Hepatitis C
Conditions
Keywords
Hepatitis C
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.
Interventions
OTHERobservation 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.
Sponsors
Janssen Services, LLC
Temple University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Evaluable Patients With Hepatitis C Viremia by Gender | Single 24 hour period | Association between the incidence of hepatitis C infection and gender. |
| 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 |
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hospitalized Patients 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 | 366 |
| Total | 366 |
Baseline characteristics
| Characteristic | Hospitalized Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 128 Participants |
| Age, Categorical Between 18 and 65 years | 238 Participants |
| h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment h/o Hepatitis C Infection | 31 participants |
| h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment h/o Hepatitis C treatment | 0 participants |
| h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment h/o Human Immunodeficiency Virus Infection | 11 participants |
| h/o: HIV, Hepatitis C infection, Intravenous drug use, HCV treatment h/o intravenous drug use | 94 participants |
| Race/Ethnicity, Customized African American | 184 participants |
| Race/Ethnicity, Customized Asian | 2 participants |
| Race/Ethnicity, Customized Caucasian | 67 participants |
| Race/Ethnicity, Customized Latino/a | 84 participants |
| Race/Ethnicity, Customized Other | 14 participants |
| Race/Ethnicity, Customized Unknown | 19 participants |
| Region of Enrollment United States | 366 participants |
| Sex: Female, Male Female | 188 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 366 |
| serious Total, serious adverse events | 0 / 366 |
Outcome results
Primary
Point Prevalence of Hepatitis C Infection
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hospitalized Patients | Point Prevalence of Hepatitis C Infection | 9 percentage of total subjects |
Other Pre-specified
Association Between Evaluable Viremic Patients and Length of Stay in the Hospital
Association between hepatitis C infection and the patient's length of stay in the hospital.
Time frame: Single 24 hour period
Population: Length of stay in days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hospitalized Patients | Association Between Evaluable Viremic Patients and Length of Stay in the Hospital | Length of stay, viremic patients w h/o HCV | 8 Days |
| Hospitalized Patients | Association Between Evaluable Viremic Patients and Length of Stay in the Hospital | Length of stay, viremic patients w/o h/o HCV | 5.5 Days |
| Hospitalized Patients | Association Between Evaluable Viremic Patients and Length of Stay in the Hospital | Length of stay, aviremic patients | 7 Days |
Other Pre-specified
Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia
Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.
Time frame: Single 24 hour period
Population: Number of patients with evaluable plasma
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hospitalized Patients | Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia | # viremic >=50 yrs w h/o HCV | 15 participants |
| Hospitalized Patients | Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia | # viremic >=50 yrs w/o h/o HCV | 9 participants |
| Hospitalized Patients | Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia | Without viremia >=50 yrs | 213 participants |
p-value: =0.04Chi-squared
Other Pre-specified
Number of Evaluable Patients by Prior Visits to the Health System
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
Population: Number of evaluable patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hospitalized Patients | Number of Evaluable Patients by Prior Visits to the Health System | Viremic patient, h/o HCV with >= 1 prior visit | 14 participants |
| Hospitalized Patients | Number of Evaluable Patients by Prior Visits to the Health System | Viremic patient, no h/o HCV with >=1 prior visit | 12 participants |
| Hospitalized Patients | Number of Evaluable Patients by Prior Visits to the Health System | Non-Viremic patient, with >=1 prior visit | 221 participants |
| Hospitalized Patients | Number of Evaluable Patients by Prior Visits to the Health System | Viremic patient, h/o HCV, no prior visit | 2 participants |
| Hospitalized Patients | Number of Evaluable Patients by Prior Visits to the Health System | Viremic patient, no h/o HCV, no prior visit | 2 participants |
| Hospitalized Patients | Number of Evaluable Patients by Prior Visits to the Health System | Non-viremic patient, no prior visit | 90 participants |
p-value: >0.05Chi-squared
Other Pre-specified
Number of Evaluable Patients With Hepatitis C Viremia by Gender
Association between the incidence of hepatitis C infection and gender.
Time frame: Single 24 hour period
Population: Number of evaluable patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hospitalized Patients | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Viremic females with history of Hepatitis C | 8 participants |
| Hospitalized Patients | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Viremic females without a history of Hepatitis C | 6 participants |
| Hospitalized Patients | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Females without viremia | 165 participants |
| Hospitalized Patients | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Viremic males with history of Hepatitis C | 8 participants |
| Hospitalized Patients | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Viremic males without history of Hepatitis C | 8 participants |
| Hospitalized Patients | Number of Evaluable Patients With Hepatitis C Viremia by Gender | Males without viremia | 146 participants |
p-value: >0.05Chi-squared
Other Pre-specified
Number of Patients With Hepatitis C Viremia by Race and Ethnicity
Association between the incidence of hepatitis C infection by race and ethnicity
Time frame: Single 24 hour period
Population: Number of evaluable patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Viremic AA | 14 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Viremic White | 8 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Viremic Latino/a | 8 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Viremic Other/unknown | 1 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Non-viremic AA | 156 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Non-viremic white | 55 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Non-viremic Latino/a | 70 Participants |
| Hospitalized Patients | Number of Patients With Hepatitis C Viremia by Race and Ethnicity | Non-viremic other/unknown | 29 Participants |
p-value: >0.05Chi-squared