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Point-of-care CD4 testing: Differentiated care for the most vulnerable
BACKGROUND: South Africa, with the highest burden of HIV infection globally, has made huge strides in its HIV/ART programme, but AIDS deaths have not decreased proportionally to ART uptake. Advanced HIV disease (CD4 < 200 cells/mm(3)) persists, and CD4 count testing is being overlooked since univ...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
International Society of Global Health
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8818294/ https://www.ncbi.nlm.nih.gov/pubmed/35136596 http://dx.doi.org/10.7189/jogh.12.04004 |
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author | Spooner, Elizabeth Reddy, Tarylee Mchunu, Nobuhle Reddy, Shabashini Daniels, Brodie Ngomane, Noluthando Luthuli, Nozipho Kiepiela, Photini Coutsoudis, Anna |
author_facet | Spooner, Elizabeth Reddy, Tarylee Mchunu, Nobuhle Reddy, Shabashini Daniels, Brodie Ngomane, Noluthando Luthuli, Nozipho Kiepiela, Photini Coutsoudis, Anna |
author_sort | Spooner, Elizabeth |
collection | PubMed |
description | BACKGROUND: South Africa, with the highest burden of HIV infection globally, has made huge strides in its HIV/ART programme, but AIDS deaths have not decreased proportionally to ART uptake. Advanced HIV disease (CD4 < 200 cells/mm(3)) persists, and CD4 count testing is being overlooked since universal test-and-treat was implemented. Point-of-care CD4 testing could address this gap and assure differentiated care to these vulnerable patients with low CD4 counts. METHODS: A time randomised implementation trial was conducted, enrolling 603 HIV positive non-ART, not pregnant patients at a primary health care clinic in Durban, South Africa. Weeks were randomised to either point-of-care CD4 testing (n = 305 patients) or standard-of-care central laboratory CD4 testing (n = 298 patients) to assess the proportion initiating ART at 3 months. Cox regression, with robust standard errors adjusting for clustering by week, were used to assess the relationship between treatment initiation and arm. RESULTS: Among the 578 (299 point-of-care and 279 standard-of-care) patients eligible for analysis, there was no significant difference in the number of eligible patients initiating ART within 3 months in the point-of-care (73%) and the standard-of-care (68%) groups (P = 0.112). The time-to-treat analysis was not significantly different in patients with CD4 counts of 201-500 cells/mm(3) which could have been due to appointment scheduling to cope with the large burden of cases. However, in patients with advanced HIV disease (CD4 < 200cells/mm(3)) 65% more patients started ART earlier in the point-of-care group (HR 1.65 (95% confidence interval (CI) = 0.99-2.75; P = 0.052) compared to the standard-of-care group. CONCLUSIONS: Point-of-care testing decreased time-to-treatment in those with advanced HIV disease. With universal test and treat for HIV, rollout of simple point-of-care CD4 testing would ensure early diagnosis of advanced HIV disease and facilitate differentiated care for these vulnerable patients as per the World Health Organisation 2020 target product profile for point-of-care CD4 testing. TRIAL REGISTRATION: ISRCTN14220457. |
format | Online Article Text |
id | pubmed-8818294 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | International Society of Global Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-88182942022-02-07 Point-of-care CD4 testing: Differentiated care for the most vulnerable Spooner, Elizabeth Reddy, Tarylee Mchunu, Nobuhle Reddy, Shabashini Daniels, Brodie Ngomane, Noluthando Luthuli, Nozipho Kiepiela, Photini Coutsoudis, Anna J Glob Health Articles BACKGROUND: South Africa, with the highest burden of HIV infection globally, has made huge strides in its HIV/ART programme, but AIDS deaths have not decreased proportionally to ART uptake. Advanced HIV disease (CD4 < 200 cells/mm(3)) persists, and CD4 count testing is being overlooked since universal test-and-treat was implemented. Point-of-care CD4 testing could address this gap and assure differentiated care to these vulnerable patients with low CD4 counts. METHODS: A time randomised implementation trial was conducted, enrolling 603 HIV positive non-ART, not pregnant patients at a primary health care clinic in Durban, South Africa. Weeks were randomised to either point-of-care CD4 testing (n = 305 patients) or standard-of-care central laboratory CD4 testing (n = 298 patients) to assess the proportion initiating ART at 3 months. Cox regression, with robust standard errors adjusting for clustering by week, were used to assess the relationship between treatment initiation and arm. RESULTS: Among the 578 (299 point-of-care and 279 standard-of-care) patients eligible for analysis, there was no significant difference in the number of eligible patients initiating ART within 3 months in the point-of-care (73%) and the standard-of-care (68%) groups (P = 0.112). The time-to-treat analysis was not significantly different in patients with CD4 counts of 201-500 cells/mm(3) which could have been due to appointment scheduling to cope with the large burden of cases. However, in patients with advanced HIV disease (CD4 < 200cells/mm(3)) 65% more patients started ART earlier in the point-of-care group (HR 1.65 (95% confidence interval (CI) = 0.99-2.75; P = 0.052) compared to the standard-of-care group. CONCLUSIONS: Point-of-care testing decreased time-to-treatment in those with advanced HIV disease. With universal test and treat for HIV, rollout of simple point-of-care CD4 testing would ensure early diagnosis of advanced HIV disease and facilitate differentiated care for these vulnerable patients as per the World Health Organisation 2020 target product profile for point-of-care CD4 testing. TRIAL REGISTRATION: ISRCTN14220457. International Society of Global Health 2022-02-05 /pmc/articles/PMC8818294/ /pubmed/35136596 http://dx.doi.org/10.7189/jogh.12.04004 Text en Copyright © 2022 by the Journal of Global Health. All rights reserved. https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 International License. |
spellingShingle | Articles Spooner, Elizabeth Reddy, Tarylee Mchunu, Nobuhle Reddy, Shabashini Daniels, Brodie Ngomane, Noluthando Luthuli, Nozipho Kiepiela, Photini Coutsoudis, Anna Point-of-care CD4 testing: Differentiated care for the most vulnerable |
title | Point-of-care CD4 testing: Differentiated care for the most vulnerable |
title_full | Point-of-care CD4 testing: Differentiated care for the most vulnerable |
title_fullStr | Point-of-care CD4 testing: Differentiated care for the most vulnerable |
title_full_unstemmed | Point-of-care CD4 testing: Differentiated care for the most vulnerable |
title_short | Point-of-care CD4 testing: Differentiated care for the most vulnerable |
title_sort | point-of-care cd4 testing: differentiated care for the most vulnerable |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8818294/ https://www.ncbi.nlm.nih.gov/pubmed/35136596 http://dx.doi.org/10.7189/jogh.12.04004 |
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