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Completed

NCT Number: NCT03420157

Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women from 30 to 65 years old
  • women living in french territorial division 37 ("Indre-et-Loire")
  • no pap smear made in the three last years (ideally)

Exclusion criteria

  • Follow-up in progress for positive screening

Treatment and study plan

Focus Group

Other

Focus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit.

Primary outcomes

  1. Focus group methodology (structured questionnaire) will use to identify group norms or a range of views and to capitalise on the interaction within the group to identify levers and brakes and improve communication media (10 women for each focus group)

    Time frame: A systematic text analysis of the transcripts will be performed after data saturation was reached (projection: 2 focus group of 2 hours in two weeks)

    The transcripts of the discussions will be reviewed by the psychologist to identify the emerging themes (anxiety, motivating information, ...) to identify levers and brakes and improve communication media.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: APACHE-4/FG

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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