Who is eligible for clinical trial NCT03644563?

Participants must meet protocol criteria for Oropharyngeal Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT03644563 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-09

Men and Women Offering Understanding of Throat HPV (NCT03644563)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Johns Hopkins University

🩺 Plain-English Summary (8th-Grade Level)

This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (7 items).

Location: Johns Hopkins Hospital — Baltimore, Maryland

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
18 and older (enrollment at most sites will be restricted to 30 and older since this demographic has the highest prevalence of infection; however, individuals and/or partners of someone with an HPV-related cancer, for example, are at increased risk so will be enrolled in the larger age range).
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 In addition, individuals must meet at least one of the following criteria:
Male, aged 30 and older, with 2 or more lifetime oral sex
History of anal or genital dysplasia or cancer
Partners of someone with an HPV-related cancer (HPV-positive OPC, anal cancer or genital cancer)
Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of number of partners.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Johns Hopkins Hospital — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗