New cream after heat treatment may help women with HIV beat HPV
NCT ID NCT07545746
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests whether a self-applied cream (5-fluorouracil) after a heat procedure (thermal ablation) can clear HPV better than a placebo cream in 140 women with HIV in Kenya. Participants will use the cream every two weeks for 24 weeks and be followed for 48 weeks total. The goal is to reduce the risk of cervical cancer in this high-risk group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
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.
- Ages
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25 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Women aged 25 years or older * Known HIV-positive status * On antiretroviral therapy (ART) for at least 60 days prior to enrollment * Positive HPV screening test screening result * Able to provide informed consent in English, Swahili, or Dholuo * Agree to use dual contraception during dosing phase if of childbearing potential * Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria * Current pregnancy or breastfeeding * History of anogenital cancer (cervical, vulvar, or anal) * Current use of immunosuppressive medications * History of total hysterectomy * Known allergy to 5FU * Medical comorbidity that would interfere with study participation * Unwilling or unable to use contraception during study participation
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Conditions
The condition(s) this trial relates to.
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
2 sites. 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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Maseno University
Kisumu, 614-40100, Kenya
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Nyanza Reproductive Health Society
Kisumu, Kenya
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