Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-16
Brief Title:
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay ROVING PUMA
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay ROVING PUMA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROVING-PUMA
Brief 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 ART1 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 andor 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 2test point-of-care adherence metric - developed by our group - should allow for real-time biofeedback and improve the impact of metric-driven adherence interventions
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 2test 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 11 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
Total duration of the study is 18 months from the time of enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI143340-06 | NIH | None | httpsreporternihgovquickSearchR01AI143340-06 |