Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03553693
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Optimizing HIV Viral Load Monitoring and Outcomes for High Risk Populations
Status:
COMPLETED
Status Verified Date:
2020-01
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:
RAPID-VL
Brief Summary:
The RAPID-VL study will take place in 20 HIV care health facilities in Southwestern Uganda. The study will test the hypothesis that a multi-component intervention package that targets barriers to efficient and timely HIV viral load (VL) testing will improve test ordering, speed up result turnaround times, and improve the quality of VL results counseling to patients. Phase 1 of the study will consist of a 1-year retrospective medical record review in all participating health facilities. In Phase 2 the intervention will be introduced in 10 randomly chosen health facilities, while the remaining 10 sites will continue with standard VL testing and counseling operations. The study will measure the speed and efficiency of VL testing, experiences of patients and clinicians with the intervention, and the cost of the intervention.
Detailed Description:
We will test the hypothesis that a multi-component intervention grounded in implementation science principles and that targets key barriers to optimal HIV viral load (VL) processing will improve viral load ordering, speed up viral load turnaround, and improve the quality of viral load counseling of results to patients within a Ugandan network of HIV care clinics. Specific objectives are as follows: Objective 1: Determine the comparative effectiveness of the RAPID-VL intervention on VL ordering and VL turnaround time: We will randomize 20 HIV clinics to the RAPID-VL multi-component intervention vs. standard of care VL procedures (n=10 clinics each, 60 patients/health facility). Objective 2: Identify facilitators and barriers to implementation, and perceived utility of the RAPID-VL intervention from both the patient and clinician perspectives. Objective 3: Determine the costs, cost-effectiveness, and incremental change costs of the RAPID-VL intervention.
Study Oversight
Has Oversight DMC:
False
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?: