Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial
In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH. The study...
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| Veröffentlicht in: | PloS one 2023-02, Vol.18 (2), p.e0281279-e0281279 |
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| creator | Kouamou, Vinie Machekano, Rhoderick Mapangisana, Tichaona Maposhere, Caroline Mutetwa, Reggie Manasa, Justen Shamu, Tinei McCarty, Kathy Munyati, Shungu Mutsvangwa, Junior Bogoshi, Mampedi Israelski, Dennis Katzenstein, David |
| description | In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.
The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.
Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.
In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH. |
| doi_str_mv | 10.1371/journal.pone.0281279 |
| format | Article |
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The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.
Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.
In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0281279</identifier><identifier>PMID: 36787296</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adolescent ; Adolescents ; Adults ; Anti-HIV Agents - therapeutic use ; Antiretroviral agents ; Antiretroviral drugs ; Antiretroviral therapy ; Assaying ; Biological products industry ; Biology and Life Sciences ; Child ; Children ; Clinics ; Complications and side effects ; Consent ; Counseling ; Diagnosis ; Drug resistance ; Ethylenediaminetetraacetic acid ; Failure rates ; Female ; Highly active antiretroviral therapy ; HIV ; HIV (Viruses) ; HIV Infections - drug therapy ; HIV Seropositivity - drug therapy ; HIV-1 ; Human immunodeficiency virus ; Humans ; Laboratories ; Male ; Medicine and Health Sciences ; Monitoring ; Patient outcomes ; People and Places ; Pharmacy ; Plasma ; Protease inhibitors ; Proteases ; Proteinase inhibitors ; Public health ; Rural areas ; Switching ; Tat protein ; Teenagers ; Viral Load - methods ; Vital signs ; Young Adult ; Young adults ; Zimbabwe - epidemiology</subject><ispartof>PloS one, 2023-02, Vol.18 (2), p.e0281279-e0281279</ispartof><rights>Copyright: © 2023 Kouamou et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</rights><rights>COPYRIGHT 2023 Public Library of Science</rights><rights>2023 Kouamou et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 Kouamou et al 2023 Kouamou et al</rights><rights>2023 Kouamou et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c622t-13d7d36d297a056b5972f1e529a65ccfd39325419c87ea763fab1a05724a29e53</citedby><cites>FETCH-LOGICAL-c622t-13d7d36d297a056b5972f1e529a65ccfd39325419c87ea763fab1a05724a29e53</cites><orcidid>0000-0003-3531-7780</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9928130/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9928130/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53769,53771,79346,79347</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36787296$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Mockridge, James</contributor><creatorcontrib>Kouamou, Vinie</creatorcontrib><creatorcontrib>Machekano, Rhoderick</creatorcontrib><creatorcontrib>Mapangisana, Tichaona</creatorcontrib><creatorcontrib>Maposhere, Caroline</creatorcontrib><creatorcontrib>Mutetwa, Reggie</creatorcontrib><creatorcontrib>Manasa, Justen</creatorcontrib><creatorcontrib>Shamu, Tinei</creatorcontrib><creatorcontrib>McCarty, Kathy</creatorcontrib><creatorcontrib>Munyati, Shungu</creatorcontrib><creatorcontrib>Mutsvangwa, Junior</creatorcontrib><creatorcontrib>Bogoshi, Mampedi</creatorcontrib><creatorcontrib>Israelski, Dennis</creatorcontrib><creatorcontrib>Katzenstein, David</creatorcontrib><title>Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.
The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.
Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.
In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.</description><subject>Adolescent</subject><subject>Adolescents</subject><subject>Adults</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral agents</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral therapy</subject><subject>Assaying</subject><subject>Biological products industry</subject><subject>Biology and Life Sciences</subject><subject>Child</subject><subject>Children</subject><subject>Clinics</subject><subject>Complications and side effects</subject><subject>Consent</subject><subject>Counseling</subject><subject>Diagnosis</subject><subject>Drug resistance</subject><subject>Ethylenediaminetetraacetic acid</subject><subject>Failure rates</subject><subject>Female</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV</subject><subject>HIV (Viruses)</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Seropositivity - drug therapy</subject><subject>HIV-1</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medicine and Health Sciences</subject><subject>Monitoring</subject><subject>Patient outcomes</subject><subject>People and Places</subject><subject>Pharmacy</subject><subject>Plasma</subject><subject>Protease inhibitors</subject><subject>Proteases</subject><subject>Proteinase inhibitors</subject><subject>Public health</subject><subject>Rural areas</subject><subject>Switching</subject><subject>Tat protein</subject><subject>Teenagers</subject><subject>Viral Load - methods</subject><subject>Vital signs</subject><subject>Young Adult</subject><subject>Young adults</subject><subject>Zimbabwe - 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Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kouamou, Vinie</au><au>Machekano, Rhoderick</au><au>Mapangisana, Tichaona</au><au>Maposhere, Caroline</au><au>Mutetwa, Reggie</au><au>Manasa, Justen</au><au>Shamu, Tinei</au><au>McCarty, Kathy</au><au>Munyati, Shungu</au><au>Mutsvangwa, Junior</au><au>Bogoshi, Mampedi</au><au>Israelski, Dennis</au><au>Katzenstein, David</au><au>Mockridge, James</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2023-02-14</date><risdate>2023</risdate><volume>18</volume><issue>2</issue><spage>e0281279</spage><epage>e0281279</epage><pages>e0281279-e0281279</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.
The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months.
Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance.
In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>36787296</pmid><doi>10.1371/journal.pone.0281279</doi><tpages>e0281279</tpages><orcidid>https://orcid.org/0000-0003-3531-7780</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2023-02, Vol.18 (2), p.e0281279-e0281279 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2776416375 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adolescent Adolescents Adults Anti-HIV Agents - therapeutic use Antiretroviral agents Antiretroviral drugs Antiretroviral therapy Assaying Biological products industry Biology and Life Sciences Child Children Clinics Complications and side effects Consent Counseling Diagnosis Drug resistance Ethylenediaminetetraacetic acid Failure rates Female Highly active antiretroviral therapy HIV HIV (Viruses) HIV Infections - drug therapy HIV Seropositivity - drug therapy HIV-1 Human immunodeficiency virus Humans Laboratories Male Medicine and Health Sciences Monitoring Patient outcomes People and Places Pharmacy Plasma Protease inhibitors Proteases Proteinase inhibitors Public health Rural areas Switching Tat protein Teenagers Viral Load - methods Vital signs Young Adult Young adults Zimbabwe - epidemiology |
| title | Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-25T16%3A51%3A12IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Clinic-based%20SAMBA-II%20vs%20centralized%20laboratory%20viral%20load%20assays%20among%20HIV-1%20infected%20children,%20adolescents%20and%20young%20adults%20in%20rural%20Zimbabwe:%20A%20randomized%20controlled%20trial&rft.jtitle=PloS%20one&rft.au=Kouamou,%20Vinie&rft.date=2023-02-14&rft.volume=18&rft.issue=2&rft.spage=e0281279&rft.epage=e0281279&rft.pages=e0281279-e0281279&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0281279&rft_dat=%3Cgale_plos_%3EA737156057%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2776416375&rft_id=info:pmid/36787296&rft_galeid=A737156057&rft_doaj_id=oai_doaj_org_article_e19469a1fc8848c5a5b09bdca143439e&rfr_iscdi=true |