Mail-delivered mouth rinse and saliva kits for HPV testing in people with HIV
Official 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
Run by University of California, San Francisco · NCT07087145 · Data updated 2026-11-12
This project tests whether people living with HIV can collect mouth rinse and saliva samples at home, mail them in, and get HPV test results that match clinic-collected samples.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 35 Years and up |
| Sex | All |
| Enrollment | 135 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | November 17, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07087145 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are sexual minority men or trans-women living with HIV who are 35 or older, can receive and return U.S. mail/FedEx packages, and can attend a clinic visit at UCSF Mt. Zion.
✕Probably not a fit
People under 35, those not living with HIV, individuals unable to receive or return mail in the U.S., or those who cannot travel to the UCSF Mt. Zion clinic are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort of racially and ethnically diverse sexual minority men and trans-women living with HIV aged 35 and older, comparing HPV DNA results from clinic-collected oral rinse (ORG) samples with self-collected home ORG samples and saliva applied to an FTA card sent by mail. Participants provide two saliva samples, complete surveys about feasibility and acceptability, attend a single clinic visit at UCSF Mt. Zion, and return mailed kits via FedEx. Follow-up occurs 7 to 10 days after initial collection to compare concordance between sample types and collection settings. The study records laboratory agreement, logistics of mail-based collection, and participant-reported comfort and acceptability.
Why it matters
Potential benefit: If successful, mailed self-collection kits could expand access to oral HPV screening and help detect infections earlier among people living with HIV.
How similar studies have gone: Mail-based self-collection for HPV (notably cervical samples) has shown reasonable agreement with clinic-collected samples in prior work, but mailed oral HPV collection is less established and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of California, San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Alexandra Hernandez Levenston, MD, MPH — University of California, San Francisco
- Study coordinator: William Juarez
- Email: William.Juarez@ucsf.edu
- Phone: 415-949-8336
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.