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

Patient Organization Veronica

Status: Enrolling

Conditions: HPV Infection; Precancerous Lesion; Cervical Cancer

Treatments: Diagnostic Test: HPV DNA self-test

Study type: Observational

Funder types: Other

Identifiers

NCT06253169

V01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

2,000 participants in 2 patient groups

Not participating in screening

Description:

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.

Treatment:

Diagnostic Test: HPV DNA self-test

Participating in the screening

Description:

All women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years.

Treatment:

Diagnostic Test: HPV DNA self-test