NCT07087145

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

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
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-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.

Conditions

• HPV Infection
• HIV Infections
• HPV-Related Malignancy

Interventions

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

Timeline

• Start date: 2024-11-17
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-25
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States