Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
BMC Cancer. 2014 Mar 19;14:207. doi: 10.1186/1471-2407-14-207.
Organized screening based on Pap tests has substantially reduced deaths from cervical cancer in many countries, including Australia. However, the impact of the program depends upon the degree to which women participate. A new method of screening, testing for human papillomavirus (HPV) DNA to detect the virus that causes cervical cancer, has recently become available. Because women can collect their own samples for this test at home, it has the potential to overcome some of the barriers to Pap tests. The iPap trial will evaluate whether mailing an HPV self-sampling kit increases participation by never- and under-screened women within a cervical screening program.
METHODS/DESIGN: The iPap trial is a parallel randomized controlled, open label, trial. Participants will be Victorian women age 30-69 years, for whom there is either no record on the Victorian Cervical Cytology Registry (VCCR) of a Pap test (never-screened) or the last recorded Pap test was between five to fifteen years ago (under-screened). Enrolment information from the Victorian Electoral Commission will be linked to the VCCR to determine the never-screened women. Variables that will be used for record linkage include full name, address and date of birth. Never- and under-screened women will be randomly allocated to either receive an invitation letter with an HPV self-sampling kit or a reminder letter to attend for a Pap test, which is standard practice for women overdue for a test in Victoria. All resources have been focus group tested. The primary outcome will be the proportion of women who participate, by returning an HPV self-sampling kit for women in the self-sampling arm, and notification of a Pap test result to the Registry for women in the Pap test arm at 3 and 6 months after mailout. The most important secondary outcome is the proportion of test-positive women who undergo further investigations at 6 and 12 months after mailout of results.
The iPap trial will provide strong evidence about whether HPV self-sampling could be used in Australia to improve participation in cervical screening for never-and under-screened women.
ANZCTR Identifier: ACTRN12613001104741; UTN: U1111-1148-3885.
在许多国家，包括澳大利亚，基于巴氏涂片的有组织筛查大大降低了宫颈癌的死亡率。然而，该项目的影响取决于女性参与的程度。一种新的筛查方法，检测人乳头瘤病毒（HPV）DNA 以检测导致宫颈癌的病毒，最近已经问世。由于女性可以在家中自行采集样本进行此项检测，因此它有可能克服巴氏涂片检测的一些障碍。iPap 试验将评估通过邮寄 HPV 自我采样试剂盒，是否会增加宫颈筛查项目中从未接受过或未定期接受筛查的女性的参与率。
方法/设计：iPap 试验是一项平行随机对照、开放性标签试验。参与者将是维多利亚州年龄在 30-69 岁的女性，她们要么在维多利亚州宫颈癌细胞学登记处（VCCR）没有巴氏涂片检查（从未筛查过）的记录，要么最后一次记录的巴氏涂片检查是在 5 至 15 年前（未定期筛查）。维多利亚州选举委员会的登记信息将与 VCCR 相关联，以确定从未筛查过的女性。用于记录链接的变量将包括全名、地址和出生日期。从未筛查过和未定期筛查过的女性将被随机分配到接受 HPV 自我采样试剂盒邀请信或巴氏涂片检查提醒信的组中，这是维多利亚州妇女逾期未接受检查的标准做法。所有资源都经过了焦点小组测试。主要结局是通过邮寄后 3 个月和 6 个月，返回 HPV 自我采样试剂盒的女性的参与比例，以及向登记处报告巴氏涂片检查结果的女性的比例。最重要的次要结局是在结果邮寄后 6 个月和 12 个月，HPV 检测阳性的女性进一步检查的比例。
iPap 试验将提供强有力的证据，证明 HPV 自我采样是否可在澳大利亚用于提高从未筛查和未定期筛查女性的宫颈癌筛查参与率。
ANZCTR 标识符：ACTRN12613001104741；UTN：U1111-1148-3885。
