Evaluating Oral HPV Infection and Lesions in People Living with HIV
The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV in a HIV Primary Care Clinic
This study is testing how common oral HPV infections and related lesions are in people living with HIV to better understand their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vivent Health Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT06205511 on ClinicalTrials.gov |
What this trial studies
This observational study will assess the prevalence of oral HPV infections and related lesions among 300 individuals living with HIV who attend the Vivent Clinic in Denver. Participants will undergo oral swish and spit sample collection, and their demographic and health data, including HPV vaccination status and lab values, will be analyzed. The study aims to identify potential predictors of oral HPV infections and lesions by comparing HPV positive and negative participants. The findings could enhance understanding of the relationship between HIV and oral HPV.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals living with HIV who have attended the Vivent Health Denver clinic at least twice and can provide informed consent.
Not a fit: Patients with a CD4 count below 200 cells/ml or a history of oral/tongue cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for oral HPV infections in people living with HIV.
How similar studies have performed: While studies have explored HPV in various populations, this specific focus on oral HPV in people living with HIV is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado
- Vivent Health — Denver, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Cynthia Firnhaber, MD
- Email: cynthia.firnhaber@cuanschutz.edu
- Phone: 3033938050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.