Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT05117541
This study explores how psychosocial factors (e.g., chronic stress, depression) may lead to liver disease progression such as liver cirrhosis or liver cancer among Korean American chronic hepatitis B infection patients. Gathering health information over time from Korean Americans with chronic hepatitis B infection may help doctors find better methods of treatment and on-going care.
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Notify Me18 year and older
All sexes
Observational
Philadelphia, Pennsylvania, 19107, United States
PRIMARY OBJECTIVES:
I. To estimate the prevalence of chronic hepatitis B (CHB) phenotype and liver disease severity at enrollment visit, and model how multiple social-environmental, psychosocial, behavioral, clinical and biological attributes are associated with variation in CHB phenotype and disease severity.
II. To identify how these same attributes are associated with disease progression over time.
SECONDARY OBJECTIVE:
I. To examine the moderating effects of these multi-level factors on the relationship between liver disease progression and adverse liver disease outcome (e.g., hepatocellular carcinoma [HCC]), as well as mediating effects of liver disease progression on the relationship between psychosocial factors and liver cancer or death.
EXPLORATORY OBJECTIVE:
I. Using an explanatory mixed methods approach, to understand the care-seeking behaviors, and dynamics of care, within an ethnically concordant liver disease care model, and how these factors may have both direct and mediational effects on adherence, treatment effectiveness, and adverse disease outcomes.
OUTLINE:
Patients participate in interviews over 20-40 minutes and undergo collection of hair samples at baseline and 18-24 months. Patients' medical records are also reviewed.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participate in interviews
Undergo collection of hair samples
Medical records are reviewed
Time frame: At start of treatment
Categorized as follows: 1) immune tolerant, 2) immune active with hepatitis B virus e antigen (HBeAg)(+), 3) immune active with HBeAg(-), and 4) inactive carrier, with patients not fitting into one of these four phenotypes classified as 5) indeterminant. Phenotype at study enrollment will be calculated
Time frame: At end of treatment
Will be estimated using fibrosis 4 (FIB-4) (a parameter calculated using alanine aminotransferase [ALT] and aspartate aminotransferase [AST] values, platelet count and age) and APRI (AST to platelet ratios).
Time frame: Baseline to 10 years
Thomas Jefferson University
Other
Bio-psycho-social Drivers of Disparities in Liver Disease Progression Among Korean Americans With Hepatitis B Infection
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