NWT RESEARCH DATABASE

Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area

Tags: health, aboriginal community, public health

Objective(s): 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.

Project Description: 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: 1. 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; 2. to conduct policy analysis to identify cost-effective H. pylori management strategies that are ethically, economically, and culturally appropriate for northern communities; and 3. 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. The Aklavik H. pylori Project was launched as a starting point for the CANHelp Working Group’s research program. It is of interest to conduct similar projects in additional Northern communities to identify differences and similarities across diverse northern settings, and increase the number of participants to facilitate statistical analysis of subgroups. This will enhance the generalizability of the results across northern populations and yield useful inputs for cost-effectiveness analysis aimed at formulating recommended H. pylori management policies to health authorities. The research protocols developed in Aklavik were piloted there and have been adapted for use in new communities. The research design is best described as a series of projects corresponding to the three main objectives listed in the introduction. Each project is made up of components outlined below. Study Populations: 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. Project Components: Recruitment and informed consent: 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. UBT Screening: The research team 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 surveys: 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 questionnaire collects individual attributes and exposures from each participant. Endoscopy: Gastroenterologists will perform upper gastrointestinal endoscopy to examine the stomach for visible lesions and collect biopsies of stomach tissue. Endoscopy will be held in temporary endoscopy units equipped with rented endoscopy towers and gastroscopes set up at local health centres, or endoscopy units in Inuvik Regional Hospital where possible. Logistics will be arranged in consultation with the local health centre, hospital in Inuvik and/or health authority. The gastroenterologists will be assisted by trained nurses and service aids. Temporary territorial medical licenses will be arranged for Alberta MDs and RNs. In keeping with field settings, procedures will be performed unsedated using ultrathin 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: 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 untaken doses 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: 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 are identified through interviews, and will evaluate plant-based medicines for anti-H. pylori activity in the laboratory in Edmonton Longitudinal follow-up: 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 the team 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 our gastroenterologists. Chart Reviews: Project staff will review participants' medical charts at the local health care facility from 5 years prior to project enrollment to up to 1 year after. Staff will use a structured form to extract the relevant information, including registered Aboriginal group (i.e. First Nations, Metis or Inuit), numbers of visits for all complaints and upper Gastrointestinal (GI) issues, number of systemic antibiotic prescriptions, visits for endoscopy, hospitalization, consultation with specialist and/or other operations/procedures for upper GI issues, diagnosis of peptic ulcer disease and/or gastroesophageal reflux disease, H. pylori testing and treatment received outside of the H. pylori project, chronic medications possibly related to upper GI issues or symptoms, family history of cancer, and visits for upper GI symptoms and/or possible adverse events from H. pylori treatment. Statistical Analysis: The prevalence of H. pylori infection and associated diseases will be estimated by community and demographic subgroups of interest. Where longitudinal data is 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: Surveillance of health care 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 or hospital staff plays an important role in supporting and facilitating study activities that require use of health centre facilities, including endoscopy and treatment. 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. Individual test results will be communicated to the participants through their preferred contact method specified at enrollment, such as phone, e-mail or mail. With regard to the overall project updates and findings, community Planning Committees have been developing strategies for communicating these to community members, with particular consideration to targeting 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 and Fort McPherson 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 research team are also developing short educational videos about general scientific knowledge of bacteria and H. pylori that will be made available on youtube and the project website. The fieldwork for this study will be conducted from January 1, 2018 to December 31, 2018.