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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 (RESISTE)

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cash incentive
no intervention
return vaginal self-swab kit in person
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

return vaginal self-swab by mail

financial incentive mail-back vaginal self-swab

handing over the vaginal swab to a professional

financial incentive the vaginal self-swab to a pro

Arm Description

Socially disadvantaged women who have received a vaginal self-swab and have to return it by mail

Socially disadvantaged women who have received a vaginal self-swab and have to return it by mail to obtain a cash incentive

Socially disadvantaged women who have received a vaginal self-swab and need to report it to a health professional

Socially disadvantaged women who have received a vaginal self-swab and have to report it to a health professional to obtain a cash incentive

Outcomes

Primary Outcome Measures

Proportion of women returning the 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
The specific effect of encouraging women to get tested by a health Professional

Secondary Outcome Measures

Full Information

First Posted
March 11, 2020
Last Updated
September 5, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT04312178
Brief 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
Acronym
RESISTE
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
return vaginal self-swab by mail
Arm Type
Other
Arm Description
Socially disadvantaged women who have received a vaginal self-swab and have to return it by mail
Arm Title
financial incentive mail-back vaginal self-swab
Arm Type
Other
Arm Description
Socially disadvantaged women who have received a vaginal self-swab and have to return it by mail to obtain a cash incentive
Arm Title
handing over the vaginal swab to a professional
Arm Type
Other
Arm Description
Socially disadvantaged women who have received a vaginal self-swab and need to report it to a health professional
Arm Title
financial incentive the vaginal self-swab to a pro
Arm Type
Other
Arm Description
Socially disadvantaged women who have received a vaginal self-swab and have to report it to a health professional to obtain a cash incentive
Intervention Type
Other
Intervention Name(s)
cash incentive
Intervention Description
cash incentive (20€ gift card)
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
no intervention
Intervention Type
Other
Intervention Name(s)
return vaginal self-swab kit in person
Intervention Description
hand-delivered to a health care professional to encourage discussion of cervical cancer prevention
Primary Outcome Measure Information:
Title
Proportion of women returning the HPV kit
Description
Own effect of the economic incentive to get tested
Time Frame
12 months after sending HPV kit
Title
Proportion of women visiting a health professional after receiving the kit and performing a pap smear or HPV test
Description
The specific effect of encouraging women to get tested by a health Professional
Time Frame
12 months after sending HPV kit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BARDOU
Phone
03 80 29 57 53
Email
marc.bardou@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BARDOU
Phone
0380295755
Ext
33
Email
marc.bardou@u-bourgogne.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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