Clinical trial NCT05166850: Preventative Intervention for Cholera for 7 Days
Official title: Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholera
Water-Related Diseases
Diarrhea Infectious
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Wellcome Sanger Institute
First posted: 2021-12-22
Enrollment: 2900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

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)

Primary outcomes:
measure: Diarrhea among household members
timeFrame: 12 months
Secondary outcomes:
measure: Child development for children under 5 years of age
timeFrame: 12 and 24 months after enrollment
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
measure: Free chlorine concentration in stored drinking water
timeFrame: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment
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
measure: WASH psychosocial factors
timeFrame: 1 week and 12 and 24 months after enrollment
measure: non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients
timeFrame: 1 Month
measure: Height-for-age among children under 2 years of age
timeFrame: 12 and 24 months after enrollment
measure: Height-for-age among children under 5 years of age
timeFrame: 12 and 24 months after enrollment
measure: Weight-for-age among children under 2 years of age
timeFrame: 12 and 24 months after enrollment
measure: Weight-for-age among children under 5 years of age
timeFrame: 12 and 24 months after enrollment
measure: Weight-for-height among children under 2 years of age
timeFrame: 12 and 24 months after enrollment
measure: Weight-for-height among children under 5 years of age
timeFrame: 12 and 24 months after enrollment
measure: Diarrhea events among household members
timeFrame: 24 months
Other outcomes:
Locations:
city: Bukavu
country: Congo, The Democratic Republic of the
facility: General Provincial Reference Hospital of Bukavu
state: South Kivu
city: Bukavu
country: Congo, The Democratic Republic of the
facility: Université Catholique de Bukavu
state: South Kivu
Study officials:
affiliation: Associate Professor
name: Christine Marie George, PhD
role: PRINCIPAL_INVESTIGATOR
References: