Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Uptake of HPV self-sampling among eligible women in Zaporizhzhia
研究概览
简要总结
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.
详细描述
Cervical cancer is the fourth leading cause of cancer-related deaths among women worldwide and is almost always caused by persistent infection with high-risk human papillomavirus (HPV). Organized screening programs using HPV testing have been shown to reduce cervical cancer incidence and mortality. However, in settings affected by armed conflict, access to preventive services is disrupted, and clinic-based screening becomes difficult to maintain.
In 2020, a cervical screening center was established in the Zaporizhzhia region of Ukraine, close to the conflict zone. A pilot HPV-based screening initiative was launched to estimate HPV prevalence and support the development of an organized national screening program. This effort was interrupted by the escalation of the war, which led to disruption of services, population displacement, and increased barriers to preventive care.
This study aims to revive and expand these efforts by implementing an HPV-based cervical cancer screening program using self-sampling in Zaporizhzhia. The project leverages the long-standing experience from Sweden in organized screening, HPV laboratory quality assurance, and self-sampling implementation, while adapting the model to conflict-affected conditions in Ukraine.
Objectives
The main objectives are to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Uptake of HPV self-sampling among eligible women in Zaporizhzhia
时间窗: Up to 12 weeks after receipt of the self-sampling kit.
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.
次要结局
- 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).)
- Functionality and use of the digital screening platform(At 6, 12, 18, and 24 months after platform deployment.)
- Follow-up completion among HPV-positive women(Within 2 months of a positive HPV result.)
研究者
Sara Arroyo Mühr
Associate Professor
Karolinska Institutet