Hepatitis B, ChronicNCT04082338
Chronic HBV Management for Asian American
A study testing VPN and TM in people with Hepatitis B, Chronic, run by Temple University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- VPN and TM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Psychology, Hunter College
New York, New York, 10065
Center for Asian Health, Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV
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.
Read the 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
- Being tested
- VPN, TM
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPNBehavioural
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.
TMBehavioural
Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
| Study group | Role | What they receive |
|---|---|---|
| VPN Toolkit+TM | Experimental | The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format. Receives: 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 Receives: Behavioral: TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Apr 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Grace X Ma, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082338
- Sponsor's protocol ID
- U54 Liver Cancer Study
- Other IDs
- 1U54CA221705-01A1
- Status last verified
- Jun 2023
- First submitted
- 5 Sep 2019
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu L, Lu W, Liu ZE, Zhu D, Yeh MC, Nguyen MT, Tan Y, Wang MQ, Ma GX. Effects of a culturally tailored intervention on medication adherence in Chinese and Vietnamese Americans with hepatitis B: a randomized controlled trial. Front Public Health. 2026 Mar 31;14:1681835. doi: 10.3389/fpubh.2026.1681835. eCollection 2026.
PubMed 41988576
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV
- ClinicalTrials.gov ID
- NCT04082338
- Acronym / sponsor ID
- U54 Liver Cancer Study
- Conditions
- Hepatitis B, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VPN Toolkit+TM | Experimental | Behavioral: VPN, Behavioral: TMThe intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format. |
| Text Messages | Active comparator | Behavioral: TMReceive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPNThe 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. | Behavioural | VPN Toolkit+TM |
| TMReceive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period. | Behavioural | Text Messages, VPN Toolkit+TM |
Primary outcome
Adherence to Recommended HBV Monitoring: Doctor's Visits
Time frame: 12 months, 18 months
percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41988576Zhu L, Lu W, Liu ZE, Zhu D, Yeh MC, Nguyen MT, Tan Y, Wang MQ, Ma GX. Effects of a culturally tailored intervention on medication adherence in Chinese and Vietnamese Americans with hepatitis B: a randomized controlled trial. Front Public Health. 2026 Mar 31;14:1681835. doi: 10.3389/fpubh.2026.1681835. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace X Ma, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPN and TM in people with Hepatitis B, Chronic, run by Temple University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Recommended HBV Monitoring: Doctor's Visits (time frame: 12 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.