- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414929
Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65 (CUTE-IPS)
June 7, 2022 updated by: Josianne Pare, Université de Sherbrooke
Prévention du Cancer du Col de l'UTÉrus Par dépistage d'Une Infection Partageable Sexuellement
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.).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, j1n4j6
- Centre Hospitalier Universitaire de Sherbrooke
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HPV self-sampling group
|
HPV self-sampling (Cobas Uniswab)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the acceptability of HPV self-sampling by patients
Time Frame: 2 months following recruitment
|
percentage of patients who prefer HPV testing to traditional cytology
|
2 months following recruitment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the percentage of samples collected correctly by patients
Time Frame: 2 months following recruitment
|
2 months following recruitment
|
Evaluate the return rate of mailed kits
Time Frame: 2 months following recruitment
|
2 months following recruitment
|
Calculate the HPV positivity rate in a population sample
Time Frame: 2 months following recruitment
|
2 months following recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 4, 2022
Primary Completion (ACTUAL)
May 15, 2022
Study Completion (ANTICIPATED)
June 30, 2022
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
June 7, 2022
First Posted (ACTUAL)
June 10, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-4535
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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