On October 21, 2010, an outbreak of cholera caused by a hybrid Vibrio cholerae O1 strain was confirmed in Haiti; large segments of the population remain at risk of disease due to inadequacies in the water, sanitation, and hygiene infrastructure worsened by the earthquake in January 2010. As of December 26, 2010, a total of 148,787 cases of cholera, resulting in 83,166 hospitalizations and 3,333 deaths, had been reported in Haiti. The Centers for Disease Control and Prevention (CDC) has been asked to provide technical and epidemiological support to the Minist?re de la Sant? Publique et de la Population in Haiti (MSPP) in Haiti to assist in the cholera response.
On October 21, 2010, an outbreak of cholera caused by a hybrid Vibrio cholerae O1 strain was confirmed in Haiti; large segments of the population remain at risk of disease due to inadequacies in the water, sanitation, and hygiene infrastructure worsened by the earthquake in January 2010. As of December 26, 2010, a total of 148,787 cases of cholera, resulting in 83,166 hospitalizations and 3,333 deaths, had been reported in Haiti. The Centers for Disease Control and Prevention (CDC) has been asked to provide technical and epidemiological support to the Minist?re de la Sant? Publique et de la Population in Haiti (MSPP) in Haiti to assist in the cholera response. Estimating resource needs, including liters of IV fluids, hospital beds, and treatment centers, is complicated by the fact that Vibrio cholerae infection causes a wide spectrum of disease, ranging from asymptomatic infection to severe watery diarrhea which can lead to death within hours if untreated. Few studies have examined the percentage of infected individuals who develop severe disease, but estimates have ranged from 2-11% depending on the outbreak setting and strain of V. cholerae. Two serologic surveys in Haiti are proposed for measuring the prevalence of V. cholerae infection, the disease attack rate, and predictors of infection, disease, and severity of disease within highly affected Haitian communities. This is of particular relevance given that this information is not available for the hybrid Vibrio cholerae O1 strain identified in the ongoing Haiti outbreak, and circulating in other cholera endemic countries.
Proposal 1 is a cross-sectional survey in a region where patients with cholera were identified in the preceding 3-6 weeks. All consenting persons older than age 2 years residing in 500 households within a predetermined study area will be recruited for an approximate total of 2,400 participants. The households will not be randomly selected as the objective is to enroll all consenting households in the defined area. Haitian enumerators will verbally administer questionnaires in Creole about demographics, symptoms, and potential risk factors for cholera. Phlebotomists will collect a single blood specimen from each participant for V. cholerae serology, as well as tests for previously identified cholera risk factors including Helicobacter pylori serology, ABO blood type, and nutritional status.
Proposal 2 is a prospective cohort survey in a region near a cholera treatment hospital with a high burden of cholera admissions. From the households of 300 consenting cholera patients non-randomly selected from the cholera treatment hospital, all consenting household contacts of the patients will be recruited for a total of about 900 persons. As in Proposal 1, the index patients and household members will be surveyed and their blood tested. In addition, the study team will return to the households 2 weeks later with a follow-up questionnaire about recent symptoms, and a second blood specimen will be tested for paired V. cholerae serology.
In addition to helping anticipate cholera response resource needs, the data obtained from these surveys will allow for risk factor analysis of progression to severe disease among infected individuals, information needed to optimally identify and protect high-risk populations. Because of the dynamics of the antibody response to V. cholerae, the study must be initiated within no more than six weeks of the time in which cholera spreads through the study area and completed within no more than two months.
US Code:
42 USC 241
Name of Law: Public Health Service Act
US Code:
42 USC 2421
Name of Law: Public Health Service Act
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
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Form 1 Serologic Survey for Vibrio cholerae Infection in Haiti with Assessment of Risk Factors for Asymptomatic, Mild, Moderate, and Severe Disease
OMB Haiti Cholera Section B Supporting Statement 1-14-11.docx
Serologic Survey for Vibrio cholerae Infection in Haiti with Assessment of Risk Factors for Asymptomatic, Mild, Moderate, and Severe Disease