Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer Screening

• Registration Number: NCT07171658
• Lead Sponsor: Jessica Di Vincenzo Sormani

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-11-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4500

Inclusion Criteria

• Women receiving Breast Cancer Screening (BCS) invitation letters in the selected five cantons (Geneva, Bern (francophone), Jura, Neuchâtel, and Vaud)
• Aged 50 to 74 years old
• Not been screened for cervical cancer in the past three years
• Speaking one of the 6 languages of the study (French, German, Italian, and in English, Spanish, and Portuguese)

Exclusion Criteria

• Prior cervical cancer diagnosis,
• Hysterectomy
• Non consent to participate to the study
• Incapable of judgment or under tutelage
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participation to Cervical Cancer Screening (CCS)	12 months	Participation to Cervical Cancer Screening (CCS) (primary HPV test or cytology) in the past 12 months, self-declared, proportion in %

Secondary Outcome Measures

Name	Time	Method
Correlation of socio-demographic characteristics with screening participation	12 months	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
Choice of primary screening methods (HPV testing vs cytology)	12 months	Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm.
Prevalence of positive primary screening (HPS test) and triage results (cytology)	12 months	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
Follow-up rates for participants screened positive	12 months	Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage
Acceptability of screening strategies	12 months	Difference between study arms of the: \- Mean satisfaction score (Likert scale, from 1 Totalement satisfied to 4 Very unsatisfied)
Reasons for non-compliance	12 months	Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance
Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors	12 months	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.

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Canton of Geneva, Switzerland