Project 2: Improving Testing, Tirage and Followup for Cervical Cancer Screening in Medically Underserved Women

Partnership

Dr. Jennifer Smith (UNC) is overseeing this validation study of testing for HPV using urine samples in collaboration with Dr. Vijay Sivaraman and Dr. LaHoma Romocki (NCCU), Dr. Lisa Rahangdale (UNC Dysplasia Clinic), Dr. Siobhan O’Connor (UNC Pathology), Dr. Julie Nelson (UNC CFAR VIM Core), and Ms. De’Angelis Carroll-Baldwin (UNC Cytopathology). Dr. Vijay Sivaraman is overseeing the assessment of E6 testing as a method of triage to follow-up screening of women with urine HPV-positive results. Dr. LaHoma Romocki is overseeing implementation of the formative research for an SMS (text message) intervention to improve adherence to follow-up on abnormal primary cervical cancer screening.

Cancer Disparity

Black, Hispanic, and Asian women in the US experience greater incidence and mortality from invasive cervical cancer compared to white women. Lower socioeconomic status is also associated with lower cervical cancer screening rates and may limit women’s ability to access preventive care due to resource-related barriers. Even in cases where primary screening has occurred, failure to timely follow-up of abnormal screening results in disparate cervical cancer outcomes in minority and low-income women. Because low-income, uninsured and publically insured women are at a higher risk of being under-screened, further research is needed focusing on improving cervical cancer screening and follow-up on abnormal results.

Abstract

This NCCU-UNC collaboration seeks to evaluate novel approaches to reduce disparities in and morbidity and mortality attributable to high-grade precancerous lesions (CIN2+) and ICC by (1) improving primary screening accessibility through use of urine samples rather than physiciancollected samples, (2) increasing adherence to follow-up of abnormal primary screening results, and (3) reducing unnecessary referral to follow-up screening among women with abnormal primary screening results.

We are evaluating these approaches by completing the following activities for our specific aims:
Aim 1: We will (1) Conduct testing for oncogenic human papillomavirus (HPV) in urine, self collected cervico-vaginal, and cervical samples from 160 patients with abnormal primary screening results attending the UNC colposcopy clinic and from 250 women with cytology normal/HPV positive results attending UNC primary screening clinics, all of whom will also complete colposcopy with biopsy, (2) Calculate the validity of the new urine diagnostic test for detection of biopsy-confirmed CIN-2+.
Aim 2: We will conduct formative research and target audience assessment for the development of an SMS (text message)-based intervention designed to improve patient follow-up to colposcopy. We will complete semi-structured questionnaires with 30 women referred to colposcopy following an abnormal screening result, and 5 in depth interviews with a subset of these women. We will use this data for the development of an R21 proposal to develop and pilot test the content of an SMS intervention.
Aim 3: We will (1) Conduct a HPV E6 urine spiking study on 20 samples to develop laboratory protocol for HPV E6 testing in urine samples; (2) Complete HPV E6 test testing on urine and cervical samples collected from Aim 1 participants with cytology negative/HPV-positive screening results, (3) Calculate the validity of HPV E6 testing for detection of biopsy-confirmed CIN-2+ among cytology negative/HPV-positive patients, to assess its utility as a triage test.

Co-Principal Investigators

Jennifer Smith, PhD UNC-CH	LaHoma Romocki, PhD NCCU	Vijay Sivaraman, PhD NCCU