Self-Sampling for HPV to Improve Cervical Cancer Screening in Women Aged 30-60 in Conflict-Affected Zaporizhzhia, Ukraine

What this Trial Is About

Researchers are evaluating a cervical cancer screening program using self-sampling for human papillomavirus HPV detection among women aged 30 to 60 years in the Zaporizhzhia region of Ukraine. This area has faced disruption due to armed conflict, which has affected traditional access to preventive services. The study aims to improve screening access, assess the feasibility of self-sampling in conflict conditions, and support the development of a sustainable cervical cancer control model applicable to similar challenging settings. The project is a collaboration between local Ukrainian institutions and Karolinska Institutet in Sweden, supported by an international cancer control organization. Participants receive an HPV self-sampling kit distributed through primary care providers, community outreach, or partner organizations. Women collect a vaginal sample themselves using the provided FLOQSwab device and return it to clinics or volunteers free of charge. Samples undergo testing for high-risk HPV types in accredited molecular laboratories with quality assurance processes. HPV-positive women receive follow-up care according to national guidelines, including referral for further examination and treatment if needed. HPV-negative women are reassured and advised on future screening intervals. The study also includes training for healthcare providers and uses a secure digital platform to manage registrations, results, and follow-up coordination. During the study, participants will be evaluated on their acceptance of self-sampling and follow-up procedures. Data will be collected on participation rates, test results, and adherence to follow-up care. Surveys and interviews with both participants and healthcare providers will assess the programs feasibility, acceptability, and sustainability amid ongoing conflict challenges such as migration and disrupted health services. The primary outcome is the uptake of HPV self-sampling within 12 weeks, with additional outcomes measuring provider adoption, test performance, and follow-up completion. The study is expected to last up to 24 months, aiming to reach about 1,000 eligible women.

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