Clinical trial NCT06205511: The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV
Official title: The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV in a HIV Primary Care Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Immunodeficiency Virus
Human Papilloma Virus
Keywords: HPV
HIV
SWISH
Lead sponsor: Vivent Health
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2024-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV positive patients of the Vivent Health Denver clinic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HPV Prevalence in people living with HIV
timeFrame: 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 outcomes:
measure: Demographics of other factors to oral HPV
timeFrame: 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
measure: Correlation of other factors to oral HPV
timeFrame: This is a single visit study for participants analyze samples and participant demographic in approximately 18 months from the start study
measure: Oral lesion prevalence with HPV positive samples
timeFrame: 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
Other outcomes:
Locations:
city: Denver
country: United States
facility: Vivent Health
state: Colorado
Study officials:
References:
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