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

Recruiting

• Conditions: Precancerous Lesion; Cervical Cancer; HPV Infection

• Registration Number: NCT06253169
• Lead Sponsor: Patient Organization Veronica

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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Study Start: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.	Through study completion, an average of 1 year	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.
Evaluation of the frequency of positivity of the HPV tests taken.	Through study completion, an average of 1 year	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.
Evaluation of follow-up gynaecological care in women who tested positive.	Through study completion, an average of 1 year	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.

Trial Locations

Locations (2)

CGOP, s.r.o.; 🇨🇿 Prague, Czechia

Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia