ESVCCSP

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 这项加州大学欧文分校（UCI）研究的总体目标是找出有多少拉丁人会使用和邮寄家庭样本试剂盒来检测自己的病毒，有时可能导致宫颈癌，并研究该过程的成本效益。 为此，研究者将比较如果由拉丁裔Health Access promotora（拉丁裔社区卫生工作者）提供或由于西班牙裔报纸或电视广告，并通过电话请求感兴趣的拉丁裔家庭采样套件，则邮寄返回的套件数量。 UCI的研究预计将接触大约4,000名合格的拉丁裔参与者。 预计家庭采样工具包的回报率为30-50%。 从这2000名受试者中，将邀请20%的受试者样本在单次访视诊所预约中进行巴氏试验。 该研究将比较家庭采样工具包的测试结果与约400名选定参与者的临床结果随机样本。 具体目标： 1. 实施和评估一个过程，以确定妇女在当地拉丁美洲/西班牙裔社区谁有致癌型HPV感染。 拟议的程序将涉及向4，000名拉丁美洲人分发HPV家庭自我管理样本采集（HSASC）试剂盒。 2. 评价Promotoras对临床试验中拉丁裔招募的影响。 Latino Health Access（LHA）是一家雇用Promotoras作为本研究关注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的组织，将提供三个Promotoras，用于招募3，200名同意接受HSASC试剂盒的拉丁裔。 一个基于媒体的广告活动将被用来分发800包邮寄给那些谁打电话，有资格，并希望收到一个家庭采样HPV试剂盒。 3. 评估HSASC计划和HPV检测作为SVP计划的辅助措施的成本效益。 我们计划使用成本效益分析来衡量计划的美元净成本或成本节约与计划效益的比率，这是非美元净计划成果。 在这些具体目标范围内有待检验的假设是： 1. 使用HSASC试剂盒采集的样本的特异性和灵敏度将与医疗保健提供者在诊所采集的样本的灵敏度和特异性相似。 2. 与目前SVP试验中的比率相比，HPV自我采样将导致更高比例的癌前宫颈发育不良妇女有资格接受SVP治疗。 3. 本研究的Promotora分发组的HPV自我样本采集试剂盒返还率高于媒介招募、邮寄分发组。 4. 与邮寄相比，由Promotoras分发HSASC套件的满意度更高。 5. 与诊所的卫生保健提供者收集相比，在家中进行HPV自我样本收集的满意度更高。 目前有两种确定HPV DNA存在的方法，杂交捕获2（HC 2）检测和聚合酶链反应（PCR）检测。 只有HC 2是FDA批准的，并且是本研究将使用的方法。 HC 2技术是一种核酸杂交测定法，旨在使用信号放大和荧光微板方法检测核酸靶标。 使用对18种病毒类型基因组具有特异性的RNA探针。 其中，13种是高风险类型：16，18，31，33，35，39，45，51，52，56，58，59和68。 建议在获得样品后两周内完成HC 2分析（参考：Digene Corporation. HPV检测：宫颈癌预防的新时代。 医生手册。 盖瑟斯堡，医学博士，2002年）。 细胞学仍然是筛查和治疗决策的标准护理。 HC 2检测将不用于做出治疗决策。 所有接受HSASC试剂盒的拉丁美洲人将被告知，宫颈癌筛查的护理标准是巴氏试验。 无论是否归还HPV HCASC试剂盒或被选中继续参与研究，都将建议所有人每年进行一次巴氏检查。 随机抽样的那些（大约2,000名拉丁人谁返回试剂盒测试在UCI将被邀请到一个单一的访问巴氏涂片和HPV诊所测试预约。 对于患有高度鳞状上皮内瘤变（HSIL指定为CIN 3级）或显著性受损的非典型腺细胞（AGUS）的受试者，将在当天免费为受试者提供转化区的透热环切除治疗。 如果可以接受，则对她们进行妊娠试验，如果她们没有怀孕，则进行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，而是选择转诊到UCI诊所接受其他标准治疗。

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.