HPV Testing With Mail-delivered Sample Collection Kits
This study is looking at new ways to test for human papillomavirus (HPV) infection in the mouth, especially for people living with human immunodeficiency virus (HIV). People with HIV have a higher risk of certain cancers, including throat cancer, which can be caused by HPV. This study will compare HPV test results from samples you collect at home using a mail-delivered kit (either a saliva sample or a mouth rinse and gargle sample) with samples collected in a clinic. We want to see if these home collection methods are accurate and easy to use. The study aims to enroll about 135 participants who are over 35, identify as sexual minority men (men who have sex with men, trans-women), and are living with HIV.
- Study design
- This is an observational study, meaning participants are not given a specific treatment. It aims to enroll about 135 participants to compare different HPV sample collection methods.
- What's involved
- You will provide two saliva samples, complete online surveys, and attend a single clinic visit. Follow-up will be between 7 and 10 days after your initial sample collection.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to 10 days after initial sample collection to measure HPV detection agreement.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of HPV Testing With Mail-delivered Sample Collection Kits
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alexandra Hernandez Levenston, MD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Percentage of participants with positive oral human papillomavirus infectionUp to 10 days
The prevalence of oral high-risk human papillomavirus (hrHPV) infection will be determined by the percentage of participants with a positive result for human papillomavirus deoxyribonucleic acid (HPV DNA) after testing
- Agreement in the detection of oral HPV DNA between the oral rinse and gargle (ORG) and the clinic sampleUp to 10 days
The agreement in the detection of oral HPV DNA between the oral rinse and gargle (ORG) sample collected at home and the sample collected at the clinic will be measured using kappa. The Kappa Coefficient, often denoted as κ (kappa), is a statistical measure used to assess the level of agreement between two events providing a way to quantify the extent to which the observed agreement exceeds what would be expected by chance alone. The Kappa Coefficient ranges from -1 to 1, where 1 indicates perfect agreement, 0 indicates no agreement beyond chance, and negative values suggest less agreement than would be expected by random chance. Substantial agreement is considered kappa (κ) at least ≥0.61
- Agreement in the detection of oral HPV DNA between Flinders Technology Associates (FTA) sample collection card and both the ORG samples (Home and Clinic).Up to 10 days
The agreement in the detection of oral HPV DNA between the sample collected and applied to an FTA sample collection card (FTA) and both the ORG samples (Home and Clinic). will be measured using kappa. The Kappa Coefficient, often denoted as κ (kappa), is a statistical measure used to assess the level of agreement between two events providing a way to quantify the extent to which the observed agreement exceeds what would be expected by chance alone. The Kappa Coefficient ranges from -1 to 1, where 1 indicates perfect agreement, 0 indicates no agreement beyond chance, and negative values suggest less agreement than would be expected by random chance. Substantial agreement is considered kappa (κ) at least ≥0.61