Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area
Tags: health, health care evaluation, aboriginal community, public health
Principal Investigator: | Goodman, Karen J (16) |
Licence Number: | 15785 |
Organization: | University of Alberta |
Licensed Year(s): |
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Issued: | Dec 02, 2015 |
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; 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. 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 create the Inuvialuit Settlement Region (ISR) H. pylori Project to include the remaining ISR communities, and by community leaders in Fort McPherson to initiate a research project in their community. The following describe the project Components: Consultation and planning component: The community partners who invited the research team into their communities are asked to identify a process for selecting individuals to serve on a local planning committee. Once the planning committee is in place and has developed a research agreement, the research team holds workshops with each committee to plan how the community-specific project will be carried out. The committees provide input on design issues and various study implementation details; the committees also edit the language used in informed consent documents and questionnaires. As information is generated by the research, the committee gives feedback on options for reporting the information to community members. This approach keeps the research centered on community priorities, and creates good will toward the project and high levels of participation. 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. Screening component: 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. 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. 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. Treatment regimens will be distributed to participants in bubble packs organized for easy identification of days and times pills are to be taken. 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 participation in the research project. The protocols of breath tests, endoscopy, pathologic assessment and antibiotic susceptibility testing remain the same. The longitudinal design allows the reseacher to estimate the incidence and reinfection rates of H. pylori infection and the progress rates of H. pylori-associated disorders. Participants who have reinfection or are newly infected with H. pylori will receive treatment from the gastroenterologists. Statistical analysis component: The prevalence of H. pylori infection and associated diseases will be estimated by community and demographic subgroups of interest. To identify risk factors for H. pylori infection and gastric abnormalities, multivariable logistic 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 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 and to formulate recommendations for H. pylori management strategies. Knowledge exchange component: 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. A novel knowledge exchange program (KEP) was developed to recruit youth from Aklavik to travel to Edmonton, AB and learn about the research process. They developed dissemination materials with scientists together and delivered the knowledge to their community in a meaningful way. Based on the community feedback, the research team will expand the program to other communities in the NWT. The fieldwork for this study will be conducted from January 1, 2016 to December 31, 2016.