Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change

Study Overview
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Brief Summary
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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
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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.

Official Title
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Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change (CHoBI7 Program)

Conditions
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Cholera

Intervention / Treatment
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* Behavioral: CHoBI7 mHealth program Arm
* Behavioral: general message on oral rehydration solution (ORS)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHoBI7 mHealth program Arm<br>The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) . | Behavioral: CHoBI7 mHealth program Arm<br>* 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.<br>Behavioral: general message on oral rehydration solution (ORS)<br>* general message on oral rehydration solution (ORS)<br>|
| Active Comparator: Standard Recommendation Arm<br>The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). | Behavioral: general message on oral rehydration solution (ORS)<br>* general message on oral rehydration solution (ORS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 Months | 
| Post Intervention Chlorine Concentration in Drinking Water | Free available chlorine in stored household drinking water | 7 Days Post Intervention Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Diarrhea | Participants will be asked if they have had diarrhea in the past two weeks. | Baseline to 12 Months |