Chronic HBV Management for Asian American

NCT04082338 | Completed Results

• 2 other identifiers: U54 Liver Cancer Study1U54CA221705-01A1
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Adherence to Recommended HBV Monitoring: Doctor's Visits

  percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up

  12 months, 18 months

Study Arms (2)

VPN Toolkit+TM

EXPERIMENTAL

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

Behavioral: VPN; Behavioral: TM

Text Messages

ACTIVE COMPARATOR

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

Behavioral: TM

Interventions

VPN 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.

VPN Toolkit+TM

TM 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; VPN Toolkit+TM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Temple University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Department of Psychology, Hunter College

New York, New York, 10065, United States

Location

Center for Asian Health, Lewis Katz School of Medicine, Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Grace X. Ma
• Organization: Center for Asian Health, Lewis Katz School of Medicine, Temple University

grace.ma@temple.edu

215-707-6493

Study Officials

• Grace X Ma, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Locations

US (2)