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| ID | Type | Description | Link |
|---|---|---|---|
| JT 17047 | Other Identifier | JeffTrial Number | |
| R01DK125541 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (interview, biospecimen collection) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Participate in interviews |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change Chronic hepatitis B (CHB) phenotype | 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 | At start of treatment |
| Change Liver disease severity | 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). | At end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels | Baseline to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Korean American patients with chronic hepatitis B infection at Liver Disease Prevention Center, Thomas Jefferson University Hospital (TJUH) or Asian Pacific Liver Center (APLC), Coalition of Inclusive Medicine
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| Name | Affiliation | Role |
|---|---|---|
| Hee-Soon Juon, PhD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| Biospecimen Collection |
| Procedure |
Undergo collection of hair samples |
|
| Electronic Health Record Review | Other | Medical records are reviewed |
|
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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