Chronic HBV Management for Asian American
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VPN
TM
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B, Chronic
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:
-
Sites / Locations
- Department of Psychology, Hunter College
- Center for Asian Health, Lewis Katz School of Medicine, Temple University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VPN Toolkit+TM
Text Messages
Arm Description
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04082338
First Posted
September 5, 2019
Last Updated
June 15, 2023
Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04082338
Brief Title
Chronic HBV Management for Asian American
Official Title
Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VPN Toolkit+TM
Arm Type
Experimental
Arm Description
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
Arm Title
Text Messages
Arm Type
Active Comparator
Arm Description
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
Intervention Type
Behavioral
Intervention Name(s)
VPN
Intervention Description
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
Intervention Name(s)
TM
Intervention Description
Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
Primary Outcome Measure Information:
Title
Adherence to Recommended HBV Monitoring: Doctor's Visits
Description
percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up
Time Frame
12 months, 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace X Ma, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Center for Asian Health, Lewis Katz School of Medicine, Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chronic HBV Management for Asian American
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