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Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States

Smith, Jennifer S. PhD, MPH*†; Des Marais, Andrea C. MPH*; Deal, Allison M. MS; Richman, Alice R. PhD, MPH; Perez-Heydrich, Carolina PhD, MPH§; Yen-Lieberman, Belinda MD; Barclay, Lynn BA; Belinson, Jerome MD**; Rinas, Allen MS CT (SCT), CM (IAC)††; Brewer, Noel T. PhD*†

Sexually Transmitted Diseases: January 2018 - Volume 45 - Issue 1 - p 42–48
doi: 10.1097/OLQ.0000000000000681
Original Study

Background Testing for high-risk human papillomavirus (HPV) infection using mailed, self-collected samples is a promising approach to increase screening in women who do not attend clinic screening at recommended intervals.

Methods To assess this intervention among high-risk women in the United States, 429 women without a Papanicolaou (Pap) test in 4 or more years (overdue by US guidelines) were recruited from the general population. Participants aged 30 to 65 years were mailed a kit to self-collect a cervicovaginal sample at home, return the sample by mail, and receive HPV results by telephone, with referral to follow-up cytological Pap testing at a local clinic. Cervicovaginal self-samples were collected with a Viba brush, stored in Scope mouthwash, and tested by Hybrid Capture 2. Data were collected in 2010 to 2011 and analyzed in 2017.

Results Two-thirds (64%) of participants returned a self-collected sample, of whom 15% tested HPV DNA positive. Human papillomavirus self-test–positive women reported higher rates of follow-up Pap tests (82%) than did those with self-test negative results (51%). No demographic differences were found in self-test return rate or HPV positivity. High acceptability was reported in participant surveys: most women (81%) had “mostly positive” overall thoughts about the self-test, and most reported being comfortable receiving the kit in the mail (99%), returning their self-collected sample by mail (82%), and receiving their test results by telephone (97%).

Conclusions Conducting HPV self-testing through population-based recruitment, mailed kit delivery and return by mail, and results delivery by telephone has the potential to reach a broad segment of US underscreened women.

Conducting human papillomavirus self-testing through population-based recruitment, mailed kit delivery and return by mail, and results delivery by telephone was highly acceptable among infrequently screened women in the United States.

From the *Gillings School of Global Public Health and †Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; ‡College of Health and Human Performance, East Carolina University, Greenville, NC; §Department of Biological Science, Meredith College, Raleigh, NC; ¶Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH; ∥American Sexual Health Association, Research Triangle Park, NC; **The Women's Health Institute, Cleveland Clinic, Cleveland, OH; and ††Department of Allied Health Sciences, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC

Acknowledgments: The authors sincerely thank Meredith Kamradt, Rachel Larsen, Kristen Ricchetti, Kelly Murphy, Stephanie Zentz, and Sara B. Smith for their work on study logistics, database, and recruitment; and Florence Paillard, Laura Baker, and Brenda Quincy for their assistance in drafting and editing the manuscript. The authors also thank Meindert Zwartz at Rovers Medical Devices for donating the Viba self-collection brushes and QIAGEN for donating kits for Hybrid Capture 2 HPV testing.

Conflict of Interest and Sources of Funding: Dr Jennifer S. Smith has received research grants and consultancies from Hologic, Becton Dickenson Corporation, and Trovagene over the past 5 years. Dr Jerome Belinson has served as a speaker and received research funding from Hologic, Becton Dickenson, and QIAGEN. Rovers Medical Devices donated the Viba brushes used for self-collection and QIAGEN donated the Hybrid Capture 2 kits for HPV testing.

Financial Support: This research was supported by Kate B. Reynolds Charitable Trust. Additional support for staff time came from the NCCU-LCCC Partnership in Cancer Research (5 U54 CA156733) and National Institutes of Health, National Cancer Institute R01 CA183891.

Correspondence: Jennifer S. Smith, PhD, MPH, Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina Chapel Hill, 2103 McGavran-Greenberg CB7435, NC 27599. E-mail:

Received for publication April 16, 2017, and accepted June 20, 2017.

© Copyright 2018 American Sexually Transmitted Diseases Association