Social-environmental, Psychosocial, Behavioral, Clinical and Biological Drivers of Disparities in Liver Disease Progression Among Korean American With Chronic Hepatitis B Infection

Sponsor

Thomas Jefferson University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05117541

Collaborator

(none)

600

Enrollment

Location

55.9

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Viral Hepatitis Hepatitis B Infection	Other: Interview Procedure: Biospecimen Collection Other: Electronic Health Record Review

Detailed Description

PRIMARY OBJECTIVES:

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.
To identify how these same attributes are associated with disease progression over time.

SECONDARY OBJECTIVE:

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:

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Bio-Psycho-Social Drivers of Disparities in Liver Disease Progression Among Korean Americans With Hepatitis B Infection

Actual Study Start Date :

Aug 2, 2021

Anticipated Primary Completion Date :

Mar 30, 2026

Anticipated Study Completion Date :

Mar 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Interview Participate in interviews Procedure: Biospecimen Collection Undergo collection of hair samples Other: Electronic Health Record Review Medical records are reviewed

Arm

Intervention/Treatment

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.

Other: Interview

Participate in interviews

Procedure: Biospecimen Collection

Undergo collection of hair samples

Other: Electronic Health Record Review

Medical records are reviewed

Outcome Measures

Primary Outcome Measures

Change Chronic hepatitis B (CHB) phenotype [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
Change Liver disease severity [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).

Secondary Outcome Measures

Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels [Baseline to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
Korean-American male or female, age over 18 and older
CHB Patients who have lab and medical record data (including hepatitis B virus [HBV] deoxyribonucleic acid [DNA] viral load, hepatitis B virus e Antigen [HBeAg] status, and liver enzyme values) exist from 2015 or before

Exclusion Criteria:

Patients who have received a diagnosis of HCC, although they may have been diagnosed with cirrhosis
Patients who have been diagnosed with other viral infections (hepatitis C virus [HCV], human immunodeficiency virus [HIV], etc.)
Patients who have total baldness