More Than a Machine: Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Uganda

Study Overview
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Brief Summary
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This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda. The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.

Detailed Description
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This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda. In Phase 1, the study team will perform/record the following: Administer a basic demographic and health questionnaire Record routine clinical parameters during visit to include: Current ARV and prophylaxis regimen Last CD4 and VL, if available Clinical illness since last visit Document the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling). Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results by phone or at next visit. Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received. Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload In Phase 2, the study team will perform/record the following: Record routine clinical parameters during visit to include: Current ARV and prophylaxis regimen Last CD4 and VL, if available Clinical illness since last visit Determine the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling). Measure the number of Xpert HIV-1 tests performed, the amount of time laboratory staff spends performing the tests and conducting maintenance, the number of tests failures and/or invalid tests, and equipment downtime related problems with software or power supply. Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results on same day, by phone, or next visit. Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received. Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload.

Official Title
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IGHID 11920 - More Than a Machine: Exploring the Ancillary Systems and Processes Required to Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Western Uganda

Conditions
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HIV-1-infection

Intervention / Treatment
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* Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic Exclusion Criteria: Patients unwilling or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Target Population<br>HIV positive individuals attending Bugoye ART clinic | Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay<br>* Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Tests Performed Successfully Each Clinic Day | HIV viral load tests performed at peripheral health center | Each clinic day for up to six months | 
| Number of Tests Performed Successfully each Month | HIV viral load tests performed at peripheral health center | Each month for up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Eligible Patients Electing to Stay to Receive Results | Acceptability of rapid HIV viral load results | Each clinic day for up to six months | 
| Proportion of Eligible Patients Electing to Stay to Receive Results | Acceptability of rapid HIV viral load results | Each month for up to six months | 
| Mean Time Clients Spend in Clinic | Impact on routine ART Clinic flow | Each clinic day for up to 9 months | 
| Provider Perception of Workload | Perceived time spent conducting on-site testing vs send-out testing | Pre- and post-intervention (approximately 6 months apart) | 
| Mean and median time-to-result | Mean and median number of days from blood draw to client receiving viral load result either from current standard of care or on-site testing | Up to 90 days after blood draw, after which considered not returned | 
| Machine Down-Time and Maintenance | Total number of hours spent in maintenance, trouble-shooting, or repair | Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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viral load, CD4