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The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV

NCT06205511 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-01-16

No results posted yet for this study

Summary

The study will evaluate 300 people living with HIV that attend the Vivent Clinic for HIV care. We will characterize our population and include age, race/ethnicity, sex at birth, tobacco use, alcohol use, other comorbidities, HPV vaccination status, other HPV disease, and lab values such as CD4 count and HIV viral load. We will compare results between participants who are HPV positive and negative. We will also evaluate the relationship between HPV oral infections and lesions and the variables above to better understand possible predictors of HPV infections and lesions.

Conditions

Interventions

DIAGNOSTIC_TEST

Oral HPV Sample

The study participant will be asked to provide an oral swish and spit sample. This sample collection will follow the procedure published by (Herrero et al 2013). The specimen is collected by a 15-second rinse followed by a 15-second gargle using 15 ml of an alcohol-based mouth wash such as a commercially available product, Scope. The 15-ml samples will then be stored at -20 and then shipped on dry ice to Dr. Anna Giuliano's laboratory in Tampa Florida for HPV testing. At present Dr. Giuliano's laboratory is using the DDL SPF10 LiPA assay for sample analysis. An oral exam will be performed for each patient by the Vivent Dentist within 30 days of the collection of the HPV sample. If a referral is needed to an oral surgeon or Ears, Nose, and Throat specialist this will be done within 60 days of the dentist visit. The HPV results will not be shared with the participants as these are research study results and not part of standard of care.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Vivent Health

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205511 on ClinicalTrials.gov