Preventative Intervention for Cholera for 7 Days (PICHA-7)

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.

Study Overview

• Status: Recruiting
• Conditions: Cholera; Diarrhea Infectious; Water-Related Diseases
• Intervention / Treatment: Behavioral: PICHA7 mHealth program; Other: Standard Arm

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.

• Study Type: Interventional
• Enrollment (Estimated): 2900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Marie George, PhD; Phone Number: (202) 657-5798; Email: cmgeorge@jhu.edu

Study Locations

• Democratic Republic of the Congo
  • South Kivu
    • Bukavu, South Kivu, Democratic Republic of the Congo
      • Recruiting
      • General Provincial Reference Hospital of Bukavu
      • Contact: Justin Cikomola, MD; Phone Number: +243 814479302; Email: cikomola.cirhuza@ucbukavu.ac.cd
    • Bukavu, South Kivu, Democratic Republic of the Congo
      • Recruiting
      • Université Catholique de Bukavu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program; 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; 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
Active Comparator: Standard Arm; Standard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea among household members	Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients	via rapid dipstick test (RDT) and bacterial culture	1 Month
Child development for children under 5 years of age	Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)	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.)	1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment
Free chlorine concentration in stored drinking water	mg / Liter	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	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	1 week and 12 and 24 months after enrollment
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 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	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	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	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	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	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)	24 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: University of New Mexico; Wellcome Sanger Institute
• Investigators: Principal Investigator: Christine Marie George, PhD, Associate professor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Vibrio Infections; Waterborne Diseases; Cholera; Dysentery
• Other Study ID Numbers: IRB00009848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be de-identified and available to our collaborators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No