HPV DNA Self-sampling in a General Practitioner's Office.

Cervical Cancer Clinical Trial

— ASTRA  

Official title:

Benefit of Self-sampling for HPV DNA in a General Practitioner's Office to Improve Participation in Cervical Screening - The ASTRA Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253169
• Other study ID #: V01
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Patient Organization Veronica
• Contact: Jirí Sláma, MD, PhD
• Phone: +420224967451
• Email: jiri.slama[@]vfn.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cervical Cancer
• HPV Infection
• Papillomavirus Infections
• Precancerous Lesion
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV DNA self-test
HPV DNA swab from the cervix performed by the patient herself.

Locations

Country	Name	City	State
Czechia	CGOP, s.r.o.	Prague
Czechia	Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Patient Organization Veronica

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View Citation

Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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