Journal of Clinical Virology 58 (2013) 168–175 Contents lists available at SciVerse ScienceDirect Journal of Clinical Virology jo u r n al hom epage: www.elsevier.com/locate/jcv Evaluation of genital self-sampling methods for HPV detection in males Brenda Y. Hernandez a,∗ , Lynne R. Wilkens a , Elizabeth R. Unger b , Martin Steinau b , Lauri Markowitz b , Keiko Garvin a , Pamela J. Thompson a , Yurii B. Shvetsov a , Kristen O’Dillon c , Eileen F. Dunne b a University of Hawaii Cancer Center, Honolulu, HI, USA b Centers for Disease Control and Prevention, Atlanta, GA, USA c University of Alabama School of Medicine, Birmingham, AL, USA a r t i c l e i n f o Article history: Received 16 March 2013 Received in revised form 19 June 2013 Accepted 24 June 2013 Keywords: Genital Self-sampling HPV Males a b s t r a c t Background: There are no population-based HPV prevalence estimates in males because optimal sampling methods are unclear. Objectives: To evaluate the acceptability, feasibility, and validity of different male genital self-sampling methods for HPV detection. Study design: A total of 450 males, 14–59 years old, were randomly assigned to one of three genital sampling methods: (1) dry polyester-tipped swab; (2) dry foam swab; and (3) emery paper and wet- ted polyester-tipped swab. Samples were both self-collected and collected by a clinician. Subjects were queried on the acceptability of sampling methods. HPV was genotyped using an L1 consensus PCR assay. Results: Specimen adequacy (92–96%, p = 0.28) and HPV detection (44–49%, p = 0.68) were comparable across the three methods. Concordance for HPV detection was observed between self- and clinician- collected specimen pairs for all methods ( = 0.70–0.80). The collection procedure was reported to be very easy by 69% of dry polyester-tipped swab users and 64% of dry foam swab users compared to 48% of emery-wet swab users (p = 0.004). Similarly, 43–44% of dry swab and foam users reported the collection to be very comfortable compared to 24% of emery-wet swab users (p = 0.002). Pain was reported by 10% of emery-wet swab users compared to 3% and 5% of dry swab and foam users, respectively (p = 0.03). Self-collection by the emery-wet swab method required an average of 6 min compared to 3.3–3.5 min for the two dry methods (p < 0.0001). Conclusions: The dry collection methods are optimal for use in large epidemiologic studies or surveillance efforts based on their acceptability and feasibility. © 2013 Elsevier B.V. All rights reserved. 1. Background Human papillomavirus (HPV) is associated with 40–90% of penile, anal, and oropharygeal cancers in men [1]. Clinic based assessments have found that HPV detection is common in healthy men [2,3]. HPV is detected in the external genitals, including the penis and scrotum and, to a lesser extent, the urethra and in semen and urine [4–11]. Although national surveys have gener- ated population-based estimates of genital HPV DNA prevalence in U.S. females [12] and HPV seroprevalence in both U.S. males and females [13], there are no population-based prevalence estimates of genital HPV DNA among US males. A major challenge has been the lack of feasible, acceptable, and standardized sampling methods ∗ Corresponding author at: University of Hawaii Cancer Center, 701 Ilalo Street, Honolulu, HI 96813, USA. Tel.: +1 808 586 2992; fax: +1 808 586 2982. E-mail address: brenda@cc.hawaii.edu (B.Y. Hernandez). for males. Investigations of HPV in men have primarily evaluated samples collected from the external penis and have utilized various methods – including dry and wet swabs [5,10,11,14–16], brushes [17–19], and abrasive paper followed by swabs [8,20,21]. The ade- quacy of specimens collected by these different methods, typically measured by human ß-globin, has ranged widely from 35% to 100% [5,8,10,11,14–21]. Standardized methods of male genital self-sampling which are reliable, efficient, and acceptable would be particularly useful for monitoring male HPV infection in the general population. Self- sampling in males may have several potential advantages over specimens collected by clinicians, including lower costs and greater convenience and acceptability. Self-sampling methods for HPV testing in women have been evaluated and utilized in research and surveillance, including the National Health and Nutrition Examination Surveys (NHANES) [12]. To date, few studies have evaluated genital self-collection methods for HPV detection in males. 1386-6532/$ – see front matter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.jcv.2013.06.032