(Men Offering Understanding of Throat HPV)
IRB: JH IRB00119537
A Research Study of Oral HPV in Healthy Men
Researchers at Johns Hopkins want to better understand how certain behaviors, such as smoking, and other risk factors affect oral HPV infection rates and how likely these infections will persist over time. While there is no approved screening for oral HPV infection or oropharynx cancer, we are evaluating promising HPV markers that may help identify people at risk of oropharyngeal cancer earlier.
What is Oral Human Papillomavirus (HPV)?
HPV is a sexually transmitted infection. HPV can be transmitted to the mouth or throat during oral sex. Oral HPV infection can lead to cancers of the oropharynx (tonsil, back of tongue).
Who Can Join?
This study is now closed for new enrollment.
What Does the Study Involve?
If you enroll, you will:
- Take a brief online survey
- Provide samples (oral rinse, urine, and small blood sample) to test for HPV
- Receive a $15 gift card for the first study visit and a $25 gift card for each follow up visit
How Long Will the Study Last?
- People without HPV will have only 1 study visit
- People with HPV will have 4 more annual study visits
Newsletters and Papers
MOUTH Study Newsletter (May 2023)
Prevalence of oral and blood oncogenic HPV biomarkers among an enriched screening population: baseline results of the MOUTH study (Cancer, April 2023)
Prevalence of human papillomavirus in head and neck cancers at tertiary care centers in the United States over time (Cancer, May 2022)
More information about HPV
- Summary from an international cancer seminar focused on human papillomavirus (HPV)-positive oropharynx cancer, convened by scientists at IARC and NCI (Oral Oncology, Sep. 2020)
- Center for HPV-Related Head and Neck Cancer
- View a webinar featuring Drs. D'Souza and Fakhry (The Public Health Foundation (PHF), Feb. 13, 2019)
- Why Oral Cancer Threatens Men: researchers wrestle with rising rates of throat cancers (Scientific American, Nov. 2018)
- Head and neck cancer on the rise (WYPR, Jan. 10, 2017)
FAQs about Oral HPV
A. It’s true that men are more likely to develop oropharyngeal cancer. We are not completely sure why. There could be some behavioral and immunological differences between men and women that contribute to incidence of the cancer. We know, for instance, that men who have a higher number of oral sex partners and who smoke are at increased risk for having an oral HPV infection. There is also some data that suggests men and women have differences in immune responses when it comes to fighting off HPV infections. For example, women may have a stronger immune response to genital Approved September 29, 2022 HPV exposure than men do, which may make them less likely to get infected if exposure to oral HPV later.
A. Currently there is no treatment for the oral HPV infection. However, most people who get an infection usually clear the virus on their own within a year or two of getting the infection with no treatment and no interventions. Most people who get an oral HPV infection will never go on to develop the cancer.
A. The HPV vaccine protects against new HPV infections. It does not help you clear HPV infections you may already have. By age 30 most adults have already been exposed to many HPV types and for that reason the vaccine provides only modest benefit in adulthood. The vaccine is primarily recommended for boys and girls ages 9 to 26. You can review the CDC website for guidelines on the HPV vaccine.
A. Treatment for oropharyngeal cancer will vary patient to patient. In general, treatments include surgery, radiation and/or chemotherapy. Patients with HPV-positive tumors respond more readily to treatment and typically live longer than those with HPV-negative head and neck cancers. For more specific information about cancer treatments and outcomes, you can go to the webpage for Johns Hopkins Center for HPV-Related Head and Neck Cancer.
A. Yes, you could have an oral HPV infection now that you acquired years ago. Current sexual behavior affects your risk of acquiring new sexually transmitted infections, but some people who are not sexually active still have an infection that they acquired years ago. Most HPV infections clear the body on their own within 1-2 years. But sometimes infections persist for many years and can progress to cancer.
For most sexually transmitted infections, infection prevalence is highest when a person is in their 20s, when people typically have the most sexual partners, and prevalence is lower among older adults. Oral HPV does not follow this trend and we are not sure why. Studies that looked at how common oral HPV infection is in the general population found there were two peaks of oral HPV prevalence observed, the first among people in their 30s (as expected for sexually transmitted infections), but also a second peak among people in their 60s, that was even larger than the first peak.
A. If you are called back for follow-up, it means our study team would like to continue screening you. Follow-up involves collecting the same samples we took at the baseline visit, completing a brief survey and doing some additional testing: head and neck exam, MRI and ultrasound. Unfortunately, we are not able to disclose any of the sample test results to participants. This is because the tests we perform are part of a research study and as these tests are not FDA approved, our institutional review board does not permit us to disclose the results. However, results for the additional testing: head and neck exam, MRI and ultrasound, can be given to participants as they are standard medical procedures. To people who are worried about their risk, remember that oral sex is common, oral HPV infection is somewhat common, but cancer is rare. Most oral HPV infections will clear on their own.
A. The simple answer is no. While there are some tests on the market, currently there are no FDA approved tests to detect oral HPV infection (meaning there are no validated tests). Providers should not be offering testing to their patients using saliva kits because the diagnostic test accuracy does not support routine use. We do not recommend any testing outside of clinical trials and studies.
A. Symptoms of oropharyngeal cancer include neck mass, difficulty swallowing, ear pain, throat pain and lump or mass in the back of the throat. You should take note of any abnormalities you may be experiencing. However, you should also take care to remember that an oral HPV infection usually clears on its own and rarely leads to cancer. For those coming to the follow-up visits, at the 2nd and 5th (last) study visit, a head and neck surgeon will perform an examination and evaluate any symptoms you may be having. If you note any of these symptoms at any time, please don’t hesitate to contact us with questions.
A. Studies have shown that the lifetime risk of HPV-positive oropharyngeal cancer is low (37 per 10,000 people). However, there is evidence that suggests certain people are at greater risk of getting an oncogenic oral HPV infection, which is the precursor for this type of cancer. Oncogenic oral HPV DNA is detected in 3.5% of all adults age 20–69 years.
Prevalence of the infection is higher in men than women (6.0% vs 1.1%). Infection is more common in people with a higher number of lifetime oral sexual partners and with smoking tobacco. Among men age 20–59 years old, for example, oncogenic oral HPV infection is somewhat common among those who have ≥5 lifetime oral sexual partners and smoke (14%) but is rare in men the same age with
≤1 lifetime oral sex partner (1.7%).
In people who do not have symptoms, screening is not currently recommended (benefits do not outweigh the harms). The purpose of the MOUTH study is to help figure out how to best screen people for HPV-related throat cancer and what markers may find people who are at higher risk.
***This research study is supported by funding from the National Institutes of Health’s National Institute of Dental and Craniofacial Research. R35 DE026631
Principal Investigator: Dr. Gypsyamber D'Souza
JH SOM eIRB#: IRB00119537