Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07087145
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mail-based Saliva Sample Kit — DIAGNOSTIC_TEST
    Sent via United States Postal Service and returned via FedEx
  • Study-related Surveys — OTHER
    Online surveys will be administered

Study Details

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.

Key Dates

Start date
Nov 17, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
135 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Percentage of participants with positive oral human papillomavirus infection [ Time Frame: Up to 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
William Juarez
[email protected]
415-949-8336
[email protected]
877-827-3222
Alexandra Hernandez Levenston, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
University of California, San Francisco· San Francisco, CA

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