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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00009255 | Other Identifier | JHSPH IRB |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHoBI7 mHealth program Arm | Experimental | The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) . |
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| Standard Recommendation Arm | Active Comparator | The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHoBI7 mHealth program Arm | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Reported 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. | 1 month, 3 months |
| Post Intervention Chlorine Concentration in Drinking Water | Free available chlorine in stored household drinking water >0.2 mg/L | 7 Days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Diarrheal Events | Participants will be asked if they have had diarrhea in the past week at the follow-up visits during the 3 month surveillance visit. Percentage of diarrheal events is reported. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Marie George, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka | Bangladesh |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHoBI7 mHealth Program Arm | The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) . CHoBI7 mHealth program Arm: The investigators 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. Participants will be provided a handwashing station, a covered water vessel, and chlorine tablets. Participants will then receive the CHoBI7 WASH mHealth program voice and text messages on handwashing with soap and water treatment bi-weekly. general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) |
| FG001 | Standard Recommendation Arm | The second arm participants will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CHoBI7 mHealth Program Arm | The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) . CHoBI7 mHealth program Arm: 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. general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Reported 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. | Participants that were available are reported | Posted | Count of Participants | Participants | 1 month, 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHoBI7 mHealth Program Arm | The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) . CHoBI7 mHealth program Arm: 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. general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Marie George | Johns Hopkins School of Public Health | (202) 657-5798 | cmgeorge@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2020 | Mar 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| general message on oral rehydration solution (ORS) | Behavioral | general message on oral rehydration solution (ORS) |
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| BG001 | Standard Recommendation Arm | The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Standard Recommendation Arm | The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) |
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| Primary | Post Intervention Chlorine Concentration in Drinking Water | Free available chlorine in stored household drinking water >0.2 mg/L | Posted | Number | Water samples with chlorine >0.2 mg/L | 7 Days after enrollment | Household water samples | Household water samples |
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| Secondary | Percentage of Diarrheal Events | Participants will be asked if they have had diarrhea in the past week at the follow-up visits during the 3 month surveillance visit. Percentage of diarrheal events is reported. | Individuals with clinical surveillance data available from follow-up visits during the 3 month-surveillance period | Posted | Mean | 95% Confidence Interval | percentage of diarrheal events | Up to 3 months |
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| 0 |
| 138 |
| 0 |
| 138 |
| 0 |
| 138 |
| EG001 | Standard Recommendation Arm | The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) | 0 | 146 | 0 | 146 | 0 | 146 |
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| D007239 | Infections |