Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluated a public health program in Haiti that introduced an oral cholera vaccine as part of comprehensive control efforts for a major cholera epidemic. Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at preventing cholera in many settings, it had not extensively been used to control an outbreak, and it had not been extensively studied in populations that were previously naive to cholera (i.e. countries that had never had cholera before). This cholera epidemic was the first ever report of cholera in Haiti. After the cholera vaccination campaign was complete, the investigators aimed to evaluate the field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and determining if cholera patients had been vaccinated. The investigators compared the rate of vaccination in cholera cases to controls from the community that had not had cholera in a case-control study. The investigators also performed a second study - a bias-indicator study - that enrolled patients with non-cholera diarrhea, and community controls. The role of the bias-indicator study was to evaluate for potential sources of bias, since the investigators could expect that cholera vaccination should have no effect on non-cholera diarrhea.

Official Title
-----------------
Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts

Conditions
-----------------
Cholera, Diarrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for cholera cases: Seeks treatment for acute non-bloody diarrhea (defined as 3 or more loose, watery or liquid stools in a 24-hour period with an onset of 3 days or fewer prior to presentation) at a participating study site Diarrhea episode is diagnosed as cholera, confirmed by Crystal VC rapid test and culture Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (i.e. ≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant during the vaccination campaign). Exclusion criteria for cholera cases: < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of the vaccination campaign Inclusion criteria for non-cholera diarrhea cases: Seeks treatment for acute non-bloody diarrhea (as defined above) at a participating study site Culture negative cholera by Crystal VC rapid test and culture Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant at the time of the campaign) Exclusion criteria for non-cholera diarrhea cases: < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of the vaccination campaign Inclusion criteria for all controls: Did not seek treatment for diarrhea between the date that study enrollment began and corresponding case's symptom onset (defined below) Resident of Bocozel or Grande Saline at the time of study initiation Was eligible for the vaccination campaign (≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant at the time of the vaccination campaign) Exclusion criteria for cholera controls and secondary controls: < 12 months of age at the time of completion of the cholera vaccine campaign Pregnant at the time of completion of the cholera vaccine campaign

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls for non-cholera diarrhea cases<br>- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case | |
| Non-cholera diarrhea cases<br>- Cases of acute watery diarrhea that present for healthcare at the study sites, but that test negative for cholera | |
| Controls for cholera cases<br>- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case | |
| Cholera cases<br>- Those with cholera-related diarrhea who present to healthcare at the study sites. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholera-related diarrhea | Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture. | We will report diarrhea rates at 12 months after the cholera vaccination campaign | 
| cholera-related diarrhea | Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture. | We will report diarrhea rates at 24 after the cholera vaccination campaign | 
| cholera-related diarrhea | Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture. | We will report diarrhea rates at 60 months after the cholera vaccination campaign | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-cholera diarrhea | Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours). 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera') | We will report diarrhea rates at 12 months after the cholera vaccination campaign | 
| non-cholera diarrhea | Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours). 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera') | We will report diarrhea rates at 24 months after the cholera vaccination campaign | 
| non-cholera diarrhea | Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours). 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera') | We will report diarrhea rates at 60 months after the cholera vaccination campaign | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholera, oral cholera vaccine, diarrhea