ESVCCSP

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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家庭样本试剂盒来检测自己是否患有有时可能导致宫颈癌的病毒，并研究该过程的成本效益。为了做到这一点，调查人员将比较拉丁裔卫生服务推广人员（拉丁裔社区卫生工作者）或西班牙裔报纸或电视广告与感兴趣的拉丁裔打电话要求家庭抽样工具包的结果通过邮件退回的工具包数量。UCI的研究预计将接触大约4000名符合条件的拉丁裔参与者。预计家庭抽样试剂盒的回收率为30-50%。从这组2000名参与者中，20%的参与者将被邀请在一次访问诊所预约中进行巴氏试验。这项研究将对大约400名选定参与者的家庭抽样试剂盒的测试结果与这种随机抽样的诊所结果进行比较。具体目标：1；实施和评估一种方法，以确定当地拉丁裔/西班牙裔社区中患有致癌型HPV感染的妇女。拟议的过程将包括向4,000名拉丁裔分发HPV家庭自我管理样本收集（HSASC）试剂盒。评估Promotoras对拉丁裔临床试验招募的影响。拉丁美洲健康通道（LHA）是一个组织，它雇用Promotoras作为本研究感兴趣的医疗服务不足的西班牙裔社区的非专业社区卫生工作者，它将提供三名Promotoras用于招募3200名同意接受HSASC试剂盒的拉丁裔人。一个以媒体为基础的广告活动将通过邮寄的方式分发800个工具包给那些打电话、有资格并希望获得家庭HPV抽样工具包的人。3. 评估HSASC项目和HPV检测作为SVP项目辅助的成本效益。我们计划使用成本效益分析来衡量项目美元净成本或成本节约与项目有效性的比率，这些是非美元净项目结果。在这些具体目标中需要检验的假设是：使用HSASC试剂盒收集的样品的特异性和敏感性将类似于卫生保健提供者在诊所采集的样品的敏感性和特异性。2. 与目前的SVP试验相比，HPV自我抽样将导致更高比例的癌前宫颈发育不良妇女有资格接受SVP治疗。3. 在promotora分布的研究组中，HPV自样本收集试剂盒的回收率将高于媒体招募，邮件分布的研究组。4. 与邮寄分发相比，通过Promotoras分发HSASC工具包会更令人满意。5. 与在诊所由卫生保健提供者收集相比，在家自行收集HPV样本的满意度更高。目前有两种确定HPV DNA存在的方法，混合捕获2 （HC2）测定和聚合酶链反应（PCR）检测。只有HC2是fda批准的，并且该方法将用于本研究。HC2技术是一种核酸杂交检测技术，旨在利用信号放大和化学发光微孔板方法检测核酸目标。使用了18种病毒型基因组特异性RNA探针。其中，有13种是高危类型：16、18、31、33、35、39、45、51、52、56、58、59和68。建议在获得样品后两周内完成HC2分析（参考文献：Digene Corporation）。HPV检测：宫颈癌预防的新时代。医生手册。盖瑟斯堡，马里兰州，2002)。细胞学检查仍然是筛查和治疗决策的标准。HC2检测不用于治疗决策。所有接受HSASC试剂盒的拉丁裔人将被告知，宫颈癌筛查的标准护理是巴氏试验。所有人都被建议每年做一次巴氏涂片检查，无论他们是否归还HPV HCASC试剂盒或被选择继续研究。从那些（大约2000名）将试剂盒归还UCI进行检测的拉丁裔人中随机抽取样本，将被邀请进行一次子宫颈抹片检查和HPV临床检查预约。高级别鳞状上皮内瘤变（HSIL指定CIN 3级）或非典型腺细胞显著性受损（AGUS）的患者当天将免费接受转化区透热环切除治疗。如果可以接受，他们会接受妊娠试验，如果他们没有怀孕，他们会进行DLE并在2周和3个月后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，转而选择转诊到UCI诊所接受其他提供的标准治疗方案。

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.