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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Ukraine
Educational and Scientific Medical Center Universitetskaya Klinika, Zaporizhzhia State Medical and Pharmaceutical University
RECRUITING
Zaporizhzhya
Contact Information
Primary
Laila Sara Arroyo Mühr, PhD
sara.arroyo.muhr@ki.se
+46700917250
Backup
Joakim Dillner, Professor
joakim.dillner@ki.se
+46724682460
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 1000
Treatments
Experimental: HPV Self-Sampling for Cervical Cancer Screening
Participants will receive an HPV self-sampling kit distributed through primary care providers, community outreach, or partner organizations in conflict-affected areas of southeastern Ukraine. Women will collect a vaginal sample using the supplied FLOQSwab® device. Samples will be tested for high-risk HPV in quality-assured Ukrainian molecular laboratories. Results will be reported through the project's secure digital platform, which will coordinate follow-up care for HPV-positive women according to clinical guidelines. All participants in this arm receive the same screening intervention.
Sponsors
Leads: Karolinska Institutet
Collaborators: World Against Cancer Foundation, Union for International Cancer Control, Zaporizhzhiya State Medical University

This content was sourced from clinicaltrials.gov

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