Purpose and Rationale

NCI Cervical Cancer ‘Last Mile’ Initiative

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-collection 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.
'Last Mile' Initiative Overview