Point-of-care viral load testing and differentiated HIV care

Abstract Point-of-care viral load tests are being developed to monitor patients on antiretroviral therapy (ART) in sub-Saharan Africa. Test design involves trade-offs between test attributes, including accuracy, complexity, robustness, and cost. We used a model of the human immunodeficiency virus epidemic and ART program in Zimbabwe and found that the attributes of a viral load testing approach that are most influential for cost effectiveness are avoidance of a high proportion of failed tests or results not received, use of an approach that best facilitates retention on ART, and the ability to facilitate greater use of differentiated care, including through expanding coverage of testing availability.

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Evaluation of the Whole-Blood Alere Q NAT Point-of-Care RNA Assay for HIV-1 Viral Load Monitoring in a Primary Health Care Setting in Mozambique

Journal of Clinical Microbiology ◽

10.1128/jcm.00362-16 ◽

2016 ◽

Vol 54 (8) ◽

pp. 2104-2108 ◽

Cited By ~ 28

Author(s):

Ilesh V. Jani ◽

Bindiya Meggi ◽

Adolfo Vubil ◽

Nádia E. Sitoe ◽

Nilesh Bhatt ◽

...

Keyword(s):

Health Care ◽

Primary Health Care ◽

Viral Load ◽

Antiretroviral Therapy ◽

Whole Blood ◽

Point Of Care ◽

Load Testing ◽

Blood Samples ◽

Viral Load Testing ◽

Primary Health

Viral load testing is the WHO-recommended monitoring assay for patients on HIV antiretroviral therapy (ART). Point-of-care (POC) assays may help improve access to viral load testing in resource-limited settings. We compared the performance of the Alere Q NAT POC viral load technology (Alere Technologies, Jena, Germany), measuring total HIV RNA using finger prick capillary whole-blood samples collected in a periurban health center, with that of a laboratory-based plasma RNA test (Roche Cobas Ampliprep/Cobas TaqMan v2) conducted on matched venous blood samples. The whole-blood Alere Q NAT POC assay produced results with a bias of 0.8593 log copy/ml compared to the laboratory-based plasma assay. However, at above 10,000 copies/ml, the bias was 0.07 log copy/ml. Using the WHO-recommended threshold to determine ART failure of 1,000 copies/ml, the sensitivity and specificity of the whole-blood Alere Q NAT POC assay were 96.83% and 47.80%, respectively. A cutoff of 10,000 copies/ml of whole blood with the Alere Q NAT POC assay appears to be a better predictor of ART failure threshold (1,000 copies/ml of plasma), with a sensitivity of 84.0% and specificity of 90.3%. The precision of the whole-blood Alere Q NAT POC assay was comparable to that observed with the laboratory technology (5.4% versus 7.5%) between detectable paired samples. HIV POC viral load testing is feasible at the primary health care level. Further research on the value of whole-blood viral load to monitor antiretroviral therapy is warranted.

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

Clinical Microbiology Reviews ◽

10.1128/cmr.00097-18 ◽

2019 ◽

Vol 32 (3) ◽

Cited By ~ 12

Author(s):

Paul K. Drain ◽

Jienchi Dorward ◽

Andrew Bender ◽

Lorraine Lillis ◽

Francesco Marinucci ◽

...

Keyword(s):

Viral Load ◽

Point Of Care ◽

Load Testing ◽

Hiv Viral Load ◽

Viral Load Testing ◽

Essential Tool ◽

Aids Pandemic ◽

Viral Load Monitoring ◽

Load Monitoring ◽

Hiv Aids

SUMMARYThe global public health community has set ambitious treatment targets to end the HIV/AIDS pandemic. With the notable absence of a cure, the goal of HIV treatment is to achieve sustained suppression of an HIV viral load, which allows for immunological recovery and reduces the risk of onward HIV transmission. Monitoring HIV viral load in people living with HIV is therefore central to maintaining effective individual antiretroviral therapy as well as monitoring progress toward achieving population targets for viral suppression. The capacity for laboratory-based HIV viral load testing has increased rapidly in low- and middle-income countries, but implementation of universal viral load monitoring is still hindered by several barriers and delays. New devices for point-of-care HIV viral load testing may be used near patients to improve HIV management by reducing the turnaround time for clinical test results. The implementation of near-patient testing using these new and emerging technologies may be an essential tool for ensuring a sustainable response that will ultimately enable an end to the HIV/AIDS pandemic. In this report, we review the current and emerging technology, the evidence for decentralized viral load monitoring by non-laboratory health care workers, and the additional considerations for expanding point-of-care HIV viral load testing.

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620: Point-of-care HIV viral load testing in HIV+ pregnant women without prenatal care: a cost- effectiveness analysis

American Journal of Obstetrics and Gynecology ◽

10.1016/j.ajog.2018.11.642 ◽

2019 ◽

Vol 220 (1) ◽

pp. S410-S411

Author(s):

Carmen M. Avram ◽

Karen S. Greiner ◽

Aaron B. Caughey

Keyword(s):

Viral Load ◽

Cost Effectiveness ◽

Prenatal Care ◽

Pregnant Women ◽

Point Of Care ◽

Cost Effectiveness Analysis ◽

Load Testing ◽

Hiv Viral Load ◽

Viral Load Testing ◽

Effectiveness Analysis

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Protocol for a randomised feasibility study of Point-Of-care HIV viral load testing to Enhance Re-suppression in South Africa: the POwER study

BMJ Open ◽

10.1136/bmjopen-2020-045373 ◽

2021 ◽

Vol 11 (2) ◽

pp. e045373

Author(s):

Jienchi Dorward ◽

Yukteshwar Sookrajh ◽

Hope Ngobese ◽

Richard Lessells ◽

Fathima Sayed ◽

...

Keyword(s):

Drug Resistance ◽

Viral Load ◽

Healthcare Workers ◽

Point Of Care ◽

Ethics Committee ◽

Second Line ◽

Load Testing ◽

Hiv Viral Load ◽

Viral Load Testing ◽

To Receive

IntroductionAccess to HIV viral load testing remains difficult for many people on antiretroviral therapy (ART) in low-income and middle-income countries. Weak laboratory and clinic systems often delay the detection and management of viraemia, which can lead to morbidity, drug resistance and HIV transmission. Point-of-care testing could overcome these challenges. We aim to assess whether it is feasible to conduct a randomised trial of point-of-care viral load testing to manage viraemia.Methods and analysisWe will conduct an open-label, single-site, individually randomised, feasibility study of Point-Of-care HIV viral load testing to Enhance Re-suppression, in Durban, South Africa. We will enrol approximately 100 people living with HIV who are aged ≥18 years, receiving first-line ART but with recent viraemia ≥1000 copies/mL, and randomise them 1:1 to receive point-of-care viral load or standard laboratory viral load monitoring, after 12 weeks. All participants will continue to receive care from public sector healthcare workers following South African HIV management guidelines. Participants with persistent viraemia ≥1000 copies/mL will be considered for switching to second-line ART. We will compare the proportion in each study arm who achieve the primary outcome of viral suppression <50 copies/mL at 24 weeks after enrolment. Additional outcomes include proportions retained in the study, proportions with HIV drug resistance, time to viral load results and time to switching to second-line ART. We will assess implementation of point-of-care viral load testing using process evaluation data, and through interviews and focus groups with healthcare workers.Ethics and disseminationUniversity of Oxford Tropical Research Ethics Committee and the Biomedical Research Ethics Committee of the University of KwaZulu-Natal have approved the study. We will present results to stakeholders, and through conferences and open-access, peer-reviewed journals.Trial registration numberPACTR202001785886049.

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