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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Tours
- Enrollment
- 10,400
- Locations
- 1
- Primary Endpoint
- Participation / no participation to complete cervical cancer screening
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 66 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •HPV cervical pathology during treatment
- •Hysterectomy including cervix
Arms & Interventions
Self-sampling kit sent at home
Sending of a vaginal self-sampling kit at home
Intervention: Self-sampling kit sent at home (Behavioral)
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
Intervention: Self-sampling kit sent at home + SMS reminder (Behavioral)
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
Intervention: Letter offering a self-sampling kit "on request"+ SMS reminder (Behavioral)
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
Intervention: SMS offering a self-sampling kit "on request"+ SMS reminder (Behavioral)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported