PrEP Adherence MonitoringNCT07725679
A Hybrid Effectiveness-Implementation Trial of Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
A study testing POC urine TFV test with DLFB in people with PrEP Adherence Monitoring, run by University of Washington.
Trial summary
The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women. Researchers will compare urine TFV assay positivity between arms. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Adherence Monitoring
- What is being tested?
- POC urine TFV test with DLFB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 1 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jennifer Morton contact
About this study
Official title: A Hybrid Effectiveness-Implementation Trial of a Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women.
Researchers will compare urine TFV assay positivity between arms. All participants will attend visits on the same schedule, and receive the same SOC counseling for PrEP adherence. Participants in the intervention arm will additionally take POC urine TFV tests and receive drug-level feedback as part of that counseling.
Read the detailed description
This will be a randomized trial conducted in four public clinic facilities in Kiambu County. We will enroll 400 AGYW ages 15-29 who have been using oral PrEP for one month and will randomize them 1:1 to our DLFB intervention or standard-of-care (SOC). Enrolled AGYW will return for follow-up two months after enrollment and quarterly thereafter through 12 months. Intervention participants will receive DLFB counseling using our urine TFV assay at all visits. SOC arm participants will receive standard counseling; urine will be collected longitudinally but will be tested at study end. We will collect behavioral data via computer assisted self-interviewing (CASI) surveys. Our primary outcome will be the proportion of positive urine assays at each visit. We will compare urine TFV assay positivity between arms using a repeated measures mixed effects logistic regression model.
- Conditions
- PrEP Adherence Monitoring
- Being tested
- POC urine TFV test with DLFB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC urine TFV test with DLFBDiagnostic test
Women randomized to the intervention arm will take POC urine TFV tests and will receive drug level feedback (DLFB) alongside SOC counseling at each visit until exit.
| Study group | Role | What they receive |
|---|---|---|
| SOC | No intervention | Standard of Care |
| Intervention + SOC | Active comparator | Standard of care plus feedback on adherence Receives: Diagnostic Test: POC urine TFV test with DLFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine TFV assay
To determine the short-term adherence to PrEP between arms, we will look at the difference in the population proportions via a positive result on urine TFV assay over follow-up.
Measured: Month 6 post-PrEP initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP Adherence MonitoringStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Velloza, University of Washington
- Investigators
- Jennnifer Velloza, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725679
- Sponsor's protocol ID
- STUDY00025989
- Other IDs
- R01AI189297
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial of a Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
- ClinicalTrials.gov ID
- NCT07725679
- Acronym / sponsor ID
- STUDY00025989
- Conditions
- PrEP Adherence Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women.
Researchers will compare urine TFV assay positivity between arms. All participants will attend visits on the same schedule, and receive the same SOC counseling for PrEP adherence. Participants in the intervention arm will additionally take POC urine TFV tests and receive drug-level feedback as part of that counseling.
Detailed description
This will be a randomized trial conducted in four public clinic facilities in Kiambu County. We will enroll 400 AGYW ages 15-29 who have been using oral PrEP for one month and will randomize them 1:1 to our DLFB intervention or standard-of-care (SOC). Enrolled AGYW will return for follow-up two months after enrollment and quarterly thereafter through 12 months. Intervention participants will receive DLFB counseling using our urine TFV assay at all visits. SOC arm participants will receive standard counseling; urine will be collected longitudinally but will be tested at study end. We will collect behavioral data via computer assisted self-interviewing (CASI) surveys. Our primary outcome will be the proportion of positive urine assays at each visit. We will compare urine TFV assay positivity between arms using a repeated measures mixed effects logistic regression model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC | No intervention | –Standard of Care |
| Intervention + SOC | Active comparator | Diagnostic Test: POC urine TFV test with DLFBStandard of care plus feedback on adherence |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC urine TFV test with DLFBWomen randomized to the intervention arm will take POC urine TFV tests and will receive drug level feedback (DLFB) alongside SOC counseling at each visit until exit. | Diagnostic test | Intervention + SOC |
Primary outcome
Urine TFV assay
Time frame: Month 6 post-PrEP initiation
To determine the short-term adherence to PrEP between arms, we will look at the difference in the population proportions via a positive result on urine TFV assay over follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Morton contact
Jennnifer Velloza, PhD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing POC urine TFV test with DLFB in people with PrEP Adherence Monitoring, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Morton (jfmorton@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine TFV assay (time frame: Month 6 post-PrEP initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.