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

Active, not recruiting

• Conditions: Chronic Viral Hepatitis; Hepatitis B Infection
• Interventions: Other: Interview; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

• Registration Number: NCT05117541
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-08-02
• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (interview, biospecimen collection)	Interview	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.
Observational (interview, biospecimen collection)	Electronic Health Record Review	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.
Observational (interview, biospecimen collection)	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.

Primary Outcome Measures

Name	Time	Method
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).
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

Secondary Outcome Measures

Name	Time	Method
Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels	Baseline to 10 years

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States