Clinical trial NCT06253169: HPV DNA Self-sampling in a General Practitioner's Office.
Official title: Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
HPV Infection
Precancerous Lesion
Keywords: Prevention
Cervical cancer
HPV test
Self-sampling
Lead sponsor: Patient Organization Veronica
Sponsor class: OTHER_GOV
First posted: 2024-02-12
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women over 30 years of age who meet the entry criteria for inclusion in the study.

Brief summary: One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.

Detailed description: Organized cervical screening in the Czech Republic has a long-term participation rate of about 56% of the target population. Despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. A significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. The aim of the ASTRA project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for HPV DNA in the GP's office.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent for statistical data processing and consent to the processing of personal data
* Age 30+
* HPV test never performed or performed more than 3 years ago or patient does not know

Exclusion Criteria:

* Refusal to participate
* Pregnancy and puerperium
* Menses
* History of hysterectomy
* HPV test performed \<3 years ago with negative result
* Regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening).

Primary outcomes:
measure: To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of the frequency of positivity of the HPV tests taken.
timeFrame: Through study completion, an average of 1 year
measure: Evaluation of follow-up gynaecological care in women who tested positive.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: CGOP, s.r.o.
city: Prague
country: Czechia
facility: Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University
Study officials:
affiliation: Patient Organisation Veronica
name: Veronika Cibulová, MS
role: STUDY_CHAIR
References:
citation: Slama J, Dvorak V, Trnkova M, Skrivanek A, Hrabcova K, Ovesna P, Novackova M. Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening? Eur J Cancer Prev. 2024 Mar 1;33(2):168-176. doi: 10.1097/CEJ.0000000000000844. Epub 2023 Sep 21.
citation: Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243.
citation: Ngo O, Chloupkova R, Cibula D, Slama J, Mandelova L, Hejduk K, Hajduch M, Minka P, Koudelakova V, Jaworek H, Trnkova M, Vanek P, Dvorak V, Dusek L, Majek O. Direct mailing of HPV self-sampling kits to women aged 50-65 non-participating in cervical screening in the Czech Republic. Eur J Public Health. 2024 Apr 3;34(2):361-367. doi: 10.1093/eurpub/ckad229.