A urine test may boost HIV prevention — a trial puts it to the test
NCT ID NCT07725679
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether a simple urine test can help adolescent girls and young women in Kenya stay on track with their daily HIV prevention pills (PrEP). Participants who get the test will receive immediate feedback on their drug levels during counseling sessions. Researchers will compare urine test results between the group that gets the test and the group that receives standard counseling alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a urine point-of-care test for tenofovir with drug-level feedback counseling
- What this could lead to
- If effective, this simple urine test could help women stay on PrEP and reduce new HIV infections.
- What could go wrong
- This is a single-site trial with 400 participants, so results may not apply broadly. The test only measures recent adherence and does not guarantee protection.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
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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18 to 29 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: * HIV uninfected * Received daily oral PrEP one month prior, with a negative result on a urine assay one-month post PrEP initiation * Currently attending or willing to attend one of the study clinics for PrEP refills * Interest in continuing on oral PrEP despite adherence challenges * No known sero-discordant relationships * Living in Kiambu County and not planning to relocate for the next year Exclusion Criteria: * Inadequate capacity to consent or complete planned study procedures * Do not speak English or Kiswahili * Test positive for HIV at screening * Concomitant participation in another PrEP adherence support study
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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 official record
ClinicalTrials.gov lists the study team's own contact details, including names. 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.
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