Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change (CHoBI7)
Primary Purpose
Cholera
Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
CHoBI7 mHealth program Arm
general message on oral rehydration solution (ORS)
Sponsored by
About this trial
This is an interventional prevention trial for Cholera
Eligibility Criteria
Inclusion Criteria:
- At least one household member must report ownership of an active mobile phone in their possession on the day of enrollment
Exclusion Criteria:
- Household has a tap or basin with running water inside their home.
Sites / Locations
- International Centre for Diarrhoeal Disease Research, Bangladesh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHoBI7 mHealth program Arm
Standard Recommendation Arm
Arm Description
The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) .
The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).
Outcomes
Primary Outcome Measures
Handwashing with soap at stool and food related events
Handwashing with soap measured by 5-hour structured at the following food and stool related events in the household: (1) after using the toilet; (2) after cleaning a child's anus; (3) before eating; (4) before feeding a child; and (5) before preparing food.
Post Intervention Chlorine Concentration in Drinking Water
Free available chlorine in stored household drinking water
Secondary Outcome Measures
Incidence of Diarrhea
Participants will be asked if they have had diarrhea in the past two weeks.
Full Information
NCT ID
NCT04816552
First Posted
March 24, 2021
Last Updated
August 12, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT04816552
Brief Title
Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change
Acronym
CHoBI7
Official Title
Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change (CHoBI7 Program)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
November 28, 2021 (Actual)
Study Completion Date
November 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Develop a scalable approach for delivering water, sanitation, and hygiene (WASH) messages to households in areas with confirmed cholera patients in Dhaka, Bangladesh. This will be done by conducting formative research through in-depth interviews, focus group discussions, and intervention planning workshops with households in areas with confirmed cholera patients and government officials to identify perceptions of WASH behaviors and to inform the development of a mobile health intervention (mHealth) for this population. This intervention approach will then be piloted in a subset of households, and revised according to feedback. Then the investigators will conduct a randomized controlled of the refined mHealth intervention.
Detailed Description
Aim 1. Develop an evidence and theory based WASH mHealth intervention for households in areas with confirmed cholera patients in Dhaka, Bangladesh through formative research
Conduct formative research through in-depth interviews, focus group discussions, and intervention planning workshops with caregivers and household members of young children, and government officials to identify perceptions of WASH behaviors and to inform the development of intervention materials.
Pilot the WASH mHealth intervention in a subset of households, and revise according to feedback.
Aim 2: Evaluate the effectiveness of the developed WASH mHealth intervention in increasing WASH behaviors and reducing fecal contamination on hands and in stored drinking water by conducting a RCT
Recruit and prospectively follow for 12 months 120 households (600 participants, 4 per household) with a child under five years of age assigned to one of two study arms (60 households per arm). The first arm will receive the CHoBI7 mHealth program (CHoBI7 mHealth program Arm) and the second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).
Compare the 2 study arms using structured observation of handwashing with soap at stool and food related events, unannounced spot checks of the presence of soap in the cooking and latrine areas of the household, and fecal coliform counts on caregiver hands and in stored drinking water.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHoBI7 mHealth program Arm
Arm Type
Experimental
Arm Description
The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) .
Arm Title
Standard Recommendation Arm
Arm Type
Active Comparator
Arm Description
The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).
Intervention Type
Behavioral
Intervention Name(s)
CHoBI7 mHealth program Arm
Intervention Description
We will start delivery of this intervention with a pictorial module delivered in the home during two 30 minute visits on cholera transmission and prevention after enrollment. Households will be provided a handwashing station, a covered water vessel, and chlorine tablets. Households will then receive the CHoBI7 WASH mHealth program voice and text messages on handwashing with soap and water treatment bi-weekly.
Intervention Type
Behavioral
Intervention Name(s)
general message on oral rehydration solution (ORS)
Intervention Description
general message on oral rehydration solution (ORS)
Primary Outcome Measure Information:
Title
Handwashing with soap at stool and food related events
Description
Handwashing with soap measured by 5-hour structured at the following food and stool related events in the household: (1) after using the toilet; (2) after cleaning a child's anus; (3) before eating; (4) before feeding a child; and (5) before preparing food.
Time Frame
Baseline to 12 Months
Title
Post Intervention Chlorine Concentration in Drinking Water
Description
Free available chlorine in stored household drinking water
Time Frame
7 Days Post Intervention Delivery
Secondary Outcome Measure Information:
Title
Incidence of Diarrhea
Description
Participants will be asked if they have had diarrhea in the past two weeks.
Time Frame
Baseline to 12 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one household member must report ownership of an active mobile phone in their possession on the day of enrollment
Exclusion Criteria:
Household has a tap or basin with running water inside their home.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Marie George, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change
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