Preventative Intervention for Cholera for 7 Days (PICHA-7)
Primary Purpose
Cholera, Water-Related Diseases, Diarrhea Infectious
Status
Recruiting
Phase
Not Applicable
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
PICHA7 mHealth program
Standard Arm
Sponsored by
About this trial
This is an interventional prevention trial for Cholera
Eligibility Criteria
Inclusion Criteria:
- Diarrhea patients presenting with three or more loose stools over a 24h period
- Having no running water inside of their home
- Plan to reside in Bukavu for the next 12 months
- Have a child <5 years in their household
- Have a working mobile phone in the household
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)
Sites / Locations
- General Provincial Reference Hospital of BukavuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program
Standard Arm
Arm Description
Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) mHealth program promoting handwashing with soap and water treatment for diarrhea patient households
Standard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities
Outcomes
Primary Outcome Measures
Diarrhea among household members
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Secondary Outcome Measures
Child development for children under 5 years of age
Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
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 our developed forms (George CM, Monira S, Zohura F, Thomas ED, Hasan MT, Parvin T, Hasan K, Rashid MU, Papri N, Islam A, Rahman Z. Effects of a water, sanitation, and hygiene mobile health program on diarrhea and child growth in Bangladesh: a cluster-randomized controlled trial of the cholera hospital-based intervention for 7 days (CHoBI7) mobile health program. Clinical Infectious Diseases. 2021 Nov 1;73(9):e2560-8.)
Free chlorine concentration in stored drining water
mg / Liter
Presence of Vibrio cholerae and E. coli in stored drinking water
bacterial culture
WASH psychosocial factors
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire
non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients
via rapid dipstick test (RDT) and bacterial culture
Height-for-age among children under 2 years of age
Height and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Height-for-age among children under 5 years of age
Height and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Weight-for-age among children under 2 years of age
Weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Weight-for-age among children under 5 years of age
Weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Weight-for-height among children under 2 years of age
Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Weight-for-height among children under 5 years of age
Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Full Information
NCT ID
NCT05166850
First Posted
December 8, 2021
Last Updated
May 8, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
University of New Mexico, Wellcome Sanger Institute
1. Study Identification
Unique Protocol Identification Number
NCT05166850
Brief Title
Preventative Intervention for Cholera for 7 Days
Acronym
PICHA-7
Official Title
Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
University of New Mexico, Wellcome Sanger Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera, Water-Related Diseases, Diarrhea Infectious
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program
Arm Type
Experimental
Arm Description
Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) mHealth program promoting handwashing with soap and water treatment for diarrhea patient households
Arm Title
Standard Arm
Arm Type
Active Comparator
Arm Description
Standard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities
Intervention Type
Behavioral
Intervention Name(s)
PICHA7 mHealth program
Intervention Description
The PICHA7 mHealth program is first 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.
Intervention Type
Other
Intervention Name(s)
Standard Arm
Intervention Description
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Primary Outcome Measure Information:
Title
Diarrhea among household members
Description
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Child development for children under 5 years of age
Description
Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Time Frame
12 months
Title
Handwashing with soap at stool and food related events
Description
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 our developed forms (George CM, Monira S, Zohura F, Thomas ED, Hasan MT, Parvin T, Hasan K, Rashid MU, Papri N, Islam A, Rahman Z. Effects of a water, sanitation, and hygiene mobile health program on diarrhea and child growth in Bangladesh: a cluster-randomized controlled trial of the cholera hospital-based intervention for 7 days (CHoBI7) mobile health program. Clinical Infectious Diseases. 2021 Nov 1;73(9):e2560-8.)
Time Frame
12 months
Title
Free chlorine concentration in stored drining water
Description
mg / Liter
Time Frame
12 months
Title
Presence of Vibrio cholerae and E. coli in stored drinking water
Description
bacterial culture
Time Frame
12 months
Title
WASH psychosocial factors
Description
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire
Time Frame
12 month
Title
non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients
Description
via rapid dipstick test (RDT) and bacterial culture
Time Frame
1 Month
Title
Height-for-age among children under 2 years of age
Description
Height and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Time Frame
12 Months
Title
Height-for-age among children under 5 years of age
Description
Height and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Time Frame
12 Months
Title
Weight-for-age among children under 2 years of age
Description
Weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Time Frame
12 Months
Title
Weight-for-age among children under 5 years of age
Description
Weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Time Frame
12 Months
Title
Weight-for-height among children under 2 years of age
Description
Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Time Frame
12 Months
Title
Weight-for-height among children under 5 years of age
Description
Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Time Frame
12 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diarrhea patients presenting with three or more loose stools over a 24h period
Having no running water inside of their home
Plan to reside in Bukavu for the next 12 months
Have a child <5 years in their household
Have a working mobile phone in the household
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Marie George, PhD
Phone
(202) 657-5798
Email
cmgeorge@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Marie George, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Provincial Reference Hospital of Bukavu
City
Bukavu
State/Province
South Kivu
Country
Congo, The Democratic Republic of the
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Cikomola, MD
Phone
+243 814479302
Email
cikomola.cirhuza@ucbukavu.ac.cd
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be de-identified and available to our collaborators
Learn more about this trial
Preventative Intervention for Cholera for 7 Days
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