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

Recruiting

• Conditions: Human Immunodeficiency Virus; Human Papilloma Virus
• Interventions: Diagnostic Test: Oral HPV Sample

• Registration Number: NCT06205511
• Lead Sponsor: Vivent Health

Brief 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.

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 Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-05-03
• Status Verified: 2023-09
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main Group	Oral HPV Sample	Single group, observational cross-sectional cohort.

Primary Outcome Measures

Name	Time	Method
HPV Prevalence in people living with HIV	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

Secondary Outcome Measures

Name	Time	Method
Demographics of other factors to 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	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
Oral lesion prevalence with HPV positive samples	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
Correlation of other factors to oral HPV	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

Trial Locations

Locations (1)

Vivent Health; 🇺🇸 Denver, Colorado, United States