Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)

NCT06498817 | Recruiting

• 1 other identifier: IRB00015070
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Diarrhea Infectious; Cholera

Keywords

randomized controlled trial; Bangladesh; cholera; diarrheal diseases; water, sanitation, and hygiene; healthcare facilities; mobile health; child health

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• Number of constructed homemade handwashing stations

  Household construction of homemade handwashing station

  3 months

Secondary Outcomes (4)

• Number of participants with diarrhea

  3 months

• Amount of free chlorine concentration in stored drinking water

  3 months

• Number of stored drinking water samples with E. coli

  3 months

• Water, sanitation, and hygiene (WASH) psychosocial factors

  3 months

Study Arms (2)

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.

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.

Behavioral: Standard Recommendation; Behavioral: CHoBI7 Scale-Up Program

Interventions

Standard Recommendation BEHAVIORAL

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 Program; Standard Recommendation

CHoBI7 Scale-Up Program BEHAVIORAL

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.

CHoBI7 Scale-Up Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No one will be excluded because of age, sex, religion, or sexual preference

Sponsors & Collaborators

• Research Training and Management International (RTMI): collaborator
• United States Agency for International Development (USAID): collaborator
• GiveWell: collaborator
• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Manikganjg Sadar (District) Hospital

Mānikganj, 1800, Bangladesh

RECRUITING

MeSH Terms

Conditions

Dysentery; Cholera

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Christine Marie George, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Marie George, PhD

CONTACT

(202) 657-5798; cmgeorge@jhu.edu

Tahmina Parvin, MS

CONTACT

tahminaph14@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 12, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)