Chronic HBV Management for Asian American

Not Applicable

Completed

Conditions: Hepatitis B, Chronic

Interventions: Behavioral: VPN
Behavioral: TM

Registration Number: NCT04082338

Lead Sponsor: Temple University

Brief Summary: About 75% of liver cancers are attributed to chronic hepatitis B (CHB). An estimated 2.2 million individuals in the U.S. have CHB. Although Asian Americans make up 6% of total U.S. population, they account for over 58% of Americans with CHB. Prevalence rates of CHB range from 8% to 13% in Asian Americans vs 1% in Non-Hispanic whites (NHW). Asian Americans are 8-13 times more likely to develop liver cancer with 60% higher death rate than NHW. Regular monitoring of CHB is vital in preventing HCC. Research indicates that regular monitoring (e.g., every six months doctor visit; blood tests) combined with antiviral treatment when appropriate, is critical to reduce the risk of liver disease (including HCC). Unfortunately, treatment effectiveness diminishes if CHB patients do not adhere to long-term monitoring and treatment guidelines. Adherence among Asian Americans with CHB is low. Poor healthcare access and significant cultural barriers prevent long-term adherence to monitoring and optimal treatment, placing Asian Americans at disproportionately high risk for HCC and increased healthcare costs.

Building on previous studies, the investigators will use a virtual patient navigation (VPN) toolkit system (a web/mobile application) to help CHB patients improving their liver disease management.

Detailed Description: Liver cancer is the second-leading cause of cancer deaths worldwide, which increased at the highest rate of all cancers in the U.S between 2003 and 2012. Asian Americans have the highest incidence and mortality rates of hepatocellular carcinoma (HCC) of all U.S. racial/ethnic groups. About 75% of liver cancers are attributed to chronic hepatitis B (CHB). An estimated 2.2 million individuals in the U.S. have CHB. Although Asian Americans make up 6% of total U.S. population, they account for over 58% of Americans with CHB. Prevalence rates of CHB range from 8% to 13% in Asian Americans vs 1% in Non-Hispanic whites (NHW). Asian Americans are 8-13 times more likely to develop liver cancer with 60% higher death rate than NHW. Regular monitoring of CHB is vital in preventing HCC. Research indicates that regular monitoring (e.g., every six months doctor visit; blood tests) combined with antiviral treatment when appropriate, is critical to reduce the risk of liver disease (including HCC). Unfortunately, treatment effectiveness diminishes if CHB patients do not adhere to long-term monitoring and treatment guidelines. Adherence among Asian Americans with CHB is as low. Poor healthcare access and significant cultural barriers prevent long-term adherence to monitoring and optimal treatment, placing Asian Americans at a disproportionately high risk for HCC and increased healthcare costs.

Building on previous studies, the investigators will use a virtual patient navigation (VPN) toolkit system (a web/mobile application) to help CHB patients improving their liver disease management. This study addresses DHHS and NIH National top priorities, Institute of Medicine's national goal of eliminating HBV and urgent need to evaluate evidence-based interventions that can be integrated into primary care setting and other relevant settings.

The specific aims of the study are:

Aim 1 (Primary) Evaluate comparative effectiveness of Text Message (TM) vs VPN+TM in improving long-term adherence to monitoring (regular doctor visit; blood tests) at 12- and 18- month follow ups. Aim 2 (Secondary) Compare the effectiveness of TM vs VPN+TM in improving and sustaining medication adherence (measured through self-report and electronic monitoring) among Asian Americans with CHB who meet antiviral treatment guidelines. Aim 3 (Exploratory) Examine mediators of intervention effectiveness, including information (knowledge), motivation, and self-efficacy, as well as dose-response.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 382

Inclusion Criteria

1. Age 18 and above
1. Self-identified Chinese, Korean or Vietnamese ethnicity
1. Chronic HBV infection with positive HBV surface antigen (HBsAg)
1. Non-compliant to HBV monitoring and treatment guidelines

Exclusion Criteria

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VPN Toolkit+TM	VPN	The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
Text Messages	TM	Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
VPN Toolkit+TM	TM	The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.

Primary Outcome Measures

Name	Time	Method
Adherence to Recommended HBV Monitoring: Doctor's Visits	12 months, 18 months	percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Department of Psychology, Hunter College
🇺🇸
New York, New York, United States
Center for Asian Health, Lewis Katz School of Medicine, Temple University
🇺🇸
Philadelphia, Pennsylvania, United States