Men and Women Offering Understanding of Throat HPV

This study will provide one of the first estimates of long-term oral HPV natural history, and
the effect of biologic and behavioral risk factors, including HIV, on this natural history.
Phase 1 of the study will screen approximately 3000 people for oncogenic oral HPV biomarkers.
Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or
HPV serum E6 antibodies from Phase 1 (and those previously identified as having oncogenic
oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV
persistence.

Understanding persistent oncogenic oral HPV infection is the focus of this study.
Understanding which factors drive oral HPV infection to become persistent or progress to
malignancy is critical to determine who is at high risk for oropharyngeal cancer and may
benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV
infections are necessary for progression to HPV-OPC.

The study is led by Dr. Amber D'Souza (Johns Hopkins) and participants are being enrolled at
three sites across the United States including Johns Hopkins (site Co-Is Dr. Amber D'Souza
and Dr. Carole Fakhry), Icahn School of Medicine at Mt. Sinai (site PI Dr. Brett Miles) and
Oregon Health and Science University (site PI Dr. Daniel Clayburgh) along with participants
identified as having oncogenic oral HPV infection in a previous study.

Participants in the Phase 1 Screening

Inclusion criteria:

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

- Male, 35- 79 years of age, with 3 or more lifetime oral sex, or

- Women and/or partners of women with cervical dysplasia or invasive cervical cancer
(ICC) or partners of HPV-positive OPC cases, who are 18 years or older, regardless of
number of partners, or

- Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of
number of partners.

- Willing to be contacted to arrange follow-up visits, if determined to be eligible for
phase 2

- Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria:

An individual who meets any of the following criteria will be excluded from participation
in this study:

- Presence of medical or psychiatric condition affecting ability to give voluntary,
informed consent.

- Participants who do not speak English cannot enroll because the consent and study
survey are only available in English. However, if there is a hearing, literacy or
minor fluency issue and the participant requests assistance from a family member or
the study coordinator, this individual may still enroll and receive this assistance to
ensure they fully hear and understand everything being asked.

- History of head and neck cancer

Participants in the Phase 2 Follow-Up

Inclusion criteria:

- Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1

- Willingness to complete annual follow up visits

Exclusion criteria:

• Unable to complete annual follow up visits