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NCT Number: NCT05166850

Preventative Intervention for Cholera for 7 Days

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Provincial Reference Hospital of Bukavu, Bukavu, South Kivu, Democratic Republic of the Congo

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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

Primary outcomes

  1. Diarrhea among household members

    Time frame: 12 months

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

Secondary outcomes

  1. Child development for children under 5 years of age

    Time frame: 12 and 24 months after enrollment

    Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)

  2. Handwashing with soap at stool and food related events

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

    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.)

  3. Free chlorine concentration in stored drinking water

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

    mg / Liter

  4. Presence of Vibrio cholerae and E. coli in stored drinking water

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

    bacterial culture

  5. WASH psychosocial factors

    Time frame: 1 week and 12 and 24 months after enrollment

    Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire

  6. non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients

    Time frame: 1 Month

    via rapid dipstick test (RDT) and bacterial culture

  7. Height-for-age among children under 2 years of age

    Time frame: 12 and 24 months after enrollment

    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

  8. Height-for-age among children under 5 years of age

    Time frame: 12 and 24 months after enrollment

    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

  9. Weight-for-age among children under 2 years of age

    Time frame: 12 and 24 months after enrollment

    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

  10. Weight-for-age among children under 5 years of age

    Time frame: 12 and 24 months after enrollment

    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

  11. Weight-for-height among children under 2 years of age

    Time frame: 12 and 24 months after enrollment

    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. Weight-for-height among children under 5 years of age

    Time frame: 12 and 24 months after enrollment

    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

  13. Diarrhea events among household members

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Marie George, PhD

CONTACT

[email protected]

(202) 657-5798

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • University of New Mexico
  • Wellcome Sanger Institute

Registry information

Official study title

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

Acronym: PICHA-7

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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