CholeraPICHA-7NCT05166850
Preventative Intervention for Cholera for 7 Days
A study testing PICHA7 mHealth program and Standard Arm in people with Cholera and Water-Related Diseases, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholera, Water-Related Diseases, Diarrhea Infectious
- What is being tested?
- PICHA7 mHealth program and Standard Arm
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- 22 Dec 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No one will be excluded because of age, sex, religion, or sexual preference
- Presenting at the health facility with a fever (COVID-19 prevention)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo2 sites, 2 recruiting
- Recruiting
General Provincial Reference Hospital of Bukavu
Bukavu, South Kivu
Justin Cikomola, MD, +243 814479302, cikomola.cirhuza@ucbukavu.ac.cd
- Recruiting
Université Catholique de Bukavu
Bukavu, South Kivu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cholera, Water-Related Diseases, Diarrhea Infectious
- Being tested
- PICHA7 mHealth program, Standard Arm
- Medical subject headings
- Cholera, Waterborne Diseases, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICHA7 mHealth programBehavioural
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 ArmOther
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Standard Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea among household members
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
Measured: 12 months
Secondary outcomes (13)
Child development for children under 5 years of age
Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Measured: 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.)
Measured: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment
Free chlorine concentration in stored drinking water
mg / Liter
Measured: 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
Measured: 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
Measured: 1 week and 12 and 24 months after enrollment
non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients
via rapid dipstick test (RDT) and bacterial culture
Measured: 1 Month
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start22 Dec 2021
- Primary completion22 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Wellcome Sanger Institute
- Responsible party
- Sponsor
- Investigators
- Christine Marie George, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166850
- Sponsor's protocol ID
- IRB00009848
- Acronym
- PICHA-7
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified and available to our collaborators
Publications
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.
PubMed 41501962George 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.
PubMed 41206550
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Targeted Water Sanitation, and Hygiene Interventions to Reduce Cholera in Hotspots in the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT05166850
- Acronym / sponsor ID
- PICHA-7 / IRB00009848
- Conditions
- Cholera, Water-Related Diseases, Diarrhea Infectious
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- University of New Mexico, Wellcome Sanger Institute
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program | Experimental | Behavioral: PICHA7 mHealth program, Other: Standard ArmPreventive-Intervention-for-Cholera-for-7-Days (PICHA7) mHealth program promoting handwashing with soap and water treatment for diarrhea patient households |
| Standard Arm | Active comparator | Other: Standard ArmStandard recommendation in the Democratic Republic of the Congo for diarrhea patients upon discharge from health facilities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- No one will be excluded because of age, sex, religion, or sexual preference
- Presenting at the health facility with a fever (COVID-19 prevention)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICHA7 mHealth programThe 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. | Behavioural | Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program |
| Standard ArmStandard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution | Other | Preventive-Intervention-for-Cholera-for-7-Days (PICHA7) Mobile Health (mHealth) Program, Standard Arm |
Primary outcome
Diarrhea among household members
Time frame: 12 months
Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
13 secondary outcomes
Child development for children under 5 years of age
Time frame: 12 and 24 months after enrollment
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
Free chlorine concentration in stored drinking water
Time frame: 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
Time frame: 1 week and 1, 3, 6, 9, 12, 18, and 24 months after enrollment
WASH psychosocial factors
Time frame: 1 week and 12 and 24 months after enrollment
non-baseline cholera infections confirmed by bacterial culture among household members of cholera patients
Time frame: 1 Month
Height-for-age among children under 2 years of age
Time frame: 12 and 24 months after enrollment
Height-for-age among children under 5 years of age
Time frame: 12 and 24 months after enrollment
Weight-for-age among children under 2 years of age
Time frame: 12 and 24 months after enrollment
Weight-for-age among children under 5 years of age
Time frame: 12 and 24 months after enrollment
Weight-for-height among children under 2 years of age
Time frame: 12 and 24 months after enrollment
Weight-for-height among children under 5 years of age
Time frame: 12 and 24 months after enrollment
Diarrhea events among household members
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 41501962Sanvura 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.
- Derived from this study: PubMed 41206550George 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.
- Individual participant dataSharing planned: No. All data will be de-identified and available to our collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Marie George, PhD principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICHA7 mHealth program and Standard Arm in people with Cholera and Water-Related Diseases, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Marie George, PhD ((202) 657-5798, cmgeorge@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea among household members (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05166850, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.