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).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
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