Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response

Drain, Paul K.; Dorward, Jienchi; Bender, Andrew T.; Lillis, Lorraine; Marinucci, Francesco; Sacks, Jilian A.; Bershteyn, Anna; Boyle, David S.; Posner, Jonathan D.; Garrett, Nigel

doi:10.1128/cmr.00097-18

Cited by 91 publications

(109 citation statements)

References 209 publications

(294 reference statements)

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“…However, even if a different technology were chosen, it would need to be more than three times more expensive before it would be out performed by centralized testing. Third, considerations for electricity requirements, staff capacity, reagent transport, cold storage and connectivity were not taken into account when determining POC candidates [33]. Whilst continuous power is not important given the battery abilities of the POC Omni, it might be required for centrifuging and plasma storage.…”

Section: Discussionmentioning

confidence: 99%

Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement

Girdwood

Nichols

Moyo³

et al. 2019

PLoS ONE

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Introduction Viral load (VL) monitoring programs have been scaled up rapidly, but are now facing the challenge of providing access to the most remote facilities (the “last mile”). For the hardest-to-reach facilities in Zambia, we compared the cost of placing point of care (POC) viral load instruments at or near facilities to the cost of an expanded sample transportation network (STN) to deliver samples to centralized laboratories. Methods We extended a previously described geospatial model for Zambia that first optimized a STN for centralized laboratories for 90% of estimated viral load volumes. Amongst the remaining 10% of volumes, facilities were identified as candidates for POC placement, and then instrument placement was optimized such that access and instrument utilization is maximized. We evaluated the full cost per test under three scenarios: 1) POC placement at all facilities identified for POC; 2)an optimized combination of both on-site POC placement and placement at facilities acting as POC hubs; and 3) integration into the centralized STN to allow use of centralized laboratories. Results For the hardest-to-reach facilities, optimal POC placement covered a quarter of HIV-treating facilities. Scenario 2 resulted in a cost per test of $39.58, 6% less than the cost per test of scenario 1, $41.81. This is due to increased POC instrument utilization in scenario 2 where facilities can act as POC hubs. Scenario 3 was the most costly at $53.40 per test, due to high transport costs under the centralized model ($36 per test compared to $12 per test in scenario 2). Conclusions POC VL testing may reduce the costs of expanding access to the hardest-to-reach populations, despite the cost of equipment and low patient volumes. An optimal combination of both on-site placement and the use of POC hubs can reduce the cost per test by 6–35% by reducing transport costs and increasing instrument utilization.

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Section: Discussionmentioning

confidence: 99%

Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement

Girdwood

Nichols

Moyo³

et al. 2019

PLoS ONE

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“…However, technology based on RT-PCR allows for calculation of viral load, which is associated with transmission risk and disease severity in other viral illnesses. 1 Viral load in COVID-19 might correlate with infectivity, disease phenotype, morbidity, and mortality. To date, no studies have assessed the association between viral load and mortality in a large patient cohort.…”

mentioning

confidence: 99%

SARS-CoV-2 viral load predicts COVID-19 mortality

Pujadas

Chaudhry

McBride

et al. 2020

The Lancet Respiratory Medicine

487

375

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“…We chose the Cepheid GeneXpert HIV-1 VL testing system because minimally trained, onsite staff can test samples individually and on-demand. 25 30 The assay is WHO prequalified for use in HIV management with plasma 31 and in an evaluation to determine its performance relative to the laboratory-based Abbott m2000sp/m2000rt assay, with a similar threshold of detection (40 copies/µL), was highly concordant 23 .…”

Section: Methods and Analysismentioning

confidence: 99%

Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect

et al. 2020

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IntroductionAdolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.Methods and analysisThis non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10–24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.Ethics and disseminationThis study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.Trial registration numberNCT03288246.

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Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response

Cited by 91 publications

References 209 publications

Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement

Optimizing viral load testing access for the last mile: Geospatial cost model for point of care instrument placement

SARS-CoV-2 viral load predicts COVID-19 mortality

Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect

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