Preventative Intervention for Cholera for 7 Days
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJohns Hopkins Bloomberg School of Public Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No one will be excluded because of age, sex, religion, or sexual preference
Presenting at the health facility with a fever (COVID-19 prevention)
Trial design
Design model
Parallel
Treatments tested in this trial
PICHA7 mHealth program
BehavioralThe 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.
Standard Arm
Other interventionStandard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Treatment groups
2,900 Participants
are divided into 2 treatment groupsGroup A: Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) ProgramExperimental treatment 2 interventions
Group B: Standard ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diarrhea among household members
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Time frame
12 monthsSecondary outcomes
1
Child development for children under 5 years of age
Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Time frame
12 and 24 months after enrollment2
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.)
Time frame
1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment3
Free chlorine concentration in stored drinking water
mg / Liter
Time frame
1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment4
Presence of Vibrio cholerae and E. coli in stored drinking water
bacterial culture
Time frame
1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
University of New Mexico
Collaborator
Wellcome Sanger Institute
Collaborator
Source ClinicalTrials.gov