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: 8887417
• 负责人: JENNIFER SUSAN SMITH
• 金额: $ 62.4万
• 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/8887417
• 关键词: Advisory Committees; Age; Appointments and Schedules; Belief; Budgets; Cervical; Cervical Cancer Screening; Cessation of life; Clinic; Collection; Communities; Data Sources; Detection; Disease; Early Diagnosis; Early treatment; Economics; Education; Effectiveness; 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; North Carolina; Oncogenic; Pap smear; Participant; Patient Self-Report; Physicians; Premalignant; Preventive; Public Health; Questionnaires; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Risk; Risk Factors; Role; Sampling; Schedule; Screening for cancer; Sensitivity and Specificity; Services; Telephone; Testing; Woman; Women' s Group; arm; base; 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（由申请人提供）：本研究将调查使用邮寄的家庭自采集试剂盒进行人乳头瘤病毒（HPV）检测是否可以改善筛查不足女性的宫颈癌筛查。浸润性宫颈癌（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没有在推荐的时间间隔内接受巴氏试验。超过一半的ICC案件发生在这些筛选不足的妇女中。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查，或者每5年进行一次医生收集的HPV检测和巴氏涂片检查（联合检测）。自我采集HPV检测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高级别宫颈病变的方法相当。 这项包含870名女性的2组随机对照试验将调查通过邮寄在家自我采集HPV检测是否会增加筛查不足的女性完成宫颈癌筛查的可能性。所有受试者将通过电话收到增强提醒：电话提供（i）宫颈癌教育，以及（ii）协助安排在研究附属诊所进行免费筛查的预约（如需要）。那些随机分配到干预组的人将被邮寄试剂盒，以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结果。HPV阴性女性将被视为已完成筛查，不接受门诊筛查的时间安排帮助。筛选完成将定义为门诊筛选或HPV自我采集结果阴性。目标1.确定在家中进行HPV自我采集是否会增加筛查不足的妇女完成宫颈癌筛查的人数，并提供增强的提醒。活动内容：我们将招募870名年龄在30-64岁之间的低收入女性，将她们随机分为干预组（自我收集加增强提醒）或对照组（仅增强提醒），并比较两组之间的宫颈癌筛查完成情况。目标二。检查解释干预效果或缺乏效果的可能机制。活动内容：我们将比较接受HPV阳性自我采集结果的妇女、不返回试剂盒的妇女和对照组妇女的门诊筛查完成情况。我们将评估所有妇女干预前后的宫颈癌感知风险，并检查完成门诊筛查的心理介导因素。目标3.估计每增加一名妇女完成筛查增加家庭HPV自我收集到增强提醒的增量成本。活动内容：我们将测量每组的经济投入，并计算每增加一名完成筛查的妇女在家进行HPV自我采集的增量成本。 如果在家中进行HPV自我采集可以增加筛查不足的妇女的筛查，那么它有可能影响未来的推广和临床实践。增加对高度癌前宫颈病变的早期发现和治疗，将通过减少全国ICC的痛苦和死亡，对公共卫生产生重大影响。