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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Cervical Cancer Screening; Cervical Cancer

Treatments: Behavioral: Self-sampling kit sent at home; Behavioral: Letter offering a self-sampling kit "on request"+ SMS reminder; Behavioral: SMS offering a self-sampling kit "on request"+ SMS reminder; Behavioral: Self-sampling kit sent at home + SMS reminder

Study type: Interventional

Funder types: Other

Identifiers

NCT03856684

DR170135-APACHE-4

Details and patient eligibility

About

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.

Enrollment: 10,400 patients

Sex: Female

Ages: 30 to 66 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10,400 participants in 4 patient groups

Self-sampling kit sent at home

Active Comparator group

Description:

Sending of a vaginal self-sampling kit at home

Treatment:

Behavioral: Self-sampling kit sent at home

Self-sampling kit sent at home + SMS reminder

Experimental group

Description:

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

Treatment:

Behavioral: Self-sampling kit sent at home + SMS reminder

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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