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

• 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
• 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' 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

 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(申请人提供)：这项研究将调查筛查不足的妇女的宫颈癌筛查是否可以通过使用邮寄的家庭自助收集试剂盒进行人乳头瘤病毒(HPV)检测来改善。侵袭性宫颈癌(ICC)是可以通过定期筛查和治疗来预防的，但五分之一的美国女性报告说，他们没有按推荐的间隔接受巴氏检测。超过一半的国际刑事法院案件发生在这些筛查不足的妇女身上。对于30岁及以上的女性，美国预防服务工作组建议每3年单独进行一次巴氏涂片检测，或者每5年进行一次医生收集的HPV检测和巴氏涂片(联合检测)。自我采集检测HPV是一种有效且被广泛接受的检测HPV感染的方法，其敏感性和特异性与医生采集检测宫颈高度病变的敏感性和特异性相当。这项对870名妇女进行的双臂随机对照试验将调查向筛查不足的妇女提供邮寄在家自我收集的HPV检测是否会增加她们完成宫颈癌筛查的可能性。所有参与者将通过电话收到增强的提醒：一个电话，提供(I)关于宫颈癌的教育，(Ii)如果需要，帮助安排在研究附属诊所进行免费筛查。那些被随机分配到干预组的人将被邮寄试剂盒，自行收集宫颈阴道样本，返回样本进行致癌HPV检测，并在增强的提醒电话中收到他们的结果。HPV阴性的妇女将被视为筛查完成，不会获得门诊筛查的日程安排协助。筛查完成将被定义为门诊筛查或HPV自我收集阴性结果。目的1.确定在家中自我收集HPV是否会增加筛查不足的妇女的宫颈癌筛查完成率，并提供更多的提醒。活动：我们将招募870名筛查不足的低收入女性，年龄在30-之间；将她们随机分为干预组(自我收集加上强化提醒)或对照组(仅强化提醒)；比较两组之间宫颈癌筛查的完成率。目的2.研究解释干预效果或效果缺失的可能机制。活动：我们将比较接受HPV阳性自我收集结果的妇女、没有退还试剂盒的妇女和对照组之间的门诊筛查完成情况。我们将评估所有女性在干预前和干预后的宫颈癌感知风险，并检查完成门诊筛查的心理中介。目的3.估计每名完成筛查的额外妇女在增强提醒中增加家庭HPV自我收集的成本。活动：我们将衡量每个手臂的经济投入，并计算每名完成筛查的额外妇女在家中自我收集HPV的增量成本。如果家庭HPV自我收集增加了筛查不足的妇女的筛查，它可能会影响未来的推广和临床实践。增加对高级别癌前病变的早期发现和治疗，将在全国范围内减少国际刑事法院的痛苦和死亡，从而对公共卫生产生重大影响。