Self-sampling for Non-attenders to Cervical Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-sampling by Evalyn Brush, Self sampling by Evalyn Brush home or in GP´s clinic.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
Overview
The trial will evaluate whether self-sampling and human papillomavirus (HPV) testing may increase cervical cancer screening attendance among under-screened women in Czech Republic. Different ways of offering self-sampling device will be evaluated.
Detailed description
Despite the existence of an effective cervical cancer screening in the Czech Republic, cervical cancer is the cause of about 800 new cases and 400 deaths every year. One of the major problem of the Czech cervical cancer screening is low participation. An effective strategy to increase cervical cancer screening attendance is one of the main challenges. The offering of self-sampling to the cervical cancer screening non-attenders could increase women's participation as was shown in several European countries.
The trial should determine acceptability of the self-sampling followed by HPV DNA test by Czech women and therefore usability of the self-sampling device to increase cervical cancer screening attendance among under-screened women. Three different approaches will be tested: women will receive a self-sampling device by mail (Arm A); receive a self-sampling device by gynecologist (Arm B); receive a self-sampling device by general practitioner (Arm C). Comparisons of the screening attendance among the arms will be made. To address also potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. Women from the database of commercial vendor will be included to the Arm A regardless of whether or not they participate in cervical cancer screening program. Women who do not participate in cytology-based cervical cancer screening program for at least three years will be included through their gynecologist (Arm B) or general practitioner (Arm C) database.
The second focus of the trial is the evaluation of high-risk human papillomavirus prevalence in screening population of Czech women (attenders and non-attenders of cervical cancer screening) since there are no relevant data for the Czech Republic. Study participants may volunteer for archiving of remaining biological materials for future studies.
Interventions
- Diagnostic test Self-sampling by Evalyn Brush
Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush. - Diagnostic test Self sampling by Evalyn Brush home or in GP´s clinic
Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush
Primary outcome measures
- Screening participation [Time frame: 12 months]
- Prevalence of high-risk HPV [Time frame: 12 months]
Secondary outcome measures (1)
- Sociodemographic characteristics [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Women with age 30-65 years; for arm A women > 65 years are allowed
- Women live in the Czech Republic.
- Women who have not participate in cervical cancer screening program in the Czech Republic for at least 3 years (Arm B and C).
- Women with completed informed consent.
- Women capable of self-sampling of cervicovaginal swab.
Exclusion criteria
- Pregnant women.
- Women with no sexual intercourse experience.
- Women after hysterectomy including cervix.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Czechia · 1 center
- University Hospital Olomouc — Olomouc
Identifiers
NCT: NCT04226313 · 5850