Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection
Conditions
Keywords
human papillomavirus, HPV, self-sampling, cervicovaginal swab, cervical cancer screening, non-attendance
Brief summary
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_TESTSelf-sampling by Evalyn Brush
Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
DIAGNOSTIC_TESTSelf 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
Sponsors
The Institute of Molecular and Translational Medicine, Czech Republic
National Institute for Cancer Research, Czech Republic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening participation | 12 months | Comparison of the percentages of women who return a cervicovaginal swab sampled by self-sampling device in different arms of the study. Identification of the best approach to address women who do not participate in standard cervical cancer screening program |
| Prevalence of high-risk HPV | 12 months | Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women within different arms of the study (attenders/non-attenders). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic characteristics | 12 months | Comparison the distribution of sociodemographic characteristics (education, age, place of residence) and reasons for previous non-attendance for screening by intervention and attendance status in women who return a questionnaire. |
Countries
Czechia
Contacts
CONTACTMarian Hajduch, MD, PhD.
CONTACTVladimira Koudelakova, MSc, Ph.D.
STUDY_DIRECTORMarian Hajduch, MD, PhD.
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
Outcome results
None listed