Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
No one will be excluded because of age, sex, religion, or sexual preference
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Recommendation
BehavioralStandard 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
BehavioralHealth 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.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Standard RecommendationActive comparator 1 intervention
Group B: CHoBI7 Scale-Up ProgramExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
Number of constructed homemade handwashing stations
Household construction of homemade handwashing station
Time frame
3 monthsSecondary outcomes
1
Number of participants with diarrhea
Number of participants with self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Time frame
3 months2
Amount of free chlorine concentration in stored drinking water
mg/Liter
Time frame
3 months3
Number of stored drinking water samples with E. coli
Number of stored drinking water samples with E. coli
Time frame
3 months4
Water, sanitation, and hygiene (WASH) psychosocial factors
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire. 5-point scale (0 = \[almost\] never/0-1 times out of 10-1 = \[almost\] always/9-10 times out of 10). with higher scores indicating higher handwashing frequency.
Time frame
3 monthsSponsors and contacts
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Research Training and Management International (RTMI)
Collaborator
United States Agency for International Development (USAID)
Collaborator
GiveWell
Collaborator
Source ClinicalTrials.gov