HPV infections of the penis among men who have sex with men

Worldwide, human papillomavirus (HPV) is the most common sexually transmitted
virus, and can infect epithelial cells of anogenital skin and mucosa. Over 40
different mucosal HPV-types have been identified. Among both sexes, anogenital
HPV infections are associated with a wide range of diseases, from benign
conditions like anogenital warts, to malignancies like cervical cancer, anal
cancer and certain head and neck cancers. Previous studies have shown that
certain HPV-types are more likely to cause benign conditions, whereas others
are associated with malignant diseases. In most cases, infection with HPV
occurs asymptomatic, causing no visible lesions at the anogenital site, and
infected individuals are not aware of carrying the viral infection. Using a
staining dilution (acetic acid 3%) at the anogenital site can result in
acetowhite lesions , and are thought to be responsible for transmission of HPV
from one individual to the other. At the penile site, these lesions are
referred to as flat penile lesions. It remains unclear if presence, size and
quantity of flat penile lesions is related to specific HPV-types and/or health
characteristics (such as hiv infection) of the infected individual.

This study's major aim is to determine whether a relation can be found between
specific penile HPV types and the presence, quantity and size of flat penile
lesions. Secondly, other possible determinants, such as HIV status,
circumcision status and sexual behaviour, will be studied for their
relationship with presence, quantity and size of flat penile lesions. Finally,
we want to determine whether HPV infected people with flat penile lesions have
the same HPV viral load as HPV infected people without flat penile lesions.

We will perform a descriptive clinical study, in which participants will be
invited to visit the GGD Amsterdam for a single study visit. During the study
visit: 1) a questionnaire on sexual behaviour and health characteristics will
be filled in by the participant, 2) two HPV swabs of the penile skin will be
collected by a research physician, and 3) the research physician will inspect
the penile skin, using a colposcope, before and after applying acetic acid 3%
staining dilution, for the presence, quantity and size of flat penile lesions.

Study subjects will be asked to pay a visit to the GGD Public Health Center in
Amsterdam, which will last for an estimated 45 minutes. During this visit they
will fill in a digital questionnaire on sexual behaviour and health
characteristics, 2 swabs of the penile skin will be collected by the research
physician, and the research physician will inspect the skin of the penis with a
colposcope before and after applying a staining dilution (acetic acid 3%). The
procedure of HPV swab collection is painless and safe, and the results
following swab analysis are of no influence on the subjects well being, need no
treatment, or further follow-up. The procedure of skin inspection with
colposcope using a staining dilution is safe, painless and is standard practice
in the diagnosis of HPV related disease, such as anogenital warts or inspection
of the cervix. The staining of the skin is temporary. Inspection of the genital
area could result in experiencing feelings of embarrassment or discomfiture.
Study subjects will be thoroughly clarified about the study procedures and have
sufficient time to decide whether they would feel comfortable in joining the
study. There is no patient-doctor relationship or otherwise dependency of the
study subject on the research group, that could influence his decision making.