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Recruiting NCT07087145

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

— Observational HPV Infection HIV Infections HPV-Related Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mail-based Saliva Sample Kit, Study-related Surveys.
Who it may be relevant to
Registry conditions: HPV Infection, HIV Infections, HPV-Related Malignancy. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Percentage of participants with positive oral human papillomavirus infection [Time frame: Up to 10 days]
  • Agreement in the detection of oral HPV DNA between the oral rinse and gargle (ORG) and the clinic sample [Time frame: Up to 10 days]
  • Agreement in the detection of oral HPV DNA between Flinders Technology Associates (FTA) sample collection card and both the ORG samples (Home and Clinic). [Time frame: Up to 10 days]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Does not meet the above criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07087145 · 240514 · R03DE033930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗