Undiagnosed Hepatitis C Infection in an Urban Hospital

April 23, 2020 updated by: Temple University

Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

366

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to Temple University Hospital on the study dates

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospitalized Patients
Observation only. All patients admitted to Temple University Hospital on the study day. Observational only, no intervention.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence 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. Results reported as percentage of subjects who are viremic.
Single 24 hour period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
Time Frame: Single 24 hour period
Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.
Single 24 hour period
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Time Frame: Single 24 hour period
Association between the incidence of hepatitis C infection and gender.
Single 24 hour period
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Time Frame: Single 24 hour period
Association between the incidence of hepatitis C infection by race and ethnicity
Single 24 hour period
Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
Time Frame: Single 24 hour period
Association between hepatitis C infection and the patient's length of stay in the hospital.
Single 24 hour period
Number of Evaluable Patients by Prior Visits to the Health System
Time Frame: Single 24 hour period
Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia
Single 24 hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Janssen Services, LLC

Investigators

  • Principal Investigator: Robert Bettiker, MD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Undiagnosed Hepatitis C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a de-identified, observational only study with no intervention. Individual participant data will not be released.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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