Evaluation of a Self-Screening Cervical Cancer Test by Mail

摘要 浸润性宫颈癌（ICC）是一种差异性疾病，在贫困，农村，非洲裔美国人，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一些障碍。行为风险因素监测系统（BRFSS）的数据显示， 北卡罗来纳州在过去三年内，符合条件的妇女缺乏ICC筛查。我们提出了一个试点研究，以验证邮寄，在家里自我筛选测试ICC。在200名妇女的样本中，我们将探讨心理接受的邮寄自我管理的筛选测试ICC。 将招募年龄超过30岁且缺乏适当筛查计划的农村妇女，要求邮寄自我采样试剂盒，退回邮寄的宫颈阴道标本，并通过电话获得HPV检测结果。HPV DNA阳性、阴性和不确定的妇女将被转诊到北卡罗来纳州乳腺癌和宫颈癌控制项目，在诊所进行第二次自我采样， 医生采集样本进行HPV和细胞学筛查，以及（如有指征）随访治疗。 将与参与者进行协商，以帮助确定自我筛查和后续筛查和治疗的障碍，以提高拟议的外联方案的有效性。这项初步研究将评估在家中收集的HPV自检以及随后在诊所自行收集和自动收集的样本的HPV检出率。将对生殖器标本进行检测 用Quigen HC-II检测高危型人乳头瘤病毒（HPV）感染。标准化测试将优化我们的努力，以评估这种邮寄自我抽样模型的有效性。如果成功的话，邮寄在家自我筛查测试可以立即影响许多高危妇女的预防性筛查。试点数据将证明有理由扩大到其他高风险区域和国家地区， 假设自行采集的样本成功返回，样本质量得到确认，诊所内筛查和适当随访得到保证。

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 ofthe 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 indeterminate 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.