Patient Navigation for the Adherence to Cervical Cancer Screening in Undeserved Women, Project CONTINUITY Trial

PRIMARY OBJECTIVE:

I. Examine adherence to the cancer screening continuum steps from screening to colposcopy for women who choose self-testing compared to women who choose Pap/human papillomavirus (HPV) testing for each step in the continuum for which the women are eligible.

SECONDARY OBECTIVE:

I. Characterize the health and sociodemographic characteristics of women who choose HPV self-testing, Pap/HPV testing or none.

EXPLORATORY OBJECTIVE:

I. Estimate the number and percentage of women who move on to the next cancer screening step for designing the subsequent larger study.

OUTLINE:

ARM I (C-LEAR TRAINING): Clinicians, navigators, and study staff attend an HPV informational training session, view a video and live demonstration, and participate in focus group role play scenarios to reinforce messaging related to the importance of screening and obtaining recommended follow-up care on study. Clinicians, navigators, and study staff recommend patients to get a pap test and link them to an appointment scheduler to schedule the test, and also send out patient reminders for keeping scheduled appointments.

RECRUITMENT: Patients participate in an educational session with clinicians and navigators and receive educational materials about HPV testing on study. Patients are assigned to 1 of 2 arms. Patients who choose to have HPV self-testing are assigned to Arm II. Patients who choose to have a pap test in clinic are assigned to Arm III.

ARM II (Self-test): Patients receive a follow up text message, telephone call, or email by a clinician or navigator to remind them to complete self-test. Patients undergo self-testing and receive a call or text reminder when test results are available. Patients who test positive schedule a pap test to confirm positive results and receive reminders of upcoming appointment. Patients who test positive schedule a colposcopy and receive a follow up reminder to attend appointment.

ARM III (In-clinic): Patients receive assistance by the clinical navigator to make a screening appointment for an in-clinic pap test. Patients receive a follow up text message, telephone call, or email by a clinical navigator to remind them of their upcoming appointment. Patients undergo pap tests in a clinic and receive a call or text reminder when test results are available. Patients who test positive schedule a colposcopy and receive a follow up reminder to attend appointment.