Cervical cancer screening improvements with self-sampling during the COVID-19 pandemic.
Miriam Elfström, Penelope Grace Gray, Joakim Dillner
https://pubmed.ncbi.nlm.nih.gov/38085566Actively Recruiting
Phase Not Applicable
Age: 30Years - 60Years
FEMALE
Healthy Volunteers
ID07275333
Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
Led by Karolinska Institutet · Updated on 2025-12-18
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
U
Union for International Cancer Control
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a cervical cancer screening program using self-sampling for human papillomavirus (HPV) detection among women aged 30 to 60 years in the Zaporizhzhia region of Ukraine. This area has faced disruption due to armed conflict, which has affected traditional access to preventive services. The study aims to improve screening access, assess the feasibility of self-sampling in conflict conditions, and support the development of a sustainable cervical cancer control model applicable to similar challenging settings. The project is a collaboration between local Ukrainian institutions and Karolinska Institutet in Sweden, supported by an international cancer control organization. Participants receive an HPV self-sampling kit distributed through primary care providers, community outreach, or partner organizations. Women collect a vaginal sample themselves using the provided FLOQSwab device and return it to clinics or volunteers free of charge. Samples undergo testing for high-risk HPV types in accredited molecular laboratories with quality assurance processes. HPV-positive women receive follow-up care according to national guidelines, including referral for further examination and treatment if needed. HPV-negative women are reassured and advised on future screening intervals. The study also includes training for healthcare providers and uses a secure digital platform to manage registrations, results, and follow-up coordination. During the study, participants will be evaluated on their acceptance of self-sampling and follow-up procedures. Data will be collected on participation rates, test results, and adherence to follow-up care. Surveys and interviews with both participants and healthcare providers will assess the program's feasibility, acceptability, and sustainability amid ongoing conflict challenges such as migration and disrupted health services. The primary outcome is the uptake of HPV self-sampling within 12 weeks, with additional outcomes measuring provider adoption, test performance, and follow-up completion. The study is expected to last up to 24 months, aiming to reach about 1,000 eligible women.
CONDITIONS
Brief Title
Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
Who Can Participate
Age: 30Years - 60Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female aged 30-60 years
- Intact uterus (no prior hysterectomy)
- Eligible for cervical cancer screening according to local guidelines
- Able to provide informed consent
- Able to perform self-sampling at home or at a clinic
You will not qualify if you...
- History of total hysterectomy
- Pregnancy at the time of enrollment
- Known diagnosis of cervical cancer
- Inability or unwillingness to provide informed consent
- Unable to perform self-sampling or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for consent and eligibility assessment
Implementation of HPV Self-Sampling
Duration - Up to 12 weeks after receipt of the self-sampling kit
Participants receive an HPV self-sampling kit to collect a vaginal sample at home or in a clinic. Samples are returned and tested for high-risk HPV in accredited laboratories. Results are communicated via a secure digital platform, and follow-up care is coordinated for HPV-positive participants.
1 visit to receive the kit and return the sample, plus remote communication of results
Follow-up for HPV-Positive Participants
Duration - Within 2 months of receiving a positive HPV result
Women who test positive for high-risk HPV receive timely clinical follow-up, including expedited gynecological assessment for HPV 16/18 and guideline-based management for other high-risk types.
1 to 2 visits depending on follow-up required
Implementation and Process Evaluation
Duration - Up to 24 months post-initiation
Participants and healthcare providers contribute to surveys and interviews to assess acceptability, adoption, feasibility, and sustainability of the HPV self-sampling program in the conflict-affected setting.
Periodic surveys and interviews, frequency varies
Trial Site Locations
Total: 1 location
1
Educational and Scientific Medical Center "Universitetskaya Klinika", Zaporizhzhia State Medical and Pharmaceutical University
Zaporizhzhya, Ukraine, 69000
Actively Recruiting
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Research Team
L
Laila Sara Arroyo Mühr, PhD
J
Joakim Dillner, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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Published Research Related To This Trial
HPV self-sampling for cervical cancer screening during wartime: a pilot implementation study from a conflict-affected region of Ukraine.
Olexiy Kovalyov, Kostyantyn Kovalyov, Olena Deinichenko...
https://pubmed.ncbi.nlm.nih.gov/42049387