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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
2,443
* Viral load (VL) ordering flowsheet with periodic health facility performance feedback * Rapid near-point-of-care VL testing and telephone delivery of results * Structured VL counseling package
Southwestern Uganda
Mbarara, Uganda
Successful VL ordering
Proportion of patients who had a VL ordered when indicated by country guidelines
Time frame: 1 year
VL turnaround time
Mean turnaround time in days from VL ordering to delivery of results to patient
Time frame: 1 year
VL suppression 12 months after the start of Phase 2 of trial
Proportion of subjects suppressed 12 months after start of RAPID-VL participation
Time frame: 12 months after the start of Phase 2 of trial
Viral re-suppression after positive VL
Proportion of patients with a positive (unsuppressed) VL whose next subsequent VL was suppressed
Time frame: 1 year
Number of patients changed from 1st line to 2nd line ART
Number of patients who switched to a 2nd line ART regimen for any reason
Time frame: 1 year
CPHL integration process
Establishment of a process for data transfer to Uganda's Central Public Health Laboratory (CPHL) (yes/no)
Time frame: 12 months after the start of Phase 2 of trial
VL results in CPHL database
Proportion of VL results generated in study that are present in CPHL database at study end
Time frame: 12 months after the start of Phase 2 of trial
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