An observational study in Human Immunodeficiency Virus and Human Papilloma Virus, sponsored by Vivent Health. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Vivent Health · Observational
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 300 is above the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Vivent Health is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV positive patients of the Vivent Health Denver clinic.
Exclusion Criteria:
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.
HPV Prevalence in people living with HIV
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
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
Demographics of other factors to oral HPV
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
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
Correlation of other factors to oral HPV
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
Time frame: 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
To evaluate the prevalence of oral lesions in patients who test positive for oral HPV through screening
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — At this time no plan to share IPD has been created, but might be a path considered in the future if requested
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→
Vivent Health