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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Educational and Scientific Medical Center "Universitetskaya Klinika", Zaporizhzhia State Medical and Pharmaceutical University
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ZaporizhzhyaUkraineRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.