NCT05117541

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 365 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Chronic Viral Hepatitis
• Hepatitis B Infection

Interventions

Type	Name	Description
OTHER	Interview	Participate in interviews
PROCEDURE	Biospecimen Collection	Undergo collection of hair samples
OTHER	Electronic Health Record Review	Medical records are reviewed

Timeline

• Start date: 2021-08-02
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2021-11-11
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States