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

January 3, 2024 updated by: Cindy Firnhaber, Vivent Health

The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV in a HIV Primary Care Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vivent Health is a non-profit medical home model dedicated to the primary care of People Living with HIV (PLWH) and also provides pre-exposure prophylaxis (PrEP), Hepatitis C, and sexually transmitted infection (STI) treatment. The organization has clinics in Wisconsin (multiple cities), Denver, St. Louis, Austin and Kansas City. All insurances except Kaiser are honored and non-insured people are able to be seen. The Denver medical clinic is a designated medical home that provides adult primary medical and specialty care to approximately 1000 + PLWH. In additional to medical care, this clinic has an onsite pharmacy, case management, HIV and Hepatitis C prevention department, syringe access program, legal department, housing specialists, food bank, a mental health program and dental services. Vivent Health in Denver cares for a diverse population with approximately 11% African-American, 13% Latino, and a recently increasing percentage of women around 13%. This clinic has a strong Electronic Health Record System (EHR- Epic) which provides ample opportunity to recruit a robust study population to investigate the following co-morbidities which might increase the risk of oral HPV infection and related lesions. Given the lack of recommended routine screening for oral HPV in the absence of established masses or lesions, there is a wealth of opportunities to investigate risk factors associated with the presence and prevalence of oral HPV which, in turn, can potentially be used to inform screening and treatment protocols. This proposal is designed to evaluate the prevalence of oral HPV infections and associated oral lesions and associated demographics in HIV treatment clinic.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Vivent Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cynthia S Firnhaber, MD
        • Sub-Investigator:
          • Daniel Taylor, PA-C
        • Sub-Investigator:
          • Blaine Wadjowicz, NP-C
        • Sub-Investigator:
          • Omar Abuzaineh, DMD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HIV positive patients of the Vivent Health Denver clinic.

Description

Inclusion Criteria:

  1. Documented HIV test on any FDA-approved HIV test
  2. Ability and willingness of participant to provide informed consent
  3. Capable of performing an oral swish and spit sample collection
  4. Willingness to have an oral exam by Denver Vivent Health Dentist
  5. Has had at least two visits at the Vivent Health Denver clinic
  6. Study participant allows demographics and medical history/laboratory results in electronic medical records to be confidentially evaluated.

Exclusion Criteria:

  1. Any medical or mental health diagnosis that the study team concludes would prohibits participation of the protocol
  2. CD4 count < 200 cells/ml
  3. History of Oral/tongue cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Group
Single group, observational cross-sectional cohort.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Prevalence in people living with HIV
Time Frame: single visit study for participants and will collect 300 oral samples at the visit and will analyze samples and statistics after completion of enrolling 300 participants in approximately 18 months from the start study
To evaluate the prevalence of positive oral HPV in a population of PLWH and to compare prevalence rate with the historically documented prevalence rates in the general population
single visit study for participants and will collect 300 oral samples at the visit and will analyze samples and statistics after completion of enrolling 300 participants in approximately 18 months from the start study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics of other factors to oral HPV
Time Frame: This is a single visit study for participants and will collect 300 oral samples at the visit and will analyze samples and will compare participant demographics with HIV disease state in approximately 18 months from the start study
To evaluate the correlation of HIV disease factors and demographics in study participatants including CD4 nadir, recent CD4, recent viral load, sexual activity, HPV vaccination status , age, sex, and race compared to participants with samples that are positive for oral HPV
This is a single visit study for participants and will collect 300 oral samples at the visit and will analyze samples and will compare participant demographics with HIV disease state in approximately 18 months from the start study
Correlation of other factors to oral HPV
Time Frame: This is a single visit study for participants analyze samples and participant demographic in approximately 18 months from the start study
To evaluate the correlation of factors including CD4 nadir, recent CD4, recent viral load, sexual activity, HPV vaccination status, age, sex, and race with the prevalence of oral HPV
This is a single visit study for participants analyze samples and participant demographic in approximately 18 months from the start study
Oral lesion prevalence with HPV positive samples
Time Frame: This is a single visit study for participants and will analyze samples and participant demographics with any oral lesions in approximately 18 months from the start study
To evaluate the prevalence of oral lesions in patients who test positive for oral HPV through screening
This is a single visit study for participants and will analyze samples and participant demographics with any oral lesions in approximately 18 months from the start study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivent Health

Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP #10965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this time no plan to share IPD has been created, but might be a path considered in the future if requested

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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