NCT07275333Recruiting
Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Karolinska Institutet
- Diseases
- Cervical cancer
- NCT number
- NCT07275333
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 1 Apr 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of total hysterectomy
- Known diagnosis of cervical cancer
Other
- Pregnancy at the time of enrollment
- Inability or unwillingness to provide informed consent
- Unable to perform self-sampling or comply with study procedures
Who the study is looking for
- 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
Age in the registry: 30 years to 60 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Educational and Scientific Medical Center "Universitetskaya Klinika", Zaporizhzhia State Medical and Pharmaceutical University Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Recruiting |
Related publications
- HPV self-sampling for cervical cancer screening during wartime: a pilot implementation study from a conflict-affected region of Ukraine.BMJ Glob Health · 2026 · PMID 42049387
This page is information, not medical advice. Discuss any trial with your doctor.