Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Uterine Cervical Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Eligible women residing in the Central Denmark Region will be assigned to intervention group. Women in the intervention group receive an invitation for HPV-based cervical cancer screening by attending either 1) GP-based screening or 2) HPV self-sampling. The self-sampling kit includes the dry Evalyn brush self-sampling device (Rovers Medical Devices B.V, Oss, Netherlands), written and picture-based user instructions on how to collect and mail the self-sample, and a prestamped return envelope addressed to the Department of Pathology, Randers Regional Hospital.

Eligible women residing in the other five Danish regions (North, Central, South, Zealand and Capital ) will be assigned to control group. Women in the control group will receive usual care, which for 65-69 year-old women is opportunistic cervical cancer screening at the GP

Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.

GP-based screening or HPV self-sampling

Mette Tranberg, Post doc PhD

Mette tranberg Nielsen, phd

Berit Andersen, MD, PhD

Mette T Tranberg, post doc phd

This study evaluates the effect and feasibility of expanding the target population in the Danish cervical cancer screening program to include women aged 65 to 69 years. The study also evaluates if HPV self-sampling constitutes an appropriate screening method among older women.

The study is a nationwide population-based prospective cohort study embedded in the routine cervical cancer screening program in the Central Denmark Region. The study includes all 65 to 69 years old Danish women with no record of a cervical cytology sample or screening invitation within the last five years. Furthermore, the women are not registered as ineligible for screening, eg due hysterectomy. Eligible women residing in the Central Denmark Region are allocated to the intervention group (n=20,000), while women residing in the other four Danish regions are allocated to the control group receiving standard care (n=71,500), which for this group is low-level opportunistic screening at the general practitioner (GP). The intervention group are invited for HPV-based screening by the GP or to request a self-sampling kit.

Only women are offered cervical cancer screening

Offering Cervical Cancer Screening to Older Women

Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling

Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling

The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral

Screening history of participants and non-participants in the intervention group

Proportion of abnormal cytological findings between the intervention and control group is compared

Proportion of abnormal histological findings between the intervention and control group is compared

The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group

The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group

University of Aarhus

An invitation to order a HPV self sampling test through an online application will be sent by SMS or electronic letter.

2019-2021 - A Cobas PCR Female swab sample packet will be sent. Response rates (participation) will be measured.

2022 and onwards - A FLOQSwab and corresponding sample tube for analysis on the BD COR platform will be sent.

Sending of screening summon.

Miriam Elfström, PhD

Helena Andersson, PhD

Viviann Mattsson, MD

Christer Borgfeldt, MD, PhD

Katarina Kylebäck, MD

Mirjam Våtz, Midwife

Hanna Milerad, MD

Lovisa Bergengren, MD, PhD

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken).

Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

Non-participation in the cervical screening program and sub-optimal follow-up after abnormalities or infection with a highly oncogenic HPV type detected in screening are the main risk factors for cervical cancer. Given this, It is important to reduce barriers to screening and facilitate participation in the screening program of cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations. Women who have been lost to follow-up can also be reached with self-sampling.

The purpose of this study is to investigate whether SMS reminders and electronic letters for screening attendance will increase participation compared to the current method where reminders are sent out with physical letters. In this study, women a with high risk of developing cervical cancer, due to not fully participating in screening or being followed up optimally, will be invited. Women are identified through registry linkages annually that examine screening history and status using a risk algorithm. Women receive an SMS or an electronic letter with an offer to request a self-sampling kit via the internet. Women with a higher risk for cervical cancer can be offered a self-sampling kit sent directly to their home address. The self-sampling kit comes with an instruction on how to take the sample and a postage-free answer envelope.

Submitted samples are analyzed with an approved and accredited method (Cobas 4800, Roche) that analyzes for HPV 16, HPV18 and other oncogenic HPV types. As the screening program changed the accredited HPV test in 2022 (to BD Onclarity), that test will be used from the timepoint of the change and onwards.

In the pilot of the study, follow-up is defined as follows:

1. For those women who are at the highest risk (previous glandular cell changes without follow-up), all HPV-positive women are referred via SMS directly to a women's clinic for investigation. HPV-negative women in this group have no increased risk and receive a text message with a calming message.
2. Women of an age above the screening program but who have either had a cell change that is not followed up or who have not participated at all in the last 10 years are treated in the same way as in paragraph 1.
3. Finally, the women of screening age who have not taken a cell sample for more than 15 years are identified. This group receive an SMS and HPV-positive women are referred, via SMS, for renewed sampling by a specially trained so-called dysplasia midwife. The sample is now being analyzed for both cytology and HPV. If the woman is HPV positive in both tests and in the case of deviating cytology, the woman is referred to a women's clinic. In other cases a text message with a reassuring message is sent.

The study has the usual level of confidence (p \<0.05 two-sided) and statistical power (80%) the ability to demonstrate an increase of participation by 3 times or more.

The protocol was piloted in the Region of Skåne in 2019 and then rolled out nationally in 2020.

The study is rolled out nationally with annual linkages to identify women with an excess risk for cervical cancer and an adaptive approach to reaching women with SMS, electronic letters, and physically letters with direct delivery of HPV self-sampling kits or an option to order a self-sampling kid (depending on risk). The study is coordinated centrally and each region has a contact person to whom women who need follow-up are referred.

SMS-based Summons in Cervical Screening

Can SMS-reminders Result in Increased Participation in Cervical Screening?

Participation rate in screening after summons.

Cytologically and histopathologically confirmed percursors of cervical cancer.

Histopathologically confirmed cervical cancers.

Region Skane

Karolinska Institutet

Affiliated Researcher

Infections

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Disease Attributes

At the three intervention clinics, clinic providers or staff will offer women the option to perform HPV self-sampling as an alternative to cervical cancer screening by a clinician.

Control clinics will have passive participation and their only involvement will be that data will be pulled from these clinics. Women in the control clinics will be offered usual care cervical cancer screening by a clinician. The research team will not have any contact with women in the control clinics.

The study will implement HPV self-sampling as an option for cervical cancer screening alongside usual care for Somali women, and evaluate changes pre and post implementation, compared to Fairview intervention clinics.

COPAN 552c.80 FLOQSwab

Christina Bliss Barsness

Rebekah Pratt, MD

This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.

Hybrid Type 2 effectiveness-implementation study; difference-in-difference methods to compare between-period changes in 3 intervention and Fairview non-intervention clinics.

HPV Self-Sampling in Somali Women

Reducing Cervical Cancer Screening Disparities in Somali Immigrant Women Through a Primary Case-based HPV Self-sampling Intervention

Our operational definition of screening uptake accounts for hybrid options that allow for either HPV self-sampling, or Pap and/or HPV testing by a clinician. We define screening uptake as follows: a) receiving Pap and/or HPV testing by a clinician; b) completing a self-sampling kit that is negative for all HPV or is HPV16/18+; or c) completing a self-sampling kit that is negative for HPV16/18 but positive for other types (i.e., "HPV+ other") or unsatisfactory.

University of Minnesota

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Women aged 50 to 65 years with no cervical smear or no gynecological examination for more than three years, attending the mobile unit for breast cancer screening in the Department of Hérault, or the Medical and Social Care Center in the Department of Aude.

* Direct offer of a vaginal self-sampling kit with information to perform at home and send back to the laboratory for HR-HPV testing
* The psychosocial determinants involved in decision-making process and compliance to cervical cancer screening will be collected from open questionnaires and by semi-directive phone interviews
* Control ; Receive reminder to send the self-sample to the laboratory : After 3 and 6 months without "return", women receive a remind letter to send the vaginal self-sample to the laboratory. We call "return" the receipt of the vaginal self-sample at the laboratory.
* Control ; Receive reminder to perform cervical smear in case of positive HR-HPV test : In case of a positive HR-HPV test, women are asked to perform a control cervical smear. After 3, 6 months and 12 months without "return", women and their health-care professional will receive a remind letter or a call to perform a cervical smear for control. We call "return" the performance of a pap smear.

Proximity-incentive strategy based on vaginal self-sampling for women 50 to 65 years who do not participate to cervical cancer screening

Nathalie BOULLE, MD/PhD

In France, cervical cancer screening is based on a cervical smear for women aged 25 to 30 years and on High Risk- HPV (HR-HPV) testing for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program, up to 40% of women, which led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU), based on remind letters, starting in 2019.

Our project is a complementary strategy to DO CCU based on direct proposal of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home will increase their participation to cervical cancer screening.

This project will be held in the Departments of Hérault and Aude, which are among those in the region of Occitanie (south of France) with the lowest participation to cervical cancer screening.

Women aged 50 to 65 years with no cervical smear and/or gynecological examination for more than three years, will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care located in a particularly deprived area of Aude (Limoux-Quillan). In each site, non attendee-women will be proposed by a trained mid-wife, a vaginal self-sample device to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored.

The primary objective of this study will be to evaluate attendance of under-screened women to vaginal self-sampling for cervical cancer screening, i.e. the number of women who accepted a self-sample device among women to whom it has been proposed.

A second objective will be to analyse psycho-social factors associated with cervical cancer screening in this population of non-attendee women, i.e. their socio-economic environment and the way women perceive and are implicated in cervical cancer screening. This secondary objective will be based on a specific questionnaire at recruitment and on semi-directive phone interviews in a sub-group of women. The efficacy of this screening strategy (number of women who performed vaginal self sample and sent it to the laboratory, and number of women who completed follow-up in case of a positive HR-HPV test) will also be monitored.

The number of women to be recruited is 300 for each site. The total estimated duration of the project is 48 months, including 24 months for women's recruitment.

Expected results from this project are:

* An increase in participation to cervical cancer screening of non-attendee women aged 50 to 65 years in the Departments of Hérault and Aude.
* Women's education about cervical cancer screening through discussion with the midwife during recruitment and information tools developed for the project
* Information of local health staff and community-based associations about cervical cancer screening and the place of HR-HPV testing.
* Identification of psycho-social factors and potential barriers to compliance to cervical cancer screening.
* Identification of organizational and practical difficulties that must be overcome to improve preventive actions towards deprived populations.

Scientific context :

In France, cervical cancer screening is based on a cervical smear every three years for women aged 25 to 30 years, and on a High-Risk HPV (HR-HPV) detection test every five years for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program. Among non-attendee women, older women (\> 50 years old) and women of unfavourable socio-economic conditions are the most represented groups. This observation led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU) starting in 2019. The Departments of Hérault and Aude are among those in Occitanie region (south of France) with the lowest participation to cervical cancer screening. In 2017, a group composed of academics, health professionals, the Regional Center for Cancer Screening in Occitanie and the Association for Breast Cancer Screening in Montpellier-Hérault organized a preliminary study based on a self-questionnaire showing high acceptability of vaginal self-sampling by women aged 25 to 65 years, particularly for women older than 50 years.

The aim of this interventional research is to increase women's participation to cervical cancer screening and to identify psycho-social determinants associated with screening observance. For this purpose, the integrative model of change (Attitude Social Influence Self-efficacy Mode - ASE model) from Vries et al. (2013) seems an interesting model to better understand behavioural changes regarding participation to cervical cancer screening using the proposed strategy.

Research hypothesis:

The project is a proximity-incentive strategy complementary to DO CCU based on direct proposal by a trained mid-wife of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home along with information on cervical cancer, will increase their participation to cervical cancer screening. Secondary hypotheses are that 1) motivational determinants of ASE and contextual opportunities are associated with the realization of vaginal self-sampling 2) and that vaginal self-sampling is an efficient strategy for cervical cancer screening (i.e. number of self-sampling performed and sent to the laboratory, and number of follow-up for women with a positive HR-HPV DNA test among women who accepted the self-sample device).

Intervention description:

Women aged 50 to 65 years with no cervical smear or no gynecological examination for more than three years will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care Center and surrounding areas, located in a particularly deprived area of Aude (Limoux-Quillan). Non attendee-women will be proposed a vaginal self-sample device (Evalyn® brush) to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing using the Cobas 4800 HPV DNA detection test. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored.

During recruitment, women will complete a questionnaire with the help of a midwife on their socio-economic environment, motivational determinants and on their willingness to perform the vaginal self-sample. These data will be analyzed according to their participation to the proposed screening strategy. In addition, semi-directive interviews will be conducted in a sub-group of women (45 women for each site) to identify the barriers and levers of screening participation.

The number of women to be recruited (i.e. non-attendee women aged 50 to 65 years, who accepted the vaginal self-sample device among those to whom it has been proposed) is 300 for each site.

The total estimated duration of the project is 48 months, based on 12 months for preparation of the questionnaires, study subject approvals package and staff recruitment and training, 24 months for women's recruitment, 12 months for follow-up of women with positive HR-HPV DNA test, for data analysis and final report.

Expected Health public impact are (a) an increase in participation to cervical cancer screening of women aged 50 to 65 years in the Departments of Hérault and Aude (b) the development of a proximity-incentive strategy to increase cervical cancer screening within vulnerable populations and populations with limited access to health care in those Departments (c) the identification of psycho social determinants involved in cervical cancer screening attendance (i.e. motivational factors, self-efficacy) (d) the construction of a regional network of professionals involved in cervical cancer screening, including health professionals, field teams, committee-based associations and researchers (e) the development of hypotheses and models for future transferability of this intervention to other Departments of the Occitanie Region as a complement of the national DO CCU program.

A Proximity-incentive Strategy for Cervical Cancer Screening

Benefit From a Proximity-incentive Strategy Based on Vaginal Self-sampling for Women Who do Not Participate to Cervical Cancer Screening in Aude and Hérault [French Departments]: an Interventional Research to Reduce Social and Territorial Inequalities.

Number of women who accepted a self-sample device among women to whom it has been proposed

The psychosocial determinants (motivation, self-efficacy) involved in decision-making process and compliance to cervical cancer screening will be collected from open questionnaires conducted during women recruitment and later by semi-directive phone interviews for a sub-group of women participating to the study. These data will be organized through a logical model of change.

The role of socio-economic factors on cervical cancer screening adherence and self-sampling attendance will be evaluated using a validated index of social deprivation (European Deprivation Index - EDI).

Number of vaginal self-samples performed and sent to the laboratory for HPV testing by women who accepted the self-sample device

Number of complete follow-up (cervical smear) obtained among women who had a positive HPV test by vaginal self-sampling

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Offering Cervical Cancer Screening to Older Women	NCT04114968	Uterine Cervica... Uterine Neoplas... Uterine Cervica... Mass Screening	GP-based screen...	65 Years - 69 Years	University of Aarhus
SMS-based Summons in Cervical Screening	NCT04061967	Cervical Cancer Uterine Cervica... Uterine Neoplas... Genital Neoplas... Genital Neoplas... Uterine Disease... Genital Disease... Neoplasms by Si... Neoplasms Uterine Cervica...	Sending of scre...	33 Years - 75 Years	Karolinska Institutet
HPV Self-Sampling in Somali Women	NCT05453006	Cervical Cancer Papillomavirus ... Uterine Disease... Uterine Cervica...	COPAN 552c.80 F...	30 Years - 65 Years	University of Minnesota
SMS-based Summons in Cervical Screening	NCT04061967	Cervical Cancer Uterine Cervica... Uterine Neoplas... Genital Neoplas... Genital Neoplas... Uterine Disease... Genital Disease... Neoplasms by Si... Neoplasms Uterine Cervica...	Sending of scre...	33 Years - 75 Years	Karolinska Institutet
Offering Cervical Cancer Screening to Older Women	NCT04114968	Uterine Cervica... Uterine Neoplas... Uterine Cervica... Mass Screening	GP-based screen...	65 Years - 69 Years	University of Aarhus
HPV Self-Sampling in Somali Women	NCT05453006	Cervical Cancer Papillomavirus ... Uterine Disease... Uterine Cervica...	COPAN 552c.80 F...	30 Years - 65 Years	University of Minnesota
A Proximity-incentive Strategy for Cervical Cancer Screening	NCT04716127	Cervical Cancer Uterine Cervica... Human Papilloma...	Proximity-incen...	50 Years - 65 Years	University Hospital, Montpellier

Spots Global Cancer Trial Database for uterine cervical disease