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

NCT04312178CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

10446

Start Date

2022-01-05

Completion Date

2024-03-28

Study Type

INTERVENTIONAL

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

Interventions

cash incentiveno interventionreturn vaginal self-swab kit in person

Conditions

Cervical Cancer

Eligibility

Age Range

30 Years – 65 Years

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

Proportion of women returning the HPV kit

Own effect of the economic incentive to get tested

Time frame: 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

Time frame: 12 months after sending HPV kit

Locations

Chu Dijon Bourgogne, Dijon, France

Linked Papers

2022-11-23

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

IntroductionCervical cancer (CC) causes thousands of deaths each year. Nearly 100% of cases are caused by oncogenic strains of human papillomavirus (HPV). In most industrialised countries, CC screening (CCS) is based on the detection of HPV infections. For many reasons including lower adherence to CCS, underserved women are more likely to develop CC, and die from it. We aim to demonstrate that the use of incentives could improve screening rates among this population.Methods and analysisOur cluster randomised, controlled trial will include 10 000 women aged 30–65 years eligible for CCS, living in deprived areas in four French departments, two mainlands and two overseas, and who did not perform physician-based HPV testing within the framework of the nationally organised screening programme. HPV self-sampling kit (HPVss) will be mailed to them. Two interventions are combined in a factorial analysis design ending in four arms: the possibility to receive or not a financial incentive of €20 and to send back the self-sampling by mail or to give it to a health professional, family doctor, gynaecologist, midwife or pharmacist. The main outcome is the proportion of women returning the HPVss, or doing a physician-based HPV or pap-smear test the year after receiving the HPVss. 12-month follow-up data will be collected through the French National Health Insurance database. We expect to increase the return rate of HPV self-samples by at least 10% (from 20% to 30%) compared with the postal return without economic incentive.Ethics and disseminationEthics approval was first obtained on 2 April 2020, then on July 29 2022. The ethics committee classified the study as interventional with low risk, thus no formal consent is required for inclusion. The use of health insurance data was approved by the Commission Nationale Informatique et Libertés on 14 September 2021 (ref No 920276). An independent data security and monitoring committee was established. The main trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04312178.

Linked Investigators