Cervical Cancer ScreeningBRAICSNCT07171658
Breast Cancer-Related Approach for Increasing Cervical Cancer Screening
A study testing Sensitization to Cervical Cancer (CC) screening and Home-based HPV self-sampling in people with Cervical Cancer Screening, run by Jessica Di Vincenzo Sormani at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Sensitization to Cervical Cancer (CC) screening and Home-based HPV self-sampling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Prior cervical cancer diagnosis,
- Hysterectomy
- Non consent to participate to the study
- Incapable of judgment or under tutelage
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Petignat, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals of Geneva
Geneva, Canton of Geneva, 1205
Patrick Petignat, MD, +41 22 372 44 32, patrick.petignat@hug.ch
About this study
Official 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
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:
- 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.
- 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
- 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.
Read the 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.
- Conditions
- Cervical Cancer Screening
- Being tested
- Sensitization to Cervical Cancer (CC) screening, Home-based HPV self-sampling
- Keywords
- cervical cancer screening, underscreened women, HPV self-sampling, Integrated approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitization to Cervical Cancer (CC) screeningBehavioural
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-samplingBehavioural
Women will receive a free-of-charge vaginal self-sampling kit for HPV infection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1: Sensitization to Cervical Cancer (CC) screening | Experimental | Women will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment. Receives: Behavioral: Sensitization to Cervical Cancer (CC) screening |
| Intervention Group 2: Home-based HPV self-sampling | Experimental | Women will receive a free-of-charge vaginal self-sampling kit for HPV infection. Receives: Behavioral: Home-based HPV self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation 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 %
Measured: 12 months
Secondary outcomes (7)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months
Reasons for non-compliance
Proportion (%) of participants among unscreened women indicating predefined reasons for non-compliance
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start7 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a 1) population-based 2) randomized trial 3) two-arm 4) open 5) national hybrid 6) completed by an observational control arm .
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica Di Vincenzo Sormani
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Jessica Di Vincenzo Sormani, School of Health Sciences Geneva
- Investigators
- Jessica Di Vincenzo Sormani, PhD, Study director, Haute École de Santé de Genève (HEdS-GE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171658
- Sponsor's protocol ID
- 32HW-0_228666
- Acronym
- BRAICS
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07171658
- Acronym / sponsor ID
- BRAICS / 32HW-0_228666
- Conditions
- Cervical Cancer Screening
- Keywords
- cervical cancer screening, underscreened women, HPV self-sampling, Integrated approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Jessica Di Vincenzo SormaniUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a 1) population-based 2) randomized trial 3) two-arm 4) open 5) national hybrid 6) completed by an observational control arm .
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1: Sensitization to Cervical Cancer (CC) screening | Experimental | Behavioral: Sensitization to Cervical Cancer (CC) screeningWomen will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment. |
| Intervention Group 2: Home-based HPV self-sampling | Experimental | Behavioral: Home-based HPV self-samplingWomen will receive a free-of-charge vaginal self-sampling kit for HPV infection. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- Prior cervical cancer diagnosis,
- Hysterectomy
- Non consent to participate to the study
- Incapable of judgment or under tutelage
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensitization to Cervical Cancer (CC) screeningWomen will receive an awareness letter explaining the importance of cervical cancer screening, the Swiss recommendations and an invitation to schedule an appointment. | Behavioural | Intervention Group 1: Sensitization to Cervical Cancer (CC) screening |
| Home-based HPV self-samplingWomen will receive a free-of-charge vaginal self-sampling kit for HPV infection. | Behavioural | Intervention Group 2: Home-based HPV self-sampling |
Primary outcome
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 %
7 secondary outcomes
Correlation of socio-demographic characteristics with screening participation
Time frame: 12 months
Choice of primary screening methods (HPV testing vs cytology)
Time frame: 12 months
Prevalence of positive primary screening (HPS test) and triage results (cytology)
Time frame: 12 months
Follow-up rates for participants screened positive
Time frame: 12 months
Acceptability of screening strategies
Time frame: 12 months
Reasons for non-compliance
Time frame: 12 months
Association between Cervical Cancer Screening (CCS) behavior and Breast Cancer Screening (BCS) screening behaviors
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Petignat, MD contact
Jessica Di Vincenzo Sormani, PhD study director
Haute École de Santé de Genève (HEdS-GE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitization to Cervical Cancer (CC) screening and Home-based HPV self-sampling in people with Cervical Cancer Screening, run by Jessica Di Vincenzo Sormani at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Di Vincenzo-Sormani, PhD (+41 22 558 58 78, jessica.di-vincenzo-sormani@hesge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation to Cervical Cancer Screening (CCS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.