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Study identifier: NCT06423612 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)

Condition: ART Adherence  ·  Sponsor: University of California, San Francisco

PhaseNA
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

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.

This description comes directly from the study's public registry record.

Talk to the study team

Monica Gandhi  ·  415 476 4082  ·  monica.gandhi@ucsf.edu

Purba Chatterjee  ·  purba.chatterjee@ucsf.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Desmond Tutu HIV FoundationEast London, South AfricaRecruiting

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Source record: clinicaltrials.gov/study/NCT06423612