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

Vivent Health

Status: Enrolling

Conditions: Human Immunodeficiency Virus; Human Papilloma Virus

Treatments: Diagnostic Test: Oral HPV Sample

Study type: Observational

Funder types: Other

Identifiers

NCT06205511

MISP #10965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Main Group

Description:

Single group, observational cross-sectional cohort.

Treatment:

Diagnostic Test: Oral HPV Sample