Enhanced Single-Visit Cervical Cancer Screening Program

描述(由研究人员提供)：作为当前一次访问宫颈癌预防计划申请的一部分，一种创新的方法正在拉丁裔/西班牙裔社区进行，以筛查妇女宫颈癌并在一次访问计划(SVP)中为严重的宫颈发育不良提供早期治疗(7/1/98-6/30/03)。这一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，以确定当地拉丁裔/拉美裔社区中患有致癌型人乳头瘤病毒(HPV)感染的妇女，并招募她们参加SVP。在种族/族裔群体中，宫颈癌的发病率存在健康差异，在发病率较高的群体中，拉美裔妇女(拉丁裔)的发病率较高。筛查拉丁裔人乳头瘤病毒致癌型感染的程序可能有助于确定宫颈癌风险最高的妇女。这一过程将涉及向4000名拉丁美洲人分发HPV Home自助样本采集(HSASC)试剂盒。招募将继续进行，直到至少1840份自我样本被送回，其中9.14%(N=168)的样本预计为HPV阳性。具有HPV阳性自我样本的拉丁裔将被邀请到两家提供SVP的诊所中的一家。此外，年龄和招募方法匹配的HPV阴性样本的妇女将被邀请参加(N=270)。敏感度和特异度分析将使用提供者在随后的临床访问中获得的样本作为参考。进入SVP的重度宫颈发育不良妇女的比例估计增加了约60%。第二个目的是评估临床试验中推动者对拉丁裔招募的影响。将使用两种招聘和HSASC工具包分发方法：通过邮件分发的基于媒体的广告宣传活动和Promota分发。推广员将招募3,200名拉丁裔人接受HSASC试剂盒，估计自我样本退回率为50%(1,600个自我样本)。基于媒体的广告活动将用于招募另外800名拉丁裔，他们将收到邮寄的HSASC工具包。第三个目标是评估HSASC计划和HPV检测作为SVP计划的辅助项目的成本效益。成本效益分析将被用来衡量计划美元净成本或成本节省与计划有效性的比率，即非美元净计划结果。将计量与质量调整寿命年(QALY)方面的成果的增量改善相关的增量净成本。

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.