Hepatitis C Infection in World Trade Center Responders

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT02982993

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), National Institute for Occupational Safety and Health (NIOSH/CDC) (U.S. Fed)

3,906

Enrollment

Location

19.3

Duration (Months)

202.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study provides Hepatitis C virus screening to the members of the World Trade Center Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965, and linkage to care for those found infected. The study will also determine if exposure to human remains, blood and/or bodily fluids during the World Trade Center Health Program activities are associated with Hepatitis C virus infection. These findings would be relevant to the larger United States population, especially to persons born during 1945-1965 who are at high risk of Hepatitis C virus infection.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Infection

Detailed Description

The purpose of the project is to determine if the World Trade Center Health Program cohort is at an increased risk of Hepatitis C virus infection, determine if human exposure to human remains, blood and/or body fluids during the World Trade Center recovery activities is associated with increased risk of Hepatitis C virus infection, and to determine if referral to a co-located site for Hepatitis C virus care is associated with improved linkage to Hepatitis C virus care in the members of the World Trade Center Health Program born during 1945 through 1965.

Study Design

Study Type:

Observational

Actual Enrollment :

3906 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Hepatitis C Infection in World Trade Center Responders

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Jul 12, 2018

Actual Study Completion Date :

Jul 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
WTC responders participating in HCV infection study Members of the World Trade Center Health Program cohort born from 1945 to 1965 who choose to participate in this research study on hepatitis C infection

Outcome Measures

Primary Outcome Measures

Prevalence of Hepatitis C virus infection [2 years]
The investigator will measure the prevalence of Hepatitis C virus infection in 3900 World Trade Center Health program members to test the hypothesis that World Trade Center Health program members have an increased risk of Hepatitis C virus infection.

Secondary Outcome Measures

Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection. [2 years]
The investigator will test the measure of association between exposure to human remains, blood and / or bodily fluids and risk of hepatitis C virus infection, while adjusting for type of activity during work at World Trade Center site and use of personal protective equipment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Member of the World Trade Center Health Program at the Icahn School of Medicine at Mount Sinai
Born during 1945-1965

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

Principal Investigator: Stephanie H Factor, MD,MPH, Icahn School of Medicine at Mount Sinai
Principal Investigator: Paolo Bofetta, MD, MPH, Icahn School of Medicine at Mount Sinai