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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Not participating in screening | All women over 30 years of age who are not participating in screening or have not had a screening visit in less than 5 years. |
| |
| Participating in the screening | All women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV DNA self-test | Diagnostic Test | HPV DNA swab from the cervix performed by the patient herself. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall. | To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort. | Through study completion, an average of 1 year |
| Evaluation of the frequency of positivity of the HPV tests taken. | Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort. | Through study completion, an average of 1 year |
| Evaluation of follow-up gynaecological care in women who tested positive. | To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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All women over 30 years of age who meet the entry criteria for inclusion in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Sláma, MD, PhD | Contact | +420224967451 | jiri.slama@vfn.cz |
| Name | Affiliation | Role |
|---|---|---|
| Veronika Cibulová, MS | Patient Organisation Veronica | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CGOP, s.r.o. | Recruiting | Prague | 12000 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37751376 | Background | 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. | |
| 33562978 | Background |
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All anonymised data will be available.
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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HPV DNA smears from the cervix
| Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University | Recruiting | Prague | 12000 | Czechia |
|
| Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243. |
| 38224266 | Background | 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. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |