To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines.
Low-income, infrequently screened women were recruited from the general population in North Carolina to participate in an observational study. Participants provided two self-collected cervicovaginal samples (one at home and one in the clinic) and a clinician-collected cervical sample. Samples were tested for high-risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Cervical samples were also tested by liquid-based cytology.
Overall, 193 women had conclusive high-risk HPV results for all three samples and cytology results. Prevalence of high-risk HPV within self-home samples (12.4%) was not different from that within clinician samples (11.4%; P=.79) and from that within self clinic samples (15.5%; P=.21). Positivity for high-risk HPV in all sample types increased with increasing grades of cervical abnormality (P<.001). Self-home samples detected high-risk HPV in all identified cases of high-grade squamous intraepithelial lesions and of cervical intraepithelial neoplasia 2 or worse. Detection was comparable across sample types for T vaginalis (range 10.2–10.8%), M genitalium (3.3–5.5%), C trachomatis (1.1–2.1%), and N gonorrhoeae (0–0.5%). Kappa values between sample types ranged from 0.56 to 0.66 for high-risk HPV, 0.86–0.91 for T vaginalis, and 0.65–0.83 for M genitalium. Most participants reported no difficulty understanding self-collection instructions (93.6%) and were willing to use self-collection in the future (96.3%).
Mail-based, at-home self-collection for high-risk HPV and sexually transmitted infection detection was valid and well accepted among infrequently screened women in our study. These findings support the future use of high-risk HPV self-collection to increase cervical cancer screening rates among higher risk women in the United States.
At-home self-collection was comparable with clinician-based collection for detection of high-risk human papillomavirus, Trichomonas vaginalis, and Mycoplasma genitalium among approximately 200 infrequently screened women in North Carolina.
Departments of Epidemiology and Health Behavior, Gillings School of Global Public Health, the School of Medicine, and the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina; Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China; the Department of Biological and Biomedical Sciences, College of Arts and Science, North Carolina Central University, Durham, North Carolina; and the American Sexual Health Association, Durham, North Carolina.
Corresponding author: Jennifer S. Smith, PhD, MPH, Department of Epidemiology, Gillings School of Global Public Health, 2103 McGavran-Greenberg Hall, Campus Box# 7435 University of North Carolina, Chapel Hill, NC 27599; email: email@example.com.
Supported by grants from the National Cancer Institute U54 CA156735 and National Institutes of Health NCI R01 CA183891 and from the University Cancer Research Fund at the University of North Carolina at Chapel Hill. Confirmatory high-risk HPV and STI testing conducted by Dr. Hobbs' laboratory was funded by U19-AI-031496. The China Scholarship Council sponsored Yuqian Zhao. The authors adhered to the Good Publication Practice guidelines with regard to all industry sponsored contributions received for this study.
Financial Disclosure High-risk HPV and STI testing, sample preservation media, ThinPrep processor slides, assay reagents, and cervical sample collection brushes and spatulas were donated by Hologic. Self-collection brushes were donated by Rovers Medical Devices. Some conference travel expenses for Ms. Des Marais were paid by Hologic. Dr. Hobbs has consulted for Hologic. Dr. Smith has received research grants, supply donations, and consultancies; served on paid advisory boards and/or has been a paid speaker for Arbor Vita, BD Diagnostics, Hologic, Rovers Medical Devices, and Trovagene in the past 5 years. Neither Hologic nor Rovers had input into the research design, analysis, or interpretation of results. The other authors did not report any potential conflicts of interest.
The authors thank our collaborators at Alamance Regional Health Services, Marlene Warren and Barbara Toth at the Buncombe County Health Department, Dr. Elliot-Bynum and Virginia Mitchell at Caare Inc, Dr. Lorraine Cummings, and our collaborators at Western North Carolina Community Health Services for providing clinical services to our participants. We thank the leadership and call center agents at the United Way’s 2-1-1 of Western NC and the American Sexual Health Association. We thank Anna Pfaff, Lanya Shapiro, and Xian Brooks for contributing to study implementation; Florence Paillard for editing the manuscript; Dana Lapple for performing STI testing in Dr. Hobbs’ laboratory; and Anne Menkens for providing substantial feedback on the draft manuscript.
Each author has indicated that he or she has met the journal's requirements for authorship.
Peer review history is available at http://links.lww.com/AOG/B184.
Received June 05, 2018
Received in revised form August 13, 2018
Accepted August 23, 2018