Clinical trial NCT05117541: Social-environmental, Psychosocial, Behavioral, Clinical and Biological Drivers of Disparities in Liver Disease Progression Among Korean American With Chronic Hepatitis B Infection
Official title: Bio-Psycho-Social Drivers of Disparities in Liver Disease Progression Among Korean Americans With Hepatitis B Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Viral Hepatitis
Hepatitis B Infection
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change Chronic hepatitis B (CHB) phenotype
timeFrame: At start of treatment
measure: Change Liver disease severity
timeFrame: At end of treatment
Secondary outcomes:
measure: Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels
timeFrame: Baseline to 10 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: