Kobetz Erin, Seay Julia, Amofah Anthony, Pierre Larry, Bispo Jordan Baeker, Trevil Dinah, Gonzalez Martha, Poitevien Martine, Koru-Sengul Tulay, Carrasquillo Olveen
Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA.
Department of Medicine, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL, 33136, USA.
Trials. 2017 Jan 13;18(1):19. doi: 10.1186/s13063-016-1721-6.
Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening. SUCCESS trial participants, as well as our community partners, provided feedback that women may prefer the HPV self-sampler to be delivered through the mail, such that they would not need to schedule an appointment with the CHW. Thus, our current trial aims to elucidate the efficacy of the HPV self-sampling method when delivered via mail.
We are conducting a randomized controlled trial among 600 Haitian, Hispanic, and African-American women from the South Florida communities of Little Haiti, Hialeah, and South Dade. Women between the ages of 30 and 65 years who have not had a Pap smear within the past 3 years are eligible for the study. Women are recruited by CHWs and complete a structured interview to assess multilevel determinants of cervical cancer risk. Women are then randomized to receive HPV self-sampling delivered by either the CHW (group 1) or via mail (group 2). The primary outcome is completion of HPV self-sampling within 6 months post enrollment.
Our trial is among the first to examine the efficacy of the mailed HPV self-sampling approach. If found to be efficacious, this approach may represent a cost-effective strategy for cervical cancer screening within underserved and underscreened minority groups.
ClinicalTrials.gov, NCT02202109 . Registered on 9 July 2014.
服务不足的少数族裔女性在宫颈癌发病率和死亡率方面存在显著差异，主要原因是缺乏宫颈癌筛查。巴氏涂片筛查的障碍包括知识缺乏、缺乏医疗保险和就医渠道，以及关于疾病预防的文化观念。在我们之前的SUCCESS试验中，我们证明了由社区卫生工作者（CHW）提供的HPV自我采样在规避这些障碍方面是有效的。相对于引导进行巴氏涂片筛查，这种方法提高了筛查接受率。SUCCESS试验的参与者以及我们的社区合作伙伴反馈称，女性可能更喜欢通过邮件方式提供HPV自我采样器，这样她们就无需与社区卫生工作者预约。因此，我们目前的试验旨在阐明通过邮件方式提供HPV自我采样方法的有效性。
我们正在对来自南佛罗里达州小海地、海厄利亚和南戴德社区的600名海地、西班牙裔和非裔美国女性进行一项随机对照试验。年龄在30至65岁之间、过去3年内未进行过巴氏涂片检查的女性有资格参加该研究。女性由社区卫生工作者招募，并完成一次结构化访谈，以评估宫颈癌风险的多层次决定因素。然后，女性被随机分为两组，分别接受由社区卫生工作者提供的HPV自我采样（第1组）或通过邮件方式提供（第2组）。主要结局是在入组后6个月内完成HPV自我采样。
我们的试验是首批检验邮寄HPV自我采样方法有效性的试验之一。如果该方法被证明有效，那么它可能是在服务不足和筛查不足的少数群体中进行宫颈癌筛查的一种具有成本效益的策略。
ClinicalTrials.gov，NCT02202109。于2014年7月9日注册。
