COORDINATING CENTER FOR THE NCI CERVICAL CANCER LAST MILE INITIATIVE SELF-SAMPLING FOR HPV TESTING TO IMPROVE CERVICAL CANCER PREVENTI

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the twentieth century, rates have plateaued for the past two decades. Despite the availability of highly sensitive screening methods such as human papillomavirus (HPV) testing, over 13,000 women continue to be diagnosed with and over 4,000 women continue to die of cervical cancer annually in the US. Over half of all new cervical cancer cases are among women who have either never been screened or who have been infrequently screened, reflecting substantial socio-economic disparities and barriers due to geographic inaccessibility. An alternative screening approach under evaluation to overcome these barriers is self-collection of samples (‘self-sampling’) by women themselves and sending the sample for HPV testing. This approach offers several benefits including ease of collection at a time/place of women’s choice without a need for a clinic appointment or a speculum examination. This intervention has significant potential to expand cervical cancer screening to never screened or under-screened women and address a pressing public health concern of lack of access to screening as a health disparity. The National Cancer Institute (NCI) has developed the Cervical Cancer ‘Last Mile’ Initiative as a public private partnership between several stakeholders (including federal agencies, industry partners, and professional societies/clinical practice guidelines organizations) to validate self-sampling-based HPV testing as a comparable (non-inferior) alternative to provider-collected cervical specimen for HPV testing in cervical cancer screening, and facilitate regulatory approvals and broader adoption of this approach in real world practice settings. Towards this goal, the NCI will support a nationwide, multicentric screening trial, the Self-sampling for HPV testing to Improve Cervical Cancer Prevention (SHIP)” Trial (‘SHIP Trial’) in diverse delivery settings. Pending discussions with the US Food and Drug Administration (FDA) and the industry partners, the SHIP Trial may be designed as a pre-approval trial or a post-approval trial, dependent on the approved regulatory pathways. This document assumes a study design of a post-approval trial