Preventative Intervention for Cholera for 7 Days

NCT05166850 | Recruiting

• 1 other identifier: IRB00009848
• Study Type: interventional
• Target: 2,900
• Locations: 1 country
• Sites: 2

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.

Conditions

Cholera; Water-Related Diseases; Diarrhea Infectious

Outcome Measures

Primary Outcomes (1)

• Diarrhea among household members

  Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)

  12 months

Secondary Outcomes (13)

• Child development for children under 5 years of age

  12 and 24 months after enrollment

• Handwashing with soap at stool and food related events

  1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment

• Free chlorine concentration in stored drinking water

  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

  1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment

• WASH psychosocial factors

  1 week and 12 and 24 months after enrollment

Study Arms (2)

Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program

EXPERIMENTAL

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; Other: Standard Arm

Standard Arm

ACTIVE COMPARATOR

Standard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities

Other: Standard Arm

Interventions

PICHA7 mHealth program BEHAVIORAL

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.

Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program

Standard Arm OTHER

Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution

Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program; Standard Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No one will be excluded because of age, sex, religion, or sexual preference
• Presenting at the health facility with a fever (COVID-19 prevention)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• University of New Mexico: collaborator
• Wellcome Sanger Institute: collaborator

Study Sites (2)

General Provincial Reference Hospital of Bukavu

Bukavu, South Kivu, Democratic Republic of the Congo

RECRUITING

Université Catholique de Bukavu

Bukavu, South Kivu, Democratic Republic of the Congo

RECRUITING

Related Publications (2)

• Sanvura P, Endres K, Bisimwa JC, Perin J, Cikomola C, Bengehya J, Maheshe G, Boroto R, Mwishingo A, Bisimwa L, Williams C, George CM. Process evaluation for the delivery of a water, sanitation, and hygiene mobile health program: randomized controlled trial of the WASHmobile PICHA7 program. Trop Med Health. 2026 Jan 7;54(1):15. doi: 10.1186/s41182-025-00881-8.

  PMID: 41501962 DERIVED

• 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.

  PMID: 41206550 DERIVED

MeSH Terms

Conditions

Cholera; Waterborne Diseases; Dysentery

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christine Marie George, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Marie George, PhD

CONTACT

(202) 657-5798; cmgeorge@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 22, 2021
• Study Start: December 22, 2021
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)