Chronic HBV Management for Asian American

NCT ID: NCT04082338

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-03-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

VPN Toolkit+TM

The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.

Group Type: EXPERIMENTAL

VPN

Intervention Type: BEHAVIORAL

The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers.

In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period.

TM

Intervention Type: BEHAVIORAL

Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.

Text Messages

Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period

Group Type: ACTIVE_COMPARATOR

TM

Intervention Type: BEHAVIORAL

Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.

Interventions

VPN

The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers.

In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period.

Intervention Type: BEHAVIORAL

TM

Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace X Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1U54CA221705-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U54 Liver Cancer Study

Identifier Type: -

Identifier Source: org_study_id