NCT07275333 Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
| NCT ID | NCT07275333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2025-04-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In 2020, a cervical screening center was established in Zaporizhzhia (Ukraine), initiating a pilot project to evaluate the prevalence of HPV among women in Eastern Ukraine. The findings were intended to lay the groundwork for the Ukrainian Ministry of Health in establishing a structured national screening program. However, all efforts were halted due to the nearby armed conflict, situated just 40 kilometers from the border. The World Health Organization's goal to eliminate cervical cancer globally has a gap when it comes to managing cancer control during crises like armed conflicts. We propose a demonstration project to assess whether a simpler, yet modern, cervical cancer control strategy (based on using self-sampling for HPV detection) could also be effective for cervical cancer screening in Zaporizhzhia. Women aged 30-60 years who have not had a recent negative HPV test will be invited to participate. Participants receive a self-sampling kit from their primary care provider and can return the sample free of charge to the clinic or community volunteers. All samples are analyzed in accredited laboratories in Zaporizhzhia. HPV-positive women will receive follow-up care according to national guidelines, including referral to gynecologists for additional tests and treatment if needed. HPV-negative women will be reassured and advised on future screening intervals. The study also evaluates how well the screening program can be implemented during conflict conditions. This includes measuring women's acceptance of self-sampling, the willingness of providers to adopt the procedures, and whether the screening process is feasible, practical, and sustainable. Additional process evaluation will explore how the program adapts to challenges such as migration, disrupted health services, and safety concerns. This project is conducted through collaboration between Zaporizhzhia State Medical and Pharmaceutical University, the Charitable Foundation "World Against Cancer," and Karolinska Institutet in Sweden, which provides quality assurance support for laboratory procedures. The goal is to establish a safe, effective, and sustainable cervical cancer screening model that can be used in conflict-affected regions and similar settings. This work is supported by a grant from the Union for International Cancer Control (UICC), as part of the Reimagining Cancer Research in Europe Initiative.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Olexiy Kovalyov, Professor
PRINCIPAL INVESTIGATOR
Zaporizhzhia State Medical and Pharmaceutical University
Frequently Asked Questions
Who can join the NCT07275333 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 60 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07275333 currently recruiting?
Yes, NCT07275333 is actively recruiting participants. Contact the research team at sara.arroyo.muhr@ki.se for enrollment information.
Where is the NCT07275333 trial being conducted?
This trial is being conducted at Zaporizhzhya, Ukraine.
Who is sponsoring the NCT07275333 clinical trial?
NCT07275333 is sponsored by Karolinska Institutet. The principal investigator is Olexiy Kovalyov, Professor at Zaporizhzhia State Medical and Pharmaceutical University. The trial plans to enroll 1,000 participants.
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