Undiagnosed Hepatitis C Infection in an Urban Hospital

Completed

• Conditions: Hepatitis C
• Interventions: Other: observation only

• Registration Number: NCT01957085
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Start: 2014-06
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Results First Submitted: 2016-04-06
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized Patients	observation only	Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention.

Primary Outcome Measures

Name	Time	Method
Point Prevalence of Hepatitis C Infection	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. Results reported as percentage of subjects who are viremic.

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States