Cervical Cancer ScreeningAPACHE-4NCT03856684
Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer
A study testing Self-sampling kit sent at home, Self-sampling kit sent at home + SMS reminder and Letter offering a self-sampling kit "on request"+ SMS reminder in people with Cervical Cancer Screening and Cervical Cancer, run by University Hospital, Tours at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening, Cervical Cancer
- What is being tested?
- Self-sampling kit sent at home, Self-sampling kit sent at home + SMS reminder and Letter offering a self-sampling kit "on request"+ SMS reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,400 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2020to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- STOP SMS
- HPV cervical pathology during treatment
- Hysterectomy including cervix
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Self-sampling kit sent at home, Self-sampling kit sent at home + SMS reminder, Letter offering a self-sampling kit "on request"+ SMS reminder, SMS offering a self-sampling kit "on request"+ SMS reminder
- Keywords
- vaginal, self-sampling, cervical cancer screening, Papillomavirus, HPV, High Risk Human papillomavirus Infection, pap smear
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-sampling kit sent at homeBehavioural
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 reminderBehavioural
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 reminderBehavioural
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 reminderBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-sampling kit sent at home | Active comparator | Sending of a vaginal self-sampling kit at home Receives: Behavioral: Self-sampling kit sent at home |
| Self-sampling kit sent at home + SMS reminder | Experimental | 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 Receives: Behavioral: Self-sampling kit sent at home + SMS reminder |
| Letter offering a self-sampling kit "on request"+ SMS reminder | Experimental | 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 Receives: Behavioral: Letter offering a self-sampling kit "on request"+ SMS reminder |
| SMS offering a self-sampling kit "on request"+ SMS reminder | Experimental | 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 Receives: Behavioral: SMS offering a self-sampling kit "on request"+ SMS reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation / no participation to complete cervical cancer screening
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)
Measured: 9 months after postal mail (with or without the kit) or SMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Feb 2020
- Primary completion14 Jul 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire, Centre d'Investigation Clinique-P1415, TOURS
- Responsible party
- Sponsor
- Investigators
- Julie BOYARD, MSc, Principal investigator, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856684
- Sponsor's protocol ID
- DR170135-APACHE-4
- Acronym
- APACHE-4
- Status last verified
- Oct 2021
- First submitted
- 26 Feb 2019
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03856684
- Acronym / sponsor ID
- APACHE-4 / DR170135-APACHE-4
- Conditions
- Cervical Cancer Screening, Cervical Cancer
- Keywords
- vaginal, self-sampling, cervical cancer screening, Papillomavirus, HPV, High Risk Human papillomavirus Infection, pap smear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,400 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire, Centre d'Investigation Clinique-P1415, TOURS
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-sampling kit sent at home | Active comparator | Behavioral: Self-sampling kit sent at homeSending of a vaginal self-sampling kit at home |
| Self-sampling kit sent at home + SMS reminder | Experimental | Behavioral: Self-sampling kit sent at home + SMS reminderSending 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 |
| Letter offering a self-sampling kit "on request"+ SMS reminder | Experimental | Behavioral: Letter offering a self-sampling kit "on request"+ SMS reminderSending 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 |
| SMS offering a self-sampling kit "on request"+ SMS reminder | Experimental | Behavioral: SMS offering a self-sampling kit "on request"+ SMS reminderSending 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 |
Who may qualify
- Ages
- 30 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- STOP SMS
- HPV cervical pathology during treatment
- Hysterectomy including cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-sampling kit sent at homeSelected 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. | Behavioural | Self-sampling kit sent at home |
| Self-sampling kit sent at home + SMS reminderSelected 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. | Behavioural | Self-sampling kit sent at home + SMS reminder |
| Letter offering a self-sampling kit "on request"+ SMS reminderSelected 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. | Behavioural | Letter offering a self-sampling kit "on request"+ SMS reminder |
| SMS offering a self-sampling kit "on request"+ SMS reminderSelected 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. | Behavioural | SMS offering a self-sampling kit "on request"+ SMS reminder |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie BOYARD, MSc principal investigator
University Hospital of TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-sampling kit sent at home, Self-sampling kit sent at home + SMS reminder and Letter offering a self-sampling kit "on request"+ SMS reminder in people with Cervical Cancer Screening and Cervical Cancer, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation / no participation to complete cervical cancer screening (time frame: 9 months after postal mail (with or without the kit) or SMS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.