Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer (APACHE-4)

October 28, 2021 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10400

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

  • France
      • Tours, France, 37044
        • Crcdc-Cvl

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

26 years to 62 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-sampling kit sent at home
Sending of a vaginal self-sampling kit at home
Behavioral: Self-sampling kit sent at home

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.
Experimental: Self-sampling kit sent at home + SMS reminder

Sending of a vaginal self-sampling kit at home + a SMS reminder is sent if the woman do not (in 2 months) :

  • perform a pap smear
  • or send her vaginal self-sample to the laboratory
  • or contact the screening center to inform to an exclusion reason
Behavioral: Self-sampling kit sent at home + SMS reminder

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

Sending of letter offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us.

If they do ask for the kit, one kit is sending to their home.

For these women, a SMS reminder is sent if the woman do not (in 2 months) :

  • perform a pap smear
  • or send her vaginal self-sample to the laboratory
  • or contact the screening center to inform to an exclusion reason
Behavioral: Letter offering a self-sampling kit "on request"+ SMS reminder

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

Sending of SMS offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us.

If they do ask for the kit, one kit is sending to their home.

For these women, a SMS reminder is sent if the woman do not (in 2 months) :

  • perform a pap smear
  • or send her vaginal self-sample to the laboratory
  • or contact the screening center to inform to an exclusion reason
Behavioral: SMS offering a self-sampling kit "on request"+ SMS reminder

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
9 months after postal mail (with or without the kit) or SMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire
Centre d'Investigation Clinique-P1415, TOURS

Investigators

  • Principal Investigator: Julie BOYARD, MSc, University hospital of Tours

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)

February 11, 2020

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR170135-APACHE-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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