Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial.
Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial.
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DOI：
10.1186/s13063-020-04790-5
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发表时间：
2020-10-21
期刊：
影响因子：
2.5
通讯作者：
Scheurer ME
中科院分区：
文献类型：
--
作者：
Montealegre JR;Anderson ML;Hilsenbeck SG;Chiao EY;Cantor SB;Parker SL;Daheri M;Bulsara S;Escobar B;Deshmukh AA;Jibaja-Weiss ML;Zare M;Scheurer ME
近20%的美国女性由于无法或不愿参加定期的临床筛查，仍有患宫颈癌的风险。自我抽样已被证明是在特定环境中筛查妇女高危人乳头瘤病毒(HR-HPV)感染的有效策略。然而，它在安全网卫生系统中医疗服务不足的妇女中的有效性尚未得到评估。此外，目前还不清楚患者导航等实施策略是否可以通过解决患者层面的参与障碍来提高自我样本筛查计划的成功。自我检测增加筛查的前瞻性评估(PRESTIS)试验是一项邮寄自我样本HPV检测的混合型2型有效性-实施性随机对照试验。其目的是评估邮寄自我样本HPV检测试剂盒的有效性，以提高安全网卫生系统中逾期进行基于临床的筛查的患者对宫颈癌筛查的参与度，同时评估患者导航作为一种实施战略。它的背景是一个大型的城市安全网卫生系统，服务于以种族/少数民族为主的患者人口。该试验的目标是招募2,268名参与者，随机分为电话召回(增强型普通护理，n = 756)、电话召回(邮寄自我样本HPV检测试剂盒(干预，n = 756))或电话召回(邮寄自我样本HPV检测试剂盒和患者导航)(干预+实施策略，n = 756)。主要的有效性结果是完成初步筛查，定义为完成并返回邮寄的自我样本试剂盒或完成以诊所为基础的巴氏试验。在筛查试验阳性的女性中，二次疗效结果是筛查和临床随访的出勤率的预测因子。实施成果包括可达性、可接受性、保真度、适应性和成本效益。需要混合设计来评估特定人群和环境中自我采样HPV检测的临床有效性，同时纳入和评估方法以优化其现实世界的实施。目前的手稿描述了在安全网卫生系统中进行自我样本HPV检测的混合型2型试验的原理和设计。试验结果有望提供有意义的数据，为最终实现消除宫颈癌的全球目标的筛查战略提供参考。临床试验.gov NCT03898167。注册日期为2019年4月1日。研究开始数据：2020年2月13日。招聘状态：邀请报名。预计初步完工日期：2023年2月15日。预计研究完成日期：2024年5月31日。协议版本1.6(2020年2月25日)。
Almost 20% of U.S. women remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts. However, its effectiveness among medically underserved women in safety net health systems has not been evaluated. Furthermore, it is also unclear whether implementation strategies such as patient navigation can be used to improve the success of self-sample screening programs by addressing patient-level barriers to participation. The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is a hybrid type 2 effectiveness-implementation pragmatic randomized controlled trial of mailed self-sample HPV testing. The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net health system who are overdue for clinic-based screening, while simultaneously assessing patient navigation as an implementation strategy. Its setting is a large, urban safety net health system that serves a predominantly racial/ethnic minority patient population. The trial targets recruitment of 2268 participants randomized to telephone recall (enhanced usual care, n = 756), telephone recall with mailed self-sample HPV testing kit (intervention, n = 756), or telephone recall with mailed self-sample HPV testing kit and patient navigation (intervention + implementation strategy, n = 756). The primary effectiveness outcome is completion of primary screening, defined as completion and return of mailed self-sample kit or completion of a clinic-based Pap test. Secondary effectiveness outcomes are predictors of screening and attendance for clinical follow-up among women with a positive screening test. Implementation outcomes are reach, acceptability, fidelity, adaptations, and cost-effectiveness. Hybrid designs are needed to evaluate the clinical effectiveness of self-sample HPV testing in specific populations and settings, while incorporating and evaluating methods to optimize its real-world implementation. The current manuscript describes the rationale and design of a hybrid type 2 trial of self-sample HPV testing in a safety net health system. Trial findings are expected to provide meaningful data to inform screening strategies to ultimately realize the global goal of eliminating cervical cancer. ClinicalTrials.gov NCT03898167. Registered on 01 April 2019. Study start data: February 13, 2020. Recruitment status: Enrolling by invitation. Estimated primary completion date: February 15, 2023. Estimated study completion date: May 31, 2024. Protocol version 1.6 (February 25, 2020).
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影响因子：
51.1
作者：
de Sanjose, Silvia;Quint, Wim G. V.;Xavier Bosch, F.
通讯作者：
Xavier Bosch, F.
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
影响因子：
4.4
作者：
Bouchard-Fortier, Genevieve;Hajifathalian, Kaveh;Gonzalez-Gonzalez, Luis Alonso
通讯作者：
Gonzalez-Gonzalez, Luis Alonso
影响因子：
6.4
作者：
Bais, Aagje G.;van Kemenade, Folkert J.;Meijer, Chris J. L. M.
通讯作者：
Meijer, Chris J. L. M.
影响因子：
3.7
作者：
Enerly, Espen;Bonde, Jesper;Nygard, Mari
通讯作者：
Nygard, Mari