Back to resultsAcceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65 (CUTE-IPS)
Primary Purpose
HPV Infection, Cervical Cancer Screening
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HPV self-sampling
Sponsored by
About this trial
This is an interventional screening trial for HPV Infection
Eligibility Criteria
Inclusion Criteria:
Speak and understand French without help
- Have internet access (for completing forms)
- Have a mailing address
Exclusion Criteria:
- Known positive HPV status • Have already had a hysterectomy
Sites / Locations
- Centre Hospitalier Universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV self-sampling group
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the acceptability of HPV self-sampling by patients
percentage of patients who prefer HPV testing to traditional cytology
Secondary Outcome Measures
Evaluate the percentage of samples collected correctly by patients
Evaluate the return rate of mailed kits
Calculate the HPV positivity rate in a population sample
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05414929
Brief Title
Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65
Acronym
CUTE-IPS
Official Title
Prévention du Cancer du Col de l'UTÉrus Par dépistage d'Une Infection Partageable Sexuellement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
We propose a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling among Quebec women. The study will invite eligible women to self-sample for HPV at home. The HPV risk factors of patients included in the study will be taken into consideration (vaccination, smoking, number of partners, date of last screening, etc.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, Cervical Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV self-sampling group
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV self-sampling
Intervention Description
HPV self-sampling (Cobas Uniswab)
Primary Outcome Measure Information:
Title
Evaluate the acceptability of HPV self-sampling by patients
Description
percentage of patients who prefer HPV testing to traditional cytology
Time Frame
2 months following recruitment
Secondary Outcome Measure Information:
Title
Evaluate the percentage of samples collected correctly by patients
Time Frame
2 months following recruitment
Title
Evaluate the return rate of mailed kits
Time Frame
2 months following recruitment
Title
Calculate the HPV positivity rate in a population sample
Time Frame
2 months following recruitment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Speak and understand French without help
Have internet access (for completing forms)
Have a mailing address
Exclusion Criteria:
Known positive HPV status • Have already had a hysterectomy
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
j1n4j6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65
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