This randomized clinical trial studies how well a human papillomavirus self-collection kit works in screening high risk women for cervical cancer. At-home self collection kits may help get women screened for cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02651883.
PRIMARY OBJECTIVES:
I. Determine whether at-home human papillomavirus (HPV) self-collection increases the completion of cervical cancer screening among under-screened women receiving enhanced reminders.
II. Examine possible mechanisms explaining the intervention’s effect, or lack of an effect.
III. Estimate the incremental cost per additional woman completing screening of adding at-home
HPV self-collection to enhanced reminders.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive an enhanced reminder call with education on cervical cancer and an offer to schedule a free Papanicolaou (Pap) smear clinic appointment.
ARM B: Patients receive an enhanced reminder call with education on cervical cancer and an HPV self-collection kit by mail to self-collect samples for the detection of HPV infection. Patients with HPV-positive self-collection results also receive an offer to schedule a free Pap smear clinic appointment.
After completion of study intervention, patients are followed for up to 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorJennifer S. Smith
