Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT07087145

Conditions

HPV Infection

HIV Infections

HPV-Related Malignancy

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

Mail-based Saliva Sample Kit

Study-related Surveys

Study Details

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

Study ID

NCT07087145

Start date

Nov 17, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Over 35 years of age
2. Member of a sexual or gender group considered sexual minority men (men who have sex with men, trans-women)
3. Person living with HIV
4. Willing and able to receive a package through United States (US) postal service
5. Willing and able to return a package through FedEx
6. Able to attend a clinic visit at University of California, San Francisco (UCSF) Mt. Zion campus

Exclusion Criteria:

  • Does not meet the above criteria

Study Design

Enrollment

135 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Mail-based Saliva Sample Kit

Sent via United States Postal Service and returned via FedEx

Study-related Surveys

Online surveys will be administered

Primary outcome measure

  • Percentage of participants with positive oral human papillomavirus infection [ Time Frame: Up to 10 days ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

William Juarez

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

William Juarez

415-949-8336william.Juarez@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Alexandra Hernandez Levenston, MD, MPH

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • HPV Testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-08-01.