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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Chu Dijon Bourgogne

    Dijon, 21000

Other trials in France

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 groups in NCT04312178
Study groupRoleWhat they receive
return vaginal self-swab by mailOtherSocially 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-swabOtherSocially 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 professionalOtherSocially 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 proOtherSocially 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.

  1. Proportion of women returning the HPV kit

    Own effect of the economic incentive to get tested

    Measured: 12 months after sending HPV kit

  2. 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.

  1. First posted18 Mar 2020
  2. Study start5 Jan 2022
  3. Primary completion28 Mar 2024
  4. Study completion28 Mar 2024

Resources

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)
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

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.

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