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Can a mouth rinse reveal hidden HPV risks in HIV patients?

NCT ID NCT06205511

Knowledge-focused Sponsor: Vivent Health Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study will check 300 people living with HIV for oral HPV infection and mouth lesions using a simple swish-and-spit sample. Researchers will compare those who test positive and negative, and look at factors like age, sex, tobacco use, and HIV lab results to see what might predict oral HPV. The goal is to understand how common oral HPV is in this group and what may increase the risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral swish-and-spit sample collection for HPV testing
What this could lead to
If it works, this could point toward better screening or prevention strategies for oral HPV in people living with HIV.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The results may not apply to all people with HIV, and the sample is limited to one clinic.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

300 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

HIV positive patients of the Vivent Health Denver clinic.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Documented HIV test on any FDA-approved HIV test 2. Ability and willingness of participant to provide informed consent 3. Capable of performing an oral swish and spit sample collection 4. Willingness to have an oral exam by Denver Vivent Health Dentist 5. Has had at least two visits at the Vivent Health Denver clinic 6. Study participant allows demographics and medical history/laboratory results in electronic medical records to be confidentially evaluated. Exclusion Criteria: 1. Any medical or mental health diagnosis that the study team concludes would prohibits participation of the protocol 2. CD4 count \< 200 cells/ml 3. History of Oral/tongue cancer

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human immunodeficiency virus Human papilloma virus

Contacts and locations

Locations

  • Vivent Health

    Denver, Colorado, 80220, United States

  • Vivent Health- Milwaukee

    Milwaukee, Wisconsin, 53212, United States

  • Vivent Health- St. Louis

    St Louis, Missouri, 63103, United States

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