Clinical trial NCT04226313: Self-sampling for Non-attenders to Cervical Cancer Screening
Official title: Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Cervical Dysplasia
Human Papillomavirus Infection
Keywords: human papillomavirus
HPV
self-sampling
cervicovaginal swab
cervical cancer screening
non-attendance
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
Collaborators: name: Cancer Research Czech Republic
First posted: 2020-01-13
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Screening participation
timeFrame: 12 months
measure: Prevalence of high-risk HPV
timeFrame: 12 months
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: 12 months
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
name: Marian Hajduch, MD, PhD.
role: STUDY_DIRECTOR
References: