To obtain local information on the burden of disease from H. pylori infection, risk factors for H. pylori-associated diseases, and factors that influence successful treatment to eliminate this infection.
This research aims to answer questions posed by community members in the Northwest Territories (NT) and their health care providers about health risks from H. pylori infection. The Canadian North Helicobacter pylori (CANHelp) Working Group formed to develop a comprehensive approach to investigating community health problems related to H. pylori infection in NT communities and to identify public health solutions aimed at reducing related health risks.
The objectives of this research program are:
- to conduct community-based participatory research projects to obtain local information on the burden of disease from H. pylori infection, risk factors for H. pylori-associated diseases, and factors that influence successful treatment to eliminate this infection;
- to conduct policy analysis to identify cost-effective H. pylori management strategies that are ethical, economically, and culturally appropriate for northern communities;
- to develop and implement knowledge exchange strategies that help community members, health care practitioners and health care decision makers understand H. pylori-associated health risks as well as solutions and unsolved challenges for reducing these risks.
Aklavik was selected for the initial project because Aklavik residents had made known their concerns about the risks posed by H. pylori infection. Due to the success of the Aklavik H. pylori Project, the CANHelp Working Group was asked by the Inuvialuit Regional Corporation to include other communities of the Inuvialuit Settlement Region in the research program, by community leaders in Fort McPherson to initiate a research project in their community, and by other community leaders in Yukon to expand the research to their communities.
The following describes the project components:
Recruitment and informed consent component: Information about the project and how to enroll are disseminated using forums recommended by planning committees; these include community gatherings, newsletters, radio, staffed tables in public locations, and door-to-door outreach. Individuals who come forward to enroll meet with a trained project staff member who reads the study information sheet with them and has them fill out and sign the consent form. Separate informed consent processes are used for each project component.
Screening component: We will screen participants for H. pylori infection using the non-invasive 13C-urea breath test. This test is regarded as the most accurate non-invasive test and can be used safely in pregnant women and human of all ages. It detects the presence of urease secreted by H. pylori in the stomach, using either mass spectrometry or nondispersive isotope-selective infrared spectroscopy to measure the 13C/12C ratio in breath samples collected before and after administration of 13C-labeled urea. Participants will also be offered the option of multiple tests for detecting H. pylori infection using breath, blood, or stool specimens, regardless of symptoms.
Community survey component: The research team will interview participants using structured questionnaires to identify environmental and behavioural risk factors and to ascertain upper gastrointestinal symptoms and previous diagnoses of H. pylori infection and related diseases. Interviews are conducted in the language and location of the participant’s preference (home or project office). A household questionnaire is administered to one individual in each household collects household attributes and exposures, while an individual questionnaire collects individual attributes and exposures from each participant.
Endoscopy component: University of Alberta gastroenterologists will perform upper gastrointestinal endoscopy to examine the stomach for visible lesions and collect biopsies of stomach tissue. Temporary endoscopy units equipped with rented endoscopy towers and gastroscopes will be set up at field sites (e.g. local health centres), with the support by technical service from Olympus Canada. The gastroenterologists will be assisted by trained Alberta Health Services endoscopy nurses and service aids. Temporary territorial medical licenses will be arranged for the Alberta MDs and RNs. In keeping with field settings, procedures will be performed without sedation using ultra-thin transoral gastroscopes. During endoscopy all relevant mucosal lesions will be noted and at least seven gastric biopsies will be collected from predetermined locations for histopathologic assessment and microbiologic cultures.
Treatment component: The gastroenterologists will prescribe treatment for H. pylori-positive participants. As the research identifies factors that influence treatment effectiveness in the participating communities, the prescribed treatments will be tailored to participants based on relevant factors, such as participants’ clinical history and antibiotic susceptibility status if known. Treatment regimens will be distributed to participants in bubble packs organized for easy identification of days and times pills are to be taken. Participants will be instructed to leave doses not taken intact and return bubble packs at the end of treatment to permit assessment of adherence. Follow-up breath tests will be offered to assess H. pylori status 8-12 weeks after treatment. If participants fail the initial treatment, the gastroenterologists will prescribe a series of rescue therapies (2nd, 3rd and 4th line) as needed.
Traditional medicines component: the research team will interview knowledge holders (usually defined as Elders) using a semi-structured open-ended interview guide to identify any local medicinal plants and Indigenous approaches to managing H. pylori-related symptoms and disease. The research team will also be distributing a self-administered structured questionnaire for local community members. The team will collect medicinal plants and associated traditional knowledge using existing community-based methods that were identified through interviews, and will evaluate plant-based medicines for anti-H. pylori activity in the laboratory in Edmonton.
Mercury exposure component: Community members expressed concern about environmental contaminants, particularly mercury, affecting digestive health. Participants relayed that since residents of Arctic communities continue to follow a subsistence lifestyle, they see themselves as uniquely vulnerable to contamination of local water sources and aquatic or land animals, on which they rely as part of a traditional diet. Their strong dependence on the natural environment coupled with the perception that they are unable to effectively intervene on processes leading to the release of pollutants in order to protect their ecosystem has led to a high level of anxiety. In order to address these concerns, this aspect of the project will investigate the hypothesis that chronic ingestion of low doses of mercury through fish consumption increases the risk of severe gastritis and precancerous gastric lesions, including gastric atrophy and intestinal metaplasia, among H. pylori¬–positive residents of Canadian Arctic communities. The research team will collect hair samples to measure methylmercury exposure. The team will conduct a data analysis to estimate the association between methylmercury exposure and fish consumption estimated with the data collected in the survey component.
Longitudinal follow-up component: Participants will be offered repeat breath tests and endoscopic examinations to assess their infection status and gastric abnormalities a few years after their initial participation in the research project. All diagnostic procedures will remain the same as those followed in the initial project components. The longitudinal design will allow us to estimate the incidence and reinfection rates of H. pylori infection and the progression rates of H. pylori-associated disorders. Participants who test positive for H. pylori on follow-up will receive treatment from the gastroenterologists.
Statistical Analysis: The prevalence of H. pylori infection and associated diseases will be estimated by the community and demographic subgroups of interest. Where longitudinal data are available, the incidence of H. pylori infection and the progression rate of gastric abnormalities will be estimated. To identify risk factors for H. pylori infection and gastric abnormalities, multivariable regression models will be used to estimate prevalence odds ratios and 95% confidence intervals as measures of association. To account for lack of independence of response probabilities given a contagious outcome, multilevel models will be used to account for the natural grouping of participants in households and communities.
Policy analysis component: Surveillance of healthcare data will be used to describe current practices pertaining to health care for H. pylori-associated diseases, and to estimate costs for H. pylori-associated medical services. Economic policy analysis will be used to assess the relative cost-effectiveness of candidate interventions against current practices and to formulate recommendations for H. pylori management strategies.
Knowledge exchange: The knowledge exchange strategies cover the interactive dimensions of learning how community members, health care practitioners, and health care decision makers understand relevant issues and providing information to them about what scientific research knows so far. Key messages and communication strategies will be identified and developed collaboratively, and knowledge exchange will be implemented at community and territorial levels.
Residents of the participating communities are actively involved in planning and implementing this project. The study design and implementation are overseen by a local community Planning Committee, which includes community representatives, local health centre staff, the Principal Investigator (PI) Dr. Karen Goodman, and project staff. The PI seeks input from the committee to finalize the details of project implementation, review forms, questionnaires and other materials to be used, and develop strategies for communicating study information to the community. Several local residents have been recruited to coordinate fieldwork and help with recruitment of participants and data collection, with training provided as necessary. Local health centre staff plays an important role in supporting and facilitating study activities that require the use of health centre facilities. Knowledge exchange activities also provide opportunities for researchers and community members to learn from each other. These activities are developed together and allow the team to share different perspectives and values, to identify questions and concerns, and to fill in gaps in the current understanding of H. pylori.
Community Planning Committees have been developing strategies for communicating study information to community members, with particular consideration to target groups such as youth and elders. Throughout the project, information has been disseminated to the community by means of radio broadcasts, flyers, and progress reports. A video documentary about the Aklavik H. pylori Project was created to convey to the community how the research has been carried out within the community and at the University of Alberta. In addition, community presentations are held periodically to present early findings from the research to the community using a slide or video presentation. A novel knowledge exchange program (KEP) was developed to recruit youth from Aklavik to travel to Edmonton and learn about the research process. They developed dissemination materials with scientists together and delivered the knowledge to their community in a meaningful way.
The fieldwork for this study was conducted from January 13, 2017 to December 31, 2017.
- Azevedo, N. F., Huntington, J., & Goodman, K. J. (2009). The epidemiology of Helicobacter pylori and public health implications. Helicobacter, 14(s1), 1-7. Retrieved from https://onlinelibrary.wiley.com/doi/epdf/10.1111/j.1523-5378.2009.00703.x
- Carraher, S., Chang, H. J., Munday, R., Goodman, K. J., & CANHelp Working Group. (2013). Helicobacter pylori incidence and re-infection in the Aklavik H. pylori Project. International Journal of Circumpolar Health, 72(1), 21594. Retrieved from https://www.tandfonline.com/doi/full/10.3402/ijch.v72i0.21594?scroll=top...
- Cheung, J., Goodman, K. J., Girgis, S., Bailey, R., Morse, J., Fedorak, R. N., ... & CANHelp Working Group. (2014). Disease manifestations of Helicobacter pylori infection in Arctic Canada: using epidemiology to address community concerns. BMJ open, 4(1), e003689. Retrieved from http://bmjopen.bmj.com/content/bmjopen/4/1/e003689.full.pdf
- Goodman, K. J., Jacobson, K., & van Zanten, S. V. (2008). Helicobacter pylori infection in Canadian and related Arctic Aboriginal populations. Canadian Journal of Gastroenterology and Hepatology, 22(3), 289-295. Retrieved from http://downloads.hindawi.com/journals/cjgh/2008/258610.pdf
- Kersulyte, D., Bertoli, M. T., Tamma, S., Keelan, M., Munday, R., Geary, J., ... & Berg, D. E. (2015). Complete genome sequences of two Helicobacter pylori strains from a Canadian Arctic Aboriginal Community. Genome Announcements, 3(2), e00209-15. Retrieved from http://genomea.asm.org/content/3/2/e00209-15.short#aHR0cDovL2dlbm9tZWEuYXNtLm9yZy9jb250ZW50LzMvMi9lMDAyMDktMTUuZnVsbC5wZGZAQEAw
Never Say Die - The Aklavik H. pylori Project https://youtu.be/VuMNX_ZHuTI
88 12 TAMAPTA Elders in Aklavik https://youtu.be/m9DCLj9BKxs