Undiagnosed Hepatitis C Infection in an Urban Hospital

NCT ID: NCT01957085

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 366 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Hospitalized Patients

Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention.

observation only

Intervention Type: OTHER

This is an observational only, nonintervention study. There will be no patient contact. This was a de-identified point prevalence study of hepatitis C infection in hospitalized patients in an inner city hospital.

Interventions

observation only

This is an observational only, nonintervention study. There will be no patient contact. This was a de-identified point prevalence study of hepatitis C infection in hospitalized patients in an inner city hospital.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Services, LLC

INDUSTRY

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bettiker, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22351712 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19473706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21825931 (View on PubMed)

Other Identifiers

Undiagnosed Hepatitis C

Identifier Type: -

Identifier Source: org_study_id