141 st APHA Annual Meeting November 2013 Richard A. Crosby, PhD

1. Feasibility of screening medically underserved rural women for cervical cancer using self-collected vaginal swabs and patient navigation 141st APHA Annual MeetingNovember 2013 Richard A. Crosby, PhD University of Kentucky College of Public Health Department of Health Behavior

2. Presenter Disclosures Richard A. Crosby, PhD Dr. Crosby served as a paid consultant for Merck Pharmaceuticals in 2012. Dr. Crosby is also a co-investigator on an investigator-initiated research project awarded to the University of Kentucky (E. Cohen, PI; MISP# 50154, 2013-2015) by Merck Pharmaceuticals. (1) The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:

3. Funding Source This presentation was supported by Cooperative Agreement Number 1U48DP001932-01 from the Centers for Disease Control and Prevention (CDC). The findings and conclusions in this presentation are those of the author(s) and do not necessarily represent the official position of the CDC.

4. UK Rural Cancer Prevention Center The Rural Cancer Prevention Center (RCPC) is a planned collaboration of community members, public health professionals, and researchers designed to reduce the health disparities associated with cervical, breast, and colorectal cancer among residents of the Kentucky River Health District in Appalachian Kentucky.

5. Estimated Annual Burden of Cervical Abnormalities in the U.S. 4,030 estimated deaths1 12,340 new cases of invasive cervical cancer1 330,000 new cases of high- grade cervical dysplasia2 360,000 new cases of genital warts3 1.4 million new cases of low-grade cervical dysplasia2 1. American Cancer Society. Cancer Facts and Figures 2013. Atlanta, Ga: American Cancer Society. 2. Schiffman M et al. Arch Pathol Lab Med. 2003;127:946–949. 3. Centers for Disease Control and Prevention. Genital HPV Infection – Fact Sheet. Atlanta, Ga: Centers for Disease Control and Prevention.

7. Cervical Cancer Screening • Cervical cancer incidence and mortality rates have decreased 67% over the past 3 decades, with most of the reduction attributed Pap testing! • One of the most reliable and effective cancer screening tests available. • Between 60%-80% of women with advanced cervical cancer have not had a Pap test in the past 5 years.

8. Percent of women aged ≥18 receiving Pap test within the past three years Kentucky Cabinet for Health and Human Services (US). Kentucky Area Development District (ADD) Profiles: 2010 Behavioral Risk Factor Surveillance System (BRFSS) 2011. [Internet]. Frankfort (KY).

9. Perceived barriers to traditional Pap testing

10. Alternative Approach: Self-Collected Specimens for HPV Testing • A recent literature review revealed that self-collected cervico-vaginal samples for high-risk HPV testing are comparable to physician-collected samples in terms of accuracy in detecting cervical intraepithelial neoplasia grade 2 (CIN2) or higher • High rates of reported acceptance for self-administered cervico-vaginal specimen collection among various populations of women • 75-93% • Women living in low-resource settings both domestically and abroad • Urban areas

11. Study Purpose The purpose of this exploratory study was to determine whether Appalachian Kentucky women would be amenable to self-collecting a cervico-vaginal specimen for HPV testing. Secondary purpose: implement and track the results of a patient counseling and navigation intervention promoting guideline-recommended cervical cancer Pap smear screening among all women participating in the study. Vanderpool et al. Self-Collecting a Cervico-Vaginal Specimen for Cervical Cancer Screening: An Exploratory Study of Acceptability Among Medically Underserved Women in Rural Appalachia. Gynecologic Oncology, in press.

12. Methods • In November 2011, women were recruited over 6 separate days from a free primary care clinicin southeastern Kentucky. • Inclusion Criteria • Women aged 30-64 • Not currently pregnant • Not been screened for cervical cancer in the past 4 years • Never tested positive for HPV • Women completed brief, self-administered questionnaire

13. Methods (cont.) • Women given written/verbal instructions for using the Fisherbrand* Cervex-Brush* Cervical Cell Sampler • Results analyzed using the Digene Hybrid-Capture 2 HPV DNA Test which detects the presence of ≥1 of 13 types of high-risk HPV infection • Women were informed of results and referred for Pap screeningaccording to current screening guidelines. • Investigators offered patient navigation assistance, including facilitation of transportation and appointment support. • Follow-ups calls were made 2 months post-results notification • Determine if Pap test appointments had been scheduled • Ascertain if women had discussed test results with others

14. Results: Participant Characteristics (N=31)

15. Results (cont).

16. Results (cont). a 19.4% of women reported having at least one abnormal Pap smear result.

18. Results (cont.) • Of the 31 women, five (16%) tested positive for oncogenic HPV. • All 5 women reported history of Pap testing • Two reported history of an abnormal Pap • No indeterminate findings, suggesting all of the women used proper self-collection methods. • Higher rates of navigation among high-risk HPV positive women compared to those testing negative.

19. Conclusion • This novel, exploratory study found 100% acceptance of self-collecting cervico-vaginal specimens for HPV testing among a high-risk population of medically underserved women in Appalachian Kentucky. • Higher acceptance rate compared to previous studies • We believe women found self-collection to be a favorable alternative to traditional, provider-performed Pap testing • Convenience, ease, privacy, brevity, and less invasive nature • Recruited from a trusted healthcare clinic • Women were aware that they were overdue for Pap test: tipping point • APRN is indigenous to the community • Women encouraged others to participate: family members, coworkers, and other acquaintances

20. Conclusion (cont.) • Self-collection may be useful for this rural population as an initial screening, as has been previously established in other low-resource areas. • Likely that a greater number of cases would be identified in the application of a two-stage screening method (self-collection followed by Pap test) in a larger clinic or community sample. • Results of our larger study of 400 women are forthcoming. • Tailoring alternative cancer screening strategies to meet complex needs of medically underserved rural women is likely to reduce the burden of cervical cancer among this vulnerable population.

21. Questions? Thank you! Richard.Crosby@uky.edu