一项在肯尼亚西部社区卫生运动与卫生机构中比较人乳头瘤病毒（HPV）为基础的宫颈癌筛查的整群随机试验的研究方案。
Study protocol for a cluster-randomized trial to compare human papillomavirus based cervical cancer screening in community-health campaigns versus health facilities in western Kenya.
机构信息
Duke University, Global Health Institute and Department of Obstetrics and Gynecology, 310 Trent Drive, Room 204, Durham, NC, 27708, USA.
Department of Epidemiology and Biostatistics, University of California San Francisco, Box 0560, San Francisco, CA, 94143-0560, USA.
出版信息
BMC Cancer. 2017 Dec 6;17(1):826. doi: 10.1186/s12885-017-3818-z.
BACKGROUND
Despite guidelines for cervical cancer prevention in low-resource countries, a very small proportion of women in these settings undergo screening, and even fewer women are successfully treated. Using pilot data from western Kenya and World Health Organization recommendations, we developed a protocol to implement evidence-based cervical cancer screening and linkage to treatment strategies to the rural communities. We describe the protocol for a cluster-randomized trial to compare two implementation strategies for human-papillomavirus (HPV)-based cervical cancer screening program using metrics described in the RE-AIM (reach, efficacy, adaption, implementation and maintenance) framework.
METHODS
The study is a three-year, two-phase cluster-randomized trial in 18 communities in western Kenya. During Phase 1, six control communities were offered screening in health facilities; and six intervention communities were offered screening in community health campaigns. Screening was done with human-papillomavirus testing through self-collected specimens. Phase 1 ended and we are working in partnership with communities to further contextualize the implementation strategy for screening, and develop an enhanced linkage to treatment plan. This plan will be tested in an additional six communities in Phase 2 (enhanced intervention). We will compare the reach, efficacy, cost-effectiveness and adaptability of the implementation strategies.
DISCUSSION
Effective low-cost cervical cancer prevention technologies are becoming more widely available in low- and middle-income countries. Despite increasing government support for cervical cancer prevention, there remains a sizeable gap in service availability. We will use implementation science to identify the most effective strategies to fill this gap through development of context-specific evidence-based solutions. This protocol design and results can help guide implementation of cervical cancer screening in similar settings, where women are most underserved and at highest risk for disease.
TRIAL REGISTRATION
This trial is registered at ClinicalTrials.gov , NCT02124252 .
背景
尽管在资源匮乏的国家有宫颈癌预防指南，但这些国家只有极少数女性接受筛查，而成功接受治疗的女性就更少了。我们利用来自肯尼亚西部的试点数据和世界卫生组织的建议，制定了一项在农村社区实施基于人乳头瘤病毒（HPV）的宫颈癌筛查和治疗策略的方案。我们描述了一项集群随机试验的方案，以比较两种基于人乳头瘤病毒的宫颈癌筛查方案的实施策略，该方案使用了 RE-AIM（可达性、效果、适应性、实施和维持）框架中描述的指标。
方法
这项为期三年的两阶段集群随机试验在肯尼亚西部的 18 个社区进行。在第一阶段，有六个对照组社区在卫生机构提供筛查；六个干预组社区在社区卫生运动中提供筛查。筛查采用自我采集样本的 HPV 检测进行。第一阶段结束后，我们正在与社区合作，进一步使筛查的实施策略本地化，并制定一个增强的治疗衔接计划。该计划将在第二阶段（增强干预）的另外六个社区中进行测试。我们将比较实施策略的可达性、效果、成本效益和适应性。
讨论
有效的低成本宫颈癌预防技术在中低收入国家越来越普及。尽管各国政府对宫颈癌预防的支持力度不断加大，但服务的提供仍存在相当大的差距。我们将利用实施科学来确定最有效的策略，通过制定特定于背景的循证解决方案来填补这一空白。本研究方案的设计和结果可以帮助指导在最需要服务和疾病风险最高的妇女所在的类似环境中实施宫颈癌筛查。
试验注册
本试验在 ClinicalTrials.gov 注册，编号为 NCT02124252。
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