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Trial record 3 of 2130 for:    Hepatitis C

Undiagnosed Hepatitis C Infection in an Urban Hospital

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ClinicalTrials.gov Identifier: NCT01957085
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
Robert Bettiker, Temple University

Brief Summary:
The Centers for Disease Control and Prevention estimates that there are approximately 3.2 million people in the United States infected with hepatitis C and a significant percentage of these patients are unaware of their diagnosis. This study will attempt to determine the point prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients admitted to the hospital on two separate days will have hepatitis C testing done on leftover serum and plasma that was collected as part of routine inpatient lab work. Our primary goal is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized population. We will also compare these rates to specific demographic characteristics, such as age, race, gender, zip code and type of insurance to see if any associations exist between these demographics and undiagnosed hepatitis C infection.

Condition or disease Intervention/treatment
Hepatitis C Other: Observation only, no intervention

Detailed Description:
De-identified study of HCV prevalence in the inpatient setting of an inner city hospital.

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Study Type : Observational
Actual Enrollment : 366 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hospitalized Patients
All patients admitted to Temple University Hospital on the study day
Other: Observation only, no intervention
HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory




Primary Outcome Measures :
  1. Incidence of hepatitis C infection [ Time Frame: Single 24 hour period ]
    The point prevalence of hepatitis C infection in our hospitalized patients will be measured on a single day. All leftover plasma/serum samples will be de-identified and tested for hepatitis C antibody and if antibody positive will be tested for hepatitis C polymerase chain reaction.


Other Outcome Measures:
  1. Association between hepatitis C infection and age [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between incidence of hepatitis C in our hospitalized patients and specific age ranges. Age ranges will be: <19, 20-24, 25-29, 30-34, 35-39, 40-44, 45-49, 50-54, 55-59, 60-64 and >64 years of age.

  2. Association between hepatitis C infection and gender [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an increased association between the incidence of hepatitis C infection and either male or female gender.

  3. Association between hepatitis C infection and race [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an increased association between the incidence of hepatitis C infection and a specific race. Races analyzed will include Caucasian, African-American, Hispanic, Asian, Native American and other.

  4. Association between hepatitis C infection and home zip code [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and the patient's home zip code.

  5. Association between hepatitis C infection and insurance type [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and type of insurance (private vs Medicaid vs Medicare vs public assistance).

  6. Association between hepatitis C infection and medical history [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and the patient's other medical history. Specific diagnoses that will be investigated are history of HIV, hepatitis B, prior sexually transmitted illness or abnormal Pap smear and psychiatric disorder.

  7. Association between hepatitis C infection and length of stay in the hospital [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and the patient's length of stay in the hospital.

  8. Association between hepatitis C infection and admission service [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and whether a patient is admitted to a medical or surgical service in the hospital

  9. Association between hepatitis C infection and admission diagnosis [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and the patient's admission diagnosis

  10. Association between hepatitis C infection and prior visits to the hospital [ Time Frame: Single 24 hour period ]
    Data will be analyzed to determine if there is an association between hepatitis C infection and how many prior visits to the hospital the patient has had in the past 3 years


Biospecimen Retention:   Samples Without DNA
All leftover sera and plasma will be banked at -70 degrees Celsius in a secure laboratory for potential future research activities


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to Temple University Hospital on the study dates
Criteria

Inclusion Criteria:

  • Patient admitted to Temple University Hospital on either of the study dates

Exclusion Criteria:

  • Patients admitted on both study dates will only be counted once

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957085


Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Janssen Services, LLC
Investigators
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Principal Investigator: Robert Bettiker, MD Temple University

Publications:
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Responsible Party: Robert Bettiker, Infectious Disease Attending, Temple University
ClinicalTrials.gov Identifier: NCT01957085     History of Changes
Other Study ID Numbers: Undiagnosed HCV
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016

Keywords provided by Robert Bettiker, Temple University:
Hepatitis C

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections