Clinical trial NCT01957085: Undiagnosed Hepatitis C Infection in an Urban Hospital
Official title: Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Janssen Services, LLC
First posted: 2013-10-08
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to Temple University Hospital on the study dates

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.

Detailed description: De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.

Eligibility 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

Primary outcomes:
measure: Point Prevalence of Hepatitis C Infection
timeFrame: Single 24 hour period
Secondary outcomes:
Other outcomes:
measure: Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
timeFrame: Single 24 hour period
measure: Number of Evaluable Patients With Hepatitis C Viremia by Gender
timeFrame: Single 24 hour period
measure: Number of Patients With Hepatitis C Viremia by Race and Ethnicity
timeFrame: Single 24 hour period
measure: Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
timeFrame: Single 24 hour period
measure: Number of Evaluable Patients by Prior Visits to the Health System
timeFrame: Single 24 hour period
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Robert Bettiker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012 Feb 21;156(4):271-8. doi: 10.7326/0003-4819-156-4-201202210-00004.
citation: Brady KA, Weiner M, Turner BJ. Undiagnosed hepatitis C on the general medicine and trauma services of two urban hospitals. J Infect. 2009 Jul;59(1):62-9. doi: 10.1016/j.jinf.2009.04.008. Epub 2009 May 3.
citation: Seamon MJ, Ginwalla R, Kulp H, Patel J, Pathak AS, Santora TA, Gaughan JP, Goldberg AJ, Tedaldi EM. HIV and hepatitis in an urban penetrating trauma population: unrecognized and untreated. J Trauma. 2011 Aug;71(2):306-10; discussion 311. doi: 10.1097/TA.0b013e31822178bd.