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
Introduction Cervical 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...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/11/e065952.full |
| _version_ | 1828097001185607680 |
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| author | Marc Bardou Alexandre Dumont Dolorès Pourette Jean-Luc Fanon Laurence Fagour Guillemette Antoni Nicolas Traversier Amir Hassine Muriel Fender Katia Slama François-Xavier Léandri Christelle Auvray Marie Christine Jaffar Bandjee Lise Rochaix Camilla Fiorina Eric Opigez Resiste Study Group |
| author_facet | Marc Bardou Alexandre Dumont Dolorès Pourette Jean-Luc Fanon Laurence Fagour Guillemette Antoni Nicolas Traversier Amir Hassine Muriel Fender Katia Slama François-Xavier Léandri Christelle Auvray Marie Christine Jaffar Bandjee Lise Rochaix Camilla Fiorina Eric Opigez Resiste Study Group |
| author_sort | Marc Bardou |
| collection | DOAJ |
| description | Introduction Cervical 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 analysis Our 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 dissemination Ethics 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 number NCT04312178. |
| first_indexed | 2024-04-11T07:40:21Z |
| format | Article |
| id | doaj.art-115659f3fd724b1fadce46d87102a1e0 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T07:40:21Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-115659f3fd724b1fadce46d87102a1e02022-12-22T04:36:36ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-065952Combined 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- RESISTEMarc Bardou0Alexandre Dumont1Dolorès Pourette2Jean-Luc Fanon3Laurence Fagour4Guillemette Antoni5Nicolas Traversier6Amir Hassine7Muriel Fender8Katia Slama9François-Xavier Léandri10Christelle Auvray11Marie Christine Jaffar Bandjee12Lise Rochaix13Camilla Fiorina14Eric Opigez15Resiste Study Group165 UMR INSERM 1231, Université de Bourgogne UFR des Sciences de Santé, Dijon, Bourgogne, FranceCEPED, Université Paris Cité, IRD, INSERM, Paris, France8 CEPED, IRD, Université Paris Descartes, INSERM, Paris, France1 Department of Geriatrics, University Hospitals of Martinique, Martinique, FranceLaboratory of Virology, CHU de Martinique, Fort-de-France, MartiniqueSC10-US19, INSERM, Villejuif, FranceLaboratory of Virology, CHD Félix Guyon, Saint-Denis, RéunionCIC-P INSERM 1432, Centre Hospitalier Universitaire de Dijon, Dijon, FranceRegional Center for the Coordination of Cancer Screening Grand Est Region, Strasbourg, FranceRegional Screening for the Coordination of Cancer Screening, Réunion, FranceRegional Center for the Coordination Screening of Cancer Screening PACA Region, Marseille, FranceLaboratory of Virology, CHU Dijon Bourgogne, Dijon, FranceLaboratory of Virology, CHD Félix Guyon, Saint-Denis, RéunionChaire de Recherche Hospinnomics, Paris School of Economics, Paris, FranceChaire de Recherche Hospinnomics, Paris School of Economics, Paris, FranceCEPED, Paris, FranceRegional Center for the Coordination of Cancer Screening Grand Est Region, Strasbourg, FranceIntroduction Cervical 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 analysis Our 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 dissemination Ethics 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 number NCT04312178.https://bmjopen.bmj.com/content/12/11/e065952.full |
| spellingShingle | Marc Bardou Alexandre Dumont Dolorès Pourette Jean-Luc Fanon Laurence Fagour Guillemette Antoni Nicolas Traversier Amir Hassine Muriel Fender Katia Slama François-Xavier Léandri Christelle Auvray Marie Christine Jaffar Bandjee Lise Rochaix Camilla Fiorina Eric Opigez Resiste Study Group 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/11/e065952.full |
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