Acceptability of HPV-self Sampling

Cervical Cancer Clinical Trial

Official title:

Evaluation of the Acceptability of HPV Self-sampling Among French Women Eligible for Cervical Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137563
• Other study ID #: UF9839
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling.

These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations

Description:

Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the Region of Occitanie in the south of France).The questionnaire will be proposed to the women attending one of these eight centers by an investigator, who will verify the inclusion and exclusion criteria. The same person will collect the filled questionnaire.

The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability of HPV self-sampling and socio-economic determinants.

These questionnaires will be collected and statistical analysis will be performed using appropriate tools.

This study will bring informations on the acceptibility of HPV self sampling among french women eligible for cervical cancer screening in 2 Departements of the South of France. Self-sampling acceptability will be linked to socio-economic determinants.

These data will be important to propose and evaluate new strategies to improve screening coverage, particularly of the context of the organized cervical cancer screening that will take place in France in 2018.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women 25-65 years old

• Living in the Aude or Herault departments

• Informed patient Exclusion criteria

• Virgins

• Previous hysterectomy

• Present or previous cervical pathology

• Patient under guardianship or tutorship

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• questionnaire
The questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Adoc11 (Carcassonne - France), Dépistages34 (Montpellier - France), Maison médicale Paul Valéry - Union Languedoc Mutualité - (Montpellier -France)

Country where clinical trial is conducted

France, 

References & Publications (1)

Bertucci M, Bonnet E, Satger L, Kreiche A, Chappert JL, Loy-Morel S, Segondy M, Daurès JP, Boulle N. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Wome — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accept HPV self-sampling for cervical cancer	Response " Yes " or " No " to the question " would you accept HPV self-sampling for cervical cancer screening ?	1 day
Secondary	Socioeconomic determinants of the response	Socioeconomic determinants of the response " yes " or " no " to the question " would you accept HPV self-sampling for cervical cancer screening ?	1 day