A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
Phase: NA
Conditions: Hepatitis B
Sponsor: Temple University

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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A Comparative Trial of Improving Care for 
Underserved Asian Americans Infected With HBV 
 
NCT number：02421666 
Document Date: 10/20/2014 
 
Principal Investigator 
 
Grace X. Ma, PhD, Temple University 
 
 
Key Co-Investigators/Consultants: 
 
Yin Tan, MD, MPH, Temple University 
Carolyn Fang, PhD, Fox Chase Cancer Center 
Brenda Seals, PhD, Temple University 
Min Qi Wang, PhD, University of Maryland 
 
 
Tsun You Ting (Patient Partner) 
Yingguo Liu (Patient Partner) 
Jenny Park (Patient Partner) 
 
Xiaoli Ma, MD (Stakeholder) 
Whan S. Chung, MD (Stakeholder) 
Philip Siu, MD (Stakeholder) 
Philip Do, MBA (Stakeholder) 
 
 
Funding Agency 
Patient-Centered Outcomes Research Institute 
 
 
Project Period 
1/1/2015-12/31/2017 
 
 
 
 
 

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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Table of Content 
 
I. PROTOCOL SUMMARY 
 
II. Objectives 
 
III. Study Description 
 
1. Overview of Study Design 
2. Selection of Patient Participants 
3. Intervention Procedures   
1) Study Timeline 
2) Intervention delivery  
4. Measurements and Data Collection Procedures 
 Statistical considerations 
1) Data Analysis Plan 
5. Withdrawal of Subjects 
6. Privacy & Confidentiality 
7. Risks to Subjects 
8. Potential Benefits to Subjects 
9. Informed Consent  
10. Data Safety and Monitoring   
11. Adverse Event Reporting 
  
 
 
 

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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I. 
PROTOCOL SUMMARY 
1. Significant Burden and Impact of Chronic HBV on Asian Americans.   
An estimated 1.4 to 2 million individuals in the U.S. are chronically infected with 
Hepatitis B Virus (HBV or CHB).1-2 The number of Americans with HBV infection has been 
rapidly rising primarily due to the increasing number of immigrants from areas with high 
rates of CHB (infection >8%) including Asian countries such as China, Korea and 
Vietnam,3-4 the three largest subgroups of Asian Americans (AAs). While AAs make up 
4.2% of U.S. total population,5 they account for more than 50% of Americans living with 
CHB.6 Since chronic HBV is usually asymptomatic over many years, the HBV screening 
rate is low; and, as a result, only 35% of infected individuals know they have this disease.7  
Among Asian Americans, fully 2 in 3 of those infected are unaware that they have HBV.8 
        Chronic HBV (CHB) is an emerging health crisis in the US. Approximately 15%-40% 
of those with chronic HBV will develop serious liver diseases during their lifetime including 
decompensated cirrhosis and hepatocellular carcinoma (HCC).4, 9-11 Asian Americans 
(AA) have the highest liver cancer mortality rates and the highest prevalence of CHB.12 
Further, inadequate disease monitoring and care will contribute to poorer outcomes and 
increased healthcare costs.  Indeed, the soaring medical costs associated with HBV 
infection are estimated to be as high as $1.5 billion each year.1, 13-15 
       Early monitoring and adherence to recommended HBV disease management 
guidelines improves health outcomes, prevents expensive complications such as cancer 
treatments or liver transplants, and reduces premature deaths.1, 11, 15, 16-20 
       Despite the health and economic advantages of early monitoring and regular follow 
up care for HBV, few people are receiving such care. One study indicated that fewer than 
50,000 US HBV patients have sought early treatment for HBV, meaning that less than 
10% of those eligible for treatment actually receive monitoring and regular follow up care. 
20 Asian Americans with CHB may not seek care because they “feel well”21, 22, have lower 
access to care (e.g., no regular healthcare provider, need for English translator), face 
more economic (e.g., lack of health insurance, low income) and cultural barriers (e.g., 
negative perceptions of Western medicine, stigma of HBV disease), or have a low level 
of knowledge about HBV and the benefits of care.21, 23-29 Even among Asian American 
CHB patients receiving care, adherence to monitoring and treatment guidelines is low as 
40%-53% at 12 month follow-up.21, 30 
       
2. Significance of the Proposed Study:  
CHB is a major contributor to the racial/ethnic health gap and HBV disparities in 
mortality between AAs and Whites are widening.6, 12  Early monitoring and adherence to 
recommended CHB management guidelines are an essential part of a comprehensive 
approach to improving CHB control for reducing incidence and mortality rates of liver 
cancer.1,7,21-23, 31, 32-35  Patient adherence to regular follow up tests every 6 and 12 months 
is associated with optimal CHB control.11 Unfortunately, early onset of liver problems 
comes without apparent symptoms and only consistent follow-up testing allows for early 
treatment. However, adherence rates to monitoring guidelines are poor among AA CHB 
patients. 

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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       This application provides a unique opportunity to address these gaps in the literature 
and respond to this critical health disparity issue by investigating a Patient Navigator-led 
Text Messaging Intervention (PMNI).  
 
II. 
OBJECTIVES 
The described study is a collaborative effort between the lead agency, Center for 
Asian Health of Temple University and its long-term clinical partners in greater 
Philadelphia area and New York city.  
 
III. STUDY DESCRIPTION 
1. Overview of Study Design 
Patient-centered and community-based participatory research approach will be 
applied to the randomized comparative trial design, a range of quantitative and 
qualitative evaluation methods, and implementation of a HBV intervention to improve 
care for underserved AA chronic HepB patients. Temple U. Center for Asian Heath 
(CAH) partnered with Federally Qualified Community Health Center (FQHC) and 
community primary care clinics that serve low-income Chinese, Korean and 
Vietnamese patients to conduct a comparative trial to evaluate the effectiveness of 
the patient navigator-led plus mobile phone text messaging intervention (PNMI), an 
interactive patient-centered culturally and linguistically appropriate approach. The 
study builds on a strong foundation of 20-year clinic-community-academic 
partnership. As shown in our pilot studies, CBPR approach were applied to engage 
patient partners and stakeholders in project planning, recruitment, delivery, evaluation 
and dissemination.  
The proposed study is a 2-arm randomized comparative trial with individual 
patients as the unit of randomization. Bilingual patient navigators will be recruited and 
trained to deliver the PNMI intervention to help patients improve adherence to HBV 
monitoring tests on time.   
 
2. Selection of Patient Participants 
Inclusion Criteria: Patients (N=500) will be included in the study if they meet the 
following criteria:  
• self-identified Chinese, Korean and Vietnamese ethnicity (these three Asian 
subgroups consist of the largest number of immigrants from countries with high 
prevalence of HBV infection,  
• age 18 and above  
• not enrolled in any chronic HBV adherence management intervention (to 
prevent a potential program impact),  
• medically diagnosed chronic HBV infection with positive for hepatitis B surface 
antigen (HBsAg) for more than six months, and  
• not had HBV monitoring tests for more than six months.  
Exclusion Criteria: Patients will be excluded from the study for the following conditions: 
• diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer 
(The purpose of regular follow up tests is to detect early signs of CHB 

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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complications). Monitoring the progression of CHB complications is different in 
schedules and tests),  
 
3. Intervention Procedures   
1) Study Timeline 
• The duration of the project 
1/1/2015-12/31/2017 
• The duration of a subject’s participation in the study. 
12-13 months  
• The duration anticipated to enroll all subjects. 
12 months 
• The estimated date that the investigators will complete the study. 
December 31, 2017 
2) Intervention delivery  
Following randomization, intervention patients will receive PNMI in-person education 
sessions from patient navigators who navigate patients through the program. PNMI 
focuses on recognizing patients as active participants in their own health care.   PNMI 
intervention bilingual patient navigator-led HBV management; text messaging; clinical 
support assistance and HBV management education visual aids. 
  
4. Statistical considerations 
Data Analysis Plan 
The primary outcome analysis will calculate the difference in adherence rates  
between two groups (PNMI – SC) at 6m or 12m post-intervention. Bonferroni  
multiple comparison adjustment will be used for two primary hypothesis tests. The  
difference of two binomial proportions and its 97.5% (due to Bonferroni adjustment)  
2-sided confidence interval (C.I) will be calculated for inference.  We expect the tests  
for intervention effects for both 6m and 12m post intervention will be highly  
significant with effect size substantially larger than 20%, based on our pilot study  
data and other screening studies. Though not a primary hypothesis, we will examine  
if the adherence rate has declined at 12m from that at 6m by calculating a 95% C.I  
for the difference of two rates.  If the decline is statistically significant, a booster  
intervention after 6m post intervention may be needed for future disseminations.  
To control for known and postulated factors, a number of variables will be included  
as covariates in most analyses, including (1) race, (2) clinics, (3) education, (4) age,  
(5) gender, (6) time living in U.S., (7) birthplace, and (8) English proficiency 
 
 
5. Withdrawal of Subjects 
If a participant to be found out with conditions meeting any of the exclusion criteria, 
she/he will be withdrawn from the research because the medical procedures of those 
conditions are very different with the purpose of proposed study. There will not be any 
consequences for participants if they decide to withdraw from any phase of our project.  
 
6. Privacy & Confidentiality 

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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All collected data will be used solely for the purpose of the research study and treated 
with full confidentiality.  Specifically, each participant will be assigned an ID number, which 
will be used in place of her/his name.  The data will be kept on computers, which will only 
be used by project research team staff.  All study team staff computer is locked by unique 
user name and password. Qquestionnaires will be stored in a locked office where only 
project staff will be permitted to view questionnaire contents. Computer research data will 
not have participants’ private information.  
 
7. Risks to Subjects 
 
We do not anticipate major risks for study participants. The study participants of both 
intervention and comparison groups will receive medical care for HBV monitoring.  There 
may be psychological response to some participants because of possible worsen test 
results from HBV monitoring status. However, the long-term benefits of early detection of 
HBV progression status are much greater than the psychological and emotional trauma 
may be precipitated by a test results. In contrast, these participants can be alerted by 
those results and take early action for necessary medical care.  The PI and study team 
members and collaborating health providers will provide adequate counseling and 
assistance to participants.  
No potential long-range risks are anticipated as a result of this research project.   
We do not anticipate major risks for study participants. The PI and her team members 
and collaborating health providers will provide adequate counseling and assistance to 
participants. In addition, all collaborating clinical partners have capacity to support 
subjects if there are any needs as result of anticipated consequences of participation in 
the research.  
 
8. Potential Benefits to Subjects 
The purpose of this study is to improve HBV routine/regular monitoring adherence. 
Subjects in intervention group of this study will receive education on knowledge about 
HBV monitoring and navigation assistance for their further medical care needs.  
Participants in comparison group will also receive standard care for their routine HBV 
care. Stay with adherence of HBV monitoring is a critical practice to ensure early detection 
of HBV progression and capture the right momentum of early treatment for HBV.  
 
9. Informed Consent  
The consent process will be taken place on site of collaborating clinical partners and 
CBOs located in greater Philadelphia area and New York City.  Project staff will inform 
participants of the nature and purpose of the study as well as participant rights.  A consent 
and HIPPA form will be provided to participants prior to participation in the study. 
Participants will be informed about the purpose and nature of the study, intervention and 
comparison contents of the project, foreseeable risks, benefits of participation and right 
of participants, confidentiality statement, voluntary participation statement, and 
institutional IRB contact and research contact. Participants will be encouraged to contact 
the PI or IRB regarding any concerns about component of the study. Participants are also 
informed that they may choose withdrawing at any time during the study without penalty. 
 
10. Data Safety and Monitoring  

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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To ensure all regulatory requirements of PCORI are met, a Data Safety Monitoring 
Committee consists of five individuals who are expert in the study areas and who are 
familiar with the community but having no conflict of interest with the proposed project.  
The Monitoring Committee will meet in person or teleconference two times a year over 
the course of the study, or at an intermediate time, if needed, in response to immediate 
needs/concerns on IRB related issues, implementation of protocol, and any unanticipated 
problems.  
  
11. Adverse Event Reporting 
Prior to commencement of the study, the project PI and staff will identify possible 
adverse events in consultation with experienced physicians, psychologists, and the Data 
Safety Monitoring Committee for handing participant concerns. Research team will be 
trained on how to respond in a comforting and compassionate manner to discomfort 
expressed by participants. Contact information of a family medical practice doctor and 
specialist will be made available to participants to consult psychological or medical 
concerns. Contact information of the PI and IRB staff is provided to participants for them 
to address any concerns about any component of the study and confidentiality issues.  
 
 

PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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PROTOCOL                                                       PI: Grace Ma, PhD, Temple University  
 
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