State Key Laboratory of Ultrasound in Medicine and Engineering, Chongqing Medical University, Chongqing, China.
Maternal and Child Health, The Maternity Service Centre of Lueyang Maternal and Child Health Care Hospital, Lueyang, Shaanxi, China.
BMJ Open. 2022 Sep 19;12(9):e062678. doi: 10.1136/bmjopen-2022-062678.
Persistent infection with high-risk human papillomavirus (hrHPV) is the main cause of cervical cancer. Thus, the effective treatment against HPV represents an opportunity to reduce the incidence of cervical cancer. Although various treatments are effective in treating HPV infection, they still provide limited benefit in reducing the rate of cervical cancer due to the lack of implementation of a standardised protocol in many low/middle-income areas. This proposed cohort study aims to describe the status quo of treatment, attributions of the treatment decision-making process and potential factors influencing treatment decisions.
This is a mixed-method, 5-year prospective longitudinal study in Lueyang County, China, one of the areas with the highest cervical cancer incidence rates and lowest mean income in China. We will enrol women with hrHPV infection (at least one HPV type in the 13 high-risk subtypes) diagnosed via a county-wide HPV infection and cervical cancer screening programme. The study procedures describe the treatment patterns and explore the potential influencing factors in treatment decision-making through questionnaires, laboratory examinations and in-depth interviews. All participants will be evaluated at baseline and at 6, 12, 24, 36, 48 and 60 months. The primary outcome is the treatment pattern, the type and duration of which will be described later. The secondary outcomes include guideline compliance and changes in the HPV infection status. The HPV impact profile, intimate relationship satisfaction, and costs within different management groups are also described and compared.
This study was reviewed, and all of the relevant approvals were obtained from the Ethics Committee of the Maternity Service Centre of Lueyang Maternal and Child Health Care Hospital (2021-001). The findings from this study will be disseminated through peer-reviewed publications, conference presentations and academic workshops.
ChiCTR2100053757.
高危型人乳头瘤病毒（hrHPV）持续感染是宫颈癌的主要病因。因此，针对 HPV 的有效治疗为降低宫颈癌发病率提供了机会。尽管各种治疗方法在治疗 HPV 感染方面都很有效，但由于在许多中低收入地区缺乏标准化方案的实施，它们在降低宫颈癌发病率方面的获益仍然有限。本拟进行的队列研究旨在描述治疗现状、治疗决策过程的归因以及可能影响治疗决策的因素。
这是一项在中国略阳县进行的混合方法、5 年前瞻性纵向研究，略阳县是中国宫颈癌发病率最高和人均收入最低的地区之一。我们将招募通过全县 HPV 感染和宫颈癌筛查计划诊断出的 hrHPV 感染（至少一种 13 种高危亚型中的 HPV 类型）的女性。研究程序描述了治疗模式，并通过问卷调查、实验室检查和深入访谈探讨了治疗决策中的潜在影响因素。所有参与者将在基线和 6、12、24、36、48 和 60 个月进行评估。主要结局是治疗模式，其类型和持续时间将在以后进行描述。次要结局包括指南依从性和 HPV 感染状态的变化。不同管理组的 HPV 影响概况、亲密关系满意度和成本也进行了描述和比较。
本研究已进行审查，并获得了略阳县妇幼保健院妇产科服务中心伦理委员会的所有相关批准（2021-001）。该研究的结果将通过同行评议的出版物、会议演讲和学术研讨会进行传播。
ChiCTR2100053757。
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