Persistent oral HPV among diverse PLWH: A pilot study to evaluate the feasibility and acceptability of testing for oral HPV DNA infection with mail-delivered sample collection kits.

PROJECT SUMMARY People living with HIV (PLWH) have an estimated 1.6-6.0 times increased risk of developing oropharyngeal cancer (OPC) compared with individuals in the general population. 70% of OPCs are caused by human papillomavirus (HPV), and PLWH also have an increased prevalence of oral HPV infection. Disparities by race/ethnicity exist. Whites have higher incidences of OPC than other racial groups, while people with OPC categorized as “Black” have worse survival rates than other groups. Disparities also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There are few data, however, on racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. Prospective studies are needed to identify risk factors, potential biomarkers, novel screening or prevention methods for OPC among PLWH. However, there are serious feasibility issues in performing prospective studies of oral HPV persistence. Oral HPV infection is rare, even among sexual minority men (SMM) living with HIV (LWH), who have the highest prevalence of oral HPV (5% HPV-16, 17% high-risk HPV). A prospective study with the ability to recruit and screen a race/ethnically diverse cohort would require screening thousands of men to identify the few with oral HPV infection. This would be costly and burden the participant with multiple clinic visits. A time and cost-saving alternative would be to conduct most of the screening for eligible study participants by mail. We propose to conduct a pilot study with 135 racially/ethnically diverse SMM-LWH to evaluate the agreement between at- home self-collected samples and clinic-collected samples for detecting HR-HPV. Participants will have HPV DNA sample collection kits sent to them through the USPS. They will be asked to collect one alcohol-based mouthwash oral rinse and gargle sample and one Foam Swab collected saliva sample applied to an FTA card and to return the two samples via FedEx refrigerated overnight shipping. A clinic visit will be within 7- 10 days of the home sample collection, and participants will have a similar ORG sample collected in the research office following gold-standard clinic procedures. We will also assess the feasibility, acceptability, and comfort of receiving oral HPV DNA sample collection kits in the mail, ease of understanding the instruction sheet, ease of collecting samples, and ability to package and mail the samples using refrigerated packaging within 24 hours of collection. The PI will use the pilot data collected through this funding mechanism for new investigators to design a future prospective cohort study among racially and ethnically diverse SMM-LWH investigating risk factors and salivary biomarkers for persistent oral HPV and early HPV- OPC. Her study directly addresses NIDCR’s initiative “Understanding Persistent Oral Human Papillomavirus and Human Immunodeficiency Virus co-infection and Its Role with Oropharyngeal Cancer Induction.”