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

April 22, 2024 updated by: Patient Organization Veronica

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 12000
        • Recruiting
        • CGOP, s.r.o.
        • Contact:
        • Principal Investigator:
          • Jiří Sláma, MD PhD
        • Sub-Investigator:
          • Lucie Mandelová, PhD
      • Prague, Czechia, 12000
        • Recruiting
        • Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University
        • Principal Investigator:
          • Jiří Sláma, MD PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All women over 30 years of age who meet the entry criteria for inclusion in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: HPV DNA self-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.
Diagnostic test: HPV DNA self-test
HPV DNA swab from the cervix performed by the patient herself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 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.
Through study completion, an average of 1 year
Evaluation of the frequency of positivity of the HPV tests taken.
Time Frame: 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.
Through study completion, an average of 1 year
Evaluation of follow-up gynaecological care in women who tested positive.
Time Frame: 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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patient Organization Veronica

Investigators

  • Study Chair: Veronika Cibulová, MS, Patient Organisation Veronica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All anonymised data will be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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