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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54CA221705-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VPN Toolkit+TM | Experimental | The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format. |
|
| Text Messages | Active Comparator | Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Grace X Ma, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, Hunter College | New York | New York | 10065 | United States | ||
| Center for Asian Health, Lewis Katz School of Medicine, Temple University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41988576 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study Baseline |
| |||||||||||||
| 12-month Follow-up |
| |||||||||||||
| 18-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | There are 3 cases (1 intervention, 2 control cases) missing information on doctor's visit at the 12-month follow-up assessment point. | Posted | Count of Participants | Participants | 12 months, 18 months |
|
through study completion, 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace X. Ma | Center for Asian Health, Lewis Katz School of Medicine, Temple University | 215-707-6493 | grace.ma@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2019 | Jun 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| TM | Behavioral | Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period. |
|
| Philadelphia |
| Pennsylvania |
| 19140 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Born in the US | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 0 |
| 191 |
| 0 |
| 191 |
| 0 |
| 191 |
| EG001 | 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. | 0 | 191 | 0 | 191 | 0 | 191 |
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| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |