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Completed

NCT Number: NCT03856684

Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer

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 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 sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.

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Key information

Conditions

Cervical Cancer Screening Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–66 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Crcdc-Cvl

Tours, 37044, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • women from 30 to 66 years old
  • women living in french territorial division 37 ("Indre-et-Loire")
  • women with a mobile phone in database
  • women who do not perform a pap smear in the last 4 years
  • women who do not answer to a first "invitation" letter to perform a pap smear

Exclusion criteria

  • STOP SMS
  • HPV cervical pathology during treatment
  • Hysterectomy including cervix

Treatment and study plan

Self-sampling kit sent at home

Behavioral

Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.

When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Self-sampling kit sent at home + SMS reminder

Behavioral

Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.

After 2 months without "return", a SMS reminder about the available self-sampling kit is sent to the woman. We call "return" :

  • the receipt of the vaginal self-sample at the laboratory
  • the performance of a pap smear
  • Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Letter offering a self-sampling kit "on request"+ SMS reminder

Behavioral

Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (kit provided on request) or to perform a pap smear.

Women are invited to ask the kit online, on our website.

For the women who ask the kit, after 2 months without "return", a SMS reminder about the available self-sampling kit is sent to the woman. We call "return" :

  • the receipt of the vaginal self-sample at the laboratory
  • the performance of a pap smear
  • Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

SMS offering a self-sampling kit "on request"+ SMS reminder

Behavioral

Selected women receive a SMS inviting them to ask a vaginal self sampling kit to perform a sample at home and send it to a laboratory (kit provided on request).

Women are invited to ask the kit by answering "1" by SMS.

For the women who ask the kit, after 2 months without "return", a SMS reminder about the available self-sampling kit is sent to the woman. We call "return" :

  • the receipt of the vaginal self-sample at the laboratory
  • the performance of a pap smear
  • Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Primary outcomes

  1. Participation / no participation to complete cervical cancer screening

    Time frame: 9 months after postal mail (with or without the kit) or SMS

    Complete cervical cancer screening is defined as one of the followings :

    • perform a pap smear
    • perform a vaginal self-sampling with negative HR-HPV test
    • perform a vaginal self-sampling with noninterpretable HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result)
    • perform a vaginal self-sampling with positive HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
  • Centre d'Investigation Clinique-P1415, TOURS

Registry information

Official study title

Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

Acronym: APACHE-4

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2019
Registry last updated
Oct 29, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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