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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorKarolinska Institutet

About this trial

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

Qualifiers

Female aged 30-60 years

Intact uterus (no prior hysterectomy)

Eligible for cervical cancer screening according to local guidelines

Able to provide informed consent

Disqualifiers

History of total hysterectomy

Pregnancy at the time of enrollment

Known diagnosis of cervical cancer

Inability or unwillingness to provide informed consent

Trial design

Treatments tested in this trial

  • HPV Self-Sampling Kit

Treatment groups

1,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Union for International Cancer Control

Collaborator

Zaporizhzhiya State Medical University

Collaborator

World Against Cancer Foundation

Collaborator