Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria

Abstract Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital...

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Published in:Clinical infectious diseases 2023-02, Vol.76 (3), p.e681-e691
Main Authors: Chang, Charlotte, Agbaji, Oche, Mitruka, Kiren, Olatunde, Bola, Sule, Halima, Dajel, Titus, Zee, Aaron, Ahmed, Mukhtar L, Ahmed, Isah, Okonkwo, Prosper, Chaplin, Beth, Kanki, Phyllis
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Language:English
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Anti-HIV Agents - therapeutic use
HIV
HIV Infections - drug therapy
Humans
Nigeria
Point-of-Care Systems
Viral Load - methods
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cited_by cdi_FETCH-LOGICAL-c413t-1061bf5bf2ab9aea191cc3718462b79ce7f1884a2b81ec00f2415494e66eb1613
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container_issue 3
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container_title Clinical infectious diseases
container_volume 76
creator Chang, Charlotte
Agbaji, Oche
Mitruka, Kiren
Olatunde, Bola
Sule, Halima
Dajel, Titus
Zee, Aaron
Ahmed, Mukhtar L
Ahmed, Isah
Okonkwo, Prosper
Chaplin, Beth
Kanki, Phyllis
description Abstract Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. Results During April 2018–October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at
doi_str_mv 10.1093/cid/ciac605
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We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. Results During April 2018–October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at &lt;1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (P = .096) in ITT analysis and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (P = .012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (P = .02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCWs thought it facilitated patient care. Conclusions POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care. Clinical Trials Registration NCT03533868. In a randomized controlled trial in Nigeria, point-of-care viral load monitoring improved documentation of viral suppression and retention in care at 12 months on antiretroviral therapy compared with standard monitoring and was preferred by 90.2% (147/163) of surveyed patients.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/cid/ciac605</identifier><identifier>PMID: 35867672</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Anti-HIV Agents - therapeutic use ; HIV ; HIV Infections - drug therapy ; Humans ; Nigeria ; Point-of-Care Systems ; Viral Load - methods</subject><ispartof>Clinical infectious diseases, 2023-02, Vol.76 (3), p.e681-e691</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2022</rights><rights>The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-1061bf5bf2ab9aea191cc3718462b79ce7f1884a2b81ec00f2415494e66eb1613</citedby><cites>FETCH-LOGICAL-c413t-1061bf5bf2ab9aea191cc3718462b79ce7f1884a2b81ec00f2415494e66eb1613</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35867672$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chang, Charlotte</creatorcontrib><creatorcontrib>Agbaji, Oche</creatorcontrib><creatorcontrib>Mitruka, Kiren</creatorcontrib><creatorcontrib>Olatunde, Bola</creatorcontrib><creatorcontrib>Sule, Halima</creatorcontrib><creatorcontrib>Dajel, Titus</creatorcontrib><creatorcontrib>Zee, Aaron</creatorcontrib><creatorcontrib>Ahmed, Mukhtar L</creatorcontrib><creatorcontrib>Ahmed, Isah</creatorcontrib><creatorcontrib>Okonkwo, Prosper</creatorcontrib><creatorcontrib>Chaplin, Beth</creatorcontrib><creatorcontrib>Kanki, Phyllis</creatorcontrib><title>Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria</title><title>Clinical infectious diseases</title><addtitle>Clin Infect Dis</addtitle><description>Abstract Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. Results During April 2018–October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at &lt;1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (P = .096) in ITT analysis and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (P = .012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (P = .02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCWs thought it facilitated patient care. Conclusions POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care. Clinical Trials Registration NCT03533868. In a randomized controlled trial in Nigeria, point-of-care viral load monitoring improved documentation of viral suppression and retention in care at 12 months on antiretroviral therapy compared with standard monitoring and was preferred by 90.2% (147/163) of surveyed patients.</description><subject>Anti-HIV Agents - therapeutic use</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>Humans</subject><subject>Nigeria</subject><subject>Point-of-Care Systems</subject><subject>Viral Load - methods</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1DAURiMEoqWwYo-8QkUo4JvEP1khFAEz0kARlLK0HMeZXhTbg50glWfhYXE7QwUbFpav5OPz2fqK4jHQF0Db-qXBIS9tOGV3imNgtSg5a-FunimTZSNreVQ8SOkbpQCSsvvFUc0kF1xUx8WvbkKPRk_kbJlNcDYR9ESTT9oPweFPO5Au-DmGacrjecRMdsHtdES_JR8D-rkMY9npaMlXnC_J5znf1HEgq8VpT9bOLT4MdkSD1psrcoFxSeR0tb54dj1n3SbogbwPHudwI835H3Brc9TD4t6op2QfHfaT4svbN-fdqtycvVt3rzelaaCeS6Ac-pH1Y6X7VlsNLRhTC5ANr3rRGitGkLLRVS_BGkrHqgHWtI3l3PbAoT4pXu29u6V3djA2f1hPahfR6Xilgkb174nHS7UNPxQAMMpAZMPpwRDD98WmWTlMxk6T9jYsSVW8rYWo6A36fI-aGFKKdrzNAaquC1W5UHUoNNNP_n7aLfunwQw83QNh2f3X9BsrDaxf</recordid><startdate>20230208</startdate><enddate>20230208</enddate><creator>Chang, Charlotte</creator><creator>Agbaji, Oche</creator><creator>Mitruka, Kiren</creator><creator>Olatunde, Bola</creator><creator>Sule, Halima</creator><creator>Dajel, Titus</creator><creator>Zee, Aaron</creator><creator>Ahmed, Mukhtar L</creator><creator>Ahmed, Isah</creator><creator>Okonkwo, Prosper</creator><creator>Chaplin, Beth</creator><creator>Kanki, Phyllis</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20230208</creationdate><title>Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria</title><author>Chang, Charlotte ; Agbaji, Oche ; Mitruka, Kiren ; Olatunde, Bola ; Sule, Halima ; Dajel, Titus ; Zee, Aaron ; Ahmed, Mukhtar L ; Ahmed, Isah ; Okonkwo, Prosper ; Chaplin, Beth ; Kanki, Phyllis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-1061bf5bf2ab9aea191cc3718462b79ce7f1884a2b81ec00f2415494e66eb1613</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Anti-HIV Agents - therapeutic use</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>Humans</topic><topic>Nigeria</topic><topic>Point-of-Care Systems</topic><topic>Viral Load - methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chang, Charlotte</creatorcontrib><creatorcontrib>Agbaji, Oche</creatorcontrib><creatorcontrib>Mitruka, Kiren</creatorcontrib><creatorcontrib>Olatunde, Bola</creatorcontrib><creatorcontrib>Sule, Halima</creatorcontrib><creatorcontrib>Dajel, Titus</creatorcontrib><creatorcontrib>Zee, Aaron</creatorcontrib><creatorcontrib>Ahmed, Mukhtar L</creatorcontrib><creatorcontrib>Ahmed, Isah</creatorcontrib><creatorcontrib>Okonkwo, Prosper</creatorcontrib><creatorcontrib>Chaplin, Beth</creatorcontrib><creatorcontrib>Kanki, Phyllis</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chang, Charlotte</au><au>Agbaji, Oche</au><au>Mitruka, Kiren</au><au>Olatunde, Bola</au><au>Sule, Halima</au><au>Dajel, Titus</au><au>Zee, Aaron</au><au>Ahmed, Mukhtar L</au><au>Ahmed, Isah</au><au>Okonkwo, Prosper</au><au>Chaplin, Beth</au><au>Kanki, Phyllis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clin Infect Dis</addtitle><date>2023-02-08</date><risdate>2023</risdate><volume>76</volume><issue>3</issue><spage>e681</spage><epage>e691</epage><pages>e681-e691</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><abstract>Abstract Background Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. Methods We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. Results During April 2018–October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at &lt;1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (P = .096) in ITT analysis and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (P = .012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (P = .02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCWs thought it facilitated patient care. Conclusions POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care. Clinical Trials Registration NCT03533868. In a randomized controlled trial in Nigeria, point-of-care viral load monitoring improved documentation of viral suppression and retention in care at 12 months on antiretroviral therapy compared with standard monitoring and was preferred by 90.2% (147/163) of surveyed patients.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>35867672</pmid><doi>10.1093/cid/ciac605</doi><oa>free_for_read</oa></addata></record>
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subjects Anti-HIV Agents - therapeutic use
HIV
HIV Infections - drug therapy
Humans
Nigeria
Point-of-Care Systems
Viral Load - methods
title Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria
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