The Prevalence of Human Papillomavirus and Its Impact on Cervical Dysplasia in the Northwest Territories: Component II

Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area, Sahtu Settlement Area, Dehcho Region, North Slave Region, South Slave Region

Tags: health, social sciences, cancer, women's health

Principal Investigator: Mao, Yang (2)
Licence Number: 14449
Organization: Public Health Agency of Canada
Licenced Year(s): 2009 2008
Issued: Dec 12, 2008

Objective(s): The objectives of this study are: 1. examine the impact of social, demographic, lifestyle and behaviour factors to the HPV infection prevalence in NWT; 2. establish the baseline for evaluating the HPV vaccine program in future.

Project Description: This license has been issued for the scientific research application #938.

The objectives of this study are: 1. examine the impact of social, demographic, lifestyle and behaviour factors to the HPV infection prevalence in NWT; 2. establish the baseline for evaluating the HPV vaccine program in future.

The study population includes: women from the following 12 communities: Behchoko (Rae-Edzo), Fort Good Hope, Fort Liard, Fort McPherson, Fort Providence, Fort Simpson, Fort Smith, Hay River, Inuvik, Norman Wells, Tuktoyaktuk and Yellowknife. The inclusion criteria are: age 18 and up, no cancer history, and attending routine Pap test. Up to 3200 women over 4 sampling periods will be part of this research project.

Bio-sample collection for HPV testing will be incorporated into routine Pap testing. Presently, all Pap tests in the NWT are collected by physicians or community health nurses and sent to the Dynacare Kasper Laboratory in Edmonton for processing. All the samples will be forwarded to the laboratory in a sealed envelope. Pap samples will be collected in a liquid-based medium, which will enable HPV typing on the same sample. The samples will be stored in the regional laboratory and shipped to the Dynacare Kasper Laboratory a few times a week with routine laboratory samples. Approximately half of the medium will be used for Pap testing, and the remainder (usually more than a quarter) will be shipped to the Winnipeg Laboratory for HPV typing.

Questionnaire data will be collected in the cervical cancer screening centres from the communities mentioned previously. As part of their program operation, the public health nurses of the screening centres will send a reminder to women for their annual smear tests. The field investigation team of the study will add an accompanying pamphlet to inform the women of the objectives and procedures of the project.
When women come for Pap tests, they will be invited to sign a consent form, indicating that they have understood the implications of the study and have given permission for the use of their records to conduct follow-up studies. A self-administered questionnaire will be implemented to collect the demographic and other risk factors of the consenting women, with relevance to the study objectives. The questionnaire will be translated into the 4 common local languages, in additional to English and French, and formatted in such a way that it is suitable for self-administration in hard copy and could also be completed personally by a subject via computer. The questionnaire data will be entered, edited, organized and prepared in a central computer for data analysis.

HPV testing will be done on the same sample as for the Pap test and will be processed for HPV typing using a selected assay, the Luminex assay. The NML Luminex assay can detect 45 mucosal HPV types. Cervical cytology and HPV testing will be done independently of each other in a blinded fashion to ensure the elimination of reporter bias.

Initially, a descriptive analysis of socio-demographic characteristics will be performed. Exposure to the risk factors will be analyzed and compared by ethnic group and age group. A table comparing the characteristics of the recruited subjects and the study population will be provided for examining the study’s representativeness. The presence of HPV infection and dysplasia will be evaluated for significant associations with factors such as age, ethnicity, smoking history, etc.

The information release must be based upon the community/health authority consultation. All results (aggregated and non-nominal) and an ongoing communication newsletter will be sent to the primary physician and the community health nurses. Women who desire the results of their HPV test will receive them through their physician.

The fieldwork fo this study will be conducted from January 01 to November 30, 2009 in Behchoko (Rae-Edzo), Fort Good Hope, Fort Liard, Fort McPherson, Fort Providence, Fort Simpson, Fort Smith, Hay River, Inuvik, Norman Wells, Tuktoyaktuk and Yellowknife.