Hepatitis C Infection in World Trade Center Responders

Completed

• Conditions: Hepatitis C Infection

• Registration Number: NCT02982993
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-06
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3906

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States