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

Human Immunodeficiency Virus Clinical Trial

— SWISH  

Official title:

The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV in a HIV Primary Care Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205511
• Other study ID #: MISP #10965
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Vivent Health
• Contact: Cynthia Firnhaber, MD
• Phone: 3033938050
• Email: cynthia.firnhaber[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Human Papilloma Virus
• Papilloma
• Papillomavirus Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Vivent Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Vivent Health	H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (11)

Chaturvedi AK, Graubard BI, Broutian T, Pickard RKL, Tong ZY, Xiao W, Kahle L, Gillison ML. Effect of Prophylactic Human Papillomavirus (HPV) Vaccination on Oral HPV Infections Among Young Adults in the United States. J Clin Oncol. 2018 Jan 20;36(3):262-267. doi: 10.1200/JCO.2017.75.0141. Epub 2017 Nov 28. — View Citation

Deeken JF, Tjen-A-Looi A, Rudek MA, Okuliar C, Young M, Little RF, Dezube BJ. The rising challenge of non-AIDS-defining cancers in HIV-infected patients. Clin Infect Dis. 2012 Nov;55(9):1228-35. doi: 10.1093/cid/cis613. Epub 2012 Jul 9. — View Citation

Grulich AE, van Leeuwen MT, Falster MO, Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. Lancet. 2007 Jul 7;370(9581):59-67. doi: 10.1016/S0140-6736(07)61050-2. — View Citation

Herrero R, Quint W, Hildesheim A, Gonzalez P, Struijk L, Katki HA, Porras C, Schiffman M, Rodriguez AC, Solomon D, Jimenez S, Schiller JT, Lowy DR, van Doorn LJ, Wacholder S, Kreimer AR; CVT Vaccine Group. Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica. PLoS One. 2013 Jul 17;8(7):e68329. doi: 10.1371/journal.pone.0068329. Print 2013. — View Citation

McQuillan G, Kruszon-Moran D, Markowitz LE, Unger ER, Paulose-Ram R. Prevalence of HPV in Adults Aged 18-69: United States, 2011-2014. NCHS Data Brief. 2017 Apr;(280):1-8. — View Citation

Patel P, Hanson DL, Sullivan PS, Novak RM, Moorman AC, Tong TC, Holmberg SD, Brooks JT; Adult and Adolescent Spectrum of Disease Project and HIV Outpatient Study Investigators. Incidence of types of cancer among HIV-infected persons compared with the general population in the United States, 1992-2003. Ann Intern Med. 2008 May 20;148(10):728-36. doi: 10.7326/0003-4819-148-10-200805200-00005. — View Citation

Plummer M, Schiffman M, Castle PE, Maucort-Boulch D, Wheeler CM; ALTS Group. A 2-year prospective study of human papillomavirus persistence among women with a cytological diagnosis of atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion. J Infect Dis. 2007 Jun 1;195(11):1582-9. doi: 10.1086/516784. Epub 2007 Apr 16. — View Citation

Rodriguez AC, Schiffman M, Herrero R, Wacholder S, Hildesheim A, Castle PE, Solomon D, Burk R; Proyecto Epidemiologico Guanacaste Group. Rapid clearance of human papillomavirus and implications for clinical focus on persistent infections. J Natl Cancer Inst. 2008 Apr 2;100(7):513-7. doi: 10.1093/jnci/djn044. Epub 2008 Mar 25. — View Citation

Shiels MS, Althoff KN, Pfeiffer RM, Achenbach CJ, Abraham AG, Castilho J, Cescon A, D'Souza G, Dubrow R, Eron JJ, Gebo K, John Gill M, Goedert JJ, Grover S, Hessol NA, Justice A, Kitahata M, Mayor A, Moore RD, Napravnik S, Novak RM, Thorne JE, Silverberg MJ, Engels EA; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of the International Epidemiologic Databases to Evaluate AIDS (IeDEA). HIV Infection, Immunosuppression, and Age at Diagnosis of Non-AIDS-Defining Cancers. Clin Infect Dis. 2017 Feb 15;64(4):468-475. doi: 10.1093/cid/ciw764. — View Citation

Van Dyne EA, Henley SJ, Saraiya M, Thomas CC, Markowitz LE, Benard VB. Trends in Human Papillomavirus-Associated Cancers - United States, 1999-2015. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-924. doi: 10.15585/mmwr.mm6733a2. — View Citation

Vokes EE, Agrawal N, Seiwert TY. HPV-Associated Head and Neck Cancer. J Natl Cancer Inst. 2015 Dec 9;107(12):djv344. doi: 10.1093/jnci/djv344. Print 2015 Dec. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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
Secondary	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	This is a single visit study for participants analyze samples and participant demographic in approximately 18 months from the start study
Secondary	Oral lesion prevalence with HPV positive samples	To evaluate the prevalence of oral lesions in patients who test positive for oral HPV through screening	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

External Links

•   Centers for Disease Control and Prevention. (2022). Human Papillomavirus.