Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205511
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-05-03
Brief Title:
The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV
Sponsor:
Vivent Health
Organization:
Vivent Health
Study Overview
Official Title:
The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV in a HIV Primary Care Clinic
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWISH
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 raceethnicity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None