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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Cancer HPV Infection Precancerous Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

HPV DNA self-test

Intervention Type DIAGNOSTIC_TEST

HPV DNA swab from the cervix performed by the patient herself.

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.

HPV DNA self-test

Intervention Type DIAGNOSTIC_TEST

HPV DNA swab from the cervix performed by the patient herself.

Interventions

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HPV DNA self-test

HPV DNA swab from the cervix performed by the patient herself.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No