An interventional study of PICHA7 mHealth program and Standard Arm in Cholera, Water-Related Diseases and Diarrhea Infectious, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 2 sites in Democratic Republic of the Congo. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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.
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.
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This study's planned enrollment of 2,900 is above the median of 262 across 72 interventional studies indexed under Cholera.
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Exclusion Criteria:
Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) mHealth program promoting handwashing with soap and water treatment for diarrhea patient households
Behavioral: PICHA7 mHealth program · Other: Standard Arm
Standard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities
Other: Standard Arm
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.
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Diarrhea among household members
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Time frame: 12 months
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 enrollment
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 enrollment
Free chlorine concentration in stored drinking water
mg / Liter
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
bacterial culture
Time frame: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment
WASH psychosocial factors
Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire
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
via rapid dipstick test (RDT) and bacterial culture
Time frame: 1 Month
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
Time frame: 12 and 24 months after enrollment
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
Time frame: 12 and 24 months after enrollment
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
Time frame: 12 and 24 months after enrollment
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
Time frame: 12 and 24 months after enrollment
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
Time frame: 12 and 24 months after enrollment
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
Time frame: 12 and 24 months after enrollment
Diarrhea events among household members
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Time frame: 24 months
Plan to share: No — All data will be de-identified and available to our collaborators
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