MOUTH HPV Research Study

Researchers at the Icahn School of Medicine at Mount Sinai’s Head and Neck Cancer Research Program are participating in the multisite MOUTH (Men/Women Offering Understanding of Throat HPV) research study in collaboration with Johns Hopkins University in an effort to better understand how risk factors, such as smoking, affect oral HPV (human papillomavirus) infection rates. They are also investigating how likely the infection may persist over time.

This study will be one of the first of its kind to provide estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on the duration of the infection. Most studies to date have had too few oncogenic oral HPV infections (due to either a small sample size or the low prevalence of these infections) to draw any assumptions or conclusions about HPV-associated oral and throat cancers. This study aims to provide the first set of data delineating natural history and risk factor correlation on HPV-associated oral infections.

Who Can and Cannot Join the Study?

If you meet the eligibility criteria listed below and are interested in participating in the study, please email your contact information to: entmouthstudy@mountsinai.org and one of our senior research coordinators will contact you to discuss how you may enroll in this study:

  • Man or woman between 35-69 years old
  • Performed oral sex on more than two partners in your lifetime or are a women and/or partner of a woman with cervical dysplasia
  • Have never had head or neck cancer
  • Willing to sign a written informed consent document and to return to Mount Sinai if a follow-up visit is required

Individuals who meet any of the following criteria are 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 (consent and study survey are only in English)
  • History of head and neck cancer

What Does the Study Involve?

If you participate in the study, researchers will ask you to:

  • Complete a survey about behaviors we believe may be related to oral HPV infection risk
  • Have a head and neck exam
  • Provide oral rinse, urine, blood, and saliva samples to be tested for HPV infection
  • Return for annual follow-up visits (four max) to provide saliva, urine and blood samples, and have a head and neck examination (at select visits) to check for abnormalities at no cost to you, if evidence of exposure to high-risk HPV is identified in your specimens.

How Long Will the Study Last?

Most study participants will have one visit to Mount Sinai. Some participants will be asked to return for annual follow up visits mentioned above.

Will I Be Paid?

Study participants receive a $25.00 gift card at each study visit and can withdraw voluntarily from the study at any time.

More Information/Contact

To receive more information or to enroll in the study, email the study team at: entmouthstudy@mountsinai.org.