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NCT Number: NCT07087145

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

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.

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Key information

Conditions

HPV Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HIV Infections HPV-Related Malignancy Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

STUDY AIMS:

  • To determine if oral HPV deoxyribonucleic acid (HPV DNA) results obtained from self-collected oral rinse and gargle samples (ORG) sent by mail agree with results obtained from ORG samples collected in a clinic setting, among race/ethnically diverse sexual minority men (SMM) living with HIV (LWH).
  • To determine if oral HPV DNA results obtained from self-collected saliva samples applied to a Flinders Technology Associates (FTA) card sent by mail agree with results obtained from (1) ORG samples collected in a clinic setting, and (2) Home ORG, among race/ethnically diverse SMM-LWH.
  • To determine the feasibility, acceptability, and comfort of receiving HPV DNA sample collection kits by mail, self-collecting samples, and returning samples by FedEx, among racially/ethnically diverse SMM-LWH.

OUTLINE:

Participants will provide two saliva samples (at the same time), complete surveys, and complete a single clinic visit. Follow-up will be between 7 and 10 days post initial sample collection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Willing and able to return a package through FedEx
  • Able to attend a clinic visit at University of California, San Francisco (UCSF) Mt. Zion campus

Exclusion criteria

  • Does not meet the above criteria

Treatment and study plan

Mail-based Saliva Sample Kit

Diagnostic Test

Sent via United States Postal Service and returned via FedEx

Other names: Mail-based Specimen Sample Kit

Study-related Surveys

Other

Online surveys will be administered

Other names: Web-based Surveys

Primary outcomes

  1. Percentage of participants with positive oral human papillomavirus infection

    Time frame: Up 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

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

    Time frame: Up 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

  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).

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

William Juarez

CONTACT

[email protected]

415-949-8336

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Persistent Oral HPV Among Diverse PLWH: A Pilot Study to Evaluate the Feasibility and Acceptability of Testing for Oral HPV DNA Infection With Mail-delivered Sample Collection Kits

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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