Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam
The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam. Seventy-one clusters (communes) were randomized in intervention or control, and a total of 64...
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Veröffentlicht in: | BMC INFECTIOUS DISEASES 2016-12, Vol.16 (1), p.759-759, Article 759 |
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creator | Cuong, Do Duy Sönnerborg, Anders Van Tam, Vu El-Khatib, Ziad Santacatterina, Michele Marrone, Gaetano Chuc, Nguyen Thi Kim Diwan, Vinod Thorson, Anna Le, Nicole K An, Pham Nhat Larsson, Mattias |
description | The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam.
Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.
Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p |
doi_str_mv | 10.1186/s12879-016-2017-x |
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Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.
Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01].
There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up.
NCT01433601 .]]></description><identifier>ISSN: 1471-2334</identifier><identifier>EISSN: 1471-2334</identifier><identifier>DOI: 10.1186/s12879-016-2017-x</identifier><identifier>PMID: 27986077</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Anti-HIV Agents - therapeutic use ; Care and treatment ; CD4 Lymphocyte Count ; Clinical trials ; Cluster Analysis ; Complications and side effects ; Counseling ; Female ; Health aspects ; Highly active antiretroviral therapy ; HIV infection ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - psychology ; HIV Infections - virology ; Humans ; Infectious diseases ; Lamivudine - therapeutic use ; Male ; Medicin och hälsovetenskap ; Nevirapine - therapeutic use ; Peer Group ; Social Support ; Stavudine - therapeutic use ; Treatment Outcome ; Vietnam - epidemiology ; Viral Load - drug effects</subject><ispartof>BMC INFECTIOUS DISEASES, 2016-12, Vol.16 (1), p.759-759, Article 759</ispartof><rights>COPYRIGHT 2016 BioMed Central Ltd.</rights><rights>Copyright BioMed Central 2016</rights><rights>The Author(s). 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c650t-aaae6e06dad0ef58678e98f948174b48d6243f219ac028e078b6e9618c1feb343</citedby><cites>FETCH-LOGICAL-c650t-aaae6e06dad0ef58678e98f948174b48d6243f219ac028e078b6e9618c1feb343</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5162085/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5162085/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,552,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27986077$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:134811348$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Cuong, Do Duy</creatorcontrib><creatorcontrib>Sönnerborg, Anders</creatorcontrib><creatorcontrib>Van Tam, Vu</creatorcontrib><creatorcontrib>El-Khatib, Ziad</creatorcontrib><creatorcontrib>Santacatterina, Michele</creatorcontrib><creatorcontrib>Marrone, Gaetano</creatorcontrib><creatorcontrib>Chuc, Nguyen Thi Kim</creatorcontrib><creatorcontrib>Diwan, Vinod</creatorcontrib><creatorcontrib>Thorson, Anna</creatorcontrib><creatorcontrib>Le, Nicole K</creatorcontrib><creatorcontrib>An, Pham Nhat</creatorcontrib><creatorcontrib>Larsson, Mattias</creatorcontrib><title>Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam</title><title>BMC INFECTIOUS DISEASES</title><addtitle>BMC Infect Dis</addtitle><description><![CDATA[The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam.
Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.
Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01].
There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up.
NCT01433601 .]]></description><subject>Adult</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Care and treatment</subject><subject>CD4 Lymphocyte Count</subject><subject>Clinical trials</subject><subject>Cluster Analysis</subject><subject>Complications and side effects</subject><subject>Counseling</subject><subject>Female</subject><subject>Health aspects</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV infection</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - psychology</subject><subject>HIV Infections - virology</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Lamivudine - therapeutic use</subject><subject>Male</subject><subject>Medicin och hälsovetenskap</subject><subject>Nevirapine - therapeutic use</subject><subject>Peer Group</subject><subject>Social Support</subject><subject>Stavudine - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Vietnam - epidemiology</subject><subject>Viral Load - drug effects</subject><issn>1471-2334</issn><issn>1471-2334</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>D8T</sourceid><recordid>eNqNk9tu1DAQhiMEoqXwANwgS9yUixQ7B9u5QaoqoCtVqsRhby2vM9m6JHawnbLlLXhjJtqeFoGEIiUT5_t_R_94suwlo0eMSf42skKKJqeM5wVlIt88yvZZJVhelGX1-EG9lz2L8ZIiI4vmabZXiEZyKsR-9msxjNok4jsyAgQSp3H0Ad8dubLB935tDem07acAxDpyuljm1nVgErRk1MmCS3GmtUs2QAoeZbon6QKCHq9JTjQx_RQTegftWj_Yn6g03iHa91imYJFH66WF5PTwPHvS6T7Ci5vnQfb1w_svJ6f52fnHxcnxWW54TVOutQYOlLe6pdDVkgsJjeyaSjJRrSrZ8qIqu4I12tBCAhVyxaHhTBrWwaqsyoMs3_rGHzBOKzUGO-hwrby26mbpG1agakpLXiPf_JMfg2_vRbdCVuLPzDfUvttqERigNRgahrRrsfPF2Qu19leqZrygct788MYg-O8TxKQGGw30vXbgp6iYrAveFJwJRF__gV76KTiMcqYqTksp5T211j0o7KjHfc1sqo4rUbGa4glB6ugvFF4tDBZ7CJ3F9R3Bmx3B3GfYpLWeYlSLz5_-nz1f7rJsy5rgYwzQ3WXHqJpnQW1nQeEsqHkW1AY1rx6Gfqe4PfzlbwgVBqc</recordid><startdate>20161216</startdate><enddate>20161216</enddate><creator>Cuong, Do Duy</creator><creator>Sönnerborg, Anders</creator><creator>Van Tam, Vu</creator><creator>El-Khatib, Ziad</creator><creator>Santacatterina, Michele</creator><creator>Marrone, Gaetano</creator><creator>Chuc, Nguyen Thi Kim</creator><creator>Diwan, Vinod</creator><creator>Thorson, Anna</creator><creator>Le, Nicole K</creator><creator>An, Pham Nhat</creator><creator>Larsson, Mattias</creator><general>BioMed Central Ltd</general><general>BioMed Central</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>ISR</scope><scope>3V.</scope><scope>7QL</scope><scope>7T2</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope></search><sort><creationdate>20161216</creationdate><title>Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam</title><author>Cuong, Do Duy ; Sönnerborg, Anders ; Van Tam, Vu ; El-Khatib, Ziad ; Santacatterina, Michele ; Marrone, Gaetano ; Chuc, Nguyen Thi Kim ; Diwan, Vinod ; Thorson, Anna ; Le, Nicole K ; An, Pham Nhat ; Larsson, Mattias</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c650t-aaae6e06dad0ef58678e98f948174b48d6243f219ac028e078b6e9618c1feb343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Care and treatment</topic><topic>CD4 Lymphocyte Count</topic><topic>Clinical trials</topic><topic>Cluster Analysis</topic><topic>Complications and side effects</topic><topic>Counseling</topic><topic>Female</topic><topic>Health aspects</topic><topic>Highly active antiretroviral therapy</topic><topic>HIV infection</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - immunology</topic><topic>HIV Infections - psychology</topic><topic>HIV Infections - virology</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Lamivudine - therapeutic use</topic><topic>Male</topic><topic>Medicin och hälsovetenskap</topic><topic>Nevirapine - therapeutic use</topic><topic>Peer Group</topic><topic>Social Support</topic><topic>Stavudine - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Vietnam - epidemiology</topic><topic>Viral Load - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cuong, Do Duy</creatorcontrib><creatorcontrib>Sönnerborg, Anders</creatorcontrib><creatorcontrib>Van Tam, Vu</creatorcontrib><creatorcontrib>El-Khatib, Ziad</creatorcontrib><creatorcontrib>Santacatterina, Michele</creatorcontrib><creatorcontrib>Marrone, Gaetano</creatorcontrib><creatorcontrib>Chuc, Nguyen Thi Kim</creatorcontrib><creatorcontrib>Diwan, Vinod</creatorcontrib><creatorcontrib>Thorson, Anna</creatorcontrib><creatorcontrib>Le, Nicole K</creatorcontrib><creatorcontrib>An, Pham Nhat</creatorcontrib><creatorcontrib>Larsson, Mattias</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: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Public Health Database</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>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</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>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>BMC INFECTIOUS DISEASES</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cuong, Do Duy</au><au>Sönnerborg, Anders</au><au>Van Tam, Vu</au><au>El-Khatib, Ziad</au><au>Santacatterina, Michele</au><au>Marrone, Gaetano</au><au>Chuc, Nguyen Thi Kim</au><au>Diwan, Vinod</au><au>Thorson, Anna</au><au>Le, Nicole K</au><au>An, Pham Nhat</au><au>Larsson, Mattias</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam</atitle><jtitle>BMC INFECTIOUS DISEASES</jtitle><addtitle>BMC Infect Dis</addtitle><date>2016-12-16</date><risdate>2016</risdate><volume>16</volume><issue>1</issue><spage>759</spage><epage>759</epage><pages>759-759</pages><artnum>759</artnum><issn>1471-2334</issn><eissn>1471-2334</eissn><abstract><![CDATA[The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam.
Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends.
Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01].
There was a low virologic failure risk during the first 2 years of ART follow-up in a rural low-income setting in Vietnam. Peer support did not show any impact on virologic and immunologic outcomes after 2 years of follow up.
NCT01433601 .]]></abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>27986077</pmid><doi>10.1186/s12879-016-2017-x</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Anti-HIV Agents - therapeutic use Care and treatment CD4 Lymphocyte Count Clinical trials Cluster Analysis Complications and side effects Counseling Female Health aspects Highly active antiretroviral therapy HIV infection HIV Infections - drug therapy HIV Infections - immunology HIV Infections - psychology HIV Infections - virology Humans Infectious diseases Lamivudine - therapeutic use Male Medicin och hälsovetenskap Nevirapine - therapeutic use Peer Group Social Support Stavudine - therapeutic use Treatment Outcome Vietnam - epidemiology Viral Load - drug effects |
title | Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam |
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