Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti
Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed w...
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| Veröffentlicht in: | PLoS medicine 2023-06, Vol.20 (6), p.e1004246 |
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| creator | Dorvil, Nancy Rivera, Vanessa R Riviere, Cynthia Berman, Richard Severe, Patrice Bang, Heejung Lavoile, Kerlyne Devieux, Jessy G Faustin, Mikerlyne Saintyl, Giovanni Mendicuti, Maria Duran Pierre, Samuel Apollon, Alexandra Dumond, Emelyne Forestal, Guyrlaine Pierre Louis Rouzier, Vanessa Marcelin, Adias McNairy, Margaret L Walsh, Kathleen F Dupnik, Kathryn Reif, Lindsey K Byrne, Anthony L Bousleiman, Stephanie Orvis, Eli Joseph, Patrice Cremieux, Pierre-Yves Pape, Jean William Koenig, Serena P |
| description | Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population.
We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA |
| doi_str_mv | 10.1371/journal.pmed.1004246 |
| format | Article |
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We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.
In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes.
This study is registered with ClinicalTrials.gov NCT03154320.</description><identifier>ISSN: 1549-1676</identifier><identifier>ISSN: 1549-1277</identifier><identifier>EISSN: 1549-1676</identifier><identifier>DOI: 10.1371/journal.pmed.1004246</identifier><identifier>PMID: 37294843</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Adult ; AIDS ; Analysis ; Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; Antiretroviral therapy ; Antiviral agents ; Biology and Life Sciences ; Criminal investigations ; Diagnosis ; Dosage and administration ; Drug therapy ; Gangs ; Haiti - epidemiology ; Health aspects ; Health behavior ; Highly active antiretroviral therapy ; HIV ; HIV (Viruses) ; HIV Infections - complications ; HIV Infections - diagnosis ; HIV Infections - drug therapy ; HIV testing ; Human immunodeficiency virus ; Humans ; Informed consent ; Labels ; Laboratories ; Medicine and Health Sciences ; Meningitis ; Questionnaires ; Ribonucleic acid ; RNA ; Tuberculosis ; Tuberculosis - complications ; Tuberculosis - diagnosis ; Tuberculosis - drug therapy ; Violent crime</subject><ispartof>PLoS medicine, 2023-06, Vol.20 (6), p.e1004246</ispartof><rights>Copyright: © 2023 Dorvil 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 Dorvil 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 Dorvil et al 2023 Dorvil et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c765t-88af847c4645ae88b6f6e9d870f4ab02a333168608adc2c0d5eed5030a4dad8d3</citedby><cites>FETCH-LOGICAL-c765t-88af847c4645ae88b6f6e9d870f4ab02a333168608adc2c0d5eed5030a4dad8d3</cites><orcidid>0000-0001-7853-633X ; 0000-0001-8063-8773 ; 0000-0001-5329-4688 ; 0000-0001-6479-0820 ; 0000-0002-9672-9474 ; 0000-0001-7100-2917 ; 0000-0002-5755-9951 ; 0000-0001-7464-275X ; 0000-0003-3427-4475</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/PMC10292694/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10292694/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37294843$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dorvil, Nancy</creatorcontrib><creatorcontrib>Rivera, Vanessa R</creatorcontrib><creatorcontrib>Riviere, Cynthia</creatorcontrib><creatorcontrib>Berman, Richard</creatorcontrib><creatorcontrib>Severe, Patrice</creatorcontrib><creatorcontrib>Bang, Heejung</creatorcontrib><creatorcontrib>Lavoile, Kerlyne</creatorcontrib><creatorcontrib>Devieux, Jessy G</creatorcontrib><creatorcontrib>Faustin, Mikerlyne</creatorcontrib><creatorcontrib>Saintyl, Giovanni</creatorcontrib><creatorcontrib>Mendicuti, Maria Duran</creatorcontrib><creatorcontrib>Pierre, Samuel</creatorcontrib><creatorcontrib>Apollon, Alexandra</creatorcontrib><creatorcontrib>Dumond, Emelyne</creatorcontrib><creatorcontrib>Forestal, Guyrlaine Pierre Louis</creatorcontrib><creatorcontrib>Rouzier, Vanessa</creatorcontrib><creatorcontrib>Marcelin, Adias</creatorcontrib><creatorcontrib>McNairy, Margaret L</creatorcontrib><creatorcontrib>Walsh, Kathleen F</creatorcontrib><creatorcontrib>Dupnik, Kathryn</creatorcontrib><creatorcontrib>Reif, Lindsey K</creatorcontrib><creatorcontrib>Byrne, Anthony L</creatorcontrib><creatorcontrib>Bousleiman, Stephanie</creatorcontrib><creatorcontrib>Orvis, Eli</creatorcontrib><creatorcontrib>Joseph, Patrice</creatorcontrib><creatorcontrib>Cremieux, Pierre-Yves</creatorcontrib><creatorcontrib>Pape, Jean William</creatorcontrib><creatorcontrib>Koenig, Serena P</creatorcontrib><title>Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti</title><title>PLoS medicine</title><addtitle>PLoS Med</addtitle><description>Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population.
We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.
In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes.
This study is registered with ClinicalTrials.gov NCT03154320.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adult</subject><subject>AIDS</subject><subject>Analysis</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral therapy</subject><subject>Antiviral agents</subject><subject>Biology and Life Sciences</subject><subject>Criminal investigations</subject><subject>Diagnosis</subject><subject>Dosage and administration</subject><subject>Drug therapy</subject><subject>Gangs</subject><subject>Haiti - epidemiology</subject><subject>Health aspects</subject><subject>Health behavior</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV</subject><subject>HIV (Viruses)</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - diagnosis</subject><subject>HIV Infections - drug therapy</subject><subject>HIV testing</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Informed consent</subject><subject>Labels</subject><subject>Laboratories</subject><subject>Medicine and Health Sciences</subject><subject>Meningitis</subject><subject>Questionnaires</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>Tuberculosis</subject><subject>Tuberculosis - complications</subject><subject>Tuberculosis - diagnosis</subject><subject>Tuberculosis - drug therapy</subject><subject>Violent crime</subject><issn>1549-1676</issn><issn>1549-1277</issn><issn>1549-1676</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqVk8Fu1DAQhiMEolB4AwSWkBAcdnFix0m4oKoCulJFJQq9WrP2ZNdVYgfbKSwPyvPgtNuqi3oA5eDI880_Y_-eLHuW03nOqvztuRu9hW4-9KjnOaW84OJe9igveTPLRSXu3_rfyx6HcE5p0dCGPsz2WFU0vObsUfb7FHqcadiQiCEauyI_TFwTY000EI2zxLUEbDQeo3cXxkNH4ho9DBviPInjEr0aOxdMINEjxB5tJBfowxhIiGA1eE0UeCRt4ocUcDaQwWNI4E29HZ2w6Yfo-kAgkqPFGdEGVnaKvCMHxCdJ15tfqIkb0M46WGJqyZvUWOtdT44gtf4ke9BCF_Dpdt3Pvn388PXwaHZ88mlxeHA8U5Uo46yuoa15pbjgJWBdL0UrsNF1RVsOS1oAYywXtaA1aFUoqktEXVJGgWvQtWb72Ysr3SG1LreWBFnUrGYFq3iRiMUVoR2cy8GbHvxGOjDycsP5lQQfjepQFqxphUBRtnnBlaqWWtQoGqxQlUzpSev9ttq4TK6rdIPJjx3R3Yg1a7lyFzJPzhei4Unh9VbBu-9jclz2JijsOrDoxqnx9Iqasrxs_OVf6N3H21IrSCcwtnWpsJpE5UFVCkYrXk3U7A5qhTY9pM5ZbE3a3uHnd_Dp09gbdWfCm52ExET8GVcwhiAXp1_-g_387-zJ2S776ha7RujiOrhunKYo7IL8ClTeheCxvXEwp3Ka7eubltNsy-1sp7Tnt92_SboeZvYHh3VO3Q</recordid><startdate>20230609</startdate><enddate>20230609</enddate><creator>Dorvil, Nancy</creator><creator>Rivera, Vanessa R</creator><creator>Riviere, Cynthia</creator><creator>Berman, Richard</creator><creator>Severe, Patrice</creator><creator>Bang, Heejung</creator><creator>Lavoile, Kerlyne</creator><creator>Devieux, Jessy G</creator><creator>Faustin, Mikerlyne</creator><creator>Saintyl, Giovanni</creator><creator>Mendicuti, Maria Duran</creator><creator>Pierre, Samuel</creator><creator>Apollon, Alexandra</creator><creator>Dumond, Emelyne</creator><creator>Forestal, Guyrlaine Pierre Louis</creator><creator>Rouzier, Vanessa</creator><creator>Marcelin, Adias</creator><creator>McNairy, Margaret L</creator><creator>Walsh, Kathleen F</creator><creator>Dupnik, Kathryn</creator><creator>Reif, Lindsey K</creator><creator>Byrne, Anthony L</creator><creator>Bousleiman, Stephanie</creator><creator>Orvis, Eli</creator><creator>Joseph, Patrice</creator><creator>Cremieux, Pierre-Yves</creator><creator>Pape, Jean William</creator><creator>Koenig, Serena P</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</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>IOV</scope><scope>ISN</scope><scope>ISR</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>COVID</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><scope>CZK</scope><orcidid>https://orcid.org/0000-0001-7853-633X</orcidid><orcidid>https://orcid.org/0000-0001-8063-8773</orcidid><orcidid>https://orcid.org/0000-0001-5329-4688</orcidid><orcidid>https://orcid.org/0000-0001-6479-0820</orcidid><orcidid>https://orcid.org/0000-0002-9672-9474</orcidid><orcidid>https://orcid.org/0000-0001-7100-2917</orcidid><orcidid>https://orcid.org/0000-0002-5755-9951</orcidid><orcidid>https://orcid.org/0000-0001-7464-275X</orcidid><orcidid>https://orcid.org/0000-0003-3427-4475</orcidid></search><sort><creationdate>20230609</creationdate><title>Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti</title><author>Dorvil, Nancy ; Rivera, Vanessa R ; Riviere, Cynthia ; Berman, Richard ; Severe, Patrice ; Bang, Heejung ; Lavoile, Kerlyne ; Devieux, Jessy G ; Faustin, Mikerlyne ; Saintyl, Giovanni ; Mendicuti, Maria Duran ; Pierre, Samuel ; Apollon, Alexandra ; Dumond, Emelyne ; Forestal, Guyrlaine Pierre Louis ; Rouzier, Vanessa ; Marcelin, Adias ; McNairy, Margaret L ; Walsh, Kathleen F ; Dupnik, Kathryn ; Reif, Lindsey K ; Byrne, Anthony L ; Bousleiman, Stephanie ; Orvis, Eli ; Joseph, Patrice ; Cremieux, Pierre-Yves ; Pape, Jean William ; Koenig, Serena P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c765t-88af847c4645ae88b6f6e9d870f4ab02a333168608adc2c0d5eed5030a4dad8d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Adult</topic><topic>AIDS</topic><topic>Analysis</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral drugs</topic><topic>Antiretroviral therapy</topic><topic>Antiviral agents</topic><topic>Biology and Life Sciences</topic><topic>Criminal investigations</topic><topic>Diagnosis</topic><topic>Dosage and administration</topic><topic>Drug therapy</topic><topic>Gangs</topic><topic>Haiti - epidemiology</topic><topic>Health aspects</topic><topic>Health behavior</topic><topic>Highly active antiretroviral therapy</topic><topic>HIV</topic><topic>HIV (Viruses)</topic><topic>HIV Infections - complications</topic><topic>HIV Infections - diagnosis</topic><topic>HIV Infections - drug therapy</topic><topic>HIV testing</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Informed consent</topic><topic>Labels</topic><topic>Laboratories</topic><topic>Medicine and Health Sciences</topic><topic>Meningitis</topic><topic>Questionnaires</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>Tuberculosis</topic><topic>Tuberculosis - complications</topic><topic>Tuberculosis - diagnosis</topic><topic>Tuberculosis - drug therapy</topic><topic>Violent crime</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dorvil, Nancy</creatorcontrib><creatorcontrib>Rivera, Vanessa R</creatorcontrib><creatorcontrib>Riviere, Cynthia</creatorcontrib><creatorcontrib>Berman, Richard</creatorcontrib><creatorcontrib>Severe, Patrice</creatorcontrib><creatorcontrib>Bang, Heejung</creatorcontrib><creatorcontrib>Lavoile, Kerlyne</creatorcontrib><creatorcontrib>Devieux, Jessy G</creatorcontrib><creatorcontrib>Faustin, Mikerlyne</creatorcontrib><creatorcontrib>Saintyl, Giovanni</creatorcontrib><creatorcontrib>Mendicuti, Maria Duran</creatorcontrib><creatorcontrib>Pierre, Samuel</creatorcontrib><creatorcontrib>Apollon, Alexandra</creatorcontrib><creatorcontrib>Dumond, Emelyne</creatorcontrib><creatorcontrib>Forestal, Guyrlaine Pierre Louis</creatorcontrib><creatorcontrib>Rouzier, Vanessa</creatorcontrib><creatorcontrib>Marcelin, Adias</creatorcontrib><creatorcontrib>McNairy, Margaret L</creatorcontrib><creatorcontrib>Walsh, Kathleen F</creatorcontrib><creatorcontrib>Dupnik, Kathryn</creatorcontrib><creatorcontrib>Reif, Lindsey K</creatorcontrib><creatorcontrib>Byrne, Anthony L</creatorcontrib><creatorcontrib>Bousleiman, Stephanie</creatorcontrib><creatorcontrib>Orvis, Eli</creatorcontrib><creatorcontrib>Joseph, Patrice</creatorcontrib><creatorcontrib>Cremieux, Pierre-Yves</creatorcontrib><creatorcontrib>Pape, Jean William</creatorcontrib><creatorcontrib>Koenig, Serena P</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Canada</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Coronavirus Research Database</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</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>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><collection>PLoS Medicine</collection><jtitle>PLoS medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dorvil, Nancy</au><au>Rivera, Vanessa R</au><au>Riviere, Cynthia</au><au>Berman, Richard</au><au>Severe, Patrice</au><au>Bang, Heejung</au><au>Lavoile, Kerlyne</au><au>Devieux, Jessy G</au><au>Faustin, Mikerlyne</au><au>Saintyl, Giovanni</au><au>Mendicuti, Maria Duran</au><au>Pierre, Samuel</au><au>Apollon, Alexandra</au><au>Dumond, Emelyne</au><au>Forestal, Guyrlaine Pierre Louis</au><au>Rouzier, Vanessa</au><au>Marcelin, Adias</au><au>McNairy, Margaret L</au><au>Walsh, Kathleen F</au><au>Dupnik, Kathryn</au><au>Reif, Lindsey K</au><au>Byrne, Anthony L</au><au>Bousleiman, Stephanie</au><au>Orvis, Eli</au><au>Joseph, Patrice</au><au>Cremieux, Pierre-Yves</au><au>Pape, Jean William</au><au>Koenig, Serena P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti</atitle><jtitle>PLoS medicine</jtitle><addtitle>PLoS Med</addtitle><date>2023-06-09</date><risdate>2023</risdate><volume>20</volume><issue>6</issue><spage>e1004246</spage><pages>e1004246-</pages><issn>1549-1676</issn><issn>1549-1277</issn><eissn>1549-1676</eissn><abstract>Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population.
We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.
In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes.
This study is registered with ClinicalTrials.gov NCT03154320.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>37294843</pmid><doi>10.1371/journal.pmed.1004246</doi><orcidid>https://orcid.org/0000-0001-7853-633X</orcidid><orcidid>https://orcid.org/0000-0001-8063-8773</orcidid><orcidid>https://orcid.org/0000-0001-5329-4688</orcidid><orcidid>https://orcid.org/0000-0001-6479-0820</orcidid><orcidid>https://orcid.org/0000-0002-9672-9474</orcidid><orcidid>https://orcid.org/0000-0001-7100-2917</orcidid><orcidid>https://orcid.org/0000-0002-5755-9951</orcidid><orcidid>https://orcid.org/0000-0001-7464-275X</orcidid><orcidid>https://orcid.org/0000-0003-3427-4475</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1549-1676 |
| ispartof | PLoS medicine, 2023-06, Vol.20 (6), p.e1004246 |
| issn | 1549-1676 1549-1277 1549-1676 |
| language | eng |
| recordid | cdi_plos_journals_2838323742 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Public Library of Science (PLoS) |
| subjects | Acquired immune deficiency syndrome Adult AIDS Analysis Anti-HIV Agents - therapeutic use Antiretroviral drugs Antiretroviral therapy Antiviral agents Biology and Life Sciences Criminal investigations Diagnosis Dosage and administration Drug therapy Gangs Haiti - epidemiology Health aspects Health behavior Highly active antiretroviral therapy HIV HIV (Viruses) HIV Infections - complications HIV Infections - diagnosis HIV Infections - drug therapy HIV testing Human immunodeficiency virus Humans Informed consent Labels Laboratories Medicine and Health Sciences Meningitis Questionnaires Ribonucleic acid RNA Tuberculosis Tuberculosis - complications Tuberculosis - diagnosis Tuberculosis - drug therapy Violent crime |
| title | Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti |
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