The Anishinaabek Cervical Cancer Screening Study

Engaging First Nations women in cervical cancer screening: assessing factors related to screening and uptake of self-sampling

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84617261

Enrollment

400

Registered

2013-12-03

Start date

2013-05-08

Completion date

Unknown

Last updated

2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer Cancer Malignant neoplasm of cervix uteri

Interventions

Participating communities are randomized to a method of cervical screening to first offer women in their community who are between 25 and 69 years of age. In arm A, Pap tests are first offered (standa

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria (cluster level): 1. First Nations community in the Robinson Superior region in Northwest Ontario 2. Ratified research agreements signed with Thunder Bay Regional Research Institute Inclusion criteria (individual level): 1. Female participant 2. Between the ages of 25 and 69 years 3. Registered with one of the eleven participating First Nations communities (band membership as per the Indian Act) or currently living on the reserve 4. Must belong to Ontario Health Insurance Plan, a provincial insurance plan that ensures residents have universal coverage for medically necessary services

Exclusion criteria

Exclusion criteria: Exclusion criteria (individual level): 1. Currently pregnant (will be asked to provide sample after pregnancy) 2. Known total hysterectomy

Design outcomes

Primary

Measure	Time frame
1. To compare the proportions of women who participate in screening based on an offer of self-sampling versus an offer of attending for a Pap test. This will be measured after the first phase of cervical screening (approximately 4 months after baseline) and after the second phase of cervical screening (approximately 9-12 months after baseline - this is the final time point). We will use 'objective' measures, using reports from CytoBase, the provincial electronic database for Pap cytology, to capture the numerator of participants attending Pap tests, divided by the total number of participants offered to receive Pap tests. For HPV self-sampling, we'll use the number of HPV reports returned to the Research Team from the laboratory, divided by the number of participants who were offered HPV tests. We will also consider using other denominators, including the total number of women invited to participate, and estimates of the total number of women registered with the communities. 2. To compare the psychosocial impact of cervical screening based on a primary offer of self-testing with that based on a primary offer of a Pap test; psychosocial impact will be assessed by questionnaire at three time points (baseline; after the first round of screening - approximately 4 months after baseline; after the final round of screening - approximately 9-12 months after baseline). Psychosocial impact is measured using nine Likert scale questions (seven-point scale), which have been tailored from the TOMBOLA study, and one free text question that asks generally about additional comments.	—

Measure

Time frame

1. To compare the proportions of women who participate in screening based on an offer of self-sampling versus an offer of attending for a Pap test. This will be measured after the first phase of cervical screening (approximately 4 months after baseline) and after the second phase of cervical screening (approximately 9-12 months after baseline - this is the final time point). We will use 'objective' measures, using reports from CytoBase, the provincial electronic database for Pap cytology, to capture the numerator of participants attending Pap tests, divided by the total number of participants offered to receive Pap tests. For HPV self-sampling, we'll use the number of HPV reports returned to the Research Team from the laboratory, divided by the number of participants who were offered HPV tests. We will also consider using other denominators, including the total number of women invited to participate, and estimates of the total number of women registered with the communities. 2. To compare the psychosocial impact of cervical screening based on a primary offer of self-testing with that based on a primary offer of a Pap test; psychosocial impact will be assessed by questionnaire at three time points (baseline; after the first round of screening - approximately 4 months after baseline; after the final round of screening - approximately 9-12 months after baseline). Psychosocial impact is measured using nine Likert scale questions (seven-point scale), which have been tailored from the TOMBOLA study, and one free text question that asks generally about additional comments.

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Secondary

Measure	Time frame
1. To measure uptake of all types of cervical screening in 11 participating First Nations communities, represented by percentage of participants who undergo Pap tests or complete HPV self-sampling tests. This will be measured after the first phase of cervical screening (approximately 4 months after baseline) and after the second phase of cervical screening (approximately 9-12 months after baseline - this is the final time point). To evaluate the impact of screening barriers on the attendance for cervical screening, measured using questionnaire and clinical records. The numerators will be the sum of the outcome records (i.e. CytoBase records and HPV test laboratory records) divided by the total women invited, in addition to the total estimates of women in the communities. 2. To compare rates of self-reported screening attendance against objective measures of screening attendance (e.g. follow-up questionnaire will collect self-report of screening attendance). We will use self-report of screening attendance from the follow-up questionnaires at 4 months following baseline and at the final collection time point at approximately 9-12 months. The denominators will include the total number of women participating and the total number of women invited to participate, in addition to the total estimated numbers of women in the communities. 3. To measure the distribution of HPV types in the study population, measured by the number of each unique type of HPV divided by the total number of women who participated in self-sampling. We will use the genotyping data from the National Microbiology Laboratory to determine the proportions of women infected with particular strains of HPV, divided by the total samples received.	—

Measure

Time frame

1. To measure uptake of all types of cervical screening in 11 participating First Nations communities, represented by percentage of participants who undergo Pap tests or complete HPV self-sampling tests. This will be measured after the first phase of cervical screening (approximately 4 months after baseline) and after the second phase of cervical screening (approximately 9-12 months after baseline - this is the final time point). To evaluate the impact of screening barriers on the attendance for cervical screening, measured using questionnaire and clinical records. The numerators will be the sum of the outcome records (i.e. CytoBase records and HPV test laboratory records) divided by the total women invited, in addition to the total estimates of women in the communities. 2. To compare rates of self-reported screening attendance against objective measures of screening attendance (e.g. follow-up questionnaire will collect self-report of screening attendance). We will use self-report of screening attendance from the follow-up questionnaires at 4 months following baseline and at the final collection time point at approximately 9-12 months. The denominators will include the total number of women participating and the total number of women invited to participate, in addition to the total estimated numbers of women in the communities. 3. To measure the distribution of HPV types in the study population, measured by the number of each unique type of HPV divided by the total number of women who participated in self-sampling. We will use the genotyping data from the National Microbiology Laboratory to determine the proportions of women infected with particular strains of HPV, divided by the total samples received.

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Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026