The primary objective of this clinical trial is to assess cervical cancer screening participation among under-screened women invited through organized breast cancer screening programs in Switzerland. This randomized trial will compare three arms: 1. Intervention group 1: Sensitization to Cervical Cancer (CC) screening Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment. 2. Intervention group 2: Home-based Human papillomavirus infection (HPV) self-sampling Women will receive a free-of-charge vaginal self-sampling kit for HPV infection 3. Observational control group Women selected in the control arm will only be recruited one year following the screening of those in the intervention arm (T0+1), as to not influence Cervical Cancer Screening (CCS) behavior during this period by being reminded of screening recommendations.
Secondary objectives are: * To identify and compare the association of socio-demographic characteristics with screening participation in all study arms (cf. 3.2 study design). * To compare the use of primary screening methods (HPV test vs. Papanicolaou test) between study arms. * To compare prevalence of positive primary screening and triage results between study arms. * To compare follow-up rates for participants screened positive in both intervention arms. * To evaluate acceptability of both screening strategies (sensitization vs. home-based). * To assess the relationship between CCS behavior and Breast Cancer Screening (BCS) behavior.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,500
Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
University Hospitals of Geneva
Geneva, Canton of Geneva, Switzerland
RECRUITINGParticipation to Cervical Cancer Screening (CCS)
Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in %
Time frame: 12 months
Correlation of socio-demographic characteristics with screening participation
Regression coefficients of screening in the past 12 months for: education level, occupation, relationship status, sexual orientation, mother tongue, country of origin, residential area, children, follow-up by general practitioner or gynecologist, age, number of years living in Switzerland, Body Mass Index (calculated based on weight and height). Measurement tool: self-reported from questionnaire
Time frame: 12 months
Choice of primary screening methods (HPV testing vs cytology)
Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm.
Time frame: 12 months
Prevalence of positive primary screening (HPS test) and triage results (cytology)
Difference between study arms of the: * Prevalence of screen-positive women (i.e. HPV-positive or Atypical squamous cells of undetermined significance - ASC-US+) * Proportion (%) of HPV-positive women with ASC-US+ upon triage * Proportion (%) of Cervical Intraepithelial Neoplasia Grade 2 (CIN2+) diagnosed * Proportion (%) of Cervical Cancer (CC) diagnosed * Proportion (%) of participants treated for CIN2+ or CC
Time frame: 12 months
Follow-up rates for participants screened positive
Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage
Time frame: 12 months
Acceptability of screening strategies
Difference between study arms of the: \- Mean satisfaction score (Likert scale, from 1 Totalement satisfied to 4 Very unsatisfied)
Time frame: 12 months
Reasons for non-compliance
Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance
Time frame: 12 months
Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors
Difference in the study arms: of the proportion (%) of participants having done all screenings, and participants having selected only one or two screenings, and participants having done none.
Time frame: 12 months
Patrick Petignat, MD
CONTACT
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