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Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol

INTRODUCTION: In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resourc...

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Autores principales: Chibwesha, Carla J., Ford, Catherine E., Mollan, Katie R., Stringer, Jeffrey S. A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JAIDS Journal of Acquired Immune Deficiency Syndromes 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113248/
https://www.ncbi.nlm.nih.gov/pubmed/27355509
http://dx.doi.org/10.1097/QAI.0000000000001050
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author Chibwesha, Carla J.
Ford, Catherine E.
Mollan, Katie R.
Stringer, Jeffrey S. A.
author_facet Chibwesha, Carla J.
Ford, Catherine E.
Mollan, Katie R.
Stringer, Jeffrey S. A.
author_sort Chibwesha, Carla J.
collection PubMed
description INTRODUCTION: In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible. METHODS AND DESIGN: The study uses a randomized, controlled design to test whether the Alere q platform for HIV DNA polymerase chain reaction (PCR) testing improves outcomes of HIV-infected children in Zambia. We aim to enroll 2867 HIV-exposed infants aged 4–12 weeks and to follow those who are HIV infected for 12 months as they receive HIV care at 6 public health facilities in Lusaka. The trial's primary endpoint is the proportion of HIV-infected infants in each study arm who start ART and remain alive, in care, and virally suppressed 12 months after their diagnostic blood draw. DISCUSSION: Our trial will provide evidence for the incremental benefit of implementing a POC EID strategy in low-resource settings where only off-site PCR services are currently available. The results will be useful in guiding future decisions regarding investments in POC virologic testing as part of overall pediatric AIDS mitigation strategies in sub-Saharan Africa. TRIAL REGISTRATION: clinicaltrials.gov NCT02682810.
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spelling pubmed-51132482016-11-23 Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol Chibwesha, Carla J. Ford, Catherine E. Mollan, Katie R. Stringer, Jeffrey S. A. J Acquir Immune Defic Syndr Supplement Article INTRODUCTION: In the absence of early infant diagnosis (EID) and immediate antiretroviral therapy (ART), some 50% of untreated HIV-infected infants die before age 2. Conventional EID requires sophisticated instruments that are typically placed in centralized or reference laboratories. In low-resource settings, centralized systems often lead to result turnaround times of several months, long delays in diagnosis, and adverse outcomes for HIV-infected children. Our clinical trial tests the effectiveness of a new point-of-care (POC) diagnostic technology to identify HIV-infected infants and start providing them life-saving ART as soon as possible. METHODS AND DESIGN: The study uses a randomized, controlled design to test whether the Alere q platform for HIV DNA polymerase chain reaction (PCR) testing improves outcomes of HIV-infected children in Zambia. We aim to enroll 2867 HIV-exposed infants aged 4–12 weeks and to follow those who are HIV infected for 12 months as they receive HIV care at 6 public health facilities in Lusaka. The trial's primary endpoint is the proportion of HIV-infected infants in each study arm who start ART and remain alive, in care, and virally suppressed 12 months after their diagnostic blood draw. DISCUSSION: Our trial will provide evidence for the incremental benefit of implementing a POC EID strategy in low-resource settings where only off-site PCR services are currently available. The results will be useful in guiding future decisions regarding investments in POC virologic testing as part of overall pediatric AIDS mitigation strategies in sub-Saharan Africa. TRIAL REGISTRATION: clinicaltrials.gov NCT02682810. JAIDS Journal of Acquired Immune Deficiency Syndromes 2016-08-01 2016-06-28 /pmc/articles/PMC5113248/ /pubmed/27355509 http://dx.doi.org/10.1097/QAI.0000000000001050 Text en Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.
spellingShingle Supplement Article
Chibwesha, Carla J.
Ford, Catherine E.
Mollan, Katie R.
Stringer, Jeffrey S. A.
Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
title Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
title_full Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
title_fullStr Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
title_full_unstemmed Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
title_short Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol
title_sort point-of-care virologic testing to improve outcomes of hiv-infected children in zambia: a clinical trial protocol
topic Supplement Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113248/
https://www.ncbi.nlm.nih.gov/pubmed/27355509
http://dx.doi.org/10.1097/QAI.0000000000001050
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