NCI Cervical Cancer ‘Last Mile’ Initiative

Background

Following substantial reductions in cervical cancer incidence rates in the United States in the last half of 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. Over half of the new cervical cancer cases in the US are among women who have been never screened or who are infrequently screened, reflecting barriers presented by socioeconomic disparities, geographic inaccessibility, among other factors. An alternative screening approach that has been widely evaluated 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 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.

BSA Presentation

Presentation to the NCI Board of Scientific Advisors (PDF, 1.13 MB)
By Vikrant Sahasrabuddhe, M.B.B.S., Dr.P.H.
Please note this PDF may not have the most updated information about the 'Last Mile Initiative'.

‘Last Mile’ Initiative

The National Cancer Institute (NCI) Division of Cancer Prevention (DCP) has developed the ‘Last Mile’ Initiative (LMI) 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. As part of this initiative, the NCI will support a nationwide, multicentric screening trial, the “Last Mile Initiative Self-sampling for HPV testing to Improve Cervical Cancer Prevention” Trial (‘LMI-SHIP Trial’) in diverse delivery settings.

This study will be supported by a Research and Development (R&D) contract.

LMI-SHIP Trial

The LMI-SHIP Trial will enroll approximately 9,000 women in the screening age range approved for standalone HPV testing (25-64 years) with a balanced representation of three groups:

  • Approximately 3000 women who are referred for abnormal cytology or positive HPV test results to colposcopy clinics, or the ‘Colposcopy Population’ (Accrual Group A: Colposcopy Population)
  • Approximately 3000 women who are under-screened (i.e., not been screened within the 4 years of the last cytology, or within 6 years of the last co-test or primary HPV test). Women in this ‘Intended-Use Population’ will be identified through diverse efforts for community outreach to attend a clinical visit to participate in the study (Accrual Group B: Intended-Use Population)
  • Approximately 3000 women undergoing routine screening per current recommendations, i.e., these will be the ‘Average-Risk Population’ who will be recruited during their routine screening visit (Accrual Group C: Average-Risk Population)

Enrolled participants will provide informed consent and undergo a provider-collected cervical sampling at the initial visit. HPV self-sampling kits will be handed (or mailed) to participants immediately after their clinic visits. Clear written instructions for self-sampling will be provided and participants will be instructed on how and where to return the self-collected specimen and in what time frame. Aliquots of self-collected samples and provider-collected samples will be sent for HPV testing to evaluate (in a masked fashion) paired results of self vs. provider-collected specimens for HPV testing assays. The HPV result on the provider-collected sample will be considered the reference standard (predicate test) for comparison with the HPV result on the self-sample. The provider-collected specimen will also inform clinical management, and women will be managed as per local clinical guidelines. The LMI-SHIP Trial will coalesce long standing efforts to formally lay out a pathway for regulatory approval for self-sampling approaches for HPV testing. Over the long-term, this initiative will have provided key evidence to change clinical care guidelines and public health practice via a new standard-of-care approach. This initiative will provide impetus for expanding screening coverage to never screened or under screened women in the United States in whom over half of the incident cervical cancers are detected every year. This may also provide a convenient and speculum-exam-free screening approach for all women and thereby strengthen adherence to current screening guidelines and likely reduce excess health care costs.

For more information, please contact Vikrant Sahasrabuddhe, M.B.B.S., Dr.P.H. in the NCI Division of Cancer Prevention.