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

RecruitingNAAges 18 Years - anyAllUniversity of California, San Francisco
NCT06423612 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 accuratel

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📋 Eligibility rules (as published)
Inclusion Criteria: 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. Exclusion Criteria: * 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
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What it tests

  • POC urine assay informed enhanced ART adherence counselling for viral suppression
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Where

1 site
Desmond Tutu HIV Foundation
East London, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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