An interventional study of CHoBI7 mHealth program Arm and general message on oral rehydration solution (ORS) in Cholera, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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
Exclusion Criteria:
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 · Behavioral: general message on oral rehydration solution (ORS)
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)
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)
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.
Time frame: 1 month, 3 months
Post Intervention Chlorine Concentration in Drinking Water
Free available chlorine in stored household drinking water \>0.2 mg/L
Time frame: 7 Days after enrollment
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.
Time frame: Up to 3 months
| Milestone | CHoBI7 mHealth Program Arm | Standard Recommendation Arm |
|---|---|---|
| Started | 138 | 146 |
| Completed | 138 | 146 |
| Not completed | 0 | 0 |
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 | CHoBI7 mHealth Program Arm | Standard Recommendation Arm |
|---|---|---|
| 1 month | 37 | 4 |
| 3 months | 27 | 10 |
Free available chlorine in stored household drinking water \>0.2 mg/L
| Water samples with chlorine >0.2 mg/L | CHoBI7 mHealth Program Arm | Standard Recommendation Arm |
|---|---|---|
| Post Intervention Chlorine Concentration in Drinking Water | 23 | 0 |
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.
| percentage of diarrheal events | CHoBI7 mHealth Program Arm | Standard Recommendation Arm |
|---|---|---|
| Percentage of Diarrheal Events | 11 (6 to 17) | 4 (1 to 7) |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHoBI7 mHealth Program Arm | 0/138 (0%) | 0/138 (0%) | 0/138 (0%) |
| Standard Recommendation Arm | 0/146 (0%) | 0/146 (0%) | 0/146 (0%) |
| Age, Categorical(Participants) | CHoBI7 mHealth Program Arm | Standard Recommendation Arm | Total |
|---|---|---|---|
| <=18 years | 63 | 58 | 121 |
| Between 18 and 65 years | 75 | 88 | 163 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | CHoBI7 mHealth Program Arm | Standard Recommendation Arm | Total |
|---|---|---|---|
| Mean | 21 ± 15 | 24 ± 17.5 | 21 ± 17 |
| Sex: Female, Male(Participants) | CHoBI7 mHealth Program Arm | Standard Recommendation Arm | Total |
|---|---|---|---|
| Female | 72 | 77 | 149 |
| Male | 66 | 69 | 135 |
| Ethnicity (NIH/OMB)(Participants) | CHoBI7 mHealth Program Arm | Standard Recommendation Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 138 | 146 | 284 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | CHoBI7 mHealth Program Arm | Standard Recommendation Arm | Total |
|---|---|---|---|
| Bangladesh | 138 | 146 | 284 |
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Johns Hopkins Bloomberg School of Public Health