Skip to content

Chronic HBV Management for Asian American

Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04082338
Enrollment
382
Registered
2019-09-09
Start date
2019-04-01
Completion date
2022-03-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

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.

Interventions

BEHAVIORALVPN

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.

BEHAVIORALTM

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Adherence to Recommended HBV Monitoring: Doctor's Visits12 months, 18 monthspercentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up

Countries

United States

Participant flow

Participants by arm

ArmCount
VPN Toolkit+TM
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format. 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. TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
191
Text Messages
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
191
Total382

Baseline characteristics

CharacteristicVPN Toolkit+TMText MessagesTotal
Age, Continuous53.29 Years
STANDARD_DEVIATION 0.91
53.18 Years
STANDARD_DEVIATION 1.04
53.23 Years
STANDARD_DEVIATION 1.38
Born in the US
No
190 Participants187 Participants377 Participants
Born in the US
Yes
1 Participants4 Participants5 Participants
Race/Ethnicity, Customized
Chinese
148 Participants150 Participants298 Participants
Race/Ethnicity, Customized
Vietnamese
43 Participants41 Participants84 Participants
Sex: Female, Male
Female
99 Participants99 Participants198 Participants
Sex: Female, Male
Male
92 Participants92 Participants184 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1910 / 191
other
Total, other adverse events
0 / 1910 / 191
serious
Total, serious adverse events
0 / 1910 / 191

Outcome results

Primary

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

Time frame: 12 months, 18 months

Population: There are 3 cases (1 intervention, 2 control cases) missing information on doctor's visit at the 12-month follow-up assessment point.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
VPN Toolkit+TMAdherence to Recommended HBV Monitoring: Doctor's VisitsDoctor's Visit by 12-month follow-up159 Participants
VPN Toolkit+TMAdherence to Recommended HBV Monitoring: Doctor's VisitsDoctor's Visit by 18-month follow-up170 Participants
Text MessagesAdherence to Recommended HBV Monitoring: Doctor's VisitsDoctor's Visit by 12-month follow-up100 Participants
Text MessagesAdherence to Recommended HBV Monitoring: Doctor's VisitsDoctor's Visit by 18-month follow-up147 Participants

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026