Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa
Abstract Introduction Antiretroviral therapy (ART) monitoring using viral load (VL) testing is challenging in high‐burden, limited‐resources settings. Chemokine IP‐10 (interferon gamma‐induced protein 10) strongly correlates with human immunodeficiency virus (HIV) VL. Its determination could serve t...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-10-01
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| Series: | Journal of the International AIDS Society |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/jia2.26176 |
| _version_ | 1797646896773201920 |
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| author | Anna Saura‐Lázaro Peter Bock Erika van den Bogaart Jessie vanVliet Laura Granés Kerry Nel Vikesh Naidoo Michelle Scheepers Yvonne Saunders Núria Leal Francesco Ramponi René Paulussen Tobias Rinke deWit Denise Naniche Elisa López‐Varela |
| author_facet | Anna Saura‐Lázaro Peter Bock Erika van den Bogaart Jessie vanVliet Laura Granés Kerry Nel Vikesh Naidoo Michelle Scheepers Yvonne Saunders Núria Leal Francesco Ramponi René Paulussen Tobias Rinke deWit Denise Naniche Elisa López‐Varela |
| author_sort | Anna Saura‐Lázaro |
| collection | DOAJ |
| description | Abstract Introduction Antiretroviral therapy (ART) monitoring using viral load (VL) testing is challenging in high‐burden, limited‐resources settings. Chemokine IP‐10 (interferon gamma‐induced protein 10) strongly correlates with human immunodeficiency virus (HIV) VL. Its determination could serve to predict virological failure (VF) and to triage patients requiring VL testing. We assessed the field performance of a semi‐quantitative IP‐10 lateral flow assay (LFA) for VF screening in South Africa, and the cost‐effectiveness of its implementation in Mozambique. Methods A cross‐sectional study was conducted between June and December 2021 in three primary health clinics in the Western Cape. Finger prick capillary blood was collected from adults on ART for ≥1 year for direct application onto the IP‐10 LFA (index test) and compared with a plasma VL result ≤1 month prior (reference test). We estimated the area under the receiver operating characteristic curves (AUC), sensitivity and specificity, to evaluate IP‐10 LFA prediction of VF (VL>1000 copies/ml). A decision tree model was used to investigate the cost‐effectiveness of integrating IP‐10 LFA combined with VL testing into the current Mozambican ART monitoring strategy. Averted disability‐adjusted life years (DALYs) and HIV acquisitions, and incremental cost‐effectiveness ratios were estimated. Results Among 209 participants (median age 38 years and 84% female), 18% had VF. Median IP‐10 LFA values were higher among individuals with VF compared to those without (24.0 vs. 14.6; p<0.001). The IP‐10 LFA predicted VF with an AUC = 0.76 (95% confidence interval (CI) 0.67–0.85), 91.9% sensitivity (95% CI 78.1–98.3) and 35.1% specificity (95% CI 28.0–42.7). Integrating the IP‐10 LFA in a setting with 20% VF prevalence and 61% VL testing coverage could save 13.0% of costs and avert 14.9% of DALYs and 55.7% new HIV acquisitions. Furthermore, its introduction was estimated to reduce the total number of routine VL tests required for ART monitoring by up to 68%. Conclusions The IP‐10 LFA is an effective VF triage test for routine ART monitoring. Combining a highly sensitive, low‐cost IP‐10 LFA‐based screening with targeted VL confirmatory testing could result in significant healthcare quality improvements and cost savings in settings with limited access to VL testing. |
| first_indexed | 2024-03-11T15:08:27Z |
| format | Article |
| id | doaj.art-11ba75b0e46048159013a9f8f84a71bf |
| institution | Directory Open Access Journal |
| issn | 1758-2652 |
| language | English |
| last_indexed | 2024-03-11T15:08:27Z |
| publishDate | 2023-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the International AIDS Society |
| spelling | doaj.art-11ba75b0e46048159013a9f8f84a71bf2023-10-30T01:48:29ZengWileyJournal of the International AIDS Society1758-26522023-10-012610n/an/a10.1002/jia2.26176Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern AfricaAnna Saura‐Lázaro0Peter Bock1Erika van den Bogaart2Jessie vanVliet3Laura Granés4Kerry Nel5Vikesh Naidoo6Michelle Scheepers7Yvonne Saunders8Núria Leal9Francesco Ramponi10René Paulussen11Tobias Rinke deWit12Denise Naniche13Elisa López‐Varela14Barcelona Institute for Global Health (ISGlobal) Hospital Clínic ‐ Universitat de Barcelona Barcelona SpainDepartment of Pediatrics and Child Health Desmond Tutu TB Centre Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South AfricaMondial Diagnostics Amsterdam The NetherlandsMondial Diagnostics Amsterdam The NetherlandsDepartment of Preventive Medicine and Epidemiology Hospital Clínic de Barcelona Barcelona SpainDepartment of Pediatrics and Child Health Desmond Tutu TB Centre Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South AfricaDepartment of Pediatrics and Child Health Desmond Tutu TB Centre Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South AfricaDepartment of Pediatrics and Child Health Desmond Tutu TB Centre Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South AfricaDepartment of Pediatrics and Child Health Desmond Tutu TB Centre Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South AfricaBarcelona Institute for Global Health (ISGlobal) Hospital Clínic ‐ Universitat de Barcelona Barcelona SpainBarcelona Institute for Global Health (ISGlobal) Hospital Clínic ‐ Universitat de Barcelona Barcelona SpainMondial Diagnostics Amsterdam The NetherlandsAmsterdam Institute for Global Health and Development (AIGHD) Amsterdam The NetherlandsBarcelona Institute for Global Health (ISGlobal) Hospital Clínic ‐ Universitat de Barcelona Barcelona SpainBarcelona Institute for Global Health (ISGlobal) Hospital Clínic ‐ Universitat de Barcelona Barcelona SpainAbstract Introduction Antiretroviral therapy (ART) monitoring using viral load (VL) testing is challenging in high‐burden, limited‐resources settings. Chemokine IP‐10 (interferon gamma‐induced protein 10) strongly correlates with human immunodeficiency virus (HIV) VL. Its determination could serve to predict virological failure (VF) and to triage patients requiring VL testing. We assessed the field performance of a semi‐quantitative IP‐10 lateral flow assay (LFA) for VF screening in South Africa, and the cost‐effectiveness of its implementation in Mozambique. Methods A cross‐sectional study was conducted between June and December 2021 in three primary health clinics in the Western Cape. Finger prick capillary blood was collected from adults on ART for ≥1 year for direct application onto the IP‐10 LFA (index test) and compared with a plasma VL result ≤1 month prior (reference test). We estimated the area under the receiver operating characteristic curves (AUC), sensitivity and specificity, to evaluate IP‐10 LFA prediction of VF (VL>1000 copies/ml). A decision tree model was used to investigate the cost‐effectiveness of integrating IP‐10 LFA combined with VL testing into the current Mozambican ART monitoring strategy. Averted disability‐adjusted life years (DALYs) and HIV acquisitions, and incremental cost‐effectiveness ratios were estimated. Results Among 209 participants (median age 38 years and 84% female), 18% had VF. Median IP‐10 LFA values were higher among individuals with VF compared to those without (24.0 vs. 14.6; p<0.001). The IP‐10 LFA predicted VF with an AUC = 0.76 (95% confidence interval (CI) 0.67–0.85), 91.9% sensitivity (95% CI 78.1–98.3) and 35.1% specificity (95% CI 28.0–42.7). Integrating the IP‐10 LFA in a setting with 20% VF prevalence and 61% VL testing coverage could save 13.0% of costs and avert 14.9% of DALYs and 55.7% new HIV acquisitions. Furthermore, its introduction was estimated to reduce the total number of routine VL tests required for ART monitoring by up to 68%. Conclusions The IP‐10 LFA is an effective VF triage test for routine ART monitoring. Combining a highly sensitive, low‐cost IP‐10 LFA‐based screening with targeted VL confirmatory testing could result in significant healthcare quality improvements and cost savings in settings with limited access to VL testing.https://doi.org/10.1002/jia2.26176cost‐effectiveness analysisCXC chemokine IP‐10human immunodeficiency viruspoint‐of‐care testSouthern Africatherapeutic drug monitoring |
| spellingShingle | Anna Saura‐Lázaro Peter Bock Erika van den Bogaart Jessie vanVliet Laura Granés Kerry Nel Vikesh Naidoo Michelle Scheepers Yvonne Saunders Núria Leal Francesco Ramponi René Paulussen Tobias Rinke deWit Denise Naniche Elisa López‐Varela Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa Journal of the International AIDS Society cost‐effectiveness analysis CXC chemokine IP‐10 human immunodeficiency virus point‐of‐care test Southern Africa therapeutic drug monitoring |
| title | Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa |
| title_full | Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa |
| title_fullStr | Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa |
| title_full_unstemmed | Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa |
| title_short | Field performance and cost‐effectiveness of a point‐of‐care triage test for HIV virological failure in Southern Africa |
| title_sort | field performance and cost effectiveness of a point of care triage test for hiv virological failure in southern africa |
| topic | cost‐effectiveness analysis CXC chemokine IP‐10 human immunodeficiency virus point‐of‐care test Southern Africa therapeutic drug monitoring |
| url | https://doi.org/10.1002/jia2.26176 |
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