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

Recruiting now · Not applicable

Conditions studied: ART Adherence

In brief

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.

Key facts

Study ID

NCT06423612

Run by

University of California, San Francisco

People needed

500

Starts

2025-05-08

Expected to finish

2026-11-30

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Desmond Tutu HIV Foundation — East London, South Africa (enrolling)

Full record on ClinicalTrials.gov

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