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

NCT ID: NCT03856684

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2021-10-20

Brief Summary

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.

Conditions

Cervical Cancer Screening; Cervical Cancer

Keywords

vaginal; self-sampling; cervical cancer screening; Papillomavirus; HPV; High Risk Human papillomavirus Infection; pap smear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Self-sampling kit sent at home

Sending of a vaginal self-sampling kit at home

Group Type: ACTIVE_COMPARATOR

Self-sampling kit sent at home

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Self-sampling kit sent at home + SMS reminder

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire

UNKNOWN

Sponsor Role: collaborator

Centre d'Investigation Clinique-P1415, TOURS

UNKNOWN

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie BOYARD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital of TOURS

Locations

Crcdc-Cvl

Tours, , France

Countries

France

Other Identifiers

DR170135-APACHE-4

Identifier Type: -

Identifier Source: org_study_id