Enhanced Single-Visit Cervical Cancer Screening Program

强化单次宫颈癌筛查计划

• 批准号: 7078540
• 负责人: ALBERTO MANETTA
• 金额: $ 51.77万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7078540
• 关键词: Hispanic Americans; behavioral /social science research tag; cancer prevention; cervix neoplasms; clinical research; culture; cytology; female; health behavior; health care service utilization; health disparity; health services research tag; human papillomavirus; human subject; mass information media; mass screening; neoplasm /cancer diagnosis; outcomes research; patient oriented research; preneoplastic state; self examination; women' s health

DESCRIPTION (provided by investigator): An innovative approach to screen women for cervix cancer and provide early treatment for severe cervix dysplasia in a single-visit program (SVP) is ongoing in a Latino/Hispanic community as part of the current Single-Visit Cervical Cancer Prevention Program application (7/1/98-6/30/03). This continuation application is designed to further increase the effectiveness of the single-visit program (SVP). The first aim is to implement and evaluate a process to identify women in local Latino/Hispanic communities who have oncogenic type human Papilloma virus (HPV) infections, known precursors for cervix dysplasia and cervical cancer, and recruit them for the SVP. Health disparities exist in the incidence of cervical cancer among racial/ethnic groups with Hispanic women (Latinas) among the groups experiencing higher rates. Screening procedures to identify Latinas with oncogenic type HPV infections may contribute to identification of women at most risk for cervix cancer. HPV self-sampling in the home, as proposed in this study, has not been tested. The process will involve the distribution of HPV Home Self-administered Sample Collection (HSASC) kits to 4000 Latinas. Recruitment will continue until a minimum of 1840 self-samples has been returned, of which 9.14% (N=168) are expected to be HPV-positive. Latinas with HPV-positive self-samples will be invited to come to one of two clinics offering the SVP. A 60% response rate (N=135) is expected. Additionally, twice as many women with HPV-negative samples matched by age and recruitment method will be invited to participate (N=270). Sensitivity and specificity analysis will be done using samples obtained by a provider during the subsequent clinic visit as the reference. Satisfaction with self-sampling compared to provider sampling will be evaluated. An increase of approximately 60% is estimated in the proportion of women with severe cervix dysplasia who enter the SVP. The second aim is to evaluate the impact of Promotoras on the recruitment of Latinas in the clinical trial. Two recruitment and HSASC kit distribution methods will be used: media-based ad campaign with mail distribution and Promotora distribution. Promotoras will recruit 3,200 Latinas to receive HSASC kits with an estimated self-sample return rate of 50% (1,600 self-samples). The media-based ad campaign will be used to recruit another 800 Latinas who will receive the HSASC kit in the mail. A 30% (N=240) self-sample return rate is expected. Comparisons of return rates and satisfaction with recruitment and distribution method will be tested. The third aim is to evaluate the cost-effectiveness of the HSASC program and HPV testing as an adjunct to the SVP program. Cost-effectiveness analysis will be used to measure the ratio of program dollar net costs or cost savings to program effectiveness, which are the non-dollar net program outcomes. The incremental net cost associated with an incremental improvement in outcomes in terms of quality-adjusted life years (QALYs) will be measured.

描述（由研究者提供）：作为当前单次访视宫颈癌预防计划申请（1998年7月1日至2003年6月30日）的一部分，一种在拉丁美洲/西班牙裔社区进行的单次访视计划（SVP）中筛查女性宫颈癌并为重度宫颈发育不良提供早期治疗的创新方法正在进行中。 此延续申请旨在进一步提高单次访问计划（SVP）的有效性。 第一个目标是实施和评估一项程序，以确定当地拉丁美洲/西班牙裔社区中患有致癌型人类乳头状瘤病毒（HPV）感染的妇女，这些妇女是宫颈发育不良和宫颈癌的已知前兆，并招募她们参加SVP。 不同种族/族裔群体的宫颈癌发病率存在健康差异，西班牙裔妇女（拉丁裔）的发病率较高。筛查程序，以确定致癌型HPV感染的拉丁美洲人可能有助于确定妇女在最危险的宫颈癌。本研究提出的在家中进行HPV自我采样尚未进行测试。该过程将涉及向4000名拉丁美洲人分发HPV家庭自我管理样本采集（HSASC）试剂盒。招募将持续至至少1840份自身样本返回，其中9.14%（N=168）预期为HPV阳性。HPV阳性的拉丁裔将被邀请到两个提供SVP的诊所之一。预期应答率为60%（N=135）。此外，将邀请两倍于年龄和招募方法匹配的HPV阴性样本的女性参加（N=270）。 将使用提供者在后续诊所访视期间获得的样本作为参考进行灵敏度和特异性分析。将评估自我抽样与提供者抽样相比的满意度。估计进入SVP的重度宫颈发育不良妇女的比例增加约60%。第二个目的是评价Promotoras对临床试验中拉丁裔招募的影响。将使用两种招募和HSASC工具包分发方法：基于媒体的广告活动，邮件分发和Promotora分发。Promotoras将招募3，200名拉丁裔接受HSASC试剂盒，估计自我样本返回率为50%（1，600份自我样本）。 基于媒体的广告活动将被用来招募另外800名拉丁裔谁将收到HSASC工具包的邮件。 预期自样本返回率为30%（N=240）。 将测试对招聘和分配方法的回报率和满意度的比较。 第三个目的是评估HSASC计划和HPV检测作为SVP计划的辅助措施的成本效益。 成本效益分析将用于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。 将衡量与按质量调整生命年（QHMs）计算的结果增量改善相关的增量净成本。