Hepatitis Outreach Network (HONE™) Clinical Study
Adults 18 years old and older with no known history of chronic HBV and HCV may be screened and be eligible for inclusion into the HONE study after providing written informed consent. Participants are asked to fill out a self-administered written questionnaire translated into their native language. Categories of data collected include demographic, clinical history, family history, chemistry, and virologic indicators of disease.
All participants have blood drawn to test for the HONE Panel which includes serum alanine aminotransferase (ALT), hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) (HONE Panel). The data collected is added to the study’s Web-based database.
Participants receive the results of their screening via a phone call, with recommendations regarding further testing and management — including treatment and vaccination when appropriate.
Participants that test positive will be administered a phone interview and invited back to Mount Sinai for additional testing to better establish recommendations regarding treatment. Tests include Hepatitis A and D screening, genotyping, liver ultrasound, overall wellbeing, and more at no cost. In addition, participants may qualify to participate in additional studies and enroll in the Institute of Personalized Medicine Biobank Program.
Participants without insurance or a primary care physician are given a referral to physicians for linkage to care, including vaccination against hepatitis B at no cost provided by the New York City Department of Health and Mental Hygiene. HONE data will be used to address research questions for clinical, epidemiological, and humanistic outcomes.
Analysis of data and dissemination of results are overseen by the HONE Advisory Board. This study is approved by the Institutional Review Board of The Mount Sinai Health System (GCO# 09-0395, Expiration 12/31/10).
For more information, please e-mail HONE@mountsinai.org.
HONE is a not for profit program through The Mount Sinai Health System.
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