Risk ReductionPUMANCT03935464
Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP
A study testing PUMA in people with Risk Reduction, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction
- What is being tested?
- PUMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- 1 Mar 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- HIV positive women
- under 18 years old
Trial locations and contacts
1 site in 1 country.
Kenya1 site
KEMRI Partners in Health and Research Development (PHRD), Thika
Thika, Near Nairobi
About this study
Official title: Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to the interpretation of the PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. We now want to test the acceptability, feasibility and preliminary impact of monitoring adherence in real-time using this novel POC assay with adherence feedback provided to the patient with supportive messaging (versus standard of care adherence counseling).
Read the detailed description
The study is a pilot randomized trial to test the acceptability to participants, feasibility for providers, and impact on long-term metric of adherence among participants (assessed via tenofovir hair levels) of implementing a POC urine tenofovir test to provide real-time adherence feedback and enhanced adherence counseling among women on PrEP in Thika, Kenya. Eligible women (n=100) will be HIV-negative, ≥18 years old, and on PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the urine assay versus standard-of-care adherence counseling. Acceptability will be assessed by a quantitative survey of participants at the end of the study, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups of 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed and messages delivered, while in-depth interviews with providers will explore the ease of administering the urine test. Tenofovir levels in hair serve as the long-term metric of adherence.
Feasibility outcome: The investigators will assess the feasibility of the intervention by interviewing health care providers, who will be administering this test at the clinical point of care in the future. The investigators will examine provider perceptions of the assay using in-depth interviews. These key informant interviews will be performed at the end of this study with the healthcare providers (up to 8) who delivered the counseling messages to intervention arm participants after performing the POC urine TFV test. The semi-structured interview guide will draw from the Unified Theory of Acceptance and Use of Technology (UTAUT) model.200 This model incorporates factors that influence technology acceptance (in this case, of the POC immunoassay): perceived usefulness (performance expectancy), complexity to use (effort expectancy), stigma/social harm (social influence), and benefits (facilitating PrEP adherence among patients). These interviews will also elicit barriers and facilitators to delivering the TFV assay-informed counseling messages.
Acceptability outcome: The investigators will conduct a mixed-methods assessment of the intervention arm participants' experiences with real-time monitoring and feedback at the end of the study. A quantitative survey and a qualitative interview guide for in-depth interviews of participants will draw from the Information-Motivation-Behavioral skills (IMB) model.205-212 Quantitative data collection will occur via standardized interviewer-administered questionnaires. Items to be assessed include the following: 1) Feelings about receiving their PrEP adherence results in real time; 2) Likelihood of participating in other studies using a similar design; 3) Likelihood of wanting to receive results of urine testing outside of a study while they are on PrEP; 4) Concern about the privacy and security of the data regarding their urine results; 5) Grading of the potential impact of knowing their urine TFV results on subsequent medication adherence; 6) Advantages and disadvantages of being told about their adherence in real time; 7) Likelihood of taking PrEP just before later study visits because they knew the urine test was being conducted; 8) Preferences regarding a yes/no assay versus an assay that provides information on "high", "moderate" or "low" adherence. A 5-point Likert item format will be used to assess graded items (such as the likelihood of wanting continued urine testing in the context of PrEP; feelings about the urine testing, ranging from negative to positive; concerns about privacy, ranging from low to high; the potential impact of real-time feedback on subsequent adherence, ranging from low to high). Other items (advantages and disadvantages of being told about adherence results) will provide pre-specified options with one "other" option for open-ended text fields.
Adherence outcome: A linear mixed effects linear regression model will estimate the effect of the intervention versus standard-of-care on logarithmically transformed levels of tenofovir in hair.
- Conditions
- Risk Reduction
- Being tested
- PUMA
- Keywords
- PrEP, women, Kenya, adherence, POC monitoring, urine test,TDF, immunoassay
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUMABehavioural
Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their adherence with provision of standard adherence counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | POC adherence testing by a urine TFV assay with feedback Receives: Behavioral: PUMA |
| Standard of Care | No intervention | Follow Kenya's PrEP guidelines on standard adherence counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir.
Primary outcome is number of participants in each arm with detectable hair concentrations of Tenofovir indicating long-term adherence at 12 months (undetectable levels defined long-term non-adherence), as well as urine concentrations of Tenofovir at 12 months as a short-term adherence metric.
Measured: 12 months for each participant from the time of enrollment
Secondary outcomes (1)
Feasibility Among Healthcare Providers of Providing Test Feedback to Participants
Themes among PrEP providers about feasibility of providing urine assay feedback to study participants on PrEP. The In-depth interviews and focus group discussions were cross-sectional.
Measured: Completed after the participants' 12-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Mar 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Model description
- Pilot Randomized Trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of Washington, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Monica Gandhi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935464
- Sponsor's protocol ID
- AI143340
- Other IDs
- R01AI167699, R01AI143340
- Acronym
- PUMA
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2019
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
Publications
Gandhi M, Bacchetti P, Rodrigues WC, Spinelli M, Koss CA, Drain PK, Baeten JM, Mugo NR, Ngure K, Benet LZ, Okochi H, Wang G, Vincent M. Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence. EClinicalMedicine. 2018 Aug-Sep;2-3:22-28. doi: 10.1016/j.eclinm.2018.08.004. Epub 2018 Aug 31.
PubMed 30906930Gandhi M, Bacchetti P, Spinelli MA, Okochi H, Baeten JM, Siriprakaisil O, Klinbuayaem V, Rodrigues WC, Wang G, Vincent M, Cressey TR, Drain PK. Brief Report: Validation of a Urine Tenofovir Immunoassay for Adherence Monitoring to PrEP and ART and Establishing the Cutoff for a Point-of-Care Test. J Acquir Immune Defic Syndr. 2019 May 1;81(1):72-77. doi: 10.1097/QAI.0000000000001971.
PubMed 30664078Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Okochi H, Kuncze K, Mehrotra M, Defechereux P, Buchbinder SP, Grant RM, Gandhi M. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS. 2019 Apr 1;33(5):867-872. doi: 10.1097/QAD.0000000000002135.
PubMed 30649051Okello P, Velloza J, Ogello V, Owidi E, Mogere P, Gakuo S, Chakravarty D, Biwott C, Chatterjee P, Mugo N, Gandhi M, Ngure K. Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya. AIDS Care. 2025 Feb;37(2):324-336. doi: 10.1080/09540121.2024.2444556. Epub 2024 Dec 28.
PubMed 39733245Gandhi M, Glidden DV, Chakravarty D, Wang G, Biwott C, Mogere P, Maina G, Njeru I, Kiptinness C, Okello P, Spinelli MA, Chatterjee P, Velloza J, Ogello V, Medina-Marino A, Okochi H, Mugo NR, Ngure K. Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial. Lancet HIV. 2024 Aug;11(8):e522-e530. doi: 10.1016/S2352-3018(24)00125-5. Epub 2024 Jul 5.
PubMed 38976993Drain P, Ngure K, Mugo N, Spinelli M, Chatterjee P, Bacchetti P, Glidden D, Baeten J, Gandhi M. Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 2;9(4):e15029. doi: 10.2196/15029.
PubMed 32238341
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay
- ClinicalTrials.gov ID
- NCT03935464
- Acronym / sponsor ID
- PUMA / AI143340
- Conditions
- Risk Reduction
- Keywords
- PrEP, women, Kenya, adherence, POC monitoring, urine test,TDF, immunoassay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of Washington, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to the interpretation of the PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. We now want to test the acceptability, feasibility and preliminary impact of monitoring adherence in real-time using this novel POC assay with adherence feedback provided to the patient with supportive messaging (versus standard of care adherence counseling).
Detailed description
The study is a pilot randomized trial to test the acceptability to participants, feasibility for providers, and impact on long-term metric of adherence among participants (assessed via tenofovir hair levels) of implementing a POC urine tenofovir test to provide real-time adherence feedback and enhanced adherence counseling among women on PrEP in Thika, Kenya. Eligible women (n=100) will be HIV-negative, ≥18 years old, and on PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the urine assay versus standard-of-care adherence counseling. Acceptability will be assessed by a quantitative survey of participants at the end of the study, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups of 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed and messages delivered, while in-depth interviews with providers will explore the ease of administering the urine test. Tenofovir levels in hair serve as the long-term metric of adherence.
Feasibility outcome: The investigators will assess the feasibility of the intervention by interviewing health care providers, who will be administering this test at the clinical point of care in the future. The investigators will examine provider perceptions of the assay using in-depth interviews. These key informant interviews will be performed at the end of this study with the healthcare providers (up to 8) who delivered the counseling messages to intervention arm participants after performing the POC urine TFV test. The semi-structured interview guide will draw from the Unified Theory of Acceptance and Use of Technology (UTAUT) model.200 This model incorporates factors that influence technology acceptance (in this case, of the POC immunoassay): perceived usefulness (performance expectancy), complexity to use (effort expectancy), stigma/social harm (social influence), and benefits (facilitating PrEP adherence among patients). These interviews will also elicit barriers and facilitators to delivering the TFV assay-informed counseling messages.
Acceptability outcome: The investigators will conduct a mixed-methods assessment of the intervention arm participants' experiences with real-time monitoring and feedback at the end of the study. A quantitative survey and a qualitative interview guide for in-depth interviews of participants will draw from the Information-Motivation-Behavioral skills (IMB) model.205-212 Quantitative data collection will occur via standardized interviewer-administered questionnaires. Items to be assessed include the following: 1) Feelings about receiving their PrEP adherence results in real time; 2) Likelihood of participating in other studies using a similar design; 3) Likelihood of wanting to receive results of urine testing outside of a study while they are on PrEP; 4) Concern about the privacy and security of the data regarding their urine results; 5) Grading of the potential impact of knowing their urine TFV results on subsequent medication adherence; 6) Advantages and disadvantages of being told about their adherence in real time; 7) Likelihood of taking PrEP just before later study visits because they knew the urine test was being conducted; 8) Preferences regarding a yes/no assay versus an assay that provides information on "high", "moderate" or "low" adherence. A 5-point Likert item format will be used to assess graded items (such as the likelihood of wanting continued urine testing in the context of PrEP; feelings about the urine testing, ranging from negative to positive; concerns about privacy, ranging from low to high; the potential impact of real-time feedback on subsequent adherence, ranging from low to high). Other items (advantages and disadvantages of being told about adherence results) will provide pre-specified options with one "other" option for open-ended text fields.
Adherence outcome: A linear mixed effects linear regression model will estimate the effect of the intervention versus standard-of-care on logarithmically transformed levels of tenofovir in hair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: PUMAPOC adherence testing by a urine TFV assay with feedback |
| Standard of Care | No intervention | –Follow Kenya's PrEP guidelines on standard adherence counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- HIV positive women
- under 18 years old
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 |
|---|---|---|
| PUMACollect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their adherence with provision of standard adherence counseling. | Behavioural | Intervention Arm |
Primary outcome
Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir.
Time frame: 12 months for each participant from the time of enrollment
Primary outcome is number of participants in each arm with detectable hair concentrations of Tenofovir indicating long-term adherence at 12 months (undetectable levels defined long-term non-adherence), as well as urine concentrations of Tenofovir at 12 months as a short-term adherence metric.
1 secondary outcome
Feasibility Among Healthcare Providers of Providing Test Feedback to Participants
Time frame: Completed after the participants' 12-month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30906930Gandhi M, Bacchetti P, Rodrigues WC, Spinelli M, Koss CA, Drain PK, Baeten JM, Mugo NR, Ngure K, Benet LZ, Okochi H, Wang G, Vincent M. Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence. EClinicalMedicine. 2018 Aug-Sep;2-3:22-28. doi: 10.1016/j.eclinm.2018.08.004. Epub 2018 Aug 31.
- Background: PubMed 30664078Gandhi M, Bacchetti P, Spinelli MA, Okochi H, Baeten JM, Siriprakaisil O, Klinbuayaem V, Rodrigues WC, Wang G, Vincent M, Cressey TR, Drain PK. Brief Report: Validation of a Urine Tenofovir Immunoassay for Adherence Monitoring to PrEP and ART and Establishing the Cutoff for a Point-of-Care Test. J Acquir Immune Defic Syndr. 2019 May 1;81(1):72-77. doi: 10.1097/QAI.0000000000001971.
- Background: PubMed 30649051Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Okochi H, Kuncze K, Mehrotra M, Defechereux P, Buchbinder SP, Grant RM, Gandhi M. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS. 2019 Apr 1;33(5):867-872. doi: 10.1097/QAD.0000000000002135.
- Derived from this study: PubMed 39733245Okello P, Velloza J, Ogello V, Owidi E, Mogere P, Gakuo S, Chakravarty D, Biwott C, Chatterjee P, Mugo N, Gandhi M, Ngure K. Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya. AIDS Care. 2025 Feb;37(2):324-336. doi: 10.1080/09540121.2024.2444556. Epub 2024 Dec 28.
- Derived from this study: PubMed 38976993Gandhi M, Glidden DV, Chakravarty D, Wang G, Biwott C, Mogere P, Maina G, Njeru I, Kiptinness C, Okello P, Spinelli MA, Chatterjee P, Velloza J, Ogello V, Medina-Marino A, Okochi H, Mugo NR, Ngure K. Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial. Lancet HIV. 2024 Aug;11(8):e522-e530. doi: 10.1016/S2352-3018(24)00125-5. Epub 2024 Jul 5.
- Derived from this study: PubMed 32238341Drain P, Ngure K, Mugo N, Spinelli M, Chatterjee P, Bacchetti P, Glidden D, Baeten J, Gandhi M. Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 2;9(4):e15029. doi: 10.2196/15029.
- Individual participant dataSharing planned: Yes. We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
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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. This study is not recruiting at the moment.
Monica Gandhi, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUMA in people with Risk Reduction, run by University of California, San Francisco at 1 site in Kenya.
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 10 inclusion and 2 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: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir. (time frame: 12 months for each participant from the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935464, which also lists 6 linked publications.
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 27 Oct 2025.