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NCT05414929 Clinical Trial

Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65

HPV Infection Clinical Trial

— CUTE-IPS  

Official title:
Prévention du Cancer du Col de l'UTÉrus Par dépistage d'Une Infection Partageable Sexuellement

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05414929
Other study ID # 2022-4535
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 4, 2022
Est. completion date June 30, 2022

Study information
Verified date June 2022
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date June 30, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• HPV self-sampling
HPV self-sampling (Cobas Uniswab)

Locations
Country Name City State
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)
Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the acceptability of HPV self-sampling by patients percentage of patients who prefer HPV testing to traditional cytology 2 months following recruitment
Secondary Evaluate the percentage of samples collected correctly by patients 2 months following recruitment
Secondary Evaluate the return rate of mailed kits 2 months following recruitment
Secondary Calculate the HPV positivity rate in a population sample 2 months following recruitment
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