A Pilot Study to Evaluate Feasibility and Acceptance of Oral HPV Detection in the National Dental PBRN
A target of 1,000 men and women aged 30-69 years will be enrolled over a 6-month period, with up to 1,200 enrollments allowed to avoid cutting off enrollment in the middle of a business day. Thirty practice locations will be recruited from the 6 National Dental PBRN regions (5 practice locations per region). Participating patients will be recruited during routine clinical visits with participating National Dental PBRN practitioners. Each practitioner will recruit 25-30 patients. Patients will be provided a tablet computer on which the study will be explained, electronic consent will be obtained, patient eligibility will be assessed, an oral HPV risk factor survey will be administered, and patient selection for oral rinse collection will be determined. Based on survey responses, the top three deciles of risk (~300) and a random selection of 1 in 12 of those in the lower deciles (~59) will be selected for oral rinse collection (~359 total). An oral rinse sample will be obtained by means of a 30 second rinse and gargle with ScopeTM mouthwash (or saline), expectorated into a sterile specimen collection cup, sealed and stored at 4°C. Specimens will be shipped by practice staff approximately weekly or twice a week to a central laboratory for human papillomavirus (HPV) detection. HPV results will be communicated to the dental practitioner through the study’s secure web application. Patients with a high-risk oral HPV infection (anticipated to be ~25 individuals) will be offered enrollment into a prospective study inclusive of a blood draw, an oral cancer examination, and a 6-month follow-up dental visit (window: 5-9 months) with a repeat oral rinse and an electronic oral cancer risk factor survey. Patients will be compensated with a gift card for each major study procedure.
The primary objective of this study is to estimate the proportion of the study population with an oral high-risk HPV infection.
The secondary objectives of this study are to:
(1) Evaluate the feasibility and acceptability of baseline study procedures performed by participating patients and staff;
(2) Measure the distribution of demographic and behavioral characteristics associated with oral HPV infection;
(3) Determine compliance with and feasibility of procedures performed at a 6-month follow-up visit (window: 5-9 months), including blood draw, second oral rinse specimen collection, oral cancer screening examination, and completion of an oral cancer risk factor survey.