Evaluation of a Self-Screening Cervical Cancer Test by Mail

摘要 浸润性宫颈癌(ICC)是一种差异较大的疾病，在贫穷、农村、非裔美国人、西班牙裔和美洲原住民妇女中风险较高。通过适当的细胞学筛查，ICC是可以预防的，尽管许多高危妇女在获得筛查和相关治疗方面存在几个障碍。这个 行为风险因素监测系统(BRFSS)的数据显示，在北卡罗来纳州，13.3%的合格女性在过去三年内没有进行ICC筛查。我们建议进行一项试点研究，以验证ICC的邮寄、在家自我筛选测试的有效性。在200名女性样本中，我们将探讨女性对ICC邮寄自填筛查测试的心理接受程度。同意的30岁以上和缺乏适当筛查程序的农村妇女将被招募，要求她们邮寄自我采样试剂盒，邮寄宫颈阴道标本，并通过电话获得HPV检测结果。HPV DNA阳性、阴性和确诊的妇女将被转介到北卡罗来纳州乳癌和宫颈癌控制计划，在诊所进行第二次自我采样，医生收集的样本用于HPV和细胞学筛查，如果需要，还将进行后续治疗。 将与参与者进行磋商，以帮助确定自我筛查和后续筛查和治疗的障碍，以提高这一拟议外展计划的有效性。这项初步研究将评估在家中收集的HPV自我检测以及随后在诊所自收集和从业者收集的样本的HPV检测率。生殖器样本将用Quigen HC-11检测高危类型的人乳头瘤病毒(HPV)感染。标准化测试将优化我们评估这种邮寄自我抽样模型的有效性的努力。如果成功，邮寄的家庭自我筛查测试可以立即影响许多高危妇女预防性筛查的提供。试点数据将证明有理由扩大到其他高危区域和国家地区，前提是自行收集的样本成功返回，样本质量得到确认，并保证门诊筛查和适当的后续行动。

Abstract Invasive cervical cancer (ICC) is a disease of disparities, with a higher risk among poor, rural, African American, Hispanic, and Native American women. ICC is preventable with adequate cytological screening, although there are several barriers to the access of screening and associated treatment for many high-risk women. The Behavioral Risk Factor Surveillance System (BRFSS) data show 13.3% of eligible women lacked screening for ICC in North Carolina within the last three years. We propose a pilot study to validate a mailed, at-home self-screening test for ICC. Among a sample of 200 women, we will explore psychological acceptance of the mailed self-administered screening test for ICC. Consenting rural women older than 30 years and lacking the proper screening schedule will recruited, asked to mail self-sampling kits, return mail cervico-vaginal specimens, and obtain HPV test results by telephone. HPV DNA positive, negative, and indetemriinate women will be referred to the North Carolina Breast and Cervical Cancer Control Program to conduct a second self-sampling at the clinic, a physician-collected sample for HPV and cytological screening, and, if indicated, follow-up treatment. Consultations with participants will be conducted to help identify barriers to self-screening and to follow-up screening and treatment in order to increase the effectiveness of this proposed outreach program. This pilot study will assess HPV detection rates for HPV self-test collected at home, and subsequent in-clinic self-collected and practitioner-collected samples. Genital specimens will be tested for high-risk types of human papillomavirus (HPV) infection with Quigen HC-ll assay. Standardized testing will optimize our efforts to evaluate the validity of this mailed self-sampling model. If successful, a mailed at-home self-screening test can immediately impact the delivery of preventive screening for many at-risk women. Pilot data would justify a scale-up to other high-risk regional and national areas, assuming the successful return of self-collected samples, sample quality is confirmed, and assurance of in-clinic screening and appropriate follow-up.