Preventative Intervention for Cholera for 7 Days

Cholera Clinical Trial

— PICHA-7  

Official title:

Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166850
• Other study ID #: IRB00009848
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Christine Marie George, PhD
• Phone: (202) 657-5798
• Email: cmgeorge[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Cholera
• Diarrhea
• Diarrhea Infectious
• Dysentery
• Water-Related Diseases
• Waterborne Diseases

Intervention

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

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	General Provincial Reference Hospital of Bukavu	Bukavu	South Kivu

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	University of New Mexico, Wellcome Sanger Institute

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

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