Clinical trial NCT02982993: Hepatitis C Infection in World Trade Center Responders
Official title: Hepatitis C Infection in World Trade Center Responders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Infection
Keywords: hepatitis C virus
linkage-to-care
World Trade Center Health Program cohort
Baby Boomer
risk factors for hepatitis C virus infection
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2016-12-06
Enrollment: 3906
Sex: ALL
Minimum age (years): 51
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The World Trade Center Health Program is a longitudinal cohort of World Trade Center rescue and recovery workers who participated in the World Trade Center Screening, Monitoring, and Treatment Program at the Icahn School of Medicine at Mount Sinai in New York, New York. Eligible World Trade Center responders were those who had worked or volunteered in lower Manhattan, or the Staten island landfill or barge-loading piers for 4 hours or more from September 11, 2001, to September 14, 2001; 24 hours or more during September, 2001; 80 hours or more from September, 2001, to December, 2001. Persons enrolled in the World Trade Center Health Program and were born from 1945-1965 are eligible.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Hepatitis C virus infection
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between the exposure to human remains, blood and/or bodily fluids to hepatitis C virus infection.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Stephanie H Factor, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Paolo Bofetta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: