Mailed Saliva Kits for Oral HPV Testing in People Living With HIV

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults over 35 who are living with HIV and belong to a sexual or gender minority group. It tests mailed kits for collecting saliva samples for oral HPV testing.

Age

Over 35 years of age (minimum 35 Years).

Sex

Open to all sexes, but participants must be sexual minority men (men who have sex with men, trans-women).

Disease stage

Living with HIV. No disease stage is given.

Main reasons for not taking part

• Not a person living with HIV
• Not over 35 years of age
• Not a member of a sexual or gender minority group (men who have sex with men, trans-women)
• Not willing and able to receive and return a package by mail
• Not able to attend a clinic visit at UCSF Mt. Zion campus

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• 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.

  Treatment: Mail-based Saliva Sample Kit and Study-related Surveys