Preventative Intervention for Cholera for 7 Days
NCT05166850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2900
Last updated 2025-12-17
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.
Conditions
- Cholera
- Water-Related Diseases
- Diarrhea Infectious
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 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.
- 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
Sponsors & Collaborators
-
University of New Mexico
collaborator OTHER -
Wellcome Sanger Institute
collaborator OTHER -
Johns Hopkins Bloomberg School of Public Health
lead OTHER
Principal Investigators
-
Christine Marie George, PhD · Associate Professor
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-22
- Primary Completion
- 2026-12-22
- Completion
- 2026-12-31
Countries
- Democratic Republic of the Congo
Study Locations
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