Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-28 @ 2:47 PM
Study NCT ID:
NCT05166850
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventative Intervention for Cholera for 7 Days
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002771', 'term': 'Cholera'}, {'id': 'D000069578', 'term': 'Waterborne Diseases'}, {'id': 'D004403', 'term': 'Dysentery'}], 'ancestors': [{'id': 'D014735', 'term': 'Vibrio Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diarrhea among household members', 'timeFrame': '12 months', 'description': 'Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)'}], 'secondaryOutcomes': [{'measure': 'Child development for children under 5 years of age', 'timeFrame': '12 and 24 months after enrollment', 'description': 'Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)'}, {'measure': 'Handwashing with soap at stool and food related events', 'timeFrame': '1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment', '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.)'}, {'measure': 'Free chlorine concentration in stored drinking water', 'timeFrame': '1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment', 'description': 'mg / Liter'}, {'measure': 'Presence of Vibrio cholerae and E. coli in stored drinking water', 'timeFrame': '1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment', 'description': 'bacterial culture'}, {'measure': 'WASH psychosocial factors', 'timeFrame': '1 week and 12 and 24 months after enrollment', 'description': 'Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire'}, {'measure': 'non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients', 'timeFrame': '1 Month', 'description': 'via rapid dipstick test (RDT) and bacterial culture'}, {'measure': 'Height-for-age among children under 2 years of age', 'timeFrame': '12 and 24 months after enrollment', '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'}, {'measure': 'Height-for-age among children under 5 years of age', 'timeFrame': '12 and 24 months after enrollment', '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'}, {'measure': 'Weight-for-age among children under 2 years of age', 'timeFrame': '12 and 24 months after enrollment', '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'}, {'measure': 'Weight-for-age among children under 5 years of age', 'timeFrame': '12 and 24 months after enrollment', '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'}, {'measure': 'Weight-for-height among children under 2 years of age', 'timeFrame': '12 and 24 months after enrollment', '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'}, {'measure': 'Weight-for-height among children under 5 years of age', 'timeFrame': '12 and 24 months after enrollment', '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'}, {'measure': 'Diarrhea events among household members', 'timeFrame': '24 months', 'description': 'Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholera', 'Water-Related Diseases', 'Diarrhea Infectious']}, 'referencesModule': {'references': [{'pmid': '41206550', 'type': 'DERIVED', 'citation': '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, Sanitation, and Hygiene Program on Diarrhea, Cholera, and Child Growth in the Democratic Republic of the Congo: A Cluster-Randomized Controlled Trial of the Preventative Intervention for Cholera for 7 Days (PICHA7 WASHmobile) Mobile Health Program. Clin Infect Dis. 2025 Nov 6;81(4):785-796. doi: 10.1093/cid/ciaf417.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diarrhea patients presenting with three or more loose stools over a 24h period\n* Having no running water inside of their home\n* Plan to reside in Bukavu for the next 12 months\n* Have a child \\<5 years in their household\n* Have a working mobile phone in the household\n\nExclusion Criteria:\n\n* No one will be excluded because of age, sex, religion, or sexual preference\n* Presenting at the health facility with a fever (COVID-19 prevention)'}, 'identificationModule': {'nctId': 'NCT05166850', 'acronym': 'PICHA-7', 'briefTitle': 'Preventative Intervention for Cholera for 7 Days', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo', 'orgStudyIdInfo': {'id': 'IRB00009848'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program', 'description': 'Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) mHealth program promoting handwashing with soap and water treatment for diarrhea patient households', 'interventionNames': ['Behavioral: PICHA7 mHealth program', 'Other: Standard Arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Arm', 'description': 'Standard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities', 'interventionNames': ['Other: Standard Arm']}], 'interventions': [{'name': 'PICHA7 mHealth program', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program']}, {'name': 'Standard Arm', 'type': 'OTHER', 'description': 'Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution', 'armGroupLabels': ['Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program', 'Standard Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bukavu', 'state': 'South Kivu', 'status': 'RECRUITING', 'country': 'Democratic Republic of the Congo', 'contacts': [{'name': 'Justin Cikomola, MD', 'role': 'CONTACT', 'email': 'cikomola.cirhuza@ucbukavu.ac.cd', 'phone': '+243 814479302'}], 'facility': 'General Provincial Reference Hospital of Bukavu', 'geoPoint': {'lat': -2.49077, 'lon': 28.84281}}, {'city': 'Bukavu', 'state': 'South Kivu', 'status': 'RECRUITING', 'country': 'Democratic Republic of the Congo', 'facility': 'Université Catholique de Bukavu', 'geoPoint': {'lat': -2.49077, 'lon': 28.84281}}], 'centralContacts': [{'name': 'Christine Marie George, PhD', 'role': 'CONTACT', 'email': 'cmgeorge@jhu.edu', 'phone': '(202) 657-5798'}], 'overallOfficials': [{'name': 'Christine Marie George, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data will be de-identified and available to our collaborators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'Wellcome Sanger Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}