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

  • Canada
    • 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
Diagnostic test: HPV self-sampling
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

Université de Sherbrooke

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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