Cervical cancer screening Cancer
Conditions
Interventions
Current interventions as of 08/10/2025:
All recruited participants will be screened with a validated HPV test to be performed on either a self-collected or provider-collected sample. The kits for se
Sponsors
Clinical Investigation Center INSERM 1432
Eligibility
Sex/Gender
Female
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Included in the vulnerable group of women as defined by other working groups of the project (which may include women of low socioeconomic status, women living with HIV or other sexually transmitted diseases, sex workers, Roma population and migrants) 2. Age within that specified in the guideline for CCS in the country/programme (Estonia: 30-65 years; Portugal: 25-64 years; Romania: 30-64 years) 3. Provides voluntary informed consent
Exclusion criteria
Exclusion criteria: 1. Screened with cytology in last 3 years or with HPV test in last 5 years 2. Those who had hysterectomy 3. Those who have been detected cervical precancer or cancer and undergoing treatment for that 4. Those suffering a debilitating illness that will prevent her from providing informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 08/10/2025: Estimate the proportion of recruited women ‘well-managed for CCS’, which is defined as those women who have been screened with HPV test and - • either tested negative and advised of negative result, • or tested positive, completed assessment and, where necessary, treatment pathway Measured at month 12. • for the trial screening completion (defined as the return of the at-home HPV self-sampling kit) _____ Previous primary outcome measure: Estimate the proportion of recruited women ‘well-managed for CCS’, which is defined as those women who have been screened with HPV test and - • either tested negative and advised of negative result, • or tested positive, completed assessment and, where necessary, treatment pathway Measured at month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation will be conducted at month 12 and follow RE-AIM dimensions: 1. Reach: 1.1. % of women invited for CCS who got screened in 12 months 1.2. % of screened women delivered with HPV test report within 1 month of testing 1.3. % of HPV-positive women undergoing further assessment (as per local protocol) 1.4. % of women who were advised treatment underwent treatment 2. Efficacy/effectiveness: 2.1. % of recruited women well managed (% of women screened and completing full pathway of HPV screening and treatment over 12 months) (primary objective) 2.2. Detection rate of CIN 2+ in the screened cohort 2.3. Health economic assessment measured by disability adjusted life years saved using the new implementation strategies compared to current standard of care cervical screening 3. Adoption: 3.1. Acceptability of HPV self-sampling when applicable (% of women providing samples successfully) 3.2. Acceptability of the invitation services (% of women undergoing HPV testing out of those invited) 3.3. Acceptability of reminder services (% of women responding positively to a reminder for screening/diagnosis/treatment) 3.4. Questionnaires/focus groups targeting the health professionals and assessing the dimensions of the Theoretical Framework of Acceptability 4. Implementation: Structural and dynamic fidelity of implementation, utilising data collected through the implementation experience from health services and participants. 4.1. Proportion of clinics that implemented the interventions 4.2. Number of health professionals providing HPV self-sampling guidance when applicable 4.3. Extent protocol delivered as intended (Proportion of healthcare providers delivering services as per protocol) 4.4. Stakeholder perceptions of implementation (qualitative study) 4.5. Facilitators and barriers (qualitative study) 5. Maintenance: Intervention Scalability Assessment Tool (ISAT) (Milat 2020) will be applied with relevant policy makers and health services in a structured process informe | — |
Countries
Estonia, Portugal, Romania
Contacts
Public ContactIsabel Mosquera
Outcome results
None listed