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Simple urine test could help HIV-Negative women stick to PrEP

NCT ID NCT03935464

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a new urine test that measures tenofovir levels to see how well HIV-negative women are taking their daily PrEP medication. Researchers provided real-time feedback based on the test results, along with standard counseling, to 100 women. The goal was to see if this approach is acceptable and feasible for improving adherence to PrEP.

What this could mean

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

Active substance
urine-based tenofovir adherence assay (behavioral intervention with feedback)
What this could lead to
If successful, this could provide a simple, real-time urine test to help people on PrEP stay adherent and reduce HIV risk.
What could go wrong
This is a small pilot study (100 participants) focused on feasibility, not effectiveness. The test may not improve adherence in larger, more diverse populations.

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

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

100 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female * Adult, age ≥18 years old * HIV-1 uninfected based on a negative HIV-1 rapid test * Not currently enrolled in an HIV-1 prevention clinical trial * Not currently in a sero-discordant relationship * Already taking PrEP and will be enrolled at the 3-month follow-up visit following PrEP initiation * Willing to be randomized to point-of-care tenofovir drug testing * Willing/able to provide informed consent to participate in the study * No contraindication to use of TDF or FTC * Note: Women who are pregnant or breast feeding at screening/enrollment are still eligible Exclusion Criteria: * HIV positive women * under 18 years old

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Conditions

The condition(s) this trial relates to.

Risk Reduction Behavior HIV infectious disease prevention target

As listed by the trial registrant

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

Risk reduction

Contacts and locations

Locations

  • KEMRI Partners in Health and Research Development (PHRD), Thika

    Thika, Near Nairobi, Kenya

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Other studies related to the condition(s) this trial covers.