Health TrialsbyHealthPanel

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

ConditionsHPV InfectionHIV InfectionsHPV-Related Malignancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35+
SponsorUniversity of California, San Francisco

About this trial

People living with human immunodeficiency virus (PLWH) have an estimated 1.6-6.0 times increased risk of developing oropharyngeal cancer (OPC) compared with individuals in the general population. 70% of OPCs are caused by human papillomavirus (HPV), and PLWH also have an increased prevalence of oral HPV infection. Disparities by race/ethnicity also include a later stage of diagnosis and less frequent cancer-directed treatment for members of ethnic minority groups. There is little known regarding the racial/ethnic differences in oral HPV infection, persistence of oral HPV infection, or progression of oral HPV infection to OPC among PLWH. This is an observational, prospective cohort study to investigate the feasibility of alternative sample collection methods for HPV testing among PLWH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 35 years of age

Member of a sexual or gender group considered sexual minority men (men who have sex with men, trans-women)

Person living with HIV

Willing and able to receive a package through United States (US) postal service

Disqualifiers

Does not meet the above criteria

Trial population

Adults living with HIV (PLWH)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mail-based Saliva Sample Kit

    Diagnostic test

    Sent via United States Postal Service and returned via FedEx

  • Study-related Surveys

    Other intervention

    Online surveys will be administered

Treatment groups

135 Participants
are divided into 1 treatment group
Group A: Samples from Persons Living With HIV (PLWH)2 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with positive oral human papillomavirus infection

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

Time frame
Up to 10 days
2

Agreement in the detection of oral HPV DNA between the oral rinse and gargle (ORG) and the clinic sample

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

Time frame
Up to 10 days
3

Agreement in the detection of oral HPV DNA between Flinders Technology Associates (FTA) sample collection card and both the ORG samples (Home and Clinic).

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

Time frame
Up to 10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Source ClinicalTrials.gov
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