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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 (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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
South Africa
Desmond Tutu HIV Foundation
RECRUITING
East London
Contact Information
Primary
Monica Gandhi
monica.gandhi@ucsf.edu
415 476 4082
Backup
Purba Chatterjee
purba.chatterjee@ucsf.edu
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 500
Treatments
Experimental: POC Urine Test Informed ART Adherence Counselling
Conduct enhanced ART adherence counselling informed by the results of the point-of-care urine assay for TFV to increase viral suppression.
No_intervention: Standard-of-care Enhanced Adherence Counselling
Follow South Africa's standard-of-care enhanced ART adherence counselling for viral suppression.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Desmond Tutu HIV Foundation, University of Cape Town
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov