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OpenTrials
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NCT Number: NCT01957085

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation only

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.

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Janssen Services, LLC

Registry information

Official study title

Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 8, 2013
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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