prevention, and (2) A diarrhea prevention package which contains chlorine tablets for water treatment, a soapy water bottle and a hand washing station, and a sealed water vessel to ensure safe water storage. The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention.
In an effort to build evidence to take the CHoBI7 intervention to scale in Bangladesh, the investigators partnered with the Bangladesh Ministry of Health and Family Welfare (MoHFW) to develop and evaluate scalable approaches for CHoBI7 intervention delivery. The CHoBI7 intervention was broaden during this time to include diarrhea patients of all etiology not just cholera. In addition, the investigators developed the CHoBI7 WASH mobile health (mHealth) program, to serve as a low cost scalable approach to reinforce the CHoBI7 WASH pictorial module delivered in the health facility without the need for home visits. After health facility delivery of the CHoBI7 pictorial module by a health worker, diarrhea patient households receive weekly voice and text messages from the CHoBI7 mHealth program over a 12 month period. The CHoBI7 WASH mHealth program significantly decreased diarrhea and stunting among young children, and lead to sustained handwashing with soap practices and improved stored drinking water quality during the 12 month surveillance period in an urban setting in Dhaka, Bangladesh during the investigators recent randomized controlled trial.
The investigators goal for this study is to develop a scalable version of the CHoBI7 program that can be delivered in district hospitals and sub-district health complexes in rural and urban Bangladesh. This scalable version of the CHoBI7 program will provide only a soapy water bottle and chlorine tablets, and encourage households to construct a handwashing station themselves using items in the homes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Recommendation | Active comparator | Behavioral: Standard RecommendationStandard recommendation given by government of Bangladesh on the use of oral rehydration solution (ORS) and a flyer on water treatment and handwashing with soap given at the health facility during the time of diarrhea patient treatment. |
| CHoBI7 Scale-Up Program | Experimental | Behavioral: Standard Recommendation, Behavioral: CHoBI7 Scale-Up ProgramHealth promoter delivery of handwashing with soap, water treatment, and safe water storage module in the health facility to diarrhea patients and the patient's household members during the time of treatment. This module includes video testimonials from diarrhea patient households on how the patient benefits from adhering to the promoted behaviors, and a demonstration on how to construct homemade handwashing washing stations. This in-person module is reinforced by weekly voice, interactive voice response, and text messages for three months sent to the mobile phones of diarrhea patient household members from a doctor at diarrhea ward at local hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diarrhea patients presenting with three or more loose stools over a 24h period
- Having no running water inside of the patient's home
- Plan to reside in current residence for the next 3 months
- Have a child <5 years in the patient's household
- Have a working mobile phone in the household
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 |
|---|---|---|
| Standard RecommendationStandard recommendation given by government of Bangladesh on the use of oral rehydration solution (ORS) and a flyer on water treatment and handwashing with soap given at the health facility during the time of diarrhea patient treatment. | Behavioural | CHoBI7 Scale-Up Program, Standard Recommendation |
| CHoBI7 Scale-Up ProgramHealth promoter delivery of handwashing with soap, water treatment, and safe water storage module in the health facility to diarrhea patients and the patient's household members during the time of treatment. This module includes video testimonials from diarrhea patient households on how the patient benefits from adhering to the promoted behaviors, and a demonstration on how to construct homemade handwashing washing stations. This in-person module is reinforced by weekly voice, interactive voice response, and text messages for three months sent to the mobile phones of diarrhea patient household members from a doctor at diarrhea ward at local hospital. | Behavioural | CHoBI7 Scale-Up Program |
Primary outcome
Rate of Handwashing with soap at stool and food related events
Time frame: 3 months
Rate of patient household members handwashing with soap at stool and food related events measured measured using a 5 hour structured observation tool in the household using form developed by the investigators.
Number of constructed homemade handwashing stations
Time frame: 3 months
Household construction of homemade handwashing station
4 secondary outcomes
Number of participants with diarrhea
Time frame: 3 months
Amount of free chlorine concentration in stored drinking water
Time frame: 3 months
Number of stored drinking water samples with E. coli
Time frame: 3 months
Water, sanitation, and hygiene (WASH) psychosocial factors
Time frame: 3 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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Tahmina Parvin, MS contact
Christine Marie George, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Recommendation and CHoBI7 Scale-Up Program in people with Diarrhea Infectious and Cholera, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 5 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of Handwashing with soap at stool and food related events (time frame: 3 months). The study lists 2 primary outcomes in all. 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 15 Apr 2026.