RecruitingNot Applicable

Feasibility of HPV Testing With Mail-delivered Sample Collection Kits

United States135 participantsStarted 2024-11-17

Plain-language 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.

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants with positive oral human papillomavirus infection

Timeframe: Up to 10 days

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

Timeframe: 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).

Timeframe: Up to 10 days

Trial details

NCT IDNCT07087145

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

William Juarez

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

View on ClinicalTrials.gov More HPV Infection trials

Plain-language summary

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of participants with positive oral human papillomavirus infection

Timeframe: Up to 10 days

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

Timeframe: 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).

Timeframe: Up to 10 days