High Risk HPV Testing and Self-sampling in Clinical Settings for Improving Access to Cervical Cancer Screening in Safety Net Health Systems

PRIMARY OBJECTIVES:

I. Evaluate the effectiveness of primary HPV testing and self-collection to increase participation in cervical cancer screening among underscreened health system patients.

II. Evaluate implementation outcomes of the program across health systems and clinics and explore mechanisms underlying outcomes, guided by the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (reach, effectiveness, adoption, implementation, maintenance).

SECONDARY OBJECTIVES:

I. Compare the proportion of clinical encounters used for opportunistic cervical cancer screening across clinics.

II. Evaluate proportion of patients receiving clinical follow-up after a positive HR-HPV test.

III. Describe the prevalence of cervical cancer and pre-cancer among patients who self-collected and tested positive for HR-HPV.

IV. Compare the effectiveness of clinic-based primary HPV testing with self-collection with and without preceding telephone-based patient education by a patient navigator.

OUTLINE:

FORMATIVE RESEARCH: Participants participate in focus group discussions and/or interviews to provide feedback on barriers and facilitators of implementing self-sampling and primary HR-HPV testing and to support the production and adaptation of intervention materials and procedures.

STEPPED WEDGE TRIAL: Clinics are cluster randomized to 1 of 10 allocation sequences.

SEQUENCE 1: Clinic providers and staff provide, and patients receive, usual care during months 1-2 (time 1 [T1]). Clinics transition to the intervention condition during months 3-4 (time 2 [T2]) and then receive the intervention beginning in month 5 and continuing through month 24. During the intervention period (time 3 [T3] through time 12 [T12]), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T3 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 2: Clinic providers and staff provide, and patients receive, usual care during months 1-4 (T1 and T2). Clinics transition to the intervention condition during months 5-6 (T3) and then receive the intervention beginning in month 7 and continuing through month 24. During the intervention period (time 4 [T4] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T4 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 3: Clinic providers and staff provide, and patients receive, usual care during months 1-6 (T1 through T3). Clinics transition to the intervention condition during months 7-8 (T4) and then receive the intervention beginning in month 9 and continuing through month 24. During the intervention period (time 5 [T5] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T5 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 4: Clinic providers and staff provide, and patients receive, usual care during months 1-8 (T1 through T4). Clinics transition to the intervention condition during months 9-10 (T5) and then receive the intervention beginning in month 11 and continuing through month 24. During the intervention period (time 6 [T6] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T6 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 5: Clinic providers and staff provide, and patients receive, usual care during months 1-10 (T1 through T5). Clinics transition to the intervention condition during months 11-12 (T6) and then receive the intervention beginning in month 13 and continuing through month 24. During the intervention period (time 7 [T7] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T7 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 6: Clinic providers and staff provide, and patients receive, usual care during months 1-12 (T1 through T6). Clinics transition to the intervention condition during months 13-14 (T7) and then receive the intervention beginning in month 15 and continuing through month 24. During the intervention period (time 8 [T8] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T8 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 7: Clinic providers and staff provide, and patients receive, usual care during months 1-14 (T1 through T7). Clinics transition to the intervention condition during months 15-16 (T8) and then receive the intervention beginning in month 17 and continuing through month 24. During the intervention period (time 9 [T9] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T9 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 8: Clinic providers and staff provide, and patients receive, usual care during months 1-16 (T1 through T8). Clinics transition to the intervention condition during months 17-18 (T9) and then receive the intervention beginning in month 19 and continuing through month 24. During the intervention period (time 10 [T10] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T10 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 9: Clinic providers and staff provide, and patients receive, usual care during months 1-18 (T1 through T9). Clinics transition to the intervention condition during months 19-20 (T10) and then receive the intervention beginning in month 21 and continuing through month 24. During the intervention period (time 11 [T11] through T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T11 through T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.

SEQUENCE 10: Clinic providers and staff provide, and patients receive, usual care during months 1-20 (T1 through T10). Clinics transition to the intervention condition during months 21-22 (T11) and then receive the intervention beginning in month 23 and continuing through month 24. During the intervention period (T12), clinic providers and staff receive education and training on the transition of HR-HPV testing for cervical cancer screening, how to utilize primary HR-HPV testing with self-sampling, and how to communicate with patients about HR-HPV testing and results. During the intervention period (T12), patients are offered cervical cancer screening by self-collection of a vaginal swab and HR-HPV testing. Patients with positive test results receive patient navigation services to ensure diagnostic follow-up and treatment as needed.