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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Christine Marie George, PhD contact

(202) 657-5798

cmgeorge@jhu.edu

Tahmina Parvin, MS contact

tahminaph14@yahoo.com

Bangladesh1 site, 1 recruiting
  • Manikganjg Sadar (District) Hospital

    Mānikganj, 1800

    Recruiting

Other trials in Bangladesh

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

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 groups in NCT06498817
Study groupRoleWhat they receive
Standard RecommendationActive comparatorStandard 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 ProgramExperimentalHealth 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.

  1. 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

  2. Number of constructed homemade handwashing stations

    Household construction of homemade handwashing station

    Measured: 3 months

Secondary outcomes (4)
  1. 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

  2. Amount of free chlorine concentration in stored drinking water

    mg/Liter

    Measured: 3 months

  3. Number of stored drinking water samples with E. coli

    Number of stored drinking water samples with E. coli

    Measured: 3 months

  4. 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.

  1. First posted12 Jul 2024
  2. Study start19 Aug 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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