NWT RESEARCH DATABASE

Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area

Tags: health, public health

Objective(s): To develop a comprehensive approach to investigating community health problems related to H. pylori infection in NWT communities and to identify public health solutions that respond to community health care needs as perceived by community members and health authorities.

Project Description: This research aims to answer questions posed by NWT community members and their health care providers. The long term objectives are to develop a comprehensive approach to investigating community health problems related to H. pylori infection in NWT communities and to identify public health solutions that respond to community health care needs as perceived by community members and health authorities. As a starting point, a project is being carried out in the Hamlet of Aklavik and will be expanded to Tuktoyaktuk and Sachs Harbour in 2011. This project targets all residents of Aklavik; inclusion of the entire community will enhance participation and achieve broad representation. Participation in additional communities will be determined by the regional planning committee. Component I was initiated in November 2007; recruitment of participants and data collection is ongoing to maximize participation. Component II has been largely completed; endoscopy was carried out in February 2008, with laboratory assessment near completion. Component III began in November 2008. Component 4 requires collection of data from additional communities. Component 5, developing strategies for communicating project information to Aklavik residents, has occurred throughout the research and is ongoing. Component I: • obtain community input for finalizing project details; • finalize an informed consent document with community input; • adapt research questionnaires based on community input; • train local project personnel on data collection protocols; • recruit participants and obtain informed consent; • interview participants using a structured questionnaire to obtain data on clinical history and symptoms; • obtain medical record data on previous H. pylori tests, and relevant diagnoses and treatments; • interview participants to obtain data on relevant social and environmental factors; • test participants for H. pylori infection using the urea breath test; and • collect blood samples to test for iron deficiency and anemia markers. Component II: • identify participants to be evaluated by endoscopy; • offer endoscopy to participants aged 10 years and older to record visible abnormalities and obtain biopsies (those who require evaluation will be particularly targeted, but any willing participants will be invited to have this examination); • process biopsies for laboratory tests; • culture H. pylori antibiotic susceptibility testing and strain typing; and • examine tissue to characterize inflammation and abnormal changes. Component III: • identify participants who are candidates for treatment; • using antibiotic resistance data, evaluate potentially effective treatments by randomizing patients to candidate therapies; and • follow those treated long-term to identify factors associated with treatment failure and reinfection. Component IV: • conduct policy analysis to develop cost-effective strategies for management of H. pylori infection. Component V: • develop and implement activities to inform community members of study findings. Community participation in the research process and sharing resulting knowledge with community members are cornerstones of accepted standards for conducting research in Aboriginal communities. This project incorporates the principles of the Association of Canadian Universities for Northern Studies (ACUNS) and the Canadian Institute for Health Research's Institute for Aboriginal People's Health. As an NEAHR co-investigator, Dr. Fletcher will oversee the incorporation of these standards in this research. Because community participation and knowledge exchange are mutually supportive, these dimensions of the research will operate from start to finish. A Study Planning Committee was formed and decided how to recruit participants, which supplemental biologic specimens (e.g., blood or stool) to collect, and how to implement data collection. This committee provided input for and approved the informed consent documents and research questionnaires. A series of workshops were held to carry out these activities. As information is generated by the research, activities have been developed to inform the community of the results and help them understand how to use this information to safeguard individual and community health. The Study Planning Committee has provided input on how to develop communication media for sharing information with the community. Standard data collection procedures were developed for informed consent, participant recruitment, questionnaire administration, obtaining data from medical records, biologic specimen collection, transport of samples to Edmonton laboratories, training of personnel on data collection procedures, laboratory analyses, data management and data quality control. A manual of procedures was prepared under Dr. Goodman’s supervision to outline each procedure. Community coordinators in Aklavik carried out the local project activities, as well as transport of specimens and transfer of data to Edmonton. Research coordinators based in Edmonton were trained on data collection procedures by study investigators, and in turn trained the Aklavik community coordinators and any participating Aklavik health centre personnel. The research coordinator periodically travels to Aklavik to monitor the quality of data collection. A project manager based in Edmonton, works closely with Dr. Goodman to oversee study operations and management of study data. The project manager maintains a central database with all study data. The data will be accessible to the research team members and the Study Planning Committee. Data on Clinical History, Symptoms, and Relevant Social and Environmental Factors: Participants have been interviewed using a structured clinical questionnaire regarding previous diagnoses of H. pylori infection or other diseases of the stomach or esophagus, previous treatments for H. pylori infection, frequency of symptoms of upper abdominal discomfort, and other indications for H. pylori testing (family history of stomach cancer, long-term use of NSAIDs or aspirin) or endoscopy (reflux, anemia, dark stools, loss of appetite, recent weight loss). In addition, relevant information will be taken from participants’ medical records. Another questionnaire has been used to interview participants about social and environmental factors. Questionnaires were based on those developed previously by members of the research team, adapted for the local population. Interviews were conducted in private and lasted approximately 20-40 minutes. Aklavik residents who tested positive for H. pylori infection were invited to participate in a treatment trial. At random, they were assigned to either the standard treatment or an alternative treatment that has shown promising results in trials conducted elsewhere. For participants who had biopsies taken and had cultures that were positive for H. pylori in the microbiology lab, there was information about which antibiotics their H. pylori organisms were susceptible to. This information was used to assign treatment. Participants with H. pylori infection who were not eligible to participate in the treatment trial were prescribed appropriate treatment based on their health status. Participants who completed treatments were offered a post-treatment breath test at least 8 weeks after completing treatment to see if their H. pylori infection cleared. In subsequent years, long term follow up of treatment will be carried out to identify factors associated with remaining infection-free. As data accumulates in subsequent years, including information from other communities where similar research will be carried out, policy experts on the research team will conduct cost-benefit analyses to identify recommended strategies to health authorities for improving management of H. pylori infection. These analyses will take into account social and cultural costs and benefits, as well as financial and health costs and benefits. Residents of Aklavik are actively involved in planning and implementing this project. The study design and implementation is being overseen by a local Study Planning Committee, which includes the Aklavik Health Committee (which represents the Hamlet Council, the Aklavik Indian Band and Gwich’in Council, the Aklavik Community Corporation, the Aklavik Health Centre, Aklavik members of the Arctic Health Research Network, and other interested Aklavik residents), along with the Inuvialuit Regional Corporation (IRC) representative, the Principal Investigator, and other project personnel. The PI seeks input from this committee to finalize the details of project implementation, approve the forms, questionnaires and other materials to be used, and develop strategies for communicating study information to the community. As IRC has invited the PI to complete similar research in the rest of the Inuvialuit communities, they have set up a regional planning committee to inform the design and implementation of this study. Representatives from each community in the ISR are included on this regional committee, and they will oversee research in the ISR in the same manner that the Aklavik committee oversees the research in their community. This research addresses a health priority identified by residents of Aklavik and leaders of other ISR communities, who are aware that H. pylori infection poses a health threat to them. NWT health officials have heard their concerns and support this project so they can find solutions to this community health problem. Few community-based studies of H. pylori infection have been conducted in Canada, and there is no systematic information specific to the NWT. NWT health officials lack information regarding the extent of the problem or cost-effective solutions. This project will fill this gap by providing for ISR residents: information about who is at risk of H. pylori infection and associated diseases and what measures might be taken to promote community health. In addition, endoscopy of the upper digestive tract has been offered to those desiring diagnostic evaluation in Aklavik, and the individual endoscopy results have been delivered in person to participants and local health care providers, with follow-up arranged as needed. Treatment for H. pylori infection has been offered to those requiring treatment. Beyond these benefits to individuals, this project will permit laboratory studies which will provide information about potentially effective treatments and cost-effective strategies for management of this infection by local health authorities. Study Planning Committee workshops in Aklavik have been developing strategies for communicating study information 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. One new strategy that is underway involves the creation of a video documentary, now completed, to convey to the community how the research has been carried out within the community and remotely at the University of Alberta. In addition, a community meeting was held in November 2009 to present early findings from the research to the community using a slide presentation. Communication in the other Inuvialuit communities will take place through each of their community corporations, as well as through methods to be identified by the study planning committee. Strategies to communicate results with other communities will be done in collaboration with the regional planning committee, primarily through each community corporation. The fieldwork for this study will be conducted from March 15, 2011 to December 31, 2011.