Community-Based Helicobacter pylori Screening in High-Risk U.S. Populations: Protocol for a Mixed-Methods Study to Inform Gastric Cancer Prevention and Migration-Informed Risk Modeling

Community-Based Helicobacter pylori Screening in High-Risk U.S. Populations: Protocol for a Mixed-Methods Study to Inform Gastric Cancer Prevention and Migration-Informed Risk Modeling | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var j=j||B.errorTimeout,l=b.createElement(a),o=0,r=0,u={t:d,s:c,e:f,a:i,x:j};1===y[c]&&(r=1,y[c]=[]),"object"==a?l.data=c:(l.src=c,l.type=a),l.width=l.height="0",l.onerror=l.onload=l.onreadystatechange=function(){k.call(this,r)},p.splice(e,0,u),"img"!=a&&(r||2===y[c]?(t.insertBefore(l,s?null:n),m(k,j)):y[c].push(l))}function j(a,b,c,d,f){return q=0,b=b||"j",e(a)?i("c"==b?v:u,a,b,this.i++,c,d,f):(p.splice(this.i++,0,a),1==p.length&&h()),this}function k(){var a=B;return a.loader={load:j,i:0},a}var l=b.documentElement,m=a.setTimeout,n=b.getElementsByTagName("script")[0],o={}.toString,p=[],q=0,r="MozAppearance"in l.style,s=r&&!!b.createRange().compareNode,t=s?l:n.parentNode,l=a.opera&&"[object Opera]"==o.call(a.opera),l=!!b.attachEvent&&!l,u=r?"object":l?"script":"img",v=l?"script":u,w=Array.isArray||function(a){return"[object Array]"==o.call(a)},x=[],y={},z={timeout:function(a,b){return b.length&&(a.timeout=b[0]),a}},A,B;B=function(a){function b(a){var a=a.split("!"),b=x.length,c=a.pop(),d=a.length,c={url:c,origUrl:c,prefixes:a},e,f,g;for(f=0;f<d;f++)g=a[f].split("="),(e=z[g.shift()])&&(c=e(c,g));for(f=0;f<b;f++)c=x[f](c);return c}function g(a,e,f,g,h){var i=b(a),j=i.autoCallback;i.url.split(".").pop().split("?").shift(),i.bypass||(e&&(e=d(e)?e:e[a]||e[g]||e[a.split("/").pop().split("?")[0]]),i.instead?i.instead(a,e,f,g,h):(y[i.url]?i.noexec=!0:y[i.url]=1,f.load(i.url,i.forceCSS||!i.forceJS&&"css"==i.url.split(".").pop().split("?").shift()?"c":c,i.noexec,i.attrs,i.timeout),(d(e)||d(j))&&f.load(function(){k(),e&&e(i.origUrl,h,g),j&&j(i.origUrl,h,g),y[i.url]=2})))}function h(a,b){function c(a,c){if(a){if(e(a))c||(j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}),g(a,j,b,0,h);else if(Object(a)===a)for(n in m=function(){var b=0,c;for(c in a)a.hasOwnProperty(c)&&b++;return b}(),a)a.hasOwnProperty(n)&&(!c&&!--m&&(d(j)?j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}:j[n]=function(a){return function(){var b=[].slice.call(arguments);a&&a.apply(this,b),l()}}(k[n])),g(a[n],j,b,n,h))}else!c&&l()}var h=!!a.test,i=a.load||a.both,j=a.callback||f,k=j,l=a.complete||f,m,n;c(h?a.yep:a.nope,!!i),i&&c(i)}var i,j,l=this.yepnope.loader;if(e(a))g(a,0,l,0);else if(w(a))for(i=0;i (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0];var j=d.createElement(s);var dl=l!='dataLayer'?'&l='+l:'';j.src='//www.googletagmanager.com/gtm.js?id='+i+dl;j.type='text/javascript';j.async=true;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-P4HH5NV'); Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search Community-Based Helicobacter pylori Screening in High-Risk U.S. Populations: Protocol for a Mixed-Methods Study to Inform Gastric Cancer Prevention and Migration-Informed Risk Modeling Chul S. Hyun , Sarah Soyeon Oh , Sung Hwi Hong , Jae Il Shin doi: https://doi.org/10.1101/2025.08.28.25334491 Chul S. Hyun 1 Department of Medicine, Section of Digestive Diseases, Yale School of Medicine , New Haven, CT, United States Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: shinji{at}yuhs.ac chul.hyun{at}yale.edu Sarah Soyeon Oh 2 Institute for Global Engagement & Empowerment, Yonsei University , Seoul, Republic of Korea Find this author on Google Scholar Find this author on PubMed Search for this author on this site Sung Hwi Hong 3 Severance Underwood Meta-Research Center, Institute of Convergence Science, Yonsei University , Seoul, Republic of Korea Find this author on Google Scholar Find this author on PubMed Search for this author on this site Jae Il Shin 1 Department of Medicine, Section of Digestive Diseases, Yale School of Medicine , New Haven, CT, United States 3 Severance Underwood Meta-Research Center, Institute of Convergence Science, Yonsei University , Seoul, Republic of Korea 4 Department of Pediatrics, Yonsei University College of Medicine , Seoul, Republic of Korea Find this author on Google Scholar Find this author on PubMed Search for this author on this site For correspondence: shinji{at}yuhs.ac chul.hyun{at}yale.edu Abstract Full Text Info/History Metrics Supplementary material Data/Code Preview PDF Abstract Introduction Gastric cancer (GC) remains a persistent and underrecognized health disparity in the United States, disproportionately affecting immigrant communities from East Asia, Latin America, and other high incidence regions. Helicobacter pylori (H. pylori), a WHO Group 1 carcinogen and the leading modifiable risk factor for non cardia GC, remains largely unaddressed in U.S. screening guidelines, despite successful international eradication programs. Methods and Analysis This prospective, mixed methods study will enroll 2,000 adults aged 30 to 80 from Asian, Hispanic, and other high risk racial/ethnic backgrounds across the Greater New York area. Participants will be recruited through partnerships with trusted community organizations. Each will complete a multilingual survey and undergo H. pylori testing (urea breath test), with confidential follow up and referral. The survey will assess demographic, clinical, and KAP (knowledge, attitudes, practices) variables. A migration informed risk index will be developed using logistic regression and validated using k fold cross validation and bootstrap resampling. Ethics and Dissemination Approved by the Yale University IRB, with informed consent obtained in preferred languages. Results will be disseminated through community forums, peer reviewed publications, academic conferences, and policy briefings. Strengths and Limitations of This Study Culturally and linguistically sensitive screening and navigation strategies tailored to high-risk immigrant populations First U.S.-based effort to develop a migration-informed risk index for H. pylori using clinical, demographic, and KAP data Combines multilingual outreach and venue-based recruitment with predictive modeling to inform risk-stratified screening Enables detailed assessment of screening barriers and supports a multidimensional prevention framework Limitations include potential selection bias, limited geographic generalizability, and reliance on self-reported data; external validation will be necessary Introduction Gastric cancer (GC) is a leading cause of cancer-related mortality worldwide and reflects persistent health disparities in the U.S., particularly among immigrants from East Asia, Latin America, and Eastern Europe. With approximately 1.1 million new cases and 770,000 deaths in 2020 alone, GC is projected to rise to 1.8 million cases and 1.3 million deaths by 2040. 1 Although often viewed as a racial/ethnic disease, GC is fundamentally migration-linked, with risk concentrated in individuals from high-incidence regions. H. pylori infection, a major contributor to GC and typically acquired in childhood, is classified as a WHO Group 1 carcinogen. Despite global eradication successes, the U.S. lacks national screening guidelines for GC or H. pylori, resulting in missed opportunities for prevention among immigrant communities. 2 In contrast, countries like Japan and South Korea have implemented large-scale, government-supported screening programs tailored to population needs. 3 Japan’s program increasingly incorporates endoscopic screening, which has demonstrated 2–8 times higher gastric cancer detection rates than radiography, and its reach continues to expand. 3 South Korea’s National Cancer Screening Program (NCSP), launched in 2002, offers biennial screening to all adults over 40, allowing individuals to choose between endoscopy and X-ray. 3 With participation rates exceeding 70% and a strong preference for endoscopy due to its greater sensitivity and low cost, South Korea’s model stands out as a scalable and effective approach to early gastric cancer detection. 3 A recent multi-state analysis (CA, NY, TX, NJ, CT, GA, NM) revealed stark disparities in GC incidence and stage at diagnosis among Asian, Hispanic, and Black populations. Immigrant-dense areas shoulder a disproportionate burden, underscoring the need for community-based, migration-informed screening models that address both clinical risk and structural determinants. 4 Increasingly, universal, interventional pilot studies such as Italy’s UNISCREEN pilot study, are illustrating the feasibility of capillary-based, population-level screening programs for detecting and/or preventing underdiagnosed conditions related to metabolic and cardiovascular risk. 5 Such studies have demonstrated that point-of-care testing that is minimally invasive, and in alignment with community-embedded screening protocols integrating demographic, clinical, and behavioral data, may be an approach directly applicable to infection-based cancer prevention strategies like H. pylori screening among high-risk immigrant populations in the U.S. 5 Similarly, recent efforts evaluating artificial intelligence (AI) in breast cancer screening through Australia’s national BreastScreen program demonstrated the feasibility of applying novel technologies in real-world, resource-limited settings. These models suggest that frameworks prioritizing clinical validity, early detection, and integration of population-based screening into existing public health infrastructures may be well-suited for H. pylori screening among high-risk immigrant populations in the United States. 6 In rural Mexico, the SMART-SCREEN study has demonstrated that smartphone-based, population-level mental health screenings focused on suicide prevention can achieve significant community outreach. As a digital tool, it enables large-scale screening across geographically and socioeconomically diverse populations. 7 This model illustrates that culturally tailored, community-based screening programs grounded in a migration-informed approach are not only feasible but also highly effective across a range of health domains. Building on these perspectives, this study aims to address the lack of scalable, culturally tailored infection screening models for high-risk immigrant populations by piloting a community-based H. pylori screening program. Its innovation lies in the development and validation of a migration-informed risk index using clinical, demographic, and behavioral data. Inclusion of KAP variables offers a unique lens into behavioral drivers of infection and patterns of engagement with care. Methods and Analysis Study Objectives and Design Primary Objective To generate data for the development and internal validation of a migration-informed H. pylori risk index tailored to high-risk immigrant populations for targeted GC prevention. Supporting Aims Implement a community-based H. pylori screening and treatment initiative Administer a multilingual survey capturing demographic, clinical, and KAP variables Establish referral pathways for H. pylori-positive individuals Evaluate screening uptake (≥30%), treatment completion (≥75%), and participant satisfaction Disseminate findings to researchers, policymakers, and community stakeholders Study Design This prospective, mixed-methods, community-based study will run from September 2025 to December 2026 and will enroll 2,000 adults aged 30–80 from high-risk Asian, Hispanic, and Black populations in the Greater New York area. Sample Size Justification The sample size of 2,000 was chosen to balance statistical power and feasibility. Assuming a conservative H. pylori prevalence of ∼30%, the study has >90% power to detect modest associations (OR 1.3–1.5) with key risk factors (α=0.05). Targeted recruitment will ensure meaningful representation from major subgroups—including Korean, Chinese, Japanese, Hispanic, and Black communities—with an expected sample size of 400–500 participants per major group. A small non-Hispanic White (NHW) reference group may be included for comparative purposes, where feasible. Projected recruitment targets by race/ethnicity are summarized in Table 1 . View this table: View inline View popup Download powerpoint Table 1. Projected Recruitment Table Study Population and Recruitment Eligibility Criteria Age 30–80 Belong to a moderate-to high-incidence stomach cancer ethnic group Able to understand English, Spanish, Korean, or Chinese Willing to provide informed consent Recruitment Strategy Participants will be recruited through community partners including Korean Community Services (KCS), ethnic associations, medical societies, and providers. Outreach will include multilingual flyers, cultural events, ethnic media, and lay health workers. Data Collection Procedures At health fairs and cultural venues, participants will: Provide informed consent Complete a 15-minute multilingual structured survey. The full structured survey instrument included as Supplementary File 1 . Undergo urea breath testing for H. pylori Survey Domains Demographic and Migration History Medical and Family History Lifestyle and Risk Factors Knowledge, Attitudes, and Practices (KAP) Symptom Assessment Post-Test Follow-Up and Referral Participants testing positive for H. pylori will be notified confidentially within approximately three weeks and offered structured follow-up support. This includes printed bilingual resource guides, navigation assistance for accessing appropriate care, and follow-up calls to ensure linkage. Participants will also receive a standardized results letter to share with their primary care providers. The full linkage-to-care strategy by target community is outlined in Table 2 . View this table: View inline View popup Download powerpoint Table 2. Post-Test Linkage-to-Care Strategy Primary Outcome H. pylori prevalence Secondary Outcomes Screening uptake, treatment adherence, risk factor prevalence, participant satisfaction Analytic Plan Logistic regression for risk factor analysis and index development Internal validation via k-fold cross-validation and bootstrapping AUC-ROC for discrimination; calibration plots for model fit Descriptive/inferential statistics (paired t-test, McNemar’s test) Risk Index Development Score weights will be derived from multivariable models including demographic, clinical, and KAP data. Ethics and Dissemination Data Management and Ethics Data Storage All data will be stored on secure Yale servers. Surveys will be de-identified and coded; linking files stored separately. Paper files locked. HIPAA standards enforced. Ethical Oversight Approved by the Yale University IRB. Informed consent will be obtained. Deviations and problems reported per IRB protocol. Conclusion This study will establish a scalable model for H. pylori screening in immigrant populations, surface structural and behavioral barriers to care, and inform future national screening policies through migration-informed risk tools and implementation strategies. Importantly, the risk index developed through this study may be externally validated and adapted for use in other U.S. cities with large immigrant populations, providing a foundation for broader implementation and comparative effectiveness research. By directly responding to community needs, this study will pilot a culturally tailored H. pylori screening program grounded in migration-informed public health. It will integrate clinical, demographic, and behavioral data to develop and validate a practical risk index designed for real-world community settings. Aligned with broader efforts to advance risk-based strategies for early detection and prevention, the model is intended to be scalable to cities with large immigrant populations across the country; ultimately generating insights to inform clinical practice, guide public health policy, and promote equitable access to screening and early intervention. Findings will also support future NIH or PCORI-funded trials comparing clinic-vs. community-based screening and development of a clinically integrated risk index. This study is particularly timely given the persistent and disproportionate burden of gastric cancer among first-generation immigrants from high-incidence regions. Unlike conditions such as hepatitis B or tuberculosis, where community-based models have led to measurable improvements in screening and care engagement, gastric cancer prevention efforts in the U.S. have remained largely hospital-centered. 2 By embedding H. pylori screening within a community-driven, migration-informed framework, this study offers a practical model for aligning prevention strategies with population-specific risk while promoting equity in early detection and access to care. 2 Dissemination Plan Results will be disseminated via: Peer-reviewed journals National conferences (ACG, DDW, AACR) Policy briefings (CDC, USPSTF) Community forums Timeline June 2025–Dec 2026: Recruitment/screening Jan–Mar 2027: Follow-up Apr–Jun 2027: Data analysis and dissemination Data Availability No data used in study. Funding and Conflicts of Interest Funding: TBA Conflicts of Interest: None declared Contributors Concept and design: Jae Il Shin, Chul S. Hyun, Sung Hwi Hong Acquisition, analysis, or interpretation of data: Chul S. Hyun Drafting of the manuscript: Chul S. Hyun, Sarah Soyeon Oh Critical revision of the manuscript for important intellectual content: Jae Il Shin, Chul S. Hyun, Sung Hwi Hong Statistical analysis: Chul S. Hyun, Sung Hwi Hong Administrative, technical, and material support: Jae Il Shin, Chul S. Hyun, Sung Hwi Hong Supervision: Jae Il Shin, Chul S. Hyun Competing Interests The authors declare that they have no competing interests. Funding/Support This work was supported by the Yonsei Fellowship, funded by Lee Youn Jae (to JAE IL SHIN). This work was supported by the Institute of Information & Communications Technology Planning & Evaluation (IITP) grant funded by the Korea government (MSIT) (RS-2024-00509257, Global AI Frontier Lab to Dong Keon Yon) Acknowledgements References 1. ↵ Morgan E , Arnold M , Camargo MC , et al. The current and future incidence and mortality of gastric cancer in 185 countries, 2020–40: a population-based modelling study . eClinicalMedicine . 2022 ; 47 : 101404 . doi: 10.1016/j.eclinm.2022.101404 . OpenUrl CrossRef PubMed 2. ↵ Hyun CS , Oh SS , Wu L , Moy RH , Shin JI . Rethinking gastric cancer prevention through an immigrant health lens . Nat Rev Gastroenterol Hepatol . 2025 ; 1 – 2 . doi: 10.1038/s41575-025-00901-0 . OpenUrl CrossRef 3. ↵ Sugano K. Screening of gastric cancer in Asia . Best Pract Res Clin Gastroenterol . 2015 ; 29 ( 6 ): 895 – 905 . doi: 10.1016/j.bpg.2015.09.013 . OpenUrl CrossRef PubMed 4. ↵ Hyun CS , Wang R , Kim YS , et al. Gastric adenocarcinoma in the United States: the toll of late diagnosis and racial and geographic disparities . JCO Oncol Adv. In press . 2025 . 5. ↵ Merolla A , De Lorenzo R , Ferrannini G , et al. Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol . BMJ Open . 2024 ; 14 ( 3 ): e078983 . doi: 10.1136/bmjopen-2023-078983 . OpenUrl Abstract / FREE Full Text 6. ↵ Marinovich ML , Wylie E , Lotter W , et al. Artificial intelligence (AI) to enhance breast cancer screening: protocol for population-based cohort study of cancer detection . BMJ Open . 2022 ; 12 ( 1 ): e054005 . doi: 10.1136/bmjopen-2021-054005 . OpenUrl CrossRef PubMed 7. ↵ Arenas-Castañeda PE , et al. Universal suicide risk screening with a focus on suicidal behaviour using smartphones in a rural area of Mexico: protocol for the SMART-SCREEN population-based survey . BMJ Open . 2020 ; 10 ( 7 ): e035041 . doi: 10.1136/bmjopen-2019-035041 . OpenUrl Abstract / FREE Full Text View the discussion thread. Back to top Previous Next Posted September 02, 2025. 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