Hepatitis C Infection in World Trade Center Responders

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 12, 2018

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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of Hepatitis C virus infection
    • Time Frame: 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 Measures

  • Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 51 Years

Maximum Age: 72 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Collaborator
    • Centers for Disease Control and Prevention
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephanie H Factor, MD,MPH, Principal Investigator, Icahn School of Medicine at Mount Sinai
    • Paolo Bofetta, MD, MPH, Principal Investigator, Icahn School of Medicine at Mount Sinai

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