ART AdherenceROVING-PUMANCT06423612
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)
A study testing POC urine assay informed enhanced ART adherence counselling for viral suppression in people with ART Adherence, run by University of California, San Francisco at 1 site in South Africa.
Trial summary
Antiretroviral therapy (ART) has significantly decreased the morbidity and mortality of HIV infection. However, adherence challenges in taking daily oral ART persist. A retrospective cohort study across 31 countries from 2010-19 reported that only 65% of people with HIV (PWH) on ART exhibited virologic suppression… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ART Adherence
- What is being tested?
- POC urine assay informed enhanced ART adherence counselling for viral suppression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 May 2025to 30 Nov 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aim 1: Individuals ≥18 years of age at the initial screening visit living with HIV, prescribed ART for at least three months, and are not virally suppressed.
- Aim 2: Same as Aim 1 for the acceptability survey and in-depth interviews. HIV care providers in the selected clinic sites for the feasibility survey and in-depth interviews.
- Aim 3: Same as Aim 1 for the cost-effectiveness study.
Who cannot join
- Currently enrolled in another ART adherence intervention
- Patients on ART regimen that does not include Tenofovir
- HIV care providers from non-study sites Failure to provide written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Purba Chatterjee contact
South Africa1 site, 1 recruiting
- Recruiting
Desmond Tutu HIV Foundation
East London
Sammy Nena, +27715153785, sammy.nena@hiv-research.org.za
Andrew Marino, PhD
About this study
Antiretroviral therapy (ART) has significantly decreased the morbidity and mortality of HIV infection. However, adherence challenges in taking daily oral ART persist. A retrospective cohort study across 31 countries from 2010-19 reported that only 65% of people with HIV (PWH) on ART exhibited virologic suppression (VS) three years after starting ART;1 the rate of VS in South Africa among PWH on ART is 60-65%. Adherence barriers span individual and structural factors, such as stigma, recall difficulties, housing and/or food insecurity, mental illness, substance use, transportation, stock-outs, and other factors that vary by country and population.
Adherence interventions can benefit from direct objective adherence monitoring. Pharmacologic metrics of adherence assess drug levels in plasma, dried blood spots, hair (a metric our group pioneered) or urine and predict outcomes more accurately than self-reported adherence. However, most of these metrics preclude real-time assessment, requiring expensive laboratory equipment and trained laboratory personnel. Thus, few adherence interventions have successfully incorporated objective metrics, likely due to laboratory and shipping delays. A low-cost (<$2/test) point-of-care adherence metric - developed by our group - should allow for real-time biofeedback and improve the impact of metric-driven adherence interventions.
Read the detailed description
This is a randomized hybrid type 1 effectiveness study design to assess the factors related to implementation of a point-of-care urine TFV assay test into routine HIV clinical care. We plan to recruit a total of 500 adults living with HIV who received primary HIV care from one of the selected study clinics in BCM, Eastern Cape. Individuals who have been prescribed ART for at least 6 months who have not achieved VS will be randomized in a 1:1 fashion at the baseline visit to the intervention arm vs. the SoC arm.
Total duration of the study is 18 months from the time of enrollment.
- Conditions
- ART Adherence
- Being tested
- POC urine assay informed enhanced ART adherence counselling for viral suppression
- Keywords
- ART, Adherence, South Africa, Viral Suppression, ART resistance, POC urine assay, TDF assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC urine assay informed enhanced ART adherence counselling for viral suppressionBehavioural
Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their ART adherence with provision of enhanced ART adherence counseling for viral suppression.
| Study group | Role | What they receive |
|---|---|---|
| POC Urine Test Informed ART Adherence Counselling | Experimental | Conduct enhanced ART adherence counselling informed by the results of the point-of-care urine assay for TFV to increase viral suppression. Receives: Behavioral: POC urine assay informed enhanced ART adherence counselling for viral suppression |
| Standard-of-care Enhanced Adherence Counselling | No intervention | Follow South Africa's standard-of-care enhanced ART adherence counselling for viral suppression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression at 6 months
The primary outcome of effectiveness will be viral suppression at 6 months.
Measured: 18 months
Secondary outcomes (4)
Viral suppression at 9, 12, and 18months
Durability of the 6-month intervention on viral suppression at 9, 12, and 18months
Measured: 18 months
Resistance testing and genotype results @ 6 and 18 months
The effect of the intervention on need for resistance testing and genotype results @ 6 and 18 months
Measured: 18 months
Feasibility and Acceptability of the intervention
Assess the feasibility and acceptability of the intervention using a survey and in-depth interviews
Measured: 18 months
Cost-effectiveness of the intervention
Assess the cost per patient, cost per additional patient with VS, and cost per disability-adjusted life-year averted from a society perspective with using the urine-based TFV adherence assay to inform adherence counseling vs. standard of care counseling.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start8 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ART AdherenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized hybrid type 1 effectiveness trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Desmond Tutu HIV Foundation, University of Cape Town, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Monica Gandhi, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423612
- Sponsor's protocol ID
- A143057
- Other IDs
- R01AI143340-06
- Acronym
- ROVING-PUMA
- Status last verified
- Jul 2026
- First submitted
- 16 May 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- 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
Niu X, Kubiak RW, Siriprakaisil O, Klinbuyaem V, Sukrakanchana PO, Cressey R, Okochi H, Gandhi M, Cressey TR, Drain PK. Tenofovir-Diphosphate in Dried Blood Spots vs Tenofovir in Urine/Plasma for Oral Preexposure Prophylaxis Adherence Monitoring. Open Forum Infect Dis. 2022 Aug 10;9(8):ofac405. doi: 10.1093/ofid/ofac405. eCollection 2022 Aug.
PubMed 36004315Spinelli MA, Haberer JE, Chai PR, Castillo-Mancilla J, Anderson PL, Gandhi M. Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions. Curr HIV/AIDS Rep. 2020 Aug;17(4):301-314. doi: 10.1007/s11904-020-00502-5.
PubMed 32424549Gandhi M, Wang G, King R, Rodrigues WC, Vincent M, Glidden DV, Cressey TR, Bacchetti P, Spinelli MA, Okochi H, Siriprakaisil O, Klinbuayaem V, Mugo NR, Ngure K, Drain PK, Baeten JM. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255-260. doi: 10.1097/QAD.0000000000002395.
PubMed 31634188Cressey TR, Siriprakaisil O, Kubiak RW, Klinbuayaem V, Sukrakanchana PO, Quame-Amaglo J, Okochi H, Tawon Y, Cressey R, Baeten JM, Gandhi M, Drain PK. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate. Int J Infect Dis. 2020 Aug;97:365-370. doi: 10.1016/j.ijid.2020.06.037. Epub 2020 Jun 14.
PubMed 32553717Drain PK, Bardon AR, Simoni JM, Cressey TR, Anderson P, Sevenler D, Olanrewaju AO, Gandhi M, Celum C. Point-of-care and Near Real-time Testing for Antiretroviral Adherence Monitoring to HIV Treatment and Prevention. Curr HIV/AIDS Rep. 2020 Oct;17(5):487-498. doi: 10.1007/s11904-020-00512-3.
PubMed 32627120Drain 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)
- ClinicalTrials.gov ID
- NCT06423612
- Acronym / sponsor ID
- ROVING-PUMA / A143057
- Conditions
- ART Adherence
- Keywords
- ART, Adherence, South Africa, Viral Suppression, ART resistance, POC urine assay, TDF assay
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Desmond Tutu HIV Foundation, University of Cape Town, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 May 2024 (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.
Antiretroviral therapy (ART) has significantly decreased the morbidity and mortality of HIV infection. However, adherence challenges in taking daily oral ART persist. A retrospective cohort study across 31 countries from 2010-19 reported that only 65% of people with HIV (PWH) on ART exhibited virologic suppression (VS) three years after starting ART;1 the rate of VS in South Africa among PWH on ART is 60-65%. Adherence barriers span individual and structural factors, such as stigma, recall difficulties, housing and/or food insecurity, mental illness, substance use, transportation, stock-outs, and other factors that vary by country and population.
Adherence interventions can benefit from direct objective adherence monitoring. Pharmacologic metrics of adherence assess drug levels in plasma, dried blood spots, hair (a metric our group pioneered) or urine and predict outcomes more accurately than self-reported adherence. However, most of these metrics preclude real-time assessment, requiring expensive laboratory equipment and trained laboratory personnel. Thus, few adherence interventions have successfully incorporated objective metrics, likely due to laboratory and shipping delays. A low-cost (<$2/test) point-of-care adherence metric - developed by our group - should allow for real-time biofeedback and improve the impact of metric-driven adherence interventions.
Detailed description
This is a randomized hybrid type 1 effectiveness study design to assess the factors related to implementation of a point-of-care urine TFV assay test into routine HIV clinical care. We plan to recruit a total of 500 adults living with HIV who received primary HIV care from one of the selected study clinics in BCM, Eastern Cape. Individuals who have been prescribed ART for at least 6 months who have not achieved VS will be randomized in a 1:1 fashion at the baseline visit to the intervention arm vs. the SoC arm.
Total duration of the study is 18 months from the time of enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized hybrid type 1 effectiveness trial
| Arm | Type | Receives |
|---|---|---|
| POC Urine Test Informed ART Adherence Counselling | Experimental | Behavioral: POC urine assay informed enhanced ART adherence counselling for viral suppressionConduct enhanced ART adherence counselling informed by the results of the point-of-care urine assay for TFV to increase viral suppression. |
| Standard-of-care Enhanced Adherence Counselling | No intervention | –Follow South Africa's standard-of-care enhanced ART adherence counselling for viral suppression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aim 1: Individuals ≥18 years of age at the initial screening visit living with HIV, prescribed ART for at least three months, and are not virally suppressed.
- Aim 2: Same as Aim 1 for the acceptability survey and in-depth interviews. HIV care providers in the selected clinic sites for the feasibility survey and in-depth interviews.
- Aim 3: Same as Aim 1 for the cost-effectiveness study.
Key exclusion criteria (3 listed)
- Currently enrolled in another ART adherence intervention
- Patients on ART regimen that does not include Tenofovir
- HIV care providers from non-study sites Failure to provide written consent
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 assay informed enhanced ART adherence counselling for viral suppressionCollect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their ART adherence with provision of enhanced ART adherence counseling for viral suppression. | Behavioural | POC Urine Test Informed ART Adherence Counselling |
Primary outcome
Viral Suppression at 6 months
Time frame: 18 months
The primary outcome of effectiveness will be viral suppression at 6 months.
4 secondary outcomes
Viral suppression at 9, 12, and 18months
Time frame: 18 months
Resistance testing and genotype results @ 6 and 18 months
Time frame: 18 months
Feasibility and Acceptability of the intervention
Time frame: 18 months
Cost-effectiveness of the intervention
Time frame: 18 months
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 20 Jul 2026.
- Background: PubMed 36004315Niu X, Kubiak RW, Siriprakaisil O, Klinbuyaem V, Sukrakanchana PO, Cressey R, Okochi H, Gandhi M, Cressey TR, Drain PK. Tenofovir-Diphosphate in Dried Blood Spots vs Tenofovir in Urine/Plasma for Oral Preexposure Prophylaxis Adherence Monitoring. Open Forum Infect Dis. 2022 Aug 10;9(8):ofac405. doi: 10.1093/ofid/ofac405. eCollection 2022 Aug.
- Background: PubMed 32424549Spinelli MA, Haberer JE, Chai PR, Castillo-Mancilla J, Anderson PL, Gandhi M. Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions. Curr HIV/AIDS Rep. 2020 Aug;17(4):301-314. doi: 10.1007/s11904-020-00502-5.
- Background: PubMed 31634188Gandhi M, Wang G, King R, Rodrigues WC, Vincent M, Glidden DV, Cressey TR, Bacchetti P, Spinelli MA, Okochi H, Siriprakaisil O, Klinbuayaem V, Mugo NR, Ngure K, Drain PK, Baeten JM. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255-260. doi: 10.1097/QAD.0000000000002395.
- Background: PubMed 32553717Cressey TR, Siriprakaisil O, Kubiak RW, Klinbuayaem V, Sukrakanchana PO, Quame-Amaglo J, Okochi H, Tawon Y, Cressey R, Baeten JM, Gandhi M, Drain PK. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate. Int J Infect Dis. 2020 Aug;97:365-370. doi: 10.1016/j.ijid.2020.06.037. Epub 2020 Jun 14.
- Background: PubMed 32627120Drain PK, Bardon AR, Simoni JM, Cressey TR, Anderson P, Sevenler D, Olanrewaju AO, Gandhi M, Celum C. Point-of-care and Near Real-time Testing for Antiretroviral Adherence Monitoring to HIV Treatment and Prevention. Curr HIV/AIDS Rep. 2020 Oct;17(5):487-498. doi: 10.1007/s11904-020-00512-3.
- Background: 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.
Purba Chatterjee contact
Monica Gandhi 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 POC urine assay informed enhanced ART adherence counselling for viral suppression in people with ART Adherence, run by University of California, San Francisco at 1 site in South Africa.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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 South Africa. 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?
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 Monica Gandhi (415 476 4082 ext. 127, monica.gandhi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression at 6 months (time frame: 18 months). 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 NCT06423612, 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 20 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.