Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

NCT07087145 | Recruiting

• 2 other identifiers: 240514R03DE033930
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Infection; HIV Infections; HPV-Related Malignancy

Keywords

HPV Testing

Outcome Measures

Primary Outcomes (3)

• 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

  Up to 10 days

• 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

  Up to 10 days

• 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

  Up to 10 days

Study Arms (1)

Samples from Persons Living With HIV (PLWH)

Participants will complete an online survey and receive a sample collection kit in the United States (US) mail. Two saliva samples will be obtained at home (one sample collected with two foam swabs and applied to a single FTA indicating card) and one oral rinse and gargle sample. Participants will complete a follow-up survey, and 7-10 days after the date of home sample collection, participants will visit the UCSF Anal Neoplasia Clinic, Research and Education (ANCRE) Clinic at Mt. Zion for a 15-minute clinic visit. During this clinic visit, participants will additionally complete one oral rinse and gargle sample.

Diagnostic Test: Mail-based Saliva Sample Kit; Other: Study-related Surveys

Interventions

Mail-based Saliva Sample Kit DIAGNOSTIC_TEST

Sent via United States Postal Service and returned via FedEx

Also known as: Mail-based Specimen Sample Kit

Samples from Persons Living With HIV (PLWH)

Study-related Surveys OTHER

Online surveys will be administered

Also known as: Web-based Surveys

Samples from Persons Living With HIV (PLWH)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living with HIV (PLWH)

You may qualify if:

• 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

You may not qualify if:

• Does not meet the above criteria

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Three saliva samples will be collected for analysis

MeSH Terms

Conditions

Papillomavirus Infections; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandra Hernandez Levenston, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Juarez

CONTACT

415-949-8336; William.Juarez@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: November 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)