Patient-Centered Cancer Prevention In Chinese Americans
Phase: NA
Conditions: H. Pylori Infection
Sponsor: NYU Langone Health

 
 
Official Title: 
Patient-Centered Stomach Cancer Prevention in Chinese Americans 
NCT Number: 
NCT03340454 
Study Number: 
17-01446 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
May 9, 2023 
 

1 
 
Protocol: s17-01446 
Version Date: 3/22/23 
 
Study Title: Patient-Centered Stomach Cancer Prevention in Chinese Americans 
Principal Investigator: Simona Kwon, DrPH, MPH 
 
TABLE OF CONTENTS 
 
I. 
PURPOSE OF THE STUDY AND BACKGROUND 
A. Purpose of the Study 
B. Background 
C. Study Design 
II. 
CHARACTERISTICS OF THE RESEARCH POPULATION 
III. 
METHODS & PROCEDURES 
A. Methods & Procedures 
B. Data Analysis and Data Monitoring 
C. Data Storage and Confidentiality 
D. Data Sharing Policy 
IV. 
RISK/BENEFIT ASSESSMENT 
V. 
INVESTIGATOR’S QUALIFICATIONS & EXPERIENCE 
VI. 
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
A. Method of Subject Identification and Recruitment 
B. Process of Consent 
C. Capacity 
D. Subject/Representative Comprehension 
E. Debriefing Procedures 
F. Consent Scripts 
G. Documentation of Consent 
H. Costs to the Subject 
I. 
Payment for Participation 
J. Subject Withdrawal 
VII. 
FUNDING SOURCE 
VIII. 
APPENDIX 
IX. 
REFERENCES 

2 
 
I. PURPOSE OF THE STUDY AND BACKGROUND 
A. 
Purpose of the Study 
The proposed study “Patient-Centered Stomach Cancer Prevention in Chinese Americans” aims to assess 
the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended 
stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. 
The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention 
using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a 
community-engaged culturally and linguistically adapted community health worker (CHW)-led patient 
navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm 
randomized controlled trial (RCT) design, we will enroll 144 Chinese American patients across NYC 
health care facilities (NYU Langone Health – which includes NYU Langone Brooklyn, NYU Langone 
Brooklyn Family Health Centers and affiliated provider practices, and NYU Ambulatory Care Centers – 
Bellevue Hospital Center and Gouverneur Hospital). The integrated intervention involves: 
1. 
A collaboratively developed and refined EHR-based clinical decision support system and 
CHW-led culturally and linguistically adapted stomach cancer prevention program for the 
Chinese American community. 
2. 
A H. pylori test-and-treat intervention using linked EHR tools with a CHW-led culturally and 
linguistically adapted program to improve H. pylori eradication and treatment among 
vulnerable Chinese American patients. 
 
In addition, using a mixed-methods approach and the RE-AIM framework,1 we aim to systematically 
assess the implementation process and delineate factors that influence feasibility, acceptability, adoption, 
sustainability and scalability of a combined EHR-CHW strategy within safety nethealth care systems. 
This will be achieved through the completion of: 
1. 
Assessment of utilization patterns through extracted MCIT files. 
2. 
Qualitative key informant interviews will be conducted by study coordinator with key 
providers (1-3 at each site), and administrator (1-2 at each site), and the CHWs (1 at each site). 
At baseline, the interviews will be incorporated into the workflow analysis to assess current 
satisfaction and EHR usage and health coaching. At follow-up, the interviews will assess 
barriers and facilitators to the implementation and adoption process of the integrated EHR- 
CHW intervention, intervention fidelity, and to solicit recommendations for the replication and 
scalability of the intervention to other clinical sites. 
3. 
Ethnographic data will be collected by CHWs in Year 1 and by the study coordinator in Year 5 
and will be guided by the 5 key steps in a rapid assessment process. 
Impact: The proposed study will inform efforts to prevent stomach cancer and reduce the burden of 
stomach cancer in Chinese American communities served in safety net health systems and establish a 
reproducible, sustainable patient-centered cancer prevention model integrated within health care systems 
serving vulnerable communities. 
 
Substudy: The proposed substudy aims to evaluate the feasibility and response rate for the collection of 
biosamples among Chinese Americans with a clinically confirmed diagnosis of H. pylori. The biosamples 
will be used to assess differences in oral and gut microbiome profiles before and after H. pylori antibiotic 
therapy. This will be achieved through the optional collection of oral and/or fecal biosamples from 
participants in EHR-CHW Intervention component of the study ‘Patient-Centered Stomach Cancer 
Prevention in Chinese Americans’. The proposed substudy will inform efforts to develop novel 

3 
 
biomarkers to improve stomach cancer prevention, risk assessment and early detection among Chinese 
Americans. 
B. 
Background 
B1. Stomach cancer rates in China and in NYC Chinese American communities. Stomach cancer is 
the third most common cause of cancer death worldwide (723,000 deaths annually).2 Approximately 42% 
of new cases of stomach cancer worldwide occur in China.3 In the US, the overall incidence of stomach 
cancer is lower than in other countries, about 8.7 per 100,000 people per year. There are clear 
disparities,however, in stomach cancer incidence in the US, particularly among Chinese American 
populations, who have incidence rates of approximately 11.1 per 100,000 persons per year.4,5 While 
Chinese Americans generally have lower incidence and mortality rates for most cancers compared with 
non-Hispanic whites, they are at higher risk of stomach cancer in the US.6 Similarly, cancer mortality 
studies indicate that Chinese Americans in NYC have lower all-cause mortality and total cancer mortality 
than whites, but they experience higher stomach cancer mortality.7,8 In 2013, stomach cancer incidence 
among Asian Americans was almost twice that of whites in NYC (15.5 vs. 8.1 per 100,000).9 
 
B2. Chinese Americans and H. pylori, the primary risk factor for stomach cancer. Globally, H. 
pylori is one of the most common bacterial infections with approximately 50% of the global population 
infected.10,11 In 1994, the International Agency for Research on Cancer classified H. pylori as a Grade I 
carcinogen in humans.12 Approximately 89% of non-cardia gastric adenocarcinomas can be attributed to 
H. pylori infection.13,14 In East Asian populations, including Chinese, H pylori infection rates can be as 
high as 47-70%.15-17 Our previous NIMHD-funded observational study of H. pylori seroprevalence in a 
NYC East Asian-born population that informs our proposal, found higher seroprevalence, 70.1% 
compared to other NYC groups (<20% seroprevalence), with higher rates reported for recent Chinese 
immigrants.18 
 
B3. Chinese Americans, a vulnerable health disparity population. In NYC, the population of Chinese 
Americans is approximately 574,886: 72% are foreign-born, 34% lack a high school diploma, 61% have 
limited English proficiency (LEP), and 21% are living in poverty.19,20 
 
B4. Chinese Americans, socio-cultural barriers and lifestyle-related stomach cancer risk factors. 
Health care access. For Chinese American communities, the risk of stomach cancer is compounded by 
difficulties in accessing healthcare services, and attendant linguistic, cultural, economic and social 
barriers, which contribute to delayed cancer screenings,21-24 poor medication adherence, and poor disease 
self-management skills.25-28 Acculturation (which includes indicators such as nativity, years in the US, 
English language proficiency) is a significant factor that influences health access and behaviors for 
Chinese American immigrant communities, including impacting screening and disease prevention.25,26 
 
B5. Evidence-base for test-and-treat in high-risk Chinese populations. 
The American College of Gastroenterology’s 2017 clinical guidelines for treating H. pylori infection 
recommends clarithromycin triple therapy consisting of a proton pump inhibitor (PPI), clarithromycin, 
and amoxicillin or metronidazole for 14 days where H. pylori clarithromycin resistance is known to be 
<15%.29 This is an oral regimen of 6-8 pills taken daily at different dosing intervals for 14 days. Test for 
treatment success of eradication therapy should occur at least 4 weeks after completion of antibiotics and 
with patients off PPI for 1-2 weeks, using urea breath test, fecal antigen test, endoscopic testing or other 
clinically approved H. pylori infection diagnostic test. 

4 
 
 
B6. Adherence to H. pylori treatment therapy. Adherence to medication, generally defined as >80% of 
medication uptake,30 is a crucial part of successful treatment and indispensable for reaching clinical 
goals.30,31 In the US, approximately 50%-60% of patients are non-adherent with their prescribed 
medicine, yet research into the causes of suboptimal adherence has been of variable quality and generally 
inconclusive.30,32-35 Adherence to the treatment regimen is the single most important factor in H.pylori 
eradication and is of paramount importance in cancer prevention.36,37 Suboptimal adherence may in fact 
contribute to antibiotic resistance and H. pylori reinfection, undermining the effectiveness of the 
therapy.38,39 The benefit gained from H. pylori eradication such as reducing long-term risk of gastric 
cancer may not be obvious to the patient. Thus, patient education is critical for H. pylori therapy, 
especially given the multiple drugs and dosing intervals of the treatment regimen, along with the 
potential non-serious but uncomfortable side effects which can include diarrhea, abdominal pain, and 
nausea/vomiting.40,41 
 
B7. Rationale for a culturally adapted multifaceted integrated approach. Two main factors that affect 
patients’ compliance are the complexity of H. pylori treatment and the treatments’ side effects.37,42 One 
study in China identified the following specific factors for H. pylori medication nonadherence: lack of 
guidance on drug administration; lack of information about side effects; and preference for traditional 
Chinese medicine due to cultural beliefs that western therapies have more side effects.43,44 Only a few H. 
pylori treatment adherence intervention studies have been conducted, most of which incorporated low- 
touch patient counseling and follow-up,36,42,44-46 and outcomes have largely been inconclusive. Patients in 
an Irish hospital who were randomized to receive detailed counseling on treatment rationale, side effects, 
and compliance importance were significantly more likely to have H. pylori eradicated (94.7% compared 
with 73.7%; p-value=0.02).45 To date, no studies have targeted LEP or vulnerable populations for the 
prevention of stomach cancer. 
 
B7a. CHW approaches: a successful strategy for disease prevention in health disparity communities. The 
role of CHWs as important members of the healthcare workforce to improve health outcomes for 
vulnerable minority communities is recognized by the Institute of Medicine, Centers for Disease Control 
and Prevention, and the American Public Health Association.47-49 (By serving as cultural and linguistic 
bridges between community resources and health systems, CHWs have the potential to address health 
disparities and disseminate efficacious interventions to vulnerable communities. Linking Chinese 
American patients with CHWs in clinical settings will help patients understand and navigate the complex 
H. pylori eradication treatment to reduce stomach cancer risk. 
 
B7b. Electronic Health Record (EHR) interventions can improve cancer prevention and cancer outcomes. 
Physician recommendation and regular visits to the doctor significantly influence rates of screening 
within Asian American communities.21,50 EHR provider prompts are effective tools in health care 
delivery51,52 and have been shown to significantly improve cancer screening, including among Asian 
Americans.53 Furthermore, EHRs can be used as a powerful tool to increase medication adherence54 and 
improve disease management.55,56 The use of clinical decision support systems or alerts using EHR can 
increase provider adherence to recommended screening guidelines and drive quality improvement for 
disease management and prevention.56-59 
 
B7c. An integrated approach (EHR + CHW) is needed to improve education and adherence to stomach 

5 
 
cancer prevention for high-risk groups. Several systematic meta-analyses35,60-63 have identified the lack 
of behavioral, theory-based, multifaceted interventions and have collectively called for future research to 
integrate multiple theories and models to inform adherence-enhancing interventions. Similarly, there is 
demonstrated adequate evidence of the effectiveness of CHWs64-68 operating within structured health 
systems69,70 and of the potential for innovations in health information technology to support medication 
adherence.54 Given the complexity of medical adherence, integrated strategies that include socio- 
behavioral science research and theories along with EHR-based decision support tools are needed to 
help identify and address these complex challenges. To our knowledge, no study has tested an 
intervention combining the complementary strategies of EHR enhancements and CHW-led coaching for 
stomach cancer prevention in a health disparity population. 
 
B8. Summary. This project builds upon an evidence base of CHW effectiveness in low-income, LEP 
communities, and CSAAH’s experience in conducting CHW and EHR-based interventions for chronic 
disease prevention, past observational and current pilot intervention study on H. pylori and stomach 
cancer prevention, and comprehensive hepatitis B-related liver cancer control work. This study proposes a 
unique integration of a health systems-based EHR and CHW-led intervention to address stomach cancer 
disparities among Chinese American communities. H. pylori eradication has demonstrated effectiveness 
in reducing the stomach cancer disparity in at-risk populations; however, insufficient numbers are being 
treated effectively in US. Hence, there is a critical need for theory-informed intervention research in real 
world settings to facilitate H. pylori eradication and reduction of stomach cancer disparities in at-risk 
Chinese American immigrants.  
 
B9. Substudy Background. Gastric cancer is usually incurable when diagnosed at an advanced stage. 
About four out of five stomach cancers in the United States are diagnosed after the cancer has spread to 
other areas of the body, with the five-year survival rate at 4 percent 105-107. Since there is no standard or 
routine screening test for gastric cancer in the US, it is therefore critical to develop novel biomarkers to 
improve prevention, risk assessment and early detection among Chinese Americans. This substudy aims 
to evaluate the feasibility and response rate for the collection of biosamples among Chinese Americans 
with a clinically confirmed diagnosis of H. pylori. The biosamples will be used to assess differences in 
oral and gut microbiome profiles before and after H. pylori antibiotic therapy. 
 
 
C. 
Study Design 
C1. Overall Design 
The purpose of this study is to implement and test the relative effectiveness of an integrated H. pylori test- 
and-treat EHR-CHW intervention among Chinese American patients compared with usual care of EHR- 
only intervention. The primary outcome of interest is H. pylori eradication. The secondary outcomes of 
interest are medication adherence, self-efficacy, health literacy and other factors. This stomach cancer 
prevention study will use a 2-arm RCT design to evaluate the efficacy, adoption, and impact of an 
integrated EHR-based decision-support intervention with CHW-led coaching for high-risk Chinese 
American patients to achieve optimal adherence to H. pylori eradication medication regimen. An advisory 
group will guide the development of a user-friendly EHR intervention and culturally adapted materials 
relevant for Chinese Americans. The interventions will be collaboratively developed and implemented in 
NYC safety net hospitals and clinic sites that serve large proportions of Chinese American patients. 
 
In Year 1, we will engage in a collaborative effort to develop and refine an evidence-based clinical 
decision-support and physician feedback mechanism that can be integrated into existing EHR systems. In 

6 
 
Years 2 to 4, we will implement and evaluate the specific EHR intervention and integrated culturally 
adapted CHW-led patient navigation program. In Year 5, we will assess the implementation process and 
use findings to develop a set of best practices and toolkits for public health and healthcare agencies 
regarding integrated EHR-CHW strategies to improve H. pylori test-and-treat strategies for this stomach 
cancer disparity population. Guided by the RE-AIM framework, we will systematically assess program 
adoption and sustainability to enhance reproducibility of findings and transferability to other Chinese 
American and vulnerable health-disparity populations. 
 
The intervention will be implemented at NYU Langone Health – which includes NYU Langone 
Brooklyn, NYU Langone Brooklyn Family Health Centers and affiliated provider practices, and NYU 
Ambulatory Care Centers – Bellevue Hospital Center and Gouverneur Hospital. 
 
Timeline. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Q1: July-September; Q2: October – December; Q3: January-March; Q4: April-June 
 
 
C2. EHR-CHW Intervention 
Planning Process. Applying a community-engaged approach, we will convene a transdisciplinary 
advisory group and meet on a monthly basis during Year 1 to engage in a collaborative planning process. 
Stakeholders will include representatives from the NYU Medical Center Information Technology 
(MCIT), physician champions from the implementation clinics, project CHWs, representatives from 
Chinese-serving community organizations (e.g. the Chinese American Planning Council) and study 
investigators and staff. We will review existing quality improvement, Health Information Technology 
(HIT) initiatives, and other patient education resources that are currently integrated with the systems. We 
will host a series of MCIT supported WebEx online web conference learning exchanges within the first 4 
months to share information about safety net hospital and clinic sites quality improvement initiatives 
addressing H. pylori eradication and stomach cancer prevention. Information from these learning 
exchanges will guide the advisory group’s efforts in planning the integrated EHR-CHW initiative. 
 
EHR Components.  We will conduct a workflow analysis,71   an analysis of the processes by which a 
clinic or hospital provides care to a patient, that will be guided by a transdisciplinary, community- 
engaged advisory group. Using a rapid assessment process72-77 that is informed by the Agency for 
Healthcare Research and Quality (AHRQ) recommendations on workflow assessments,71 a baseline 
analysis will be conducted at each site. The workflow analysis consists of an iterative process, including 
ethnographic observation and key informant interviews, to provide contextual data on organizational 
workflow, culture, and practice. Analysis results will inform the design of alert and registry functions and 
alignment with the workflow of each site. 
 
Table 4. Project Timeline 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 
Convene advisory group 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Conduct formative data (workflow analysis) 
X 
X 
X 
X 
X 
Develop, adapt, integrate intervention, tools 
X X 
X 
X 
Train CHWs, providers and staffs on tools 
X 
X 
X 
Recruit, randomize & implement intervention 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Baseline and follow-up data collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ongoing supervision and fidelity checks 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Data analysis and process evaluation 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dissemination implemented 
X 
X 
X 
X 
X 
X 
X 
X 
Conduct Substudy 
 
 
X 
X 
X 
X 
X 
X 

7 
 
CHW Components. We will refine the CHW protocol and curriculum. We will conduct a scan of CHW 
and/or care coordination efforts at the sites to determine possible leverage points for the placement of 
CHW initiatives or opportunities to support train-the-trainer models. The advisory group will also review 
any existing materials, adapt them culturally and linguistically for the target population, and integrate 
with the existing pilot CHW educational curriculum. The Ecological Validity Model78 complemented by a 
social marketing approach79 will be applied, to assess and adapt the materials. Small media materials will 
be produced by the advisory group using a participatory process, adapted from our previous studies,80-82 
and may include bilingual palm cards and pamphlets on H. pylori eradication therapy, side effects and 
stomach cancer prevention. 
 
To enhance scientific rigor, measure selection was based on: 1) brevity; 2) presence of domains with face 
validity for Asian American or low-literacy communities; and 3) valid psychometric properties. The 
primary outcome measure is the most rigorous outcome measure related to H. pylori eradication: 
confirmation of H. pylori eradication by fecal antigen test or other clinically approved H. pylori infection 
diagnostic test conducted 4 weeks–3 months post-treatment (to be extracted from EHR). Secondary 
outcomes include: self-efficacy, health literacy, medication adherence and other factors. Medication 
adherence measured using simplified medication adherence questionnaire (SMAQ) and medication 
adherence report scale (MARS-5). Self-efficacy will be measured by the Ottawa Decision Self-Efficacy 
Scale. Health literacy will be assessed using the short form of the European Health Literacy Survey 
Questionnaire (HLS-EU-Q12). Health-related quality of life will be measured by the Patient-Reported 
Outcome Measurement Information System Global Health Scale (PROMIS).86 
 
During the intervention period, patients that meet the eligibility criteria will be identified. The bilingual 
CHWs will complete a brief screening form with potential participants in person or via phone (See Script 
for Telephone Screening and Screening form). The screening form will assess demographic characteristics, 
participant eligibility, interest in our program, and reasons for refusal to participate. For in-person 
screenings, if the patient is eligible and interested in the study, the CHW will obtain verbal informed consent 
for study participation and describe the randomization process (See Combined Verbal Informed Consent ). 
For individuals identified from the EHR registry list, CHWs will conduct phone screenings, and will 
complete the verbal consent process by phone with interested, eligible individuals. CHWs will compile and 
share contact information for consented study participants with the study coordinator on a weekly basis. All 
consented participants will be randomized in a 1:1 ratio using a computer-generated randomization87scheme 
to one of the study arms. 
 
Consented participants randomized to the EHR-CHW intervention arm will receive a standardized 
protocol. The protocol, designed to be flexible, consists of 4 educational sessions to be delivered in a 
group, or per the participant’s preference one-on-one or via telephone or other social networking 
platforms (eg. WeChat). The sessions employ adult learning techniques and group-based learning 
activities. All session materials will be culturally and linguistically adapted. The in-person sessions will 
be held at the clinics and community spaces identified by partner agencies. Data will be collected by 
study staff via surveys at baseline, 2, and 6 months. Scheduled office visits will be tracked via data pulls 
from the EHR system. If no visit is scheduled during the follow-up period, project CHWs will conduct 
follow-up calls to schedule participants for data collection events in the community, at the clinic, or in 
their home, with permission. 
 

8 
 
C 3. Assessment of Implementation, Adoption, Sustainability, and Scalability 
To capture data on utilization patterns of the tailored EHR decision support, provider feedback tools and 
integrated EHR-CHW initiatives, Dr. Mann will work with MCIT to extract system files monthly that 
indicate date and time stamps and user logins for each time the tools were used and/or CHW embedded 
templates were accessed. Data will be extracted into a spreadsheet and analyzed by the study staff. 
Qualitative key informant interviews (See Key Informant Interview Guide) will be conducted by study 
coordinator with key providers (1-3 at each site), administrators (1-2 at each site), and the CHWs (1 at 
each site). At baseline, the interviews will be incorporated into the workflow analysis to assess current 
satisfaction and EHR usage and health coaching. At follow-up, the interviews will assess barriers and 
facilitators to the implementation and adoption process of the integrated EHR-CHW intervention, 
intervention fidelity, and to solicit recommendations for the replication and scalability of the 
intervention to other clinical sites. Questions will be adapted from existing validated measures on 
acceptability, feasibility, adoption, organizational culture, and scalability.88-93 
 
Qualitative ethnographic data will be collected through observations at the clinic sites. Ethnographic data 
will be collected by CHWs in Year 1 and by the study coordinator in Year 5 and will be guided by the 5 
key steps in a rapid assessment process. Observations will occur in clinic waiting and administrative 
areas. Fidelity checklists will be conducted during CHW educational sessions and follow-up. 
 
C4. SUBSTUDY 
Substudy Design. The substudy is an observational feasibility pilot study. We aim to enroll a minimum 
of 10 participants. Only participants already enrolled in the main study are eligible for the substudy (see 
Section II). After enrollment into the main study, trained study staff will introduce study subjects to the 
substudy and offer subjects the opportunity to participate in the substudy in several ways: 1) provision of 
oral wash sample only; 2) provision of stool sample only; and 3) provision of both oral wash and stool 
samples. Study staff will obtain verbal informed consent from interested individuals (See Combined 
Verbal Informed Consent). Study staff who have obtained the verbal consent will document the consent 
and the date of consent on the Enrolled Participants Log. The Enrolled Participants Log is the only 
record linking a participant’s name, subject ID and substudy ID (if applicable).  Substudy participants 
will have the option of mail or in-person pick-up for receiving study materials, which include the kits to 
collect oral wash and fecal samples, participant instructions (See Substudy Instruction Booklet), and 
return stamped envelope. Once the substudy materials are received, study staff will set up an 
appointment to call or meet with substudy subjects remotely via WebEx and answer any questions about 
sample collection and returning the samples of the participant’s choice.  
 
After the completion of their H. pylori antibiotic therapy (approximately two months after enrollment), 
subjects will be sent or given another biosample collection kit with instructions and a return stamped 
envelope for sample collection. For those who did not return study samples, study staff will give a 
reminder call by phone and/or text message (See Script for Substudy Telephone Text Reminders). 
Subjects who return incomplete or unusable study samples will be sent or given another biosample 
collection kit with instructions and return stamped envelope.  
 
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
The overall number of subjects expected to participate in the EHR-CHW Intervention study is 144. Key 

9 
 
informant interviews will be conducted with approximately 10-12 individuals (project CHWs, providers, 
and administrators). 
 
EHR-CHW Intervention 
Inclusion Criteria: An individual is eligible for the intervention if s/he: a) self identifies as Chinese 
American; b) is an outpatient aged 21+; c) plans to continue to live in the region during the next 12 
months; d) is willing to be randomized to either treatment or control groups; and e) has a confirmed 
diagnosis of H. pylori infection by at least one of the following methods: C-urea breath test, histology, 
rapid urease test or bacterial culture, fecal stool antigen test or other clinically approved H. pylori 
infection diagnostic test.94 
 
Exclusion Criteria: The exclusion criteria include: a) advanced chronic disease that would not allow the 
patient to complete follow-up or attend visits; b) allergy to any of the treatment drugs; c) previous gastric 
surgery; d) pregnancy or currently breastfeeding; e) taking antibiotics or bismuth salts within 2 weeks 
before the study. 
 
Rationale for proposed exclusion of gender and racial/ethnic group members: Individuals from other 
racial/ethnic groups are excluded from participation in the intervention as this study is focused on Chinese 
American adults. Men and women will both be invited to participate in this intervention. No children or 
vulnerable subjects will be enrolled in this study. 
 
Substudy 
Inclusion criteria: An individual is eligible for the substudy if s/he is: a) enrolled in the EHR-CHW 
Intervention main study; and b) is willing to provide either an oral sample, a fecal sample, or both. 
Individuals will be excluded from the substudy if they are unable to mail the samples back to the study 
team. 
 
Key Informant Interviews 
Inclusion Criteria: Interviewees must be an adult (18 years and over) and they must be a provider, an 
administrator, or a community health worker. Individuals will be excluded from the interview if the 
interview cannot be conducted in the English language. 
 
III. 
METHODS & PROCEDURES 
A. 
Methods & Procedures 
A1. EHR-CHW Intervention Components 
EHR Component 
Epic, the EHR system, has been integrated at NYU Langone Health, and is being implemented at 
Bellevue and Gouverneur Hospitals. Dr. Mann will oversee MCIT in creating the proposed EHR 
enhancements. 
 
The integrated EHR-CHW protocol will support team-based care by supporting feedback between clinic 
staff and CHWs, including: First, templates will be created that CHWs can complete and upload into the 
EHR. Healthcare providers will be able to access these templates using EHR and building upon existing 
workflow. Second, health coaching and referral materials, to be developed by the advisory committee, 
will be made available to providers through the EHR. Third, CHW communication with the healthcare 

10 
 
team will be facilitated by participation and report-backs from CHWs during regular team “huddles” or 
staff meetings; the frequency of participation will be site-specific and determined by findings from the 
workflow analysis. 
 
Integrated EHR-CHW Protocol Intervention. 
Orientation, Implementation and Training. CHWs have been trained through the NYU-CUNY Prevention 
Research Center Training Program in a set of core competencies, which was developed by CSAAH 
faculty Trinh-Shevrin and Islam.95 
Enrollment & Randomization. H. pylori infected individuals will be identified and recruited into the study 
from NYC health care facilities (NYU Langone Health – which includes NYU Langone Brooklyn, NYU 
Langone Brooklyn Family Health Centers and affiliated provider practices, and NYU Ambulatory Care 
Centers – Bellevue Hospital Center and Gouverneur Hospital). Participants will be identified by 2 
approaches: 1) using ICD codes for H. pylori and Chinese ethnicity identified through a race and 
language code available in EHR, with recently diagnosed H. pylori infection (within 7-days) will be 
identified; via a EHR registry list, and 2) patients will be recruited directly from the above mentioned 
clinics. All consented participants will be randomized in a 1:1 ratio using a computer-generated 
randomization scheme87 to one of the study arms. 
 
CHW Intervention Components. The intervention arm protocol consists of 4 educational sessions: session 
1 will focus on medication adherence, treatment side effects, and the link between H. pylori and stomach 
cancer; and sessions 2 through 4 will focus on reinforcing session 1 themes, stomach cancer risk 
reduction, and links to community-based resources. The sessions employ adult learning techniques and 
group-based learning activities. All session materials are culturally and linguistically adapted. The in-
person sessions will be held at the clinics, community spaces identified by partner agencies or by 
telephone. These sessions will be accompanied by phone call, text or voicemail medication and follow-up 
reminders in the preferred language (frequency depending on participant preference). The intervention 
materials will model scripts and messages informed by Social Cognitive Theory and will include 
reviewing and reinforcing individualized challenges, strategies and action plans for medication adherence 
and stomach cancer prevention. 
 
 
A2. Data Collection 
The recruitment and data collection protocol will be finalized with substantial feedback from the advisory 
group. All study staff involved in recruitment and data collection will receive a standardized training 
orientation on administering surveys and will be certified in human subjects research via the 
Collaborative Institutional Training Initiative (CITI Program). 
 
EHR data will be used for recruitment and for the determination of primary outcomes. Dr. Mann will 
work with MCIT to identify potential participants from EPIC databases. During the recruitment period, 
registry lists will be generated weekly from EHR for physicians who have approved participation of their 
patients. Patients will be contacted either by phone (up to 3 calls) or in person by CHW. All preliminary 
EHR data will be deleted or shredded after one week of retrieval. EHR data to be shared with the study 
team include: demographics (gender, age, race/ethnicity (if available), language (if available), diagnosis 
of H. pylori through ICD codes, dates of clinic visits, name, and telephone number. Scheduled office 
visits will be tracked via quarterly EHR data pulls. EHR data will also be used to follow-up with the 

11 
 
outcome of treatment regimens and to determine H.pylori eradication via fecal stool antigen tests based 
on treatment follow-up procedures of physicians. 
 
Contact information will be collected from participants, including cell phone and home phone numbers, 
home and work address, email address, and Facebook/social networking account information. We will 
also assess whether participants are willing to receive text reminders on their cell phone. Additionally, a 
reminder letter and a small gift (tote bag, etc) will be sent to every participant who is willing to receive 
mail 4 months after enrollment. These strategies have been shown to be effective in retaining participants 
in community-based research. 
 
Data will be collected by study staff via surveys at baseline, 2, and 6 months. Scheduled office visits will 
be tracked via quarterly data pulls form the EHR system. If no visit is scheduled during the follow-up 
period, project CHWs will conduct follow-up calls to schedule participants for data collection events in 
the community, at the clinic, or at their home, with permission. Participants will be compensated $25 for 
each assessments and will receive reminder calls and/or texts 2 weeks prior to data collection events to 
ensure attendance. 
 
Substudy Biosample Collection. Substudy participants will have the option of mail or in-person pick-up 
for receiving study materials, which include the kits to collect oral wash and/or fecal samples and return 
stamped envelope. Once the substudy materials are received, study staff will set up an appointment to 
call or meet with substudy subjects remotely via WebEx and answer any questions about sample 
collection and return. 
 
Substudy subjects will have the option to provide oral wash sample only, fecal sample only, or both. 
Study staff who have obtained the verbal consent will document the consent on the Enrolled Participants 
Log. The Enrolled Participants Log is the only record linking a participant’s name, subject ID and 
substudy ID (if applicable).  
 
Fecal biospample collection: Substudy participants will provide fecal samples (about 8 grams which is 
about 2 teaspoons) in a OMNIgeneGUT fecal sample tube (DNAgenotek, Ontario, Canada). 
Directions for performing the test:  
1) Remove the fecal sample tube with preservation liquid inside from packaging.  
2) Flush the toilet, allow it to refill. The stool cannot touch the toilet bowl or water. Use one of the 
following collection options:  
a. Place saran wrap or provided stool collection paper over the toilet bowl to collect a 
sample of stool.  
b. Just before finishing a bowel movement, use a piece of toilet paper to collect a small 
sample of stool. 
3) Use spoon attached to cap to collect 2 marble sized samples. 
4) Carefully screw the cap closed with sample on spoon. Shake well.  
5) Once the collection is complete, place the tube in the preaddressed package and seal carefully. 
Return to the study center by mail within one day of collection. 
 
Oral wash biosample collection:  Study participants will be asked to swish vigorously with one aliquot 
of 10 ml Scope Original mouthwash sample (Proctor & Gamble, Cincinnati, OH) for 30 seconds.  

12 
 
Participants will be directed to expectorate the mouthwash into a clean specimen tube, and return to the 
study center by mail within one day of collection. 
 
 
B. 
Data Analysis and Data Monitoring 
B1. EHR-CHW Intervention Analysis. 
We will conduct analyses to determine the comparability of the participants in the 2-arms using standard 
techniques, including Student’s t-tests for normally distributed variables (after necessary transformations) 
and chi-squared tests for dichotomous variables. If the randomized groups differ in baseline 
characteristics, we will adjust for those variables in subsequent analyses of program effects. Descriptive 
statistics will be calculated to characterize study participants and to evaluate the distribution of key 
clinical, sociodemographic, and outcome variables. Summary data on medical history, years in the US, 
access to and utilization of primary health care services, and social characteristics (e.g., marital status, 
employment) will be reported. 
 
All analyses will be conducted using intention-to-treat methods to minimize the risk of attrition bias. The 
primary analyses of differences in H. pylori eradication between the intervention and usual care groups 
will first be tested using a chi-squared test of binomial proportions. We will assess level of participation 
for those randomized into the intervention arm, and explore whether level of participation is associated 
with greater changes in health outcomes. Logistic regression analysis will be used to analyze differences 
in outcome between those who receive the intervention and those who do not, controlling for potential 
confounding factors. All quantitative data will be entered and analyzed using standard statistical packages 
(e.g., SAS, R, Stata).The primary analysis will assume that any patient lost to follow-up failed to achieve 
H. pylori eradication. As a sensitivity analysis, we will apply multiple imputation to impute missing 
outcomes assuming a missing-at-random mechanism. 
 
The analysis of secondary outcomes is guided in part by the Social Cognitive Theory. We hypothesize 
that the intervention group, when compared with usual care, will report: 1) increased medication 
adherence; 2) increased self-efficacy for adherence; 3) improved health literacy; 4) improved knowledge 
about stomach cancer prevention; and 5) higher levels of perceived health related quality of life. We will 
compare these intermediate outcomes between groups using t-test or its non-parametric equivalent, the 
Wilcoxon rank-sum test. Sex as a biological variable will be addressed by exploring gender as a potential 
moderator of intervention effects. 
 
Power calculations. For the control group, we conservatively estimate that approximately 55% will 
achieve H. pylori eradication based on several studies of overall and, specifically, Chinese American 
populations.36,45,46,100 We wish to detect an increase in this rate to approximately 80% in the intervention 
group; this difference is reasonable based on studies in Ireland and China that showed increases of 
approximately this magnitude in rates of knowledge and high adherence in similar populations.36,44,45 
Accrual of 144 participants, evenly randomized to intervention or usual care, provide greater than 80% 
power to detect this difference, using a 2-sided, 0.05-level test. 
 
B1a. Substudy Data Analysis.  
Oral and gut microbiome data will be derived from the 16S rRNA sequencing assay from the oral wash 
and fecal samples. Based on barcoded 16S rRNA gene sequence read, each sample will be described as 

13 
 
having “relative abundance of taxa (from bacterial phyla, genera, and species)”.  The pre-processed 
sequences will be further analyzed using QIIME pipeline for analysis of community sequence data.  In 
short, the pipeline consists of the following baseline/upstream statistical analyses: (a) sequence sorting by 
barcode into individual samples; (b) pairwise alignment and clustering of sequences into operational 
taxonomic units (OTUs); (c) computation of absolute abundance matrix; (d) computation of alpha 
(species richness, Shannon index, Simpson index) and beta diversity (e.g. weighted and unweighted 
Unifrac) with rarefaction; and (e) principal component analysis (PCA) generation.  All representative 
sequences from OTUs will be classified at taxonomic levels from phylum to genus using the high 
throughput Classifier at RDP II.  Community structure will be described using membership and 
distribution of every member for a given sample.  Because the number of reads generated from samples 
will vary, we will compare the relative distribution instead of the absolute frequency of organisms 
between samples.  The relative abundance for a given taxon will be calculated as the number of reads 
from this taxon divided by the total number of reads from all taxa. 
 
Anonymized demographic information will be extracted from the main study database and shared with 
authorized study staff on a weekly basis. Descriptive statistics will be calculated to characterize substudy 
participants and to evaluate the distribution of key clinical, sociodemographic, and outcome variables. 
Summary data on medical history, years in the US, access to and utilization of primary health care 
services, and social characteristics (e.g., marital status, employment) will be reported. 
 
B2: Assessment of Implementation, Adoption, Sustainability, and Scalability Analysis. 
B2a. Evaluation Framework. Guided by RE-AIM,1,101 we will collect data on the delivery of the 
intervention and its potential for sustainability and scalability with the goal of facilitating its 
implementation into routine practice. The process evaluation will assess the feasibility, acceptability, and 
sustainability of the intervention. 
 
B2b. Data Sources and Collection. We will use mixed methods to document challenges, barriers, and 
facilitators associated with implementing the multifaceted intervention; these will help to characterize 
feasibility and acceptability in clinic settings, to assess fidelity to the evidence-based strategy, and to 
determine model sustainability and scalability. Data sources will include: 1) quantitative data on 
utilization patterns captured from the EHR; 2) qualitative in-depth interview data (key informant 
interviews) from providers, clinic staff, and CHWs; and 3) ethnographic observational data of workflow 
at clinic sites, use of EHR tools, and organizational barriers and facilitators. 
 
B2c. Analysis. Analysis to address this aim will be guided by the following questions: 
1. 
Utilization Patterns: How frequently do providers utilize the integrated EHR-CHW system and does 
the utilization pattern change over time? Does the intervention increase the utilization and quality of 
measurement reports? The system utilization files from MCIT will be used to analyze utilization patterns 
of the enhanced decision-support or physician alert function, as well as the integrated EHR-CHW options. 
These data will yield descriptive trends for frequency of utilization across the clinic sites as well as an 
estimate of the percentage of adoption in terms of patient follow-up visits. The frequency of quality 
measurement reports will be described and compared 6 months pre- and post-intervention. 
2. 
Providers and Clinic Staffs’ Attitudes Regarding the Integrated Intervention: What are providers’ 
attitudes regarding H. pylori eradication guidelines? How satisfied or dissatisfied are the providers and 
staff with the integrated EHR-CHW tools? What are the barriers and facilitators of point-of-care use of 

14 
 
the tools? How does the intervention affect providers and staffs’ satisfaction with workflow for stomach 
cancer prevention and H. pylori eradication? This set of research questions and the following set will be 
primarily addressed with data from in-depth interviews. Qualitative analysis is described below. 
3. 
Barriers and Facilitators to Implementation Adoption and Implications for Scalability: What 
organizational barriers and facilitators appear to influence implementation of the integrated EHR-CHW 
intervention and its component strategies and how? Did members of the clinics understand and respect 
the respective roles of providers, CHWs, and other members of the team? How were users involved in 
design and implementation? Interview data will be transcribed and observational data will be collected in 
the form of field notes. 
 
Analysis of qualitative data from transcriptions and field notes will follow the "constant comparison" 
analytic approach.102 The “constant comparison” approach is a method of explanation building in which 
the findings of an initial case are compared with a provisional category, property or proposition, revised 
as necessary and then other details or new cases are then compared against the revision and revised again 
as needed. This iterative process is continued until theoretical saturation is reached.102 Central to this 
process is the "thematic" coding scheme. We will develop an initial set of codes, which will be reviewed 
by the advisory group to ensure that they are relevant and complete. For each core code, we will 
ultimately develop one or more "secondary codes" that represent either more specific or restricted aspects 
of the phenomenon, to contextualize it, or to suggest underlying meanings. The secondary codes will vary 
in specificity or subtlety depending on the judged substantive value of additional refinements. Transcripts 
will be coded by at least 4 coders. Coding discrepancies will be discussed and resolved, then the process 
will be repeated with a new set of transcripts until an acceptable level of inter-coder reliability has been 
achieved, estimated using an appropriate chance-corrected statistic (e.g., kappa for nominal data and T- 
index for ordinal data).103 Coded transcripts will be analyzed with ATLAS.ti, a software package for 
qualitative data analysis.104 Analysis will be conducted to inform best practices for dissemination and 
scalability. 
 
C. 
Data Storage and Confidentiality 
Confidentiality will be maintained for participants according to mandatory Institutional Review Board 
regulations, under the supervision of Dr. Simona Kwon. 
 
EHR-CHW Intervention. Data safety procedures will be implemented for this study to minimize the 
likelihood that PHI will be improperly used or disclosed. All patient data will be de-identified by NYU 
staff prior to transfer to NYU databases via a secure sftp site. All electronic PHI associated with the 
study, including data received from EHR and information received from questionnaires will be stored on 
password-protected computers behind the NYULMC firewall. Data will ultimately be disseminated 
through oral presentations, reports and manuscripts and will only contain anonymized data (no PHI). 
The following steps will be taken to keep subject’s private information secured: any paper files will be 
stored in locked file cabinets; only NYULMC IT approved and encrypted storage devices will be used to 
transport/store patient data. Databases will be secured with password protection. The data will be stored 
indefinitely. Patients’ personal information will be kept confidential to the extent permitted by law and 
will not be released without their written permission except as described in this paragraph. To safeguard 
confidentiality and anonymity, a unique code will be assigned to participants. Only the study staff will 
have access to the information that links participants with their unique code. Names of survey 
participants will not be reported in any publication. All computer systems are protected from possible 

15 
 
external access. Only necessary study personnel will have access to subjects’ private information. 
Efforts will be made to minimize invasion of privacy by using the minimum PHI needed to conduct this 
research and by protecting the confidentiality of all private information through restricted access and 
protected storage of study data. 
 
Patient Surveys 
To safeguard confidentiality and anonymity, unique identifiers will be assigned to all participants for all 
portions of the study and all data collection instruments will identify participants only by these unique 
identifiers. On the baseline and follow-up surveys, the first page of the survey will ask participants for 
updated contact information so that study staff can maintain contact throughout the intervention period. 
After the data is collected, the first page of the survey will be removed from the remainder of the survey 
instrument (which will only contain unique identifiers). Data will be entered into REDCap, a survey 
database platform, by a study staff member. Only study staff will have password protected access to the 
data. Laura Wyatt, MPH will serve as the data manager for this study. The Data Manager will be 
responsible for the management of information obtained at the various clinic sites. 
The database will be stored on REDCap’s secure database system, which will be utilized for data 
management purposes. Survey pages containing participant names and contact information and logs 
linking subjects’ identifying information to study numbers will be kept locked in a file cabinet in a secure 
location. Paper baseline and follow-up survey data will be kept separate from identifiable information and 
kept in locked file cabinets in a secure location. Contact information from consented participants will be 
kept on file for the duration of the trial and will be destroyed (both electronic and hard copy) upon the 
dissemination of trial results (approximately 5 years). 
 
Substudy Biosample Handling and Security. The samples in containers will be received by mail via USPS 
at NYU Smilow Research Center and stored at -80 ˚C at a laboratory facility with space dedicated to our 
study samples. Within two weeks of receipt, DNA will be isolated from these specimens and used to 
conduct microbiome assays.  Vials will only be labeled with unique study numbers and be clearly marked 
as substudy samples. No samples will be collected in a vial labeled with patient identifiers. If a sample 
does arrive with patient identifiers, those identifiers will be removed and discarded by study staff before 
storage and will be replaced with a unique study number. Samples will be stored for the duration of the 
study and destroyed upon the dissemination of trial results (approximately 5 years). 
 
Substudy Data Handling and Security. All samples are traced with a computer database that records 
sample type, storage location, date of collection and storage, and study identification number. A separate 
Enrolled Participants’ Log will be maintained which links the specimen to the patient through the study 
identification number. This log will also link the patient to the main study. This log will only be 
accessible to authorized study staff. Neither patient identifiers nor the key will be available to staff 
managing samples at the specimen bank. Data and specimens will be stored without linkage codes to 
ensure the permanent anonymity of the study subjects. Anonymized demographic information will be 
extracted from the main study database and shared with authorized substudy staff on a weekly basis. 
Main study and substudy data will be maintained on separate password-protected databases and server 
locations, and made accessible only to study staff. 
 
Key Informant Interviews. Unique study IDs will be assigned to each key informant in REDCap, and 
these unique study IDs will track interview logistics (including interview date/time, location), interview 
audio file names, and interview transcripts. The REDCap data, audio-recordings and interview transcripts 

16 
 
will be saved on a password protected desktop and backed up on a password protected external hard 
drive, which will be locked in a file cabinet at the NYU Center for the Study of Asian American Health 
office. Once audio recordings are transcribed and entered onto a password protected database, the 
recordings will be deleted from the study files. Only study staff will have access to these audio- 
recordings and study data. To safeguard confidentiality and anonymity, audio-files are de-identified, and 
subject names will not be collected or included in interview transcripts. 
 
D. 
Data Sharing Policy 
The Principal Investigator, advisory committee and research team staff will be responsible for developing 
publication procedures and establishing authorship policies. This study will comply with the NIH Public 
Access Policy, the public will have access to the published results of this intervention. Manuscripts will 
be submitted to peer-reviewed journals and accepted manuscripts will be submitted to PubMed Central 
upon acceptance of publication. The study will be submitted to clinicaltrials.gov and updated as necessary 
in accordance with study development. The clinicaltrials.gov record id is NCT03340454. 
 
IV. RISK/BENEFIT ASSESSMENT 
Risks and protection against risks 
The proposed study and substudy poses minimal risk to participants.  Loss of confidentiality is the 
greatest potential risk to study subjects. There is very minimal risk in providing oral and/or fecal 
biosamples. Participants may feel uncomfortable collecting the samples. Participants can choose not to 
collect the sample(s) if they are uncomfortable. Locked file cabinets will be used to store materials with 
identifying information. All computer systems are protected from possible external access. All data and 
interviews will be stored on a password-protected computer at the NYUGSOM. Names will be replaced 
with identification numbers. All audio recorded key informant interviews will be stored on a password-
protected secure computer at the NYUGSOM. Once audio recordings are transcribed and entered onto a 
password protected database, the recordings will be deleted from the study files. Key informant 
participants will have the right to refuse to participate without any compromise of their employment 
status, reputation or professional relationships. Records of participations will not be linked to employment 
records. Also, if a participant is uncomfortable during an interview situation, they may stop the interview 
at any time without penalty. The data collected for this study will be used strictly for the purposes stated 
in this application and will only be available to NYU research staff. 
 
Potential Benefits to the Subjects 
CHW Intervention: By participating in the proposed research, participants may gain the benefit of 
augmented services related to their H. pylori treatment and stomach cancer-related risk factors. Some 
patients may individually experience no benefit. This study will yield knowledge regarding methods for 
increasing adherence to evidence-based guidelines for treating H. pylori among providers and health staff 
serving Chinese American populations. Overall, the benefits of understanding effective methods for 
helping patients reduce their risk of stomach cancer through incomplete treatment of H. pylori far 
outweigh the remote possibility of a breach of confidentiality. 
 
Substudy: While participants may individually experience no benefit, the substudy will yield further 
knowledge of the oral and gut health of Chinese Americans with H. pylori and the impact of antibiotic 
therapy on their microbiome. 
 

1 7 
 
Key I nf or m a nt I ntervie ws: Partici pati n g pr o vi ders a n d cli nic staff ma y be nefit fr o m t he i nter ve nti o ns 
w hic h are mea nt t o assist t he m wit h i m pr o vi n g t he q ualit y of care t he y pr o vi de f or C hi nese A merica n 
patie nts at -ris k of st o mac h ca ncer. T he st u d y ma y als o ha ve rele va nce t o t he U S healt h care s yste m b y 
testi n g a practice facilitati o n m o del t o e n ha nce i m ple me ntati o n of tea m-base d care i nte grate d wit h E H R 
s yste ms f or pre ve nti n g st o mac h ca ncer. 
 
U n a ntici p ate d a d verse e ve nts  
A n a d verse e ve nt will be c o nsi dere d u ne x pecte d if t he nat ure, se verit y, or fre q ue nc y of t he e ve nt is n ot 
c o nsiste nt wit h t he ris k i nf or mati o n pre vi o usl y descri be d f or t he st u d y i nter ve nti o n. 
A n y i nci de nt, e x perie nce, or o utc o me t hat meets all of t he f oll o wi n g criteria:  
 U ne x pecte d i n nat ure, se verit y, or fre q ue nc y  (i.e. n ot descri be d i n st u d y-relate d d oc u me nts s uc h 
as t he I R B -a p pr o ve d pr ot oc ol or c o nse nt f or m, t he i n vesti gat ors br oc h ure, etc)  
 Relate d or p ossi bl y relate d t o partici pati o n i n t he researc h  (i.e. p ossi bl y relate d mea ns t here is a 
reas o na ble p ossi bilit y t hat t he i nci de nt e x perie nce, or o utc o me ma y ha ve bee n ca use d b y t he 
pr oce d ures i n v ol ve d i n t he researc h) 
S u g gests t hat t he researc h places s u bj ects or ot hers at greater ris k of har m  (i ncl u di n g p h ysical, 
ps yc h ol o gical, ec o n o mic, or s ocial ha r m). 
 
U n a ntici p ate d a d verse e ve nts re p orti n g  
I nci de nts or e ve nts t hat meet t he O H R P criteria f or u na ntici pate d pr o ble ms re q uire t he creati o n a n d 
c o m pleti o n of a n u na ntici pate d pr o ble m re p ort f or m. T he i n vesti gat or is res p o nsi ble t o re p ort 
u na ntici pate d pr o ble ms t o t heir I R B a n d t o t he st u d y s p o ns or. T he u na ntici pate d pr o ble m re p ort 
will i ncl u de t he f oll o wi n g i nf or mati o n:  
•  
Pr ot oc ol i de ntif yi n g i nf or mati o n: pr ot oc ol title a n d n u m ber, PI’s na me, a n d t he I R B pr oj ect  
n u m ber; 
 A detaile d descri pti o n of t he e ve nt, i nci de nt, e x perie nce, or o utc o me;  
 A n e x pla nati o n of t he basis f or deter mi ni n g t hat t he e ve nt, i nci de nt, e x perie nce, or o utc o me 
re prese nts a n u na ntici pate d pr o ble m; 
 A descri pti o n of a n y c ha n ges t o t he pr ot oc ol or ot her c orrecti ve acti o ns t hat ha ve be e n ta ke n or 
are pr o p ose d i n res p o nse t o t he u na ntici pate d  pr o ble m.  
T o satisf y t he re q uire me nt f or pr o m pt re p orti n g, U na ntici pate d pr o ble ms will be re p orte d usi n g t he 
f oll o wi n g ti meli ne: 
 U na ntici pate d pr o ble ms t hat are seri o us a d verse e ve nts will be re p orte d t o t he I R B a n d t o t he  
st u d y s p o ns or wit hi n 1 0 b usi ness da ys of t he i n vesti gat or bec o mi n g a ware of t he e ve nt. 
 All u na ntici pate d pr o ble ms will be re p orte d t o t he I R B a n d t o t he st u d y s p o ns or wit hi n 1 0 
b usi ness da ys of t he i n vesti gat or bec o mi n g a ware of t he  pr o ble m. 
 
V.  
I N V E S TI G A T O R’ S Q U A LI FI C A TI O N S & E X P E RI E N C E 
N Y U  Pers o n nel  
Si m o n a K w o n, Dr P H, M P H is a n Ass ociate Pr ofess or of P o p ulati o n Healt h wit hi n t he N Y U Sc h o ol of 
Me dici ne  a n d will  ser ve as t he PI  of t his st u d y; s he has  s u bsta ntial e x perie nce  i n a da pti n g a n d i m ple me nti n g 
e vi de nce -base d researc h i nter ve nti o ns i n Asia n A merica n c o m m u nities. Dr. K w o n is t he direct or of t he 
C S A A H ( NI M H D U 5 4 M D 0 0 0 5 3 8) a n d has esta blis he d researc h part ners hi ps wit h 2 0 Asia n A merica n - 
ser vi n g c o m m u nit y or ga nizati o ns wit h  a trac k rec or d of recr uiti n g t h o usa n ds of st u d y partici pa nts i n vari o us 
C S A A H researc h trials. Dr. K w o n’s researc h i ncl u des t he f oll o wi n g: direct or of t he 5 -year B Free C E E D: 

18 
 
National Center of Excellence in the Elimination of Hepatitis B Disparities, a multi-level hepatitis B and 
liver cancer prevention center (CDC U58DP001022) where she played a critical role in the design and 
dissemination of evidence-based strategies to reduce hepatitis B and liver cancer disparities among Asian 
American communities; and co-investigator on several CHW-led interventions, including Project DREAM 
examining the effectiveness of CHWs in diabetes management in Bangladeshi Americans in community 
settings (NIMHD P60MD000538). This proposal builds on a completed Perlmutter Cancer Center pilot 
grant (PI: Kwon) to test the feasibility and acceptability of a CHW intervention for stomach cancer 
prevention to enhance adherence to H. pylori eradication treatment in LEP, Chinese American patients. 
 
Devin Mann, MD, MS, is an Associate Professor of Medicine at the NYU School of Medicine and the 
Senior Director of Informatics Innovation and will serve as co-investigator on this study. Dr. Mann has 
extensive expertise in health systems and EHR-based interventions which will be critical for ensuring 
pragmatic workflow integration and clinical adoption for the proposed integration of the Community Health 
Worker workflows into the electronic health record. 
 
Thaddeus Tarpey, PhD will serve as the biostatistician for the study. He is the current Director of the 
PhD Graduate Program in Biostatistics. Dr. Tarpey will provide epidemiological and biostatistical 
support. 
 
Chau Trinh-Shevrin, DrPH, is an Associate Professor of Population Health and Medicine, the Vice 
Chair for Research within the Department of Population Health and the Chief for the Section for Health 
Equity within the New York School of Medicine. Dr. Trinh-Shevrin and will serve as a scientific advisor 
to this study. Dr. Trinh-Shevrin ‘s research for the last 20 years has been centered on the rigorous 
development and evaluation of multi-level strategies to reduce health disparities and advance health 
equity. 
 
Renee Williams, MD is an Assistant Professor of Medicine within the Division of Gastroenterology at 
the NYU Langone Medical Center and will serve as co-investigator from NYC Health+Hospital/Bellevue. 
Dr. Williams will provide clinical and site workflow experience and access to the patient communities. 
 
Yu Chen, PhD, MPH is a Professor of Population Health and Environmental Medicine within the NYU 
School of Medicine and will serve as a co-investigator of the substudy. She has extensive experience as a 
chronic disease epidemiologist. Her research has focused on the role of the gastric and oral microbiome in 
gastric premalignant and malignant lesions. 
 
Yi-Ling Tan, MPH is the Program Manager for the NYU Center for the Study of Asian American 
Health. She has managed various multi-site clinical trials and community-based research studies in 
numerous settings. Ms. Tan received her MPH in Forced Migration and Health from Columbia 
University, Mailman School of Public Health. 
 
Angel Mui, MEd, is the Project Coordinator for the NYU Center for the Study of Asian American Health. She provides 
patient and community outreach and engagement and assist with project and research coordination activities including data 
collection, data analysis, and participant recruitment and retention. She has experience in supporting a number of public 
health projects in the fields of community health research for Chinese-American communities. She received her BA in 
Psychology and Asian Studies from Cornell University and earned her MEd in Mental Health Counseling at Teachers 
College, Columbia University.  

19 
 
 
 
Laura Wyatt, MPH is the Research Data Manager for the NYU Center for the Study of Asian American 
Health. She manages and oversees the data sources across CSAAH, which includes the NYU-CUNY PRC, 
and performs analyses and assists with the dissemination of study findings. In addition, she provides 
epidemiological and biostatistical support for grant development activities within the center. Ms. Wyatt 
received her MPH in Epidemiology from Columbia University, Mailman School of Public Health and also 
studied public health at the University of North Carolina at Chapel Hill. 
 
 
VI. 
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
A. Method of Subject Identification and Recruitment 
EHR-CHW Intervention: H. pylori infected individuals will be identified and recruited into the study from 
the following NYC health care facilities: NYU Langone Health – which includes NYU Langone 
Brooklyn, NYU Langone Brooklyn Family Health Centers and affiliated provider practices, and NYU 
Ambulatory Care Centers – Bellevue Hospital Center and Gouverneur Hospital. Participants will be 
identified by 2 approaches: 1) using ICD codes for H. pylori and Chinese ethnicity identified through a 
race and language code available in EHR, patients with recently diagnosed H. pylori infection (within 7- 
days) will be identified; via a EHR registry list, and 2) patients will be recruited directly at the above 
mentioned sites, all of which serve a substantial Chinese American population. In endoscopy clinics, 
patients are routinely evaluated for H. pylori infection. 
 
CHWs will complete a brief screening form with potential participants in person or via phone, depending 
on the preference of the potential participant and the safety of the study staff and potential participants. The 
form will assess demographic characteristics, participant eligibility, COVID-19 symptoms, interest in our 
program, and reasons for refusal to participate. For in-person screenings, if the patient is eligible and 
interested in the study, the CHW will obtain verbal informed consent for study participation and describe 
the randomization process (See Combined Verbal Informed Consent). All study staff will follow COVID-
19 workplace safety, personal protective equipment and social distancing policies at each recruiting clinic 
site and as required by NYUGSOM. 
 
Individuals identified from the registry list will receive phone calls by CHWs (See Combined Script for 
Telephone Screening), during which CHWs will explain the study and elements of informed consent, and 
will complete the process for verbal informed consent over the phone with interested, eligible individuals. 
Participant names and phone numbers will be needed in order for the CHWs to contact participants regarding 
participation in the intervention (Please see Application for Waiver of Authorization and Documentation of 
Consent). In addition, a screening form (See Telephone Screening Form for CHW Intervention) will be 
completed to verify eligibility. CHWs will call patients a maximum of 3 times over a one-week period at 
varying times of the day to invite them to enroll in the study. CHWs will compile and share contact 
information for consented study participants with the study coordinator on a weekly basis. 
 
Substudy. The substudy is only open to participants who are enrolled in the EHR-CHW intervention. 
Once participants have consented to being in the EHR-CHW intervention, CHWs will explain the 
substudy and elements of informed consent, and will complete the process for verbal informed consent 
over the phone with interested individuals. Study staff who have obtained the verbal consent will 

20 
 
document the consent and the date of consent on the Enrolled Participants Log. The Enrolled Participants 
Log is the only record linking a participant’s name, subject ID and substudy ID (if applicable).  
 No undue pressure will be given to subjects to participate in both studies as participation is entirely 
voluntary (See Combined Verbal Informed Consent). 
 
 
Key Informant Interviews. Participating providers, administrative staff and community health workers 
of clinic sites will receive an invitation to participate in the interview (See Invitation and Elements of 
Informed Consent for Key Informant Interview). No undue pressure will be given to subjects for 
participation as the participation is entirely voluntary (See Verbal Consent Script for Key Informant 
Interview). 
 
B. Process of Consent 
All study personnel will have completed the NYU IRB Mandatory Tutorial and IRB Health Insurance 
Portability and Accountability Act (HIPAA) Training before commencing any data collection activities. 
The informed consent form for this study have been created by the NYU School of Medicine Office of 
Science and Research in accordance with Federal guidelines, including HIPAA. 
EHR-CHW Intervention. To maintain consistency in consent procedures and to reduce selection bias, 
verbal informed consent obtained for both in-person and telephone enrollment (see Application for 
Waiver of Authorization and Documentation of Consent).  
 
If screening is conducted in person, consent processes will take place at clinic sites in a manner that 
maximizes confidentiality and privacy and allows questions to be asked. All study staff will follow 
COVID-19 workplace safety and personal protective equipment policies at each recruiting clinic site and 
as required by NYUGSOM. Participants will be screened in advance for symptoms and asked in advance 
to wear a mask/face covering. All study staff and participants will follow efforts for social distancing 
whenever possible. Eligible participants demonstrating interest in participating in the project will meet 
with a study team member who will explain the intervention and answer any questions. Verbal consent 
(see Combined Verbal Informed Consent) will be obtained in a location allowing privacy and appropriate 
social distancing, on a one-on-one basis.  
 
Participants are free to withdraw from participating in the study at any time without repercussions. 
Participants will be advised during the consent process that they have the right to withdraw entirely and 
that their refusal will not jeopardize their relationships with their CHW or primary care physician. 
 
Substudy. Only participants already enrolled in the main study are eligible for the substudy. Study staff 
will obtain verbal consent from interested participants (see Combined Verbal Informed Consent) and 
offer subjects the opportunity to participate in the substudy in several ways: 1) provision of oral wash 
sample only; 2) provision of stool sample only; and 3) provision of both oral wash and stool samples. 
Participants will be advised participation in the substudy is optional and that their refusal to participate 
in the substudy will not jeopardize their participation in the EHR-CHW Intervention. Participants are 
free to withdraw from the substudy at any time without repercussions. 
 
Key Informant Interviews. A Waiver of Documentation of Consent is being requested for participants of 
Key Informant Interviews for this study (See Application for Waiver of Documentation of Consent for 

21 
 
Key Informant Interview). This request is being made because the consent form, if collected would 
require names to be collected and in doing so would be the only record linking the subject’s name to the 
research. Verbal consent will be obtained to audio-record prior to the start of the interview, but we will 
not collect any personal information or identifiers. Individual names will not be recorded or appear in 
interview notes. Participants will be free to withdraw from the interview at any time without 
repercussions. Participants will be provided with an invitation including the elements of the written 
consent as well as contact information for the study PI. Verbal consent will be obtained from the key 
informants prior to beginning the interview in-person or over the phone as preferred by participant (See 
Verbal Consent Script for Key Informant Interview). 
 
C. Capacity 
We anticipate that all subjects will have the capacity to give informed consent. Language barriers will be 
minimized by having data collectors who speak Chinese and translated consent scripts for the CHW 
intervention (to be translated upon approval of the English version). 
 
D. Subject/Representative Comprehension 
To determine that the subject or his/her authorized representative understood the information presented, 
they will be given the opportunity to ask questions before giving consent to participate. They can also 
choose at that time not to be in the study. The individuals authorized to obtain consent will do so by going 
over the Verbal Informed Consent script with the potential subject. The individuals will explain the 
purpose of the study, the procedures, possible risks and anticipated benefits, that it is voluntary, and how 
to withdraw if they choose to at a later time. Chinese speaking personnel will obtain consent from limited 
English-speaking individuals using a translated Verbal Informed Consent script. Subjects will also be 
asked if they are willing to receive key information about the study by text message. If they are, the Key 
Information Sheet will be texted to them using an NYU-issued, password-protected telephone. 
 
E. Debriefing Procedures 
Information will not be withheld from the subjects related to their participation in the study. 
 
F. Consent Scripts 
Please refer to the consent scripts: Combined Verbal Informed Consent Script and the Key Information 
Sheets  for CHW Intervention and the substudy;  and Invitation and Elements of Consent and Verbal 
Consent Script documents for the Key Informant Interview. 
 
G. Documentation of Consent 
EHR-CHW Intervention and Substudy. Study staff will obtain consent by reading the verbal informed 
consent script to the subject or the subject’s legally authorized representative, and the subject or 
representative will be given adequate opportunity to ask questions before verbally consenting. The 
subject will receive a copy of the key information sheet by text message if they choose so. A translated 
verbal informed consent and key information sheet will be used for non-English speaking subjects, 
depending on their preferred language. 
 
Study staff who have obtained the verbal consent will document the consent and the date of consent on 
the Enrolled Participants Log. The Enrolled Participants Log is the only record linking a participant’s 
name, subject ID and substudy ID (if applicable).  

22 
 
 
Signed informed consent forms from participants consented in earlier versions of the protocol will be 
stored in a separate folder in a locked cabinet accessible only to study staff. 
 
Key Informant Interviews. A Waiver of Documentation of Consent is being requested for participants of 
the Key Informant Interview for this study (see Application for Waiver of Documentation of Consent for 
Key Informant Interview). This request is being made because the consent form, if collected, would 
require names to be collected and in doing so would be the only record linking the subjects name to the 
research. Verbal consent will be obtained prior to the start of the interview, but we will not collect any 
personal information or identifiers. Names of individuals will not be recorded nor appear in interview 
notes. Participants will be free to withdraw from the interview at any time without repercussions. 
Participants will be provided with an invitation including the elements of written consent as well as 
contact information for the study PI. Verbal consent will be obtained from the key informants prior to 
beginning the interview (See Verbal Consent Script for Key Informant Interview). 
 
H. Costs to the Subject 
There are no costs to participate in this study. Any doctor visits and laboratory tests, including the fecal 
antigen test or other clinically approved H. pylori infection diagnostic test, are part of standard care. 
 
I. Payment for Participation 
Participants will receive a payment of $25 each time they complete a questionnaire (baseline, 2 months 
and 6 months). Participants may receive metro cards for travel associated with the project. 
 
Substudy. Subjects will be given a $20 gift card if they provide one type of sample only (either oral 
wash or stool), and a $35 gift card if they provide both oral wash and stool samples. Gift cards will be 
mailed or given to subjects upon successful return of biosamples collected post-H. pylori medication 
completion. 
 
J. Subject Withdrawal 
Any of the participants may withdraw from the study at any time. This will not affect their services and 
care at the clinic site. If a participant is uncomfortable during an interview or survey administration, the 
participant may stop at any time without penalty. If a participant withdraws consent, no further data from 
that participant will be collected. 
 
Early Termination. The study may be suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or termination, will 
be provided by the suspending or terminating party to the investigator and/or the NIH NIMHD, as 
applicable. If the study is prematurely terminated or suspended, the PI will promptly inform the 
Institutional Review Boards (IRBs) and provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination include, but are not limited to: 
• 
Determination of an unexpected, significant, or unacceptable risk to subjects. 
• 
Insufficient adherence to protocol requirements. 
• 
Data that are not sufficiently complete and/or evaluable. 
 
VII. 
FUNDING SOURCE 

23 
 
The main study is supported by NIH-NIMHD U54 MD000538. The substudy is supported by NIH-1P20CA252728-01 
 
 
VIII. 
APPENDIX 
A. Combined Script for Telephone Screening  
B. Screening Form for CHW Intervention 
C. Combined Verbal Informed Consent  
D. Key Information Sheet for CHW Intervention 
E. Key Information Sheet for Substudy 
F. Baseline Survey for CHW Intervention 
G. Follow-up Survey for CHW Intervention 
H. Script for Substudy Telephone Text Reminders 
I. 
Substudy Instruction Booklet 
J. 
Key Informant Interview Guide 
K. Invitation and Elements of Informed Consent Written Text for Key Informant Interview 
L. Verbal Consent Script for Key Informant Interview 
M. Application for Waiver of Authorization for Telephone Screening Form 
N. Application for Waiver of Documentation of Consent for Key Informant Interview 
O. Application for Waiver of Authorization and Documentation of Consent 
 
 
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