Regions: North Slave Region
Tags: health, northern community, physical health, vaccines, COVID-19
Principal Investigator: | Sharma, Sangita (15) |
Licence Number: | 17175 |
Organization: | University of Alberta |
Licensed Year(s): |
2024
2023
|
Issued: | Jan 13, 2023 |
Project Team: | Fariba Kolahdooz, Karen Doucette, Carolyn Gotay, Stephanie Irlbacher-Fox, John Zoe, Jesse Papenburg, Mercedes Yanes-Lane, Rachel Oystek, Katie O'Beirne, Radha Shukla, Jennifer McKeen, Se Lim Jang, Kami Kandola, Jo-Anne Cecchetto, Marc-Andre Langlois, Corey Arnold, Danielle Dewar-Darch |
Objective(s): To determine the immune response to COVID-19 vaccines and how long this protection lasts in Indigenous community members.
Project Description: This licence has been issued for the scientific research application No.5465. In four Northwest Territories communities, we aim to determine the immune response to COVID-19 vaccines and how long this protection lasts in Indigenous community members. In partnership with the Tli?cho Government, the research team aim to determine COVID-19 immune protection (immunity) among community members (age 19+) in the four Tli?cho communities. This will be achieved through a dry blood spot test collected in the communities and analyzed in a lab in Ottawa. The test will be done at two time points: once at the beginning of the project, and again three or more months later (time points to be planned with community partners). This will show changes in immunity over time. Community members will also respond to a ten-minute questionnaire to gather information about sex, gender, age, health status, and COVID-19 vaccination and infection history. Following analysis, the team will work with the community and government partners to disseminate the findings using an integrated knowledge translation (i.e. collaborative) approach. The knowledge generated in this study may guide policy and practice (e.g. timing of booster shots) for optimal protection against COVID-19. The project team includes expertise in community-based-participatory research, immunology and medicine, Indigenous cultural safety, and context experts from the communities. To support cultural safety, the project is being co-led by an Indigenous person from the Northwest Territories, who is the primary contact for community partners and community members who are participating in the project. Data collection will be carried out by the Indigenous co-lead, staff, and/or Indigenous community members hired as project team members. The project team will enter into a memorandum of understanding (MOU) with the Tli?cho Government and all aspects of the project have been, and will continue to be, developed in partnership with communities. The lab test will be carried out by research team members at the Langlois Lab, University of Ottawa. The tests will measure the level of COVID-19 antibodies, as well as the effectiveness of the antibodies in targeting several variants of the COVID-19 virus. As a result of previous consultation with the Tli?cho Government and subsequent agreement to participate in this project, the project will take place in Behchoko, Whatì, Wekweètì, and Gamètì. Study design: A mixed methods community-based participatory research approach will be used, using a Two-Eyed Seeing lens. In this approach the research team members work with the community on all aspects of the project to ensure the methods and questions are effective and appropriate. Two-Eyed Seeing is a concept describing the ability to see a situation from one eye with the strengths of Indigenous knowledge, wisdom, and ways of knowing, and from the other with the strengths of Western knowledge and ways of knowing, and learning to use both eyes together, for the benefit of all. The well-established Community Advisory Board of Elders, Indigenous leaders, and community members will guide all aspects of the project. The team will engage staff and community partners through in-person meetings, email, teleconference, and videoconferencing. The Indigenous co-lead will work with Northwest Territories-based project team member(s). The research team will provide training to the team members, supporting sustainable capacity building and local employment. The training manual and protocol include training on interview-administered screening, questionnaire, and dry blood spot by finger prick use/administration, storage, and shipment. Training sessions will be hosted both in-person and via videoconferencing (Zoom), and laptops will be provided to local community team members, as necessary. The Indigenous co-lead will travel to the communities, as needed, and abiding by any travel restrictions. Recruitment and information gathering: The research team will recruit 306 community members adults, both men and women, and inclusive of transgender/two spirit identities. Community members will be recruited via community advertisements in the local Band Office and community health centres, community radio, local rolling television channel, and/or community Facebook page and other social media that we have successfully used in other projects. The team have used this approach successfully in the past. Community members will be providing written consent for participation. Anyone who is not able to consent will not be enrolled. Each community member will be invited to a designated private place in the community, where a trained team member will ask about the person’s age, gender, and other personal and health information using a questionnaire, taking approximately 10 minutes. If the person agrees, the interview will be audio recorded. A screening questionnaire will also be used prior to the dried blood spot by finger prick being collected. If someone has a major clotting disorder, the team will not do a finger prick. If a person has had a lymph node dissection for a disease such as breast cancer, the team will use the hand opposite to the side the lymph node was removed (as per the STAT Can protocol). For all aspects of the interview/data collection, local languages will be utilized when necessary, and all interview transcripts will be translated into English prior to analysis. Results will be entered in real time into REDCap, and will be audio recorded with the person’s permission, as with the other projects. Dry blood spots by finger prick will be collected at two time points (three or more months apart). Following laboratory instructions, blood spots will be collected by dropping a few drops of blood on cards made from specially manufactured absorbent filter paper that will be dried. The community member will use a sterile alcohol swab to wipe the tip of the finger, the sterilized needle will be loaded into the finger prick device by the team member. The finger prick will be administered by the community member or the trained project team member (whichever the participant is more comfortable with). The needle will be disposed of in a bio-hazard container that contains a one-way valve and stored securely. The container will be disposed of at the health centre, as with all the other needles used in the communities, and per community safety protocol. The team member will then instruct the community member to place the drop of blood in each of five small circles. To be extra safe, the team member will wear disposable gloves, although the team member will not touch the person’s blood at all. Five such usable (non-overlapping) drops will be collected per person at each time point. After air drying to saturate the paper for at least 2 hours, flaps will be closed and placed in sealed Ziploc bags with desiccant and moisture indicators. The team member will ensure that the blood spots are air dried and placed in a Ziploc bag and then placed in an envelope for courier to the lab in Ottawa. The dry blood spot by finger prick will be shipped and stored at the Langlois Lab at the University of Ottawa to measure COVID-19 antibody analysis. Dry blood spot by finger prick was chosen as the preferred method to maximize participation and the assays chosen have been used extensively on this type of specimen. Collected dry blood spots by finger prick will not be used in the future for any future analysis and will be destroyed immediately upon completion of the above mentioned laboratory analysis. Some details of the plan may be amended based on community preferences. The research team acknowledge that changes to project protocol may require amendments to Ethics and subsequent re-submission of Ethics documents to ARI, and possibly amendments to the Aurora Research Institute license as well. The project team will work closely with community partners and the Community Advisory Board to ensure ongoing communication throughout the life of the project. The team includes members living and working in Northern communities, who will liaise with local partners and advisors on development of questionnaires, data collection, recruitment, analysis, sharing and dissemination of the results, and knowledge translation/mobilization. The Principal Investigator and other team members have met with community leaders to establish community interest in the project and to begin planning. The Indigenous project co-lead (Rachel Oystrek) has further engaged in person several times with community leaders, staff and Elders during community visits in each of the four Tlicho communities (Behchoko`, Gamètì, Wekweètì, Whatì). Communication between the Principal Investigator, the Indigenous project co-lead, and community leaders and staff has also occurred over video/tele-conference and email correspondence. Regular meetings and correspondence with a leadership team and a logistics team are planned for the duration of the project. Using an integrated knowledge translation approach, all findings, de-identified and aggregated, will be shared with all communities, partners, Indigenous organizations, and all levels of government for immediate planning, practice, and policy around COVID-19 vaccination. Various media will be used depending on the communities’ and partners’ preferences and the public health recommendations, including website, community workshop, and virtual (Zoom) workshops. If restrictions allow, the Indigenous co-lead will travel to the communities to present the results in person. The project represents an opportunity to evaluate COVID-19 vaccine immune response in the Northwest Territories, and it will generate critical knowledge that can strengthen the health system’s response to COVID-19 and ensure that all Indigenous people in Northwest Territories are protected against COVID-19. The fieldwork for this study will be conducted from January 13, 2023 to December 31, 2023.