RecruitingNot ApplicableNCT07275333

Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine


Sponsor

Karolinska Institutet

Enrollment

1,000 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 30 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

Interventions

DEVICEHPV Self-Sampling Kit

Participants will receive an HPV self-sampling kit consisting of a sterile vaginal swab and collection tube for home or clinic-based sample collection. The kit includes illustrated instructions to enable unsupervised self-sampling. Women collect the sample themselves and return it. Samples are tested for high-risk HPV using validated PCR-based assays in Ukrainian molecular laboratories participating in the project. Results are communicated through a secure digital platform, which coordinates appropriate clinical follow-up for HPV-positive women. All enrolled participants receive the same intervention.


Locations(1)

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

Zaporizhzhya, Ukraine

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NCT07275333


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