Cholera Clinical Trial
— PICHA-7Official title:
Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo
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.
Status | Recruiting |
Enrollment | 2900 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | General Provincial Reference Hospital of Bukavu | Bukavu | South Kivu |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | University of New Mexico, Wellcome Sanger Institute |
Congo, The Democratic Republic of the,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diarrhea among household members | Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period) | 12 months | |
Secondary | Child development for children under 5 years of age | Assessed by Extended Age and Stages Assessment Questionnaire (EASQ) | 12 months | |
Secondary | 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.) | 12 months | |
Secondary | Free chlorine concentration in stored drinking water | mg / Liter | 12 months | |
Secondary | Presence of Vibrio cholerae and E. coli in stored drinking water | bacterial culture | 12 months | |
Secondary | WASH psychosocial factors | Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire | 12 month | |
Secondary | non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients | via rapid dipstick test (RDT) and bacterial culture | 1 Month | |
Secondary | 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 | 12 Months | |
Secondary | 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 | 12 Months | |
Secondary | 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 | 12 Months | |
Secondary | 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 | 12 Months | |
Secondary | 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 | 12 Months | |
Secondary | 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 | 12 Months |
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