Cervical CancerRESISTENCT04312178
Combined Incentive Actions, Focusing on Primary Care, to Improve Cervical Cancer Screening in Women Residing in Socio-economically Disadvantaged and Untracked Geographical Areas: a Hybrid Efficacy and Implementation Trial
A study testing cash incentive and return vaginal self-swab kit in person in people with Cervical Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Though potentially eradicable, cervical cancer is the 3rd most prevalent gynecological cancer, and the 2nd most prevalent before the age of 45. In France, approximately 1100 women die from cervical cancer each year, with 5-year survival strongly linked to the stage at diagnosis (93%, 63%, 35% and 16% for stages IA… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- cash incentive and return vaginal self-swab kit in person
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,446 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2022to 28 Mar 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman between 30 and 65 years of age.
- Covered by a Regional Cancer Screening Coordination Centre for cervical cancer in 4 of the pilot departments for the implementation of this organised screening, and participating in the study.
- eligible for cervical cancer screening.
- Having not had a screening test for at least three years.
- Not having responded within 12 months to a letter inviting a screening test.
- Residing in a Block Grouped for Disadvantaged Statistical Information, quintiles 4 \& 5 according to the European Deprivation Index classification.
- Covered by health insurance or AME
Who cannot join
- Ineligible for screening (e.g. hysterectomy or history of cervical cancer).
- Having returned a refusal coupon or NPAI (does not live at the address indicated)
Trial locations and contacts
1 site in 1 country.
About this study
Though potentially eradicable, cervical cancer is the 3rd most prevalent gynecological cancer, and the 2nd most prevalent before the age of 45. In France, approximately 1100 women die from cervical cancer each year, with 5-year survival strongly linked to the stage at diagnosis (93%, 63%, 35% and 16% for stages IA, IIA, IIIA and IVA). The prevention of cervical cancer is currently based on the combination of the vaccination of adolescent girls against the most common high-risk oncogenic human papilloma virus types and routine Papanicolaou cytology (Pap smears) every three years in women aged 25 to 65 years. The Health and Social Protection Survey conducted by the Institute for Research and Documentation in Health Economics in 2012 showed that young women who are not vaccinated have a socio-economic profile similar to that of women who do not attend cervical cancer screening, mainly: (i) the least screened women and least vaccinated young women live in low-income families; (ii) a low level of education is associated with fewer Pap smears; (iii) an absence of pap smears in mothers in the last three years is associated with less human papillomavirus vaccination in their daughters. Cervical cancer is the female cancer which, in France, has the highest proportion attributable to precariousness (21.1%), and for which there are strong territorial disparities in incidence.
Several factors may explain the difficulties in obtaining satisfactory rates of screening, such as geographical remoteness, the disengagement of general practitioners, economic constraints, or the geographical origin of women. Several countries such as the Netherlands have started routinely screening for cervical cancer by testing for human papillomavirus. This approach appears to be as beneficial as a screening campaign based on the Pap smear.
Read more
This approach has also just been validated by the French Health Authority which, in its public health recommendation dated 11 July 2019, states that "From the age of 30, the High Authority for Health recommends that the human papillomavirus test replace the cytological examination in primary screening for cervical cancer." In addition, this recommendation states that "Vaginal self-sampling is an alternative to cervical sampling by a health professional to detect the human papillomavirus test for undetected or under-detected women. This makes it easier to screen women who never get tested or who do not get tested as recommended." Moreover, the French Authority for Health specifies "In addition, complementary studies should be carried out to evaluate the feasibility and effectiveness of the different modalities for making these vaginal self-samples available, depending on the specific populations concerned (French Guyana, Mayotte, women living on the street, in shantytowns, migrant women, with limited access to health services, etc.)".
Two French trials show that when women ignored a letter sent to the home to invite them to receive a Pap smear, only 16 to 18% of women performed vaginal self-sampling when a kit was subsequently sent to their home. The delivery of a vaginal swab by a health professional does not increase adherence to screening compared to a reminder letter for a Pap smear (12% vs. 11.9%). Economic incentives may increase adherence to prevention policies, including those against human papillomavirus infections. They are often used to combat "present bias", i.e. the tendency to seek immediate, even limited, satisfaction rather than greater future satisfaction. A factorial design will be used to analyze the respective contribution of the delivery of the vaginal swab to a healthcare professional and an economic incentive of 20€. The hypothesis is that the the fact of returning the vaginal self-sampling to a health professional or an economic incentive will increase the participation of socially disadvantaged women in cervical cancer screening compared to simply returning it by mail without an incentive. It also postulate that health professionals will encourage women to perform a vaginal swab and adhere to the recommendations of the French Health Authority in case of a positive human papillomavirus test and that socially disadvantaged women will accept vaginal swabbing as a method of cervical cancer screening. Factors such as precariousness, life and migration paths, the socio-sanitary context, and the provision of primary care all play a role in prevention behaviors and may explain the heterogeneity of the observed effects.
- Conditions
- Cervical Cancer
- Being tested
- cash incentive, no intervention, return vaginal self-swab kit in person
- 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.
cash incentiveOther
cash incentive (20€ gift card)
no interventionOther
no intervention
return vaginal self-swab kit in personOther
hand-delivered to a health care professional to encourage discussion of cervical cancer prevention
| Study group | Role | What they receive |
|---|---|---|
| return vaginal self-swab by mail | Other | Socially disadvantaged women who have received a vaginal self-swab and have to return it by mail Receives: Other: no intervention |
| financial incentive mail-back vaginal self-swab | Other | Socially disadvantaged women who have received a vaginal self-swab and have to return it by mail to obtain a cash incentive Receives: Other: cash incentive |
| handing over the vaginal swab to a professional | Other | Socially disadvantaged women who have received a vaginal self-swab and need to report it to a health professional Receives: Other: no intervention; Other: return vaginal self-swab kit in person |
| financial incentive the vaginal self-swab to a pro | Other | Socially disadvantaged women who have received a vaginal self-swab and have to report it to a health professional to obtain a cash incentive Receives: Other: cash incentive; Other: return vaginal self-swab kit in person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women returning the HPV kit
Own effect of the economic incentive to get tested
Measured: 12 months after sending HPV kit
Proportion of women visiting a health professional after receiving the kit and performing a pap smear or HPV test
The specific effect of encouraging women to get tested by a health Professional
Measured: 12 months after sending HPV kit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start5 Jan 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312178
- Sponsor's protocol ID
- BARDOU DEPREV PREPS 2019
- Acronym
- RESISTE
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hassine A, Antoni G, Fender M, Slama K, Leandri FX, Fanon JL, Auvray C, Jaffar Bandjee MC, Traversier N, Fagour L, Rochaix L, Fiorina C, Pourette D, Opigez E, Dumont A, Bardou M, Study Group R. Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE. BMJ Open. 2022 Nov 23;12(11):e065952. doi: 10.1136/bmjopen-2022-065952.
PubMed 36418118
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Incentive Actions, Focusing on Primary Care, to Improve Cervical Cancer Screening in Women Residing in Socio-economically Disadvantaged and Untracked Geographical Areas: a Hybrid Efficacy and Implementation Trial
- ClinicalTrials.gov ID
- NCT04312178
- Acronym / sponsor ID
- RESISTE / BARDOU DEPREV PREPS 2019
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,446 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 18 Mar 2020 (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.
Though potentially eradicable, cervical cancer is the 3rd most prevalent gynecological cancer, and the 2nd most prevalent before the age of 45. In France, approximately 1100 women die from cervical cancer each year, with 5-year survival strongly linked to the stage at diagnosis (93%, 63%, 35% and 16% for stages IA, IIA, IIIA and IVA). The prevention of cervical cancer is currently based on the combination of the vaccination of adolescent girls against the most common high-risk oncogenic human papilloma virus types and routine Papanicolaou cytology (Pap smears) every three years in women aged 25 to 65 years. The Health and Social Protection Survey conducted by the Institute for Research and Documentation in Health Economics in 2012 showed that young women who are not vaccinated have a socio-economic profile similar to that of women who do not attend cervical cancer screening, mainly: (i) the least screened women and least vaccinated young women live in low-income families; (ii) a low level of education is associated with fewer Pap smears; (iii) an absence of pap smears in mothers in the last three years is associated with less human papillomavirus vaccination in their daughters. Cervical cancer is the female cancer which, in France, has the highest proportion attributable to precariousness (21.1%), and for which there are strong territorial disparities in incidence.
Several factors may explain the difficulties in obtaining satisfactory rates of screening, such as geographical remoteness, the disengagement of general practitioners, economic constraints, or the geographical origin of women. Several countries such as the Netherlands have started routinely screening for cervical cancer by testing for human papillomavirus. This approach appears to be as beneficial as a screening campaign based on the Pap smear.
This approach has also just been validated by the French Health Authority which, in its public health recommendation dated 11 July 2019, states that "From the age of 30, the High Authority for Health recommends that the human papillomavirus test replace the cytological examination in primary screening for cervical cancer." In addition, this recommendation states that "Vaginal self-sampling is an alternative to cervical sampling by a health professional to detect the human papillomavirus test for undetected or under-detected women. This makes it easier to screen women who never get tested or who do not get tested as recommended." Moreover, the French Authority for Health specifies "In addition, complementary studies should be carried out to evaluate the feasibility and effectiveness of the different modalities for making these vaginal self-samples available, depending on the specific populations concerned (French Guyana, Mayotte, women living on the street, in shantytowns, migrant women, with limited access to health services, etc.)".
Two French trials show that when women ignored a letter sent to the home to invite them to receive a Pap smear, only 16 to 18% of women performed vaginal self-sampling when a kit was subsequently sent to their home. The delivery of a vaginal swab by a health professional does not increase adherence to screening compared to a reminder letter for a Pap smear (12% vs. 11.9%). Economic incentives may increase adherence to prevention policies, including those against human papillomavirus infections. They are often used to combat "present bias", i.e. the tendency to seek immediate, even limited, satisfaction rather than greater future satisfaction. A factorial design will be used to analyze the respective contribution of the delivery of the vaginal swab to a healthcare professional and an economic incentive of 20€. The hypothesis is that the the fact of returning the vaginal self-sampling to a health professional or an economic incentive will increase the participation of socially disadvantaged women in cervical cancer screening compared to simply returning it by mail without an incentive. It also postulate that health professionals will encourage women to perform a vaginal swab and adhere to the recommendations of the French Health Authority in case of a positive human papillomavirus test and that socially disadvantaged women will accept vaginal swabbing as a method of cervical cancer screening. Factors such as precariousness, life and migration paths, the socio-sanitary context, and the provision of primary care all play a role in prevention behaviors and may explain the heterogeneity of the observed effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| return vaginal self-swab by mail | Other | Other: no interventionSocially disadvantaged women who have received a vaginal self-swab and have to return it by mail |
| financial incentive mail-back vaginal self-swab | Other | Other: cash incentiveSocially disadvantaged women who have received a vaginal self-swab and have to return it by mail to obtain a cash incentive |
| handing over the vaginal swab to a professional | Other | Other: no intervention, Other: return vaginal self-swab kit in personSocially disadvantaged women who have received a vaginal self-swab and need to report it to a health professional |
| financial incentive the vaginal self-swab to a pro | Other | Other: cash incentive, Other: return vaginal self-swab kit in personSocially disadvantaged women who have received a vaginal self-swab and have to report it to a health professional to obtain a cash incentive |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Woman between 30 and 65 years of age.
- Covered by a Regional Cancer Screening Coordination Centre for cervical cancer in 4 of the pilot departments for the implementation of this organised screening, and participating in the study.
- eligible for cervical cancer screening.
- Having not had a screening test for at least three years.
- Not having responded within 12 months to a letter inviting a screening test.
Key exclusion criteria (2 listed)
- Ineligible for screening (e.g. hysterectomy or history of cervical cancer).
- Having returned a refusal coupon or NPAI (does not live at the address indicated)
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 |
|---|---|---|
| cash incentivecash incentive (20€ gift card) | Other | financial incentive mail-back vaginal self-swab, financial incentive the vaginal self-swab to a pro |
| no interventionno intervention | Other | handing over the vaginal swab to a professional, return vaginal self-swab by mail |
| return vaginal self-swab kit in personhand-delivered to a health care professional to encourage discussion of cervical cancer prevention | Other | financial incentive the vaginal self-swab to a pro, handing over the vaginal swab to a professional |
Primary outcome
Proportion of women returning the HPV kit
Time frame: 12 months after sending HPV kit
Own effect of the economic incentive to get tested
Proportion of women visiting a health professional after receiving the kit and performing a pap smear or HPV test
Time frame: 12 months after sending HPV kit
The specific effect of encouraging women to get tested by a health Professional
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 25 Jun 2024.
- Derived from this study: PubMed 36418118Hassine A, Antoni G, Fender M, Slama K, Leandri FX, Fanon JL, Auvray C, Jaffar Bandjee MC, Traversier N, Fagour L, Rochaix L, Fiorina C, Pourette D, Opigez E, Dumont A, Bardou M, Study Group R. Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE. BMJ Open. 2022 Nov 23;12(11):e065952. doi: 10.1136/bmjopen-2022-065952.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cash incentive and return vaginal self-swab kit in person in people with Cervical Cancer, run by Centre Hospitalier Universitaire Dijon 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 7 inclusion and 2 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 25 Jun 2024. 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?
Proportion of women returning the HPV kit (time frame: 12 months after sending HPV kit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312178, which also lists 1 linked publication.
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 25 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.