Cholera-Hospital-Based-Intervention-for-7-days

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Brief Title

Cholera-Hospital-Based-Intervention-for-7-days

Official Title

CHoBI7 Trial: A Hospital Based Water, Sanitation and Hygiene Intervention for Households of Diarrheal Patients in Bangladesh

Brief Summary

      The Cholera Hospital Based Intervention for 7 Days (CHoBI7) randomized controlled trial for
      transition to scale aimed to: (1) Develop and evaluate scalable approaches to integrate the
      CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health
      facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to
      a sustained uptake of the promoted hand washing with soap and water treatment behaviors and
      significant reductions in diarrheal disease over time.
    

Detailed Description

      The findings from the recent randomized controlled trial of The Cholera Hospital Based
      Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in
      significantly reducing symptomatic cholera infections in intervention households, and had
      significant sustained impacts on hand washing with soap behaviors and improved water quality
      12 months post intervention. Next steps to transition to scale were: (1) Develop and evaluate
      scalable approaches to integrate the CHoBI7 intervention into the services provided for
      hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the
      ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing
      with soap and water treatment behaviors and significant reductions in diarrheal disease over
      time.
    


Study Type

Interventional


Primary Outcome

Diarrhea prevalence among children under 2 years of age

Secondary Outcome

 Diarrhea prevalence among participants ages 5-9 years

Condition

Cholera

Intervention

CHoBI7 health facility program

Study Arms / Comparison Groups

 Standard recommendation (ORS)
Description:  Participants received the standard recommendation on oral rehydration solution use

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

2626

Start Date

December 4, 2016

Completion Date

April 26, 2019

Primary Completion Date

April 26, 2019

Eligibility Criteria

        Inclusion Criteria:

        Diarrhea patients will be defined as patients having acute watery diarrhea three or more
        loose stools over a 24-hour period in the past three days. Diarrhea patients admitted to
        ICDDRB Dhaka Hospital or Mugda General Hospital will be eligible for the trial if:

          1. have had 3 or more loose stools over the past 24 hours

          2. plan to reside in Dhaka for the next 12 months

          3. have no basin for running water in their home

          4. have a child under five years of age in their household (including themselves) that
             produced a stool sample at baseline

          5. have a working mobile phone in the household.

        Household members of the diarrhea patient will be eligible for the trial if:

          1. they have shared the same cooking pot and resided in the same home with the diarrhea
             patient for the last three days

          2. plan to reside in their current household with the diarrhea patient for the next 12
             months

        Exclusion Criteria:

        (1) Children in foster care will be excluded from all research study activities.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Christine Marie George, PhD, , 



Administrative Informations


NCT ID

NCT04008134

Organization ID

IRB00006785

Secondary IDs

PR-15133

Responsible Party

Sponsor

Study Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

 International Centre for Diarrhoeal Disease Research, Bangladesh

Study Sponsor

Christine Marie George, PhD, Principal Investigator, Johns Hopkins Bloomberg School of Public Health


Verification Date

January 2022