This clinical trial studies the effect of mail-in HPV self-sampling kits and patient navigation on the participation rate in cervical cancer screenings among minority/underserved women compared to standard scripted phone calls. Information from this study may help researchers better understand how to increase participation in cervical cancer screening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03898167.
PRIMARY OBJECTIVE:
I. Compare the effectiveness of mailed self-sample human papillomavirus (HPV) testing alone and in combination with patient navigation to increase primary screening participation (primary outcome) and clinical follow-up (secondary outcome).
SECONDARY OBJECTIVES:
I. Describe characteristics of women who under-attend for cervical cancer screening in a safety net health system.
II. Explore patterns of detection and treatment of cervical pre-cancers across study arms.
III. Compare characteristics of screening participants across study arms.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive a scripted phone call from a patient navigator who gives them the contact information for the call center that can walk them through the steps of accessing telehealth. Patient navigators also inform participants that their records indicate that they are overdue for a Papanicolaou (Pap) test and that primary care, including well woman exams and Pap testing is still important during the COVID-19 pandemic.
ARM II: Participants receive a scripted phone call from a patient navigator as in Arm I and receive a HPV self-sampling kit in the mail. Participants in the nested study may participate in an interview or telephone survey.
ARM III: Participants receive a scripted phone call from a patient navigator as in Arm I and receive HPV self-sampling kit in the mail. Participants receive an additional phone call from a patient navigator 3-5 days later. Participants in the nested study may participate in an interview or telephone survey.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorMichael Scheurer
