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Chronic HBV Management for Asian American

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082338
Recruitment Status : Active, not recruiting
First Posted : September 9, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Temple University

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.


Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Behavioral: VPN Behavioral: TM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VPN Toolkit+TM
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
Behavioral: 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.


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

Active Comparator: Text Messages
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
Behavioral: TM
Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.




Primary Outcome Measures :
  1. adherence to recommended HBV monitoring (doctor's visits and blood tests) [ Time Frame: 18 months ]
    percentage of subjects, who visited doctor office for HBV blood tests at 12-month and 18-month Follow Up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082338


Locations
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United States, New York
Department of Psychology, Hunter College
New York, New York, United States, 10065
United States, Pennsylvania
Center for Asian Health, Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Grace X Ma, PhD Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04082338    
Other Study ID Numbers: U54 Liver Cancer Study
1U54CA221705-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic