Cervical cancer, caused by human papillomavirus (HPV), is highly preventable by HPV vaccination and by early detection and treatment of cervical precancerous changes. Yet, over half of all cervical cancer cases diagnosed in the United States occur in individuals who have never been screened or who are infrequently screened. The barriers that keep people from being screened by a clinician via a cervical sample collection include socioeconomic disparities, geographic inaccessibility, cultural issues, personal preferences, physical disabilities, and a variety of other factors. This initiative focuses on ways to reach unscreened and under-screened people in an effort to reach this ‘Last Mile’ of the goal of ensuring everyone who needs cervical cancer screening can access it.
An alternative approach to cervical sample collection via a pelvic exam done by a clinician in a medical office is self-collection of vaginal samples that can be done at home and sent to the laboratory for HPV testing. This method of self-sampling has significant potential to address a persistent cancer health disparity by expanding cervical cancer screening access to reach individuals who are never screened or are under-screened. While the self-collection method has been implemented in other countries, the Food and Drug Administration (FDA) has provisionally approved two self-collection devices for use in the United States with additional evaluation of the devices to occur in Last Mile studies.
- The GOAL is to overcome the barrier of lack of FDA approval for self-collection approaches for HPV testing-based cervical cancer screening.
- The APPROACH is to engage public and private sector stakeholders, including the FDA, HPV assay manufacturers, and self-collection device manufacturers to find pathways to get approvals for self-collection approaches.
- The OUTCOME of this work would be better access to cervical cancer screening and a reduction in the incidence of cervical cancer.
On This Page
- Key Activities of the Last Mile Initiative
- About the Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial
- Program Contact Information
Key Activities of the Last Mile Initiative
The National Cancer Institute (NCI) Cervical Cancer ‘Last Mile’ Initiative is a public-private partnership bringing together federal agencies, industry partners, and professional societies to contribute evidence about the accuracy and clinical effectiveness of self-collection-based HPV testing for cervical cancer screening. Among its key activities, the ‘Last Mile’ Initiative is focused on the following:
NCI Cervical Cancer 'Last Mile' Initiative SHIP Trial Network
- Facilitating discussions for regulatory approvals of self-collection: The partnership efforts have led to publication of meta-analyses that have pooled currently published evidence on self-collection to inform regulatory agencies about possible paths to approval of new devices. Last Mile partners have been engaged in discussions to define approval pathways for self-collection approaches for primary HPV testing.
- Supporting a U.S.-based study of HPV self-collection, the Self-collection for HPV testing to Improve Cervical Cancer Prevention (SHIP) Trial. This will be a nationwide multicenter clinical trial and associated studies, with independent evaluation of multiple self-collection devices and HPV assays for usability, acceptability, accuracy, and effectiveness. In January 2024, the NCI announced the SHIP Trial network of 25 clinical sites across the US, with participant enrollment expected to begin in Summer 2024
- Disseminating evidence on self-collection to change and inform clinical practice. NCI has built partnerships with professional societies to assist them with updating practice guidelines incorporating self-collection-based screening approaches. NCI is also working to create a publicly available repository of resources on self-collection for use in public health education.
About the Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial
The SHIP Trial will provide an independent platform to evaluate the usability, acceptability, and accuracy of multiple self-collection device-assay combinations for the detection of cancer-causing types of HPV.
Currently some companies with FDA-approved HPV testing assays have developed self-collection devices that are either conditionally approved or under review by the FDA. The first stage of FDA approval allows the self-collection device to be used in a clinical setting by a person when a clinician is present but unable to collect the sample.
Self-collection for HPV testing to Improve Cervical Cancer Prevention (SHIP) Trial
Industry partners involved in the SHIP Trial have agreed to provide their self-collection kits and assays to be used in the study, to undertake blinded testing of their samples, and have data be unblinded and analyzed by the NCI and be reported back to the FDA simultaneously to fulfill regulatory requirements. These data will inform further FDA review of self-collection devices regarding usability, acceptability, accuracy, and effectiveness of such tests before they are widely used in the United States. As of May 2024, three industry partners with current FDA approvals for clinician-collection for primary HPV testing-based cervical cancer screening have been actively working on this project: Becton Dickinson and Company (BD), Frankin Lakes, NJ; Roche Molecular Systems, Basel, Switzerland; and Abbott, Abbott Park, Ill.
Overall coordination for the ‘Last Mile’ Initiative SHIP Trial Network is being supported by Leidos Biomedical Research, Inc., which operates NCI’s Frederick National Laboratory for Cancer Research (FNLCR), a Federally-Funded Research and Development Center.
The SHIP Trial will involve clinical sites across the United States representing a diverse spectrum of healthcare delivery settings. The trial is slated to open in 2024.
The ‘Last Mile’ Initiative SHIP Trial Network was announced at a White House Cervical Cancer Forum by NCI Director Dr. Kimryn Rathmell on January 25, 2024.
Program Contact Information
Email: CervicalCancerLastMile@nih.gov
Phone: 240-276-7332
Fax: 240-276-7828
Program Director
Vikrant Sahasrabuddhe, M.B.B.S., Dr.P.H.
Email: vikrant.sahasrabuddhe@nih.gov