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

NCT07275333 | Recruiting

• 1 other identifier: 2024-06579-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer Screening; Cervical Cancer; Human Papillomavirus (HPV) Infection; Cervical Intraepithelial Neoplasia

Keywords

hpv self-sampling; hpv testing; cervical cancer prevention; cervical screening; implementation science; war-affected regions; ukraine; High-risk HPV; self-collection; Screening uptake

Outcome Measures

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.

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

Secondary Outcomes (7)

• Acceptability of HPV self-sampling among participants

  Within 4 weeks after sample return

• Adoption of the screening intervention by healthcare providers

  Up to 3 months after provider training.

• Feasibility of implementing HPV self-sampling during conflict

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

• Proportion of women who have never been screened prior to participation

  At enrollment

• Performance and reliability of locally used HPV tests

  At annual proficiency testing cycles (0,12,18 months) and at each HPV test run (up to 24 months).

Study Arms (1)

HPV Self-Sampling for Cervical Cancer Screening

EXPERIMENTAL

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.

Device: HPV Self-Sampling Kit

Interventions

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.

Also known as: FLOQSwab® self-collection device, self-sampling

HPV Self-Sampling for Cervical Cancer Screening

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zaporizhzhiya State Medical University: collaborator
• World Against Cancer Foundation: collaborator
• Karolinska Institutet: lead
• Union for International Cancer Control: collaborator

Study Sites (1)

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

Zaporizhzhya, 69000, Ukraine

RECRUITING

Related Publications (3)

• Elfstrom 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 BACKGROUND

• World 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.

  BACKGROUND

• World 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

  BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Infections; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Precancerous Conditions

Study Officials

• Olexiy Kovalyov, Professor

  Zaporizhzhia State Medical and Pharmaceutical University

  PRINCIPAL INVESTIGATOR

• Laila Sara Arroyo Mühr, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Laila Sara Arroyo Mühr, PhD

CONTACT

+46700917250; sara.arroyo.muhr@ki.se

Joakim Dillner, Professor

CONTACT

+46724682460; joakim.dillner@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants receive the same intervention consisting of HPV self-sampling and HPV DNA testing. There is no control or comparator arm.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)