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NCT Number: NCT07171658

Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

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.

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Key information

Conditions

Cervical Cancer Screening

Age range

50 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Patrick Petignat, MD

CONTACT

[email protected]

+41 22 372 44 32

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensitization to Cervical Cancer (CC) screening

Behavioral

Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment.

Home-based HPV self-sampling

Behavioral

Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.

Primary outcomes

  1. Participation to Cervical Cancer Screening (CCS)

    Time frame: 12 months

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

Secondary outcomes

  1. Correlation of socio-demographic characteristics with screening participation

    Time frame: 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

  2. Choice of primary screening methods (HPV testing vs cytology)

    Time frame: 12 months

    Difference between study arms of the proportion of participants screened by HPV test versus cytology in each arm.

  3. Prevalence of positive primary screening (HPS test) and triage results (cytology)

    Time frame: 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

  4. Follow-up rates for participants screened positive

    Time frame: 12 months

    Difference between study arms of the proportion (%) of primary screen-positive women who have undergone triage

  5. Acceptability of screening strategies

    Time frame: 12 months

    Difference between study arms of the:

    • Mean satisfaction score (Likert scale, from 1 Totalement satisfied to 4 Very unsatisfied)

  6. Reasons for non-compliance

    Time frame: 12 months

    Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance

  7. Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Di Vincenzo-Sormani, PhD

CONTACT

[email protected]

+41 22 558 58 78

Patrick Petignat, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Jessica Di Vincenzo Sormani

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

Improving Cervical Cancer Screening Coverage Among Underscreened Women Aged 50 to 74 in Switzerland Using HPV Self-sampling Strategies: A Randomized Study - Breast Cancer-Related Approach for Increasing Cervical Cancer Screening

Acronym: BRAICS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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