Preventative Intervention for Cholera for 7 Days
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PICHA7 mHealth program, Standard Arm.
- Who it may be relevant to
- Registry conditions: Cholera, Water-Related Diseases, Diarrhea Infectious. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Democratic Republic of the Congo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo
Overview
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.
Interventions
- Behavioral PICHA7 mHealth program
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 - Other Standard Arm
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 measures
- Diarrhea among household members [Time frame: 12 months]
Secondary outcome measures (12)
- Child development for children under 5 years of age [Time frame: 12 and 24 months after enrollment]
- Handwashing with soap at stool and food related events [Time frame: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment]
- Free chlorine concentration in stored drinking water [Time frame: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment]
- Presence of Vibrio cholerae and E. coli in stored drinking water [Time frame: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment]
- WASH psychosocial factors [Time frame: 1 week and 12 and 24 months after enrollment]
- non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients [Time frame: 1 Month]
- Height-for-age among children under 2 years of age [Time frame: 12 and 24 months after enrollment]
- Height-for-age among children under 5 years of age [Time frame: 12 and 24 months after enrollment]
- Weight-for-age among children under 2 years of age [Time frame: 12 and 24 months after enrollment]
- Weight-for-age among children under 5 years of age [Time frame: 12 and 24 months after enrollment]
- Weight-for-height among children under 2 years of age [Time frame: 12 and 24 months after enrollment]
- Weight-for-height among children under 5 years of age [Time frame: 12 and 24 months after enrollment]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Democratic Republic of the Congo · 2 centers
- General Provincial Reference Hospital of Bukavu — Bukavu
- Université Catholique de Bukavu — Bukavu
Publications
- Sanvura P, Endres K, Bisimwa JC, Perin J, Cikomola C, Bengehya J, Maheshe G, Boroto R, Mwishingo A, Bisimwa L, Williams C, George CM. Process evaluation for the delivery of a water, sanitation, and hygiene mobile health program: randomized controlled trial of the WASHmobile PICHA7 program. Trop Med Health. 2026 Jan 7;54(1):15. doi: 10.1186/s41182-025-00881-8. PMID 41501962
- George CM, Sanvura P, Bisimwa JC, Endres K, Namunesha A, Felicien W, Banywesize BM, Williams C, Perin J, Sack DA, Boroto R, Nsimire G, Rugusha F, Endeleya F, Kitumaini P, Lunyelunye C, Buhendwa E, Kitumaini Bujiriri P, Tumusifu J, Munyerenkana B, Trivedi S, Davis KL, Jacobson K, Al-Dandashi KM, Leung DT, Caulfield LE, Bengehya J, Maheshe G, Cikomola C, Mwishingo A, Bisimwa L. Effects of a Water, S PMID 41206550
Identifiers
NCT: NCT05166850 · IRB00009848