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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:

• Over 35 years of age

• Member of a sexual or gender group considered sexual minority men (men who have sex with men, trans-women)

• Person living with HIV

• Willing and able to receive a package through United States (US) postal service

• Willing and able to return a package through FedEx

• Able to attend a clinic visit at University of California, San Francisco (UCSF) Mt. Zion campus

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
William Juarez
William.Juarez@ucsf.edu
415-949-8336
Time Frame
Start Date: 2024-11-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 135
Treatments
Samples from Persons Living With HIV (PLWH)
Participants will complete an online survey and receive a sample collection kit in the United States (US) mail. Two saliva samples will be obtained at home (one sample collected with two foam swabs and applied to a single FTA indicating card) and one oral rinse and gargle sample. Participants will complete a follow-up survey, and 7-10 days after the date of home sample collection, participants will visit the UCSF Anal Neoplasia Clinic, Research and Education (ANCRE) Clinic at Mt. Zion for a 15-minute clinic visit. During this clinic visit, participants will additionally complete one oral rinse and gargle sample.
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)

This content was sourced from clinicaltrials.gov