Undiagnosed Hepatitis C Infection in an Urban Hospital

• Sponsor: Temple University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01957085
• Collaborator: Janssen Services, LLC (Industry)
• Enrollment: 366
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 19.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Other: observation only

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 366 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Other Outcome Measures

1. Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University
• Janssen Services, LLC

Investigators

• Principal Investigator: Robert Bettiker, MD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Erratum in: Ann Intern Med. 2012 Jun 5;156(11):840.
• 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.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT01957085
• Other Study ID Numbers: Undiagnosed Hepatitis C
• First Posted: Oct 8, 2013
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Temple University: Hepatitis C
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis

Study Results

Participant Flow

Arm/Group Title	Hospitalized Patients
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: Hepatitis C antibody and RNA measured from leftover sera and plasma from the clinical laboratory
Period Title: Overall Study
STARTED	366
COMPLETED	366
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hospitalized Patients
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Overall Participants	366
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	238 65%
>=65 years	128 35%
Sex: Female, Male (Count of Participants)
Female	188 51.4%
Male	178 48.6%
Race/Ethnicity, Customized (participants) [Number]
African American	184 50.3%
Caucasian	67 18.3%
Latino/a	84 23%
Asian	2 0.5%
Other	14 3.8%
Unknown	19 5.2%
Region of Enrollment (participants) [Number]
United States	366 100%
h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment (participants) [Number]
h/o Human Immunodeficiency Virus Infection	11 3%
h/o Hepatitis C Infection	31 8.5%
h/o intravenous drug use	94 25.7%
h/o Hepatitis C treatment	0 0%

Outcome Measures

1. Primary Outcome

Title	Point Prevalence of Hepatitis C Infection
Description	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.
Time Frame	Single 24 hour period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hospitalized Patients
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Measure Participants	366
Number [percentage of total subjects]	9

2. Other Pre-specified Outcome

Title	Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
Description	Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.
Time Frame	Single 24 hour period

Outcome Measure Data

Analysis Population Description

Number of patients with evaluable plasma

Arm/Group Title	Hospitalized Patients/Participants
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Measure Participants	237
# viremic >=50 yrs w h/o HCV	15 4.1%
# viremic >=50 yrs w/o h/o HCV	9 2.5%
Without viremia >=50 yrs	213 58.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hospitalized Patients
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=.04
	Comments	Statistical significance was set at .05 to determine statistical significance.
	Method	Chi-squared
	Comments

3. Other Pre-specified Outcome

Title	Number of Evaluable Patients With Hepatitis C Viremia by Gender
Description	Association between the incidence of hepatitis C infection and gender.
Time Frame	Single 24 hour period

Outcome Measure Data

Analysis Population Description

Number of evaluable patients

Arm/Group Title	Hospitalized Patients/Participants
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Measure Participants	341
Viremic females with history of Hepatitis C	8 2.2%
Viremic females without a history of Hepatitis C	6 1.6%
Females without viremia	165 45.1%
Viremic males with history of Hepatitis C	8 2.2%
Viremic males without history of Hepatitis C	8 2.2%
Males without viremia	146 39.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hospitalized Patients
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	Chi-squared
	Comments

4. Other Pre-specified Outcome

Title	Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Description	Association between the incidence of hepatitis C infection by race and ethnicity
Time Frame	Single 24 hour period

Outcome Measure Data

Analysis Population Description

Number of evaluable patients

Arm/Group Title	Hospitalized Patients/Participants
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Measure Participants	341
Viremic AA	14 3.8%
Viremic White	8 2.2%
Viremic Latino/a	8 2.2%
Viremic Other/unknown	1 0.3%
Non-viremic AA	156 42.6%
Non-viremic white	55 15%
Non-viremic Latino/a	70 19.1%
Non-viremic other/unknown	29 7.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hospitalized Patients
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	Chi-squared
	Comments

5. Other Pre-specified Outcome

Title	Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
Description	Association between hepatitis C infection and the patient's length of stay in the hospital.
Time Frame	Single 24 hour period

Outcome Measure Data

Analysis Population Description

Length of stay in days

Arm/Group Title	Hospitalized Patients
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Measure Participants	341
Length of stay, viremic patients w h/o HCV	8
Length of stay, viremic patients w/o h/o HCV	5.5
Length of stay, aviremic patients	7

6. Other Pre-specified Outcome

Title	Number of Evaluable Patients by Prior Visits to the Health System
Description	Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia
Time Frame	Single 24 hour period

Outcome Measure Data

Analysis Population Description

Number of evaluable patients

Arm/Group Title	Hospitalized Patients
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
Measure Participants	341
Viremic patient, h/o HCV with >= 1 prior visit	14 3.8%
Viremic patient, no h/o HCV with >=1 prior visit	12 3.3%
Non-Viremic patient, with >=1 prior visit	221 60.4%
Viremic patient, h/o HCV, no prior visit	2 0.5%
Viremic patient, no h/o HCV, no prior visit	2 0.5%
Non-viremic patient, no prior visit	90 24.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hospitalized Patients
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	This was an observation only, no intervention study. There were no adverse advents due to the study.
Arm/Group Title	Hospitalized Patients
Arm/Group Description	All patients admitted to Temple University Hospital on the study day Observation only, no intervention: HCV ab and RNA measured from leftover sera and plasma from the clinical laboratory
All Cause Mortality
	Hospitalized Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hospitalized Patients
	Affected / at Risk (%)	# Events
Total	0/366 (0%)
Other (Not Including Serious) Adverse Events
	Hospitalized Patients
	Affected / at Risk (%)	# Events
Total	0/366 (0%)

Limitations/Caveats

These results may apply only to inner city, academic medical center hospitals.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.