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
University of California, San Francisco
Summary
People living with human immunodeficiency virus (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 also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There is little known regarding the racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. This is an observational, prospective cohort study to investigate the feasibility of alternative sample collection methods for HPV testing among PLWH.
Description
STUDY AIMS: 1. To determine if oral HPV deoxyribonucleic acid (HPV DNA) results obtained from self-collected oral rinse and gargle samples (ORG) sent by mail agree with results obtained from ORG samples collected in a clinic setting, among race/ethnically diverse sexual minority men (SMM) living with HIV (LWH). 2. To determine if oral HPV DNA results obtained from self-collected saliva samples applied to a Flinders Technology Associates (FTA) card sent by mail agree with results obtained from (1) ORG samples collected in a clinic setting, and (2) Home ORG, among race/ethnically diverse SMM-LW…
Eligibility
- Age range
- 35+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Over 35 years of age 2. Member of a sexual or gender group considered sexual minority men (men who have sex with men, trans-women) 3. Person living with HIV 4. Willing and able to receive a package through United States (US) postal service 5. Willing and able to return a package through FedEx 6. Able to attend a clinic visit at University of California, San Francisco (UCSF) Mt. Zion campus Exclusion Criteria: * Does not meet the above criteria
Interventions
- Diagnostic TestMail-based Saliva Sample Kit
Sent via United States Postal Service and returned via FedEx
- OtherStudy-related Surveys
Online surveys will be administered
Location
- University of California, San FranciscoSan Francisco, California