Preventative Intervention for Cholera for 7 Days

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Brief Title

Preventative Intervention for Cholera for 7 Days

Official Title

Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo

Brief Summary

      The first objective of our study is to develop a theory-driven evidence-based targeted water,
      sanitation, and hygiene (WASH) intervention for household members of diarrhea patients in
      South Kivu, Democratic Republic of the Congo (DRC) through formative research and community
      engagement. The second objective is to conduct a randomized controlled trial of 2,320
      household members of 580 severe diarrhea patients to evaluate the effectiveness of the
      developed targeted WASH intervention in terms of: 1. reducing diarrheal diseases household
      members of cholera and severe diarrhea patients; and 2. increasing WASH behaviors.
    

Detailed Description

      This study develops and evaluates a targeted water, sanitation, and hygiene (WASH)
      intervention to reduce cholera and severe diarrhea among the household members of diarrhea
      patients in South Kivu, Democratic Republic of the Congo (DRC) through formative research and
      a randomized controlled trial. This study will also investigate cholera and severe diarrhea
      transmission dynamics among diarrhea patient households using genomics and a risk factor
      analysis. The study will be divided into two phases: (1) the Formative Research and
      Intervention Development Phase; and (2) the Intervention Implementation and Evaluation Phase.

      In the two arm randomized controlled trial of diarrhea patient households, we compare the
      standard message given in DRC to diarrhea patients to the PICHA7 mHealth program. The
      standard message arm is the standard recommendation given in DRC to diarrhea patients at
      discharge on the use of oral rehydration solution (ORS) for dehydration, and the importance
      of handwashing with soap and water treatment for disease prevention. The PICHA7 mHealth
      program arm will first be delivered during a health facility visit by a health promoter
      bedside to a diarrhea patient (adults and child) and their accompanying household members
      during the time of illness followed by two home visits during the 7-day high risk period for
      diarrheal disease transmission. The health promoter delivers a pictorial WASH module on how
      diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe
      water storage. A diarrhea prevention package is provided containing: a one-month supply of
      chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing
      station, and a water vessel with a lid and tap to ensure safe water storage. After health
      facility delivery of the program, patient households receive weekly voice and text messages
      from the PICHA7 mHealth program over 12 months on the recommended WASH behaviors.
    


Study Type

Interventional


Primary Outcome

Diarrhea among household members

Secondary Outcome

 Child development for children under 5 years of age

Condition

Cholera

Intervention

PICHA7 mHealth program

Study Arms / Comparison Groups

 Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program
Description:  Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) mHealth program promoting handwashing with soap and water treatment for diarrhea patient households

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

2900

Start Date

December 22, 2021

Completion Date

June 1, 2023

Primary Completion Date

June 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Diarrhea patients presenting with three or more loose stools over a 24h period

          -  Having resided in their home for at least 3 nights prior to hospitalization

          -  Having no running water inside of their home

        Exclusion Criteria:

          -  No one will be excluded because of age, sex, religion, or sexual preference

          -  Presenting at the health facility with a fever (COVID-19 prevention)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Christine Marie George, PhD, (202) 657-5798, [email protected]

Location Countries

Congo, The Democratic Republic of the

Location Countries

Congo, The Democratic Republic of the

Administrative Informations


NCT ID

NCT05166850

Organization ID

IRB00009848


Responsible Party

Sponsor

Study Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

 University of New Mexico

Study Sponsor

Christine Marie George, PhD, Principal Investigator, Associate Professor


Verification Date

March 2022