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Background: Human Papilloma virus (HPV) infection is strongly related to cervical cancer and its precursors, but the natural history of HPV infection in men is still unknown. In this field, more information is needed for preventive strategies, especially in view of the role that men would play in transmitting the virus to their female sexual partners. Male HPV infection is frequently subclinical and cytologic changes distinctive of viral infection have low frequency. Moreover, currently there is no FDA-approved molecular test to detect HPV in men. The goals of this prospective study were to assess a reliable method to collect cells from penis, to investigate the prevalence of HPV infection in asymptomatic male partners of women affected by cervical abnormalities, and to evaluate HPV-types concordance between sexual partners. Methods: 217 asymptomatic men, who were sexual partners of women with cervical lesions, were enrolled. Exfoliated cells from different penile areas were both cytologically and molecularly evaluated to detect HPV infection and viral oncogenic expression. Results: Cytologic signs of penile HPV infection were founded in 13.8% of the cases. No inadequate samples have been found at β-globin analysis. 62.7% of men and 78.8% of female partners were found to be HPV-positive. Concordant HPV status has been achieved in 50% of the cases. 32% of the couple, where both partners tested positive, harboured the same HPV genotype(s). HPV oncogenic expression did not correlate with the grade of infection status in men. Conclusions: Our data would suggest the high level of reliability and the high rate of adequacy reached by sampling multiple penile areas. HPV infection demonstrated more prevalent in asymptomatic male partner of women with cervical lesions. Molecular testing on penile brushing would represent the more accurate tool to diagnose HPV infection, in view to limit the spread of the virus within the couple. Journal of Molecular Biomarkers & Diagnosis J o u r n a l o f M ole cul ar iorkers & iag n o s i s

HPV Model: From Gender Medicine to Healthcare of the Couple