A simple Self-Test could transform cervical cancer screening access
NCT ID NCT05390567
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests whether giving women the choice to use an HPV self-test at home, instead of only offering in-clinic Pap tests, improves their adherence to cervical cancer screening. It involves 800 women aged 25-65 who have not had cervical cancer or a hysterectomy. Participants may choose between a self-test kit or a standard Pap test, and the study tracks whether they complete screening and follow-up steps. The goal is to see if offering self-testing helps overcome barriers like transportation and increases screening rates among underserved populations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HPV self-test kit and standard in-clinic Pap test
- What this could lead to
- If offering HPV self-tests improves screening adherence, it could help reduce cervical cancer rates among underserved women who face barriers to clinic visits.
- What could go wrong
- The trial is still in progress, and results may not show a significant improvement. Some women may not return the self-test or may still miss follow-up care.
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
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
Adults age 25 to 65 years old whose assigned sex at birth is female.
- Ages
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25 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible. 2. Assigned sex at birth is female 3. No previous history of cervical cancer 4. No previous history of a hysterectomy 5. Not currently pregnant (self-report) 6. Not currently menstruating\* 7. Have not used any vaginal products (e.g., oil-based lubricants, antifungal, and douches) in prior 2 days\*. Use of vaginal contraceptives, condoms and water-based lubricants are allowed. 8. Have not given birth in the prior 12 weeks\* 9. Self-report they have not undergone cancer screening in the past 4 years or more OR report being past due according to provider recommended screening schedule. 10. Self-report of using the MOC in the past, no current usual source of care OR usual source of care is a non-UFH provider and/or cervical cancer screening is not accessible through that provider 11. Reside in census tracts where the Mobile Outreach Clinic travels. 12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address. Exclusion Criteria: * For patients who are excluded for criterion 6, 7, and 8, the outreach team (community clinical navigator and CHW) will ask the participant if they can be re-contacted for potential future study eligibility assessment. If the participant agrees, the navigator or CHW will collect contact information to re-contact the participant at a later (pre-determined) date up to 20 weeks later for eligibility screening.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States
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