ESVCCSP

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 加州大学欧文分校(UCI)这项研究的总体目标是找出有多少拉丁裔人会使用并邮寄回家的样本试剂盒来检测自己是否感染了有时可能导致宫颈癌的病毒，并研究这一过程的成本效益。为了做到这一点，调查人员将比较如果拉丁裔健康获取促进者(拉丁裔社区卫生工作者)给他们的邮寄退回多少试剂盒，或者是拉美裔报纸或电视广告与感兴趣的拉丁裔电话要求家庭采样试剂盒的结果。UCI的研究预计将联系大约4,000名符合条件的拉丁裔参与者。预计家庭采样试剂盒的退货率为30%-50%。从这2000名参与者中，20%的参与者将被邀请在一次门诊预约中进行纸质测试。这项研究将把家庭采样试剂盒的测试结果与随机抽取的约400名参与者的临床结果进行比较。 具体目标： 1.执行和评估一项进程，以查明当地拉丁裔/拉美裔社区中感染致癌型HPV的妇女。拟议的程序将涉及向4,000名拉丁美洲人分发人乳头瘤病毒家庭自我管理样本采集试剂盒。 2.评价临床试验中推动者对拉丁裔招募的影响。拉美裔健康获取(LHA)是一家在本研究感兴趣的医疗服务不足的拉美裔社区雇用促进者作为非专业社区卫生工作者的组织，该组织将提供三名促进者，招募3200名拉丁裔，他们将同意接受HSASC试剂盒。基于媒体的广告活动将通过邮寄方式向那些来电、符合条件并希望收到家庭HPV样本试剂盒的人分发800个试剂盒。 3.评估HSASC计划和HPV检测作为SVP计划的辅助项目的成本-效果。我们计划使用成本效益分析来衡量计划美元净成本或成本节约与计划有效性的比率，即非美元净计划结果。 在这些具体目标范围内需要检验的假设是： 1.使用HSASC试剂盒收集的样本的敏感性和敏感性将与医护人员在临床上采集的样本的敏感性和特异性相似。 2.与目前SVP试验中的比率相比，HPV自我采样将导致患有癌前宫颈异型增生的妇女有资格在SVP中接受治疗的比例更高。 3.在研究的Promota分发部门中，HPV自我样本收集试剂盒的退货率将高于媒体招募的邮件分发部门。 4.与邮件分发相比，由推广者分发HSASC试剂盒的满意度更高。 5.在家中自行采集HPV样本比在诊所由医护人员采集更令人满意。 目前有两种方法可以确定HPV DNA的存在，即杂交捕获2(HC2)试验和聚合酶链式反应(PCR)试验。只有HC2是FDA批准的，也是本研究将使用的方法。HC2技术是一种核酸杂交实验，旨在利用信号放大和化学发光微板法检测核酸靶标。使用了18个病毒型基因组特有的RNA探针。其中，13个是高风险类型：16、18、31、33、35、39、45、51、52、56、58、59和68。建议在获得样本后两周内完成HC2分析(参考：Digene公司。HPV检测：宫颈癌预防的新纪元。医生手册。盖瑟斯堡，马里兰州，2002年)。 细胞学仍然是筛查和治疗决策的标准护理。HC2检测不会被用来做出治疗决定。所有接受HSASC试剂盒的拉丁裔人都将被告知，宫颈癌筛查的标准是巴氏试验。无论是否退还HPV HCASC试剂盒或被选中继续研究，所有患者都将被建议每年进行巴氏试验。在UCI退回试剂盒进行检测的随机样本(约2,000名拉丁裔)将被邀请参加一次纸片涂片和HPV临床检测预约。对于高度鳞状上皮内瘤变(HSIL指定为CIN 3级)或不典型腺细胞(AGUS)的患者，当天将免费接受转化区的透热环切除治疗。如果可以接受，她们会接受怀孕测试，如果她们没有怀孕，她们就会得到DLE，并在2周和3个月内返回进行标准护理随访。参与者也可以选择退出DLE治疗和研究，而是选择转诊到UCI诊所，以获得其他提供的标准护理选择。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this University of California, Irvine (UCI) study is to find out how many Latinas will use and mail in a home sample kit to test themselves for a virus that may sometimes cause cervical cancer and to study the cost effectiveness of the process. To do this, the investigators will compare how many kits are returned in the mail if given to them by a Latino Health Access promotora (Latina community health worker) or as a result of a Hispanic newspaper or television advertisement with a phone call request for the home sampling kit from the interested Latina. The UCI study expects to contact approximately 4,000 eligible Latina participants. A 30-50% return of the home sampling kit is expected. From this group of 2000 participants a 20% sample of participants will be invited to have a pap test in a single visit clinic appointment. The study will compare test results of home sampling kits with this random sample of clinic results on about 400 selected participants. Specific Aims: 1. To implement and evaluate a process to identify women in local Latino/Hispanic communities who have oncogenic type HPV infections. The proposed process will involve the distribution of HPV Home Self-administered Sample Collection (HSASC) kits to 4,000 Latinas. 2. To evalute the impact of Promotoras on the recruitment of Latinas in the clinical trial. Latino Health Access (LHA), an organization that employs Promotoras as lay community health workers in the medically underserved Hispanic communities of interest to this study, will provide three Promotoras for recruitment of 3,200 Latinas who will agree to receive HSASC kits. A media based ad campaign will be used to distribute 800 kits by mail to those who call in, are eligible, and wish to receive a home sampling HPV kit. 3. To evaluate the cost-effectiveness of the HSASC program and HPV testing as an adjunct to the SVP program. We plan to use cost-effectiveness analysis to measure the ratio of program dollar net costs or cost savings to program effectiveness which are the non-dollar net program outcomes. The hypotheses to be tested within these specific aims are: 1. The specificity and sensitivity of the samples collected using the HSASC kits will be similar to the sensitivity and specificity of samples taken by the health care provider in the clinic. 2. HPV self-sampling will lead to a higher percentage of women with pre-cancerous cervical dysplasia who are eligible to undergo treatment in the SVP compared to rates in teh current SVP trial. 3. The HPV self-sample collection kit return rate will be higher in the Promotora-distributed arm of the study than in the media-recruited, mail-distributed arm. 4. Satisfaction will be greater when HSASC kits are distributed by Promotoras as compared to mail distribution. 5. Satisfaction will be greater with HPV self-sample collection at home compared to collection by a health care provider at the clinic. Two methods of determining the presence of HPV DNA are currently available, Hybrid Capture 2 (HC2) assay and polymerase chain reaction (PCR) testing. Only HC2 is FDA-approved andis the method that will be used in this study. HC2 technology is a nucleic acid, hybridization assay designed to detect nucleic acid targets using signal amplification and chemiluminescent microplate methods. RNA probes specific for 18 viral type genomes are used. Of these, 13 are high-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. It is recommended that HC2 analysis be completed within two weeks of obtaining the sample (reference: Digene Corporation. HPV Detection: A New Era in Cervical Cancer Prevention. Physician Brochure. Gaithersburg, MD, 2002). Cytology remains the standard of care for screening and for treatment decisions. HC2 assays will not be used to make treatment decisions. All Latinas who receive the HSASC kits will be told that the standard of care for cervical cancer screening is a Pap test. All will be advised to get a Pap test yearly whether or not they return the HPV HCASC kit or are selected to continue in the study. A random sample of those (approximately 2,000 Latinas who return the kit for testing at UCI will be invited to a single visit pap smear and HPV clinic test appointment. Those with high grade squamous intraepithelia neoplasia (HSIL designated CIN grade 3) or atypical glandular cells of undermined significance (AGUS) will be offered a diathermy loop excision treatment of the transformation zone that day at no cost to the participant. If acceptable, they are given a pregnancy test and if they are not pregnant they have the DLE and return in 2 weeks and at 3 months for standard of care follow-up. The participant also may opt out of the DLE treatment and study and instead choose a referral to a UCI clinic for other offered options that are standard of care.