Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women

HPV自采集对高危女性宫颈癌筛查的影响

基本信息

批准号：
9267943
负责人：
JENNIFER SUSAN SMITH
金额：
$ 60.27万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-04-09 至 2020-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9267943
关键词：
Advisory Committees Age Appointment Appointments and Schedules Belief Budgets Cancer Burden Cervical Cervical Cancer Screening Cessation of life Clinic Collection Communities Data Sources Detection Disease Early Diagnosis Early treatment Economics Education Effectiveness Eligibility Determination Europe Evidence based intervention Future Guidelines Healthcare Systems High Risk Woman Home environment Human Papillomavirus Human papilloma virus infection Intervention Lesion Low income Malignant neoplasm of cervix uteri Measures Mediator of activation protein Methods Modernization North Carolina Oncogenic Pap smear Participant Patient Self-Report Phonation Physicians Premalignant Preventive service Public Health Questionnaires Randomized Randomized Controlled Trials Recruitment Activity Registries Reporting Risk Risk Factors Role Sampling Schedule Screening for cancer Sensitivity and Specificity Services Telephone Testing Woman Women&apos s Group arm cervicovaginal clinical practice cost cost effectiveness effective intervention high risk improved intervention effect mortality novel strategies outreach post intervention psychologic public health relevance screening uptake

项目摘要

DESCRIPTION (provided by applicant): This study will investigate whether cervical cancer screening among under-screened women could be improved with testing for human papillomavirus (HPV) using at-home self-collection kits delivered by mail. Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions. This 2-arm randomized control trial of 870 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received an enhanced reminder by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study- affiliated clinic, if needed. Those randomized to the intervention arm will be mailed kits to self-collect cervicovaginal samples, return the samples for oncogenic HPV testing, and receive their results during the enhanced reminder call. HPV negative women will be considered screening complete and not receive scheduling assistance for in-clinic screening. Screening completion will be defined as in-clinic screening or a negative HPV self-collection result. Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders. Activities: We will recruit 870 under-screened, low-income women ages 30-64; randomize them to intervention (self-collection plus enhanced reminders) or control (enhanced reminders alone); and compare cervical cancer screening completion between the arms. Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect. Activities: We will compare in-clinic screening completion between women who receive HPV-positive self-collection results, those who do not return a kit, and the control arm. We will assess perceived risk of cervical cancer pre- and post-intervention in all women, and examine psychological mediators of completing in-clinic screening. Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self- collection to enhanced reminders. Activities: We will measure economic inputs for each arm and calculate the incremental cost of at-home HPV self-collection per additional woman completing screening. If at-home HPV self-collection increases screening among under-screened women, it has potential to influence future outreach and clinical practice. Increasing early detection and treatment of high-grade precancerous cervical lesions will have a major public health impact by reducing suffering and death from ICC nationwide.

描述（由适用提供）：本研究将调查使用邮件提供的家庭自我收集套件测试人类乳头瘤病毒（HPV），是否可以改善筛查不足妇女之间的宫颈癌筛查。可以通过定期筛查和治疗来预防侵入性宫颈癌（ICC），但美国五分之一的妇女报告未按建议的时间进行PAP测试。这些幕后妇女中有超过一半的ICC病例发生。对于30岁及30岁以上的女性，美国预防服务工作组建议每3年单独使用PAP涂片，或者每5年通过PAP涂片（共同测试）进行身体收集的HPV测试。 HPV测试的自集合是一种有效且良好的方法，用于检测HPV感染，具有可比的敏感性和特异性，可用于检测高级宫颈病变。这项由870名妇女进行的2臂随机对照试验将调查是否通过邮寄的家庭自我收集来提供HPV测试，以增加屏幕不足的妇女，这会增加完成宫颈癌筛查的可能性。所有参与者都将通过电话获得增强的提醒：提供（i）宫颈癌教育的电话，（ii）协助安排在研究附属诊所免费筛查的预约（如果需要）。那些随机分配给干预臂的人将被邮寄到自收宫颈阴道样品中，返回样品进行致癌HPV测试，并在增强的提醒呼叫中获得结果。 HPV负面女性将被视为筛查完整，并且不会获得临界筛查的日程安排辅助。筛选完成将定义为临界筛查或负HPV自我收集结果。 AIM 1。确定在屏幕不足的妇女中是否会增加宫颈癌筛查的完整性，提供了增强的提醒。活动：我们将招募870个屏幕少，低收入妇女30-64岁；将它们随机进行干预（自我收集加增强的提醒）或控制（仅增强的提醒）；并比较手臂之间的宫颈癌筛查完成。目标2。检查解释干预作用或缺乏效果的可能机制。活动：我们将比较接受HPV阳性自我收集结果，不返回套件的女性和控制部门的妇女之间的临界筛查完成。我们将评估所有女性干预前和干预后的宫颈癌风险，并检查完成临床筛查的心理介体。目标3。估计每增加女性的增量成本，完成筛选，将在增强的提醒中添加在家中的HPV自我收集。活动：我们将衡量每个手臂的经济投入，并计算每次完成筛查的女性HPV自我收集的增量成本。如果HPV自我收集会增加筛选不足的妇女的筛查，则它有可能影响未来的外展和临床实践。通过减少全国ICC的痛苦和死亡，增加对高级癌前颈病变的早期发现和治疗将对公共卫生产生重大影响。