Clinical trial · Interventional
Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer Screening | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus (HPV) Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV Self-Sampling Kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV Self-Sampling for Cervical Cancer Screening
- description
- 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.
- interventionNames
- Device: HPV Self-Sampling Kit
Primary outcomes (1)
- measure
- Uptake of HPV self-sampling among eligible women in Zaporizhzhia
- timeFrame
- Up to 12 weeks after receipt of the self-sampling kit.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (4)
- BACKGROUNDElfstrom M, Gray PG, Dillner J. Cervical cancer screening improvements with self-sampling during the COVID-19 pandemic. Elife. 2023 Dec 12;12:e80905. doi: 10.7554/eLife.80905. PMID 38085566
- BACKGROUNDWorld Health Organization (2022) HPV self-sampling in Sweden leading to faster elimination of cervical cancer. Retrieved from: https://www.who.int/europe/news/item/08-09-2022-hpv-self-sampling-in-sweden-leading-to-faster-elimination-of-cervical-cancer, accessed on 2024-03-05.
- BACKGROUNDWorld Health Organization. (2018). WHO calls for global action on cervical cancer. Retrieved from https://www.who.int/news-room/detail/17-11-2018-who-calls-for-global-action-on-cervical-cancer, accesed on 2024-02-07
- DERIVEDKovalyov O, Kovalyov K, Deinichenko O, Dillner J, Arroyo Muhr LS. HPV self-sampling for cervical cancer screening during wartime: a pilot implementation study from a conflict-affected region of Ukraine. BMJ Glob Health. 2026 Apr 28;11(4):e023478. doi: 10.1136/bmjgh-2026-023478. PMID 42049387