Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV
Phase: NA
Conditions: Hepatitis B, Chronic
Sponsor: Temple University

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
Page 1 of 4 
     Revision: January 23, 2019 
 
 
 
Official title of the study 
Long-Term Adherence To 
Monitoring/Treatment In Underserved Asian 
Americans With Chronic HBV 
 
 
 
NCT number: NCT04082338    
 
 
 
Date of the study protocol with SAP: June 13, 
2019 
 
 
 

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
Page 2 of 4 
     Revision: January 23, 2019 
 
1) Abstract of the study 
Although Asian Americans make up 6% of total U.S. population, they 
account for over 50% of Americans with chronic hepatitis B (CHB), 
which is associated with 75% of hepatocellular carcinoma (HCC). 
Asian Americans as a liver cancer disparity population are 8-13 times 
more likely to develop liver cancer with 60% higher death rate than 
non-Hispanic whites (NHWs). Research indicates that blood tests 
every six months and an abdominal ultrasound every 12 months, 
combined with antiviral treatment (e.g. entecavir or tenofovir) when 
appropriate, is the gold standard of care to reduce the risk of liver 
disease (including HCC). However, adherence to monitoring and 
antiviral treatment guidelines among Asian American patients with 
CHB is as low as 40% to 53%. Poor healthcare access and significant 
cultural barriers may 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, we developed and pilot tested a virtual patient navigation 
toolkit system (VPN toolkit, a web/mobile application that helps 
patients with chronic HBV infection management) to replace our 
traditional patient navigator-led CHB management. Since our 
preliminary data and other studies indicate that text messaging (TM) 
interventions have potential to significantly improve adherence to 
treatment across illnesses, we propose to test the effectiveness of TM 
versus enhanced mHealth intervention (VPN Toolkit + TM) designed to 
help sustain and improve long-term adherence (i.e., 18 months follow 
ups) to monitoring and antiviral treatment guidelines, thereby reducing 
cancer health disparities among underserved at-risk Asian Americans 
with CHB leveraging our existing cohort of CHB subjects. 
2) Protocol Title 
Long-Term Adherence to Monitoring/Treatment in Underserved Asian 
Americans with Chronic HBV 
3) Objectives 
The specific aims are: 1) Evaluate the comparative effectiveness of TM 
vs VPN+TM for improving long-term adherence to monitoring (doctor 
visit and blood tests) at 12- and 18-month follow-ups; 2) 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; 3) Examine mediators of intervention 
effectiveness, including dose-response (i.e., utilization of the TM and 
VPN toolkit), information (knowledge), motivation, and self-efficacy. 

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
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     Revision: January 23, 2019 
Our comparative study of mHealth approaches will demonstrate how 
technology-based interventions can be integrated most effectively into 
real-world clinical settings to reduce HBV-related liver cancer 
disparities. If effective, this VPN+TM intervention is a highly 
disseminable intervention with the potential to have a significant impact 
on reducing viral-related cancer disparities among underserved Asian 
Americans and other highest-risk populations.  
4) Resources and Setting  
The study will be conducted in Philadelphia (Temple University,) and New 
York City (Hunter College). Our long-term collaborating local health care 
providers, communities and organizations, together with our well-trained 
research staff will identify and recruit qualified subjects for this research 
study. 
5) 
Study Design 
a) 
Recruitment Methods 
N=436 (male=218 and female=218) will be recruited. 
The study will start on 01/01/2019, at Temple University and Hunter 
College. 
Recruitment flyer will be used. 
Each subject will receive a $25 gift card as compensation for completion 
at each assessment point including baseline survey and 12-m and 18-m 
follow ups in this study. So the total compensation for each participant will 
be $75 (3x$25.00) for completing the study. 
 
b) Inclusion and Exclusion Criteria 
 
Eligibility: Subjects will be included in the study if they meet the following 
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. Diagnosed for over 12 months  
5. Non-compliant to HBV monitoring and treatment guidelines 
for more than 6 months 
6. Cell phone accessible by receiving text messaging 
7. Not enrolled in any other HBV Management intervention (to 
prevent a potential program impact). 

Protocol Template for Minimal Risk Studies not Regulated by FDA 
 
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     Revision: January 23, 2019 
  
c) Study Procedures, Method, and Data Analysis Plan 
Subjects will be mainly recruited from a cohort of participants in a 
previous study who have known their chronic HBV infection status. 
That was a 2-arm randomized controlled trial (RCT) with individual 
subjects as the unit of randomization. We will correspondingly 
enroll the randomized subjects from the cohort to form the 2-arm 
groups in this study.  
We propose to compare the effectiveness of Text Messaging (TM) 
versus enhanced eHealth intervention of Virtual Patient Navigation 
+ Text Messaging (VPN Toolkit + TM) designed to help sustain and 
improve long-term adherence to chronic HBV monitoring (doctors’ 
visit and blood tests) and medication across 18-month follow ups in 
underserved at risk Asian Americans with chronic hepatitis B. VPN 
toolkit and TM will be delivered via e-Platform. VPN-led CHB 
education has interactive features of multilingual voice over and 
plain texts and knowledge questions with feedback to subjects.  
For primary aim 1, we will compare 4 adherence outcomes: 
doctors’ visits and blood tests at 12 and 18 months. We have at 
least 80% power to detect a 20% difference between arms for 
adherence to doctors’ visits and blood tests, with a 2-sided 
Bonferroni adjusted type-I error of 0.01 (0.05/5 outcomes= 0.01).