Rapid HIV Viral Load Monitoring in High Risk Patients In Uganda

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-11-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative effectiveness cluster-randomized trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Clinics

RAPID-VL study intervention testing and counseling package, which includes near point-of-care viral load (VL) testing at local testing hubs, structured VL counseling, forms to track VL ordering and testing, with feedback and performance evaluations at regular intervals.

Group Type EXPERIMENTAL

RAPID-VL study intervention

Intervention Type OTHER

* 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

Control Clinics

Standard of care VL testing and counseling procedures consistent with country guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RAPID-VL study intervention

* 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Phase 1, Intervention and Control Clinics:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date, plus the following:

Phase 2, Intervention Clinics:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 2 start date; able to consent for study participation; plus the following:

Phase 2, Control Clinics:

"High risk" subgroups of patients (n=10 each per clinic, total of 40 per clinic): registered for care, with a clinic visit within a year of the Phase 1 start date; able to provide consent; plus the following:

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No