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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HPV Self-Sampling Kit

    Device

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: HPV Self-Sampling for Cervical Cancer ScreeningExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Uptake of HPV self-sampling among eligible women in Zaporizhzhia

Proportion of eligible women aged 30-60 who receive an HPV self-sampling kit and return a valid sample for testing. This outcome reflects the feasibility and adoption of the screening intervention during wartime conditions and directly corresponds to the project objective of improving access to cervical cancer screening through self-sampling.

Time frame
Up to 12 weeks after receipt of the self-sampling kit.

Secondary outcomes

1

Acceptability of HPV self-sampling among participants

Participant acceptability measured through brief surveys and semi-structured interviews assessing comfort, ease of use, clarity of instructions, and overall satisfaction with self-sampling and follow-up procedures. Designed to evaluate acceptability according to implementation science outcomes.

Time frame
Within 4 weeks after sample return
2

Adoption of the screening intervention by healthcare providers

Number and proportion of primary care providers trained who offer self-sampling, register participants in the database, and report results. Includes qualitative feedback on provider experience, appropriateness, and barriers to implementation as described in the project plan.

Time frame
Up to 3 months after provider training.
3

Feasibility of implementing HPV self-sampling during conflict

Assessment of logistical feasibility including kit distribution pathways, sample return methods (post, clinic, NGO volunteers), laboratory capacity, screening workflow continuity, and challenges related to resource availability or security conditions. Based directly on feasibility indicators in the UICC proposal.

Time frame
At 12 months and at project completion (up to 24 months post-initiation).
4

Proportion of women who have never been screened prior to participation

Percentage of enrolled women who report no prior cervical cancer screening or no HPV test within the past 3 years. This evaluates reach and equity of the intervention, as outlined in the project's objectives.

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Union for International Cancer Control

Collaborator

Zaporizhzhiya State Medical University

Collaborator

World Against Cancer Foundation

Collaborator