Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam
Identifieur interne : 000F77 ( Main/Exploration ); précédent : 000F76; suivant : 000F78Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam
Auteurs : Do Duy Cuong [Suède, Viêt Nam] ; Anders Sönnerborg [Suède] ; Vu Van Tam [Suède, Viêt Nam] ; Ziad El-Khatib [Suède, Canada] ; Michele Santacatterina [Suède] ; Gaetano Marrone [Suède] ; Nguyen Thi Kim Chuc [Viêt Nam] ; Vinod Diwan [Suède] ; Anna Thorson [Suède] ; Nicole K. Le [États-Unis] ; Pham Nhat An [Viêt Nam] ; Mattias Larsson [Suède, Viêt Nam]Source :
- BMC Infectious Diseases [ 1471-2334 ] ; 2016.
Abstract
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);
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.
Url:
DOI: 10.1186/s12879-016-2017-x
PubMed: 27986077
PubMed Central: 5162085
Affiliations:
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Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Chuc, Nguyen Thi Kim" sort="Chuc, Nguyen Thi Kim" uniqKey="Chuc N" first="Nguyen Thi Kim" last="Chuc">Nguyen Thi Kim Chuc</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Hanoi Medical University, Hanoi, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Hanoi Medical University, Hanoi</wicri:regionArea><wicri:noRegion>Hanoi</wicri:noRegion></affiliation></author><author><name sortKey="Diwan, Vinod" sort="Diwan, Vinod" uniqKey="Diwan V" first="Vinod" last="Diwan">Vinod Diwan</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country 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Le</name><affiliation wicri:level="2"><nlm:aff id="Aff9">Morsani College of Medicine, University of South Florida, Tampa, FL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Morsani College of Medicine, University of South Florida, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="An, Pham Nhat" sort="An, Pham Nhat" uniqKey="An P" first="Pham Nhat" last="An">Pham Nhat An</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Hanoi Medical University, Hanoi, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Hanoi Medical University, Hanoi</wicri:regionArea><wicri:noRegion>Hanoi</wicri:noRegion></affiliation></author><author><name sortKey="Larsson, Mattias" sort="Larsson, Mattias" uniqKey="Larsson M" first="Mattias" last="Larsson">Mattias Larsson</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, 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first="Do Duy" last="Cuong">Do Duy Cuong</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Infectious Diseases Department, Bach Mai Hospital, Hanoi, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Infectious Diseases Department, Bach Mai Hospital, Hanoi</wicri:regionArea><wicri:noRegion>Hanoi</wicri:noRegion></affiliation></author><author><name sortKey="Sonnerborg, Anders" sort="Sonnerborg, Anders" uniqKey="Sonnerborg A" first="Anders" last="Sönnerborg">Anders Sönnerborg</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Medicine Huddinge, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff4">Division of Clinical Virology, Department of Laboratory Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Division of Clinical Virology, Department of Laboratory Medicine Huddinge, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Van Tam, Vu" sort="Van Tam, Vu" uniqKey="Van Tam V" first="Vu" last="Van Tam">Vu Van Tam</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5">Vietnam-Sweden Uong Bi General Hospital, Quang Ninh, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Vietnam-Sweden Uong Bi General Hospital, Quang Ninh</wicri:regionArea><wicri:noRegion>Quang Ninh</wicri:noRegion></affiliation></author><author><name sortKey="El Khatib, Ziad" sort="El Khatib, Ziad" uniqKey="El Khatib Z" first="Ziad" last="El-Khatib">Ziad El-Khatib</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff6">World Health Programme, Université du Québec en Abitibi-Témiscamingue (UQAT), Rouyn-Noranda, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>World Health Programme, Université du Québec en Abitibi-Témiscamingue (UQAT), Rouyn-Noranda</wicri:regionArea><wicri:noRegion>Rouyn-Noranda</wicri:noRegion></affiliation></author><author><name sortKey="Santacatterina, Michele" sort="Santacatterina, Michele" uniqKey="Santacatterina M" first="Michele" last="Santacatterina">Michele Santacatterina</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Marrone, Gaetano" sort="Marrone, Gaetano" uniqKey="Marrone G" first="Gaetano" last="Marrone">Gaetano Marrone</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Chuc, Nguyen Thi Kim" sort="Chuc, Nguyen Thi Kim" uniqKey="Chuc N" first="Nguyen Thi Kim" last="Chuc">Nguyen Thi Kim Chuc</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Hanoi Medical University, Hanoi, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Hanoi Medical University, Hanoi</wicri:regionArea><wicri:noRegion>Hanoi</wicri:noRegion></affiliation></author><author><name sortKey="Diwan, Vinod" sort="Diwan, Vinod" uniqKey="Diwan V" first="Vinod" last="Diwan">Vinod Diwan</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Thorson, Anna" sort="Thorson, Anna" uniqKey="Thorson A" first="Anna" last="Thorson">Anna Thorson</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Le, Nicole K" sort="Le, Nicole K" uniqKey="Le N" first="Nicole K." last="Le">Nicole K. Le</name><affiliation wicri:level="2"><nlm:aff id="Aff9">Morsani College of Medicine, University of South Florida, Tampa, FL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Morsani College of Medicine, University of South Florida, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="An, Pham Nhat" sort="An, Pham Nhat" uniqKey="An P" first="Pham Nhat" last="An">Pham Nhat An</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Hanoi Medical University, Hanoi, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Hanoi Medical University, Hanoi</wicri:regionArea><wicri:noRegion>Hanoi</wicri:noRegion></affiliation></author><author><name sortKey="Larsson, Mattias" sort="Larsson, Mattias" uniqKey="Larsson M" first="Mattias" last="Larsson">Mattias Larsson</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff10">Oxford University Clinical Research Unit (OUCRU), Hanoi, Vietnam</nlm:aff><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Oxford University Clinical Research Unit (OUCRU), Hanoi</wicri:regionArea><wicri:noRegion>Hanoi</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Infectious Diseases</title><idno type="eISSN">1471-2334</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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); <italic>p</italic> < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2–4.3); <italic>p</italic> < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1–8.9); <italic>p</italic> < 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); <italic>p</italic> < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): −5.7 (−6.3;−5.4); <italic>p</italic> < 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); <italic>p</italic> < 0.01].</p></sec><sec><title>Conclusion</title><p>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.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrialbase.com/study/NCT01433601">NCT01433601</ext-link>.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Gardner, Emb" uniqKey="Gardner E">EMB Gardner</name></author><author><name sortKey="William, J" uniqKey="William J">J William</name></author><author><name sortKey="Steiner, Jf" uniqKey="Steiner J">JF Steiner</name></author><author><name sortKey="Anderson, Pl" uniqKey="Anderson P">PL Anderson</name></author><author><name sortKey="Bangsberg, Dr" uniqKey="Bangsberg D">DR Bangsberg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bangsberg, Drhf" uniqKey="Bangsberg D">DRHF Bangsberg</name></author><author><name 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uniqKey="Cuong D" first="Do Duy" last="Cuong">Do Duy Cuong</name></region><name sortKey="Diwan, Vinod" sort="Diwan, Vinod" uniqKey="Diwan V" first="Vinod" last="Diwan">Vinod Diwan</name><name sortKey="El Khatib, Ziad" sort="El Khatib, Ziad" uniqKey="El Khatib Z" first="Ziad" last="El-Khatib">Ziad El-Khatib</name><name sortKey="Larsson, Mattias" sort="Larsson, Mattias" uniqKey="Larsson M" first="Mattias" last="Larsson">Mattias Larsson</name><name sortKey="Marrone, Gaetano" sort="Marrone, Gaetano" uniqKey="Marrone G" first="Gaetano" last="Marrone">Gaetano Marrone</name><name sortKey="Santacatterina, Michele" sort="Santacatterina, Michele" uniqKey="Santacatterina M" first="Michele" last="Santacatterina">Michele Santacatterina</name><name sortKey="Sonnerborg, Anders" sort="Sonnerborg, Anders" uniqKey="Sonnerborg A" first="Anders" last="Sönnerborg">Anders Sönnerborg</name><name sortKey="Sonnerborg, Anders" sort="Sonnerborg, Anders" uniqKey="Sonnerborg A" first="Anders" last="Sönnerborg">Anders Sönnerborg</name><name sortKey="Thorson, Anna" sort="Thorson, Anna" uniqKey="Thorson A" first="Anna" last="Thorson">Anna Thorson</name><name sortKey="Van Tam, Vu" sort="Van Tam, Vu" uniqKey="Van Tam V" first="Vu" last="Van Tam">Vu Van Tam</name></country><country name="Viêt Nam"><noRegion><name sortKey="Cuong, Do Duy" sort="Cuong, Do Duy" uniqKey="Cuong D" first="Do Duy" last="Cuong">Do Duy Cuong</name></noRegion><name sortKey="An, Pham Nhat" sort="An, Pham Nhat" uniqKey="An P" first="Pham Nhat" last="An">Pham Nhat An</name><name sortKey="Chuc, Nguyen Thi Kim" sort="Chuc, Nguyen Thi Kim" uniqKey="Chuc N" first="Nguyen Thi Kim" last="Chuc">Nguyen Thi Kim Chuc</name><name sortKey="Larsson, Mattias" sort="Larsson, Mattias" uniqKey="Larsson M" first="Mattias" last="Larsson">Mattias Larsson</name><name sortKey="Van Tam, Vu" sort="Van Tam, Vu" uniqKey="Van Tam V" first="Vu" last="Van Tam">Vu Van Tam</name></country><country name="Canada"><noRegion><name sortKey="El Khatib, Ziad" sort="El Khatib, Ziad" uniqKey="El Khatib Z" first="Ziad" last="El-Khatib">Ziad El-Khatib</name></noRegion></country><country name="États-Unis"><region name="Floride"><name sortKey="Le, Nicole K" sort="Le, Nicole K" uniqKey="Le N" first="Nicole K." last="Le">Nicole K. 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