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

NCT06205511 | Unknown

• 1 other identifier: MISP #10965
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; Human Papilloma Virus

Keywords

HPV; HIV; SWISH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Demographics of other factors to 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

• Correlation of other factors to oral HPV

  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

  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

Study Arms (1)

Main Group

Single group, observational cross-sectional cohort.

Diagnostic Test: Oral HPV Sample

Interventions

Oral HPV Sample DIAGNOSTIC_TEST

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.

Main Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV positive patients of the Vivent Health Denver clinic.

You may qualify if:

• Documented HIV test on any FDA-approved HIV test
• Ability and willingness of participant to provide informed consent
• Capable of performing an oral swish and spit sample collection
• Willingness to have an oral exam by Denver Vivent Health Dentist
• Has had at least two visits at the Vivent Health Denver clinic
• Study participant allows demographics and medical history/laboratory results in electronic medical records to be confidentially evaluated.

You may not qualify if:

• Any medical or mental health diagnosis that the study team concludes would prohibits participation of the protocol
• CD4 count \< 200 cells/ml
• History of Oral/tongue cancer

Sponsors & Collaborators

• Vivent Health: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

Vivent Health

Denver, Colorado, 80220, United States

RECRUITING

Related 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.

  PMID: 29182497 BACKGROUND

• 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.

  PMID: 22776851 BACKGROUND

• 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.

  PMID: 17617273 BACKGROUND

• 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.

  PMID: 18490686 BACKGROUND

• 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.

  PMID: 28463105 BACKGROUND

• 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.

  PMID: 18364507 BACKGROUND

• 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.

  PMID: 17471427 BACKGROUND

• 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.

  PMID: 27940936 BACKGROUND

• 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.

  PMID: 30138307 BACKGROUND

• 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.

  PMID: 26656751 BACKGROUND

• 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.

  PMID: 23873171 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Cynthia Firnhaber, MD

CONTACT

3033938050; cynthia.firnhaber@cuanschutz.edu

Billie Thomas

CONTACT

303-393-8050; billie.thomas@viventhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of Research

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: January 16, 2024
• Study Start: April 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2023-09

Locations

US (1)