Summary

Eligibility
for people ages 35 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Alexandra Hernandez Levenston, MD, MPH

Description

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.

Official Title

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

Details

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-LWH.
  3. To determine the feasibility, acceptability, and comfort of receiving HPV DNA sample collection kits by mail, self-collecting samples, and returning samples by FedEx, among racially/ethnically diverse SMM-LWH.

OUTLINE:

Participants will provide two saliva samples (at the same time), complete surveys, and complete a single clinic visit. Follow-up will be between 7 and 10 days post initial sample collection.

Keywords

HPV Infection, HIV Infections, HPV-Related Malignancy, HPV Testing, Infections, Communicable Diseases, Papillomavirus Infections

Eligibility

You can join if…

Open to people ages 35 years and up

  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

You CAN'T join if...

  • Does not meet the above criteria

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07087145
Study Type
Observational
Participants
Expecting 135 study participants
Last Updated