Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial.
<h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service deli...
Ausführliche Beschreibung
Autor*in: |
Nadine Tschumi [verfasserIn] Malebanye Lerotholi [verfasserIn] Mathebe Kopo [verfasserIn] Mpho Kao [verfasserIn] Blaise Lukau [verfasserIn] Bienvenu Nsakala [verfasserIn] Ntoiseng Chejane [verfasserIn] Lipontso Motaboli [verfasserIn] Tristan Lee [verfasserIn] Ruanne Barnabas [verfasserIn] Adrienne E Shapiro [verfasserIn] Alastair van Heerden [verfasserIn] Thabo I Lejone [verfasserIn] Alain Amstutz [verfasserIn] Jennifer A Brown [verfasserIn] Jesse Heitner [verfasserIn] Jennifer M Belus [verfasserIn] Frédérique Chammartin [verfasserIn] Niklaus D Labhardt [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2022 |
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Übergeordnetes Werk: |
In: PLoS ONE - Public Library of Science (PLoS), 2007, 17(2022), 5, p e0268100 |
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Übergeordnetes Werk: |
volume:17 ; year:2022 ; number:5, p e0268100 |
Links: |
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DOI / URN: |
10.1371/journal.pone.0268100 |
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Katalog-ID: |
DOAJ04122857X |
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520 | |a <h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). | ||
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10.1371/journal.pone.0268100 doi (DE-627)DOAJ04122857X (DE-599)DOAJ5582e63d7c9442a9b4874f860bd81602 DE-627 ger DE-627 rakwb eng Nadine Tschumi verfasserin aut Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). Medicine R Science Q Malebanye Lerotholi verfasserin aut Mathebe Kopo verfasserin aut Mpho Kao verfasserin aut Blaise Lukau verfasserin aut Bienvenu Nsakala verfasserin aut Ntoiseng Chejane verfasserin aut Lipontso Motaboli verfasserin aut Tristan Lee verfasserin aut Ruanne Barnabas verfasserin aut Adrienne E Shapiro verfasserin aut Alastair van Heerden verfasserin aut Thabo I Lejone verfasserin aut Alain Amstutz verfasserin aut Jennifer A Brown verfasserin aut Jesse Heitner verfasserin aut Jennifer M Belus verfasserin aut Frédérique Chammartin verfasserin aut Niklaus D Labhardt verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 17(2022), 5, p e0268100 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:17 year:2022 number:5, p e0268100 https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/article/5582e63d7c9442a9b4874f860bd81602 kostenfrei https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2022 5, p e0268100 |
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10.1371/journal.pone.0268100 doi (DE-627)DOAJ04122857X (DE-599)DOAJ5582e63d7c9442a9b4874f860bd81602 DE-627 ger DE-627 rakwb eng Nadine Tschumi verfasserin aut Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). Medicine R Science Q Malebanye Lerotholi verfasserin aut Mathebe Kopo verfasserin aut Mpho Kao verfasserin aut Blaise Lukau verfasserin aut Bienvenu Nsakala verfasserin aut Ntoiseng Chejane verfasserin aut Lipontso Motaboli verfasserin aut Tristan Lee verfasserin aut Ruanne Barnabas verfasserin aut Adrienne E Shapiro verfasserin aut Alastair van Heerden verfasserin aut Thabo I Lejone verfasserin aut Alain Amstutz verfasserin aut Jennifer A Brown verfasserin aut Jesse Heitner verfasserin aut Jennifer M Belus verfasserin aut Frédérique Chammartin verfasserin aut Niklaus D Labhardt verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 17(2022), 5, p e0268100 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:17 year:2022 number:5, p e0268100 https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/article/5582e63d7c9442a9b4874f860bd81602 kostenfrei https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2022 5, p e0268100 |
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10.1371/journal.pone.0268100 doi (DE-627)DOAJ04122857X (DE-599)DOAJ5582e63d7c9442a9b4874f860bd81602 DE-627 ger DE-627 rakwb eng Nadine Tschumi verfasserin aut Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). Medicine R Science Q Malebanye Lerotholi verfasserin aut Mathebe Kopo verfasserin aut Mpho Kao verfasserin aut Blaise Lukau verfasserin aut Bienvenu Nsakala verfasserin aut Ntoiseng Chejane verfasserin aut Lipontso Motaboli verfasserin aut Tristan Lee verfasserin aut Ruanne Barnabas verfasserin aut Adrienne E Shapiro verfasserin aut Alastair van Heerden verfasserin aut Thabo I Lejone verfasserin aut Alain Amstutz verfasserin aut Jennifer A Brown verfasserin aut Jesse Heitner verfasserin aut Jennifer M Belus verfasserin aut Frédérique Chammartin verfasserin aut Niklaus D Labhardt verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 17(2022), 5, p e0268100 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:17 year:2022 number:5, p e0268100 https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/article/5582e63d7c9442a9b4874f860bd81602 kostenfrei https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2022 5, p e0268100 |
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10.1371/journal.pone.0268100 doi (DE-627)DOAJ04122857X (DE-599)DOAJ5582e63d7c9442a9b4874f860bd81602 DE-627 ger DE-627 rakwb eng Nadine Tschumi verfasserin aut Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). Medicine R Science Q Malebanye Lerotholi verfasserin aut Mathebe Kopo verfasserin aut Mpho Kao verfasserin aut Blaise Lukau verfasserin aut Bienvenu Nsakala verfasserin aut Ntoiseng Chejane verfasserin aut Lipontso Motaboli verfasserin aut Tristan Lee verfasserin aut Ruanne Barnabas verfasserin aut Adrienne E Shapiro verfasserin aut Alastair van Heerden verfasserin aut Thabo I Lejone verfasserin aut Alain Amstutz verfasserin aut Jennifer A Brown verfasserin aut Jesse Heitner verfasserin aut Jennifer M Belus verfasserin aut Frédérique Chammartin verfasserin aut Niklaus D Labhardt verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 17(2022), 5, p e0268100 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:17 year:2022 number:5, p e0268100 https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/article/5582e63d7c9442a9b4874f860bd81602 kostenfrei https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2022 5, p e0268100 |
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10.1371/journal.pone.0268100 doi (DE-627)DOAJ04122857X (DE-599)DOAJ5582e63d7c9442a9b4874f860bd81602 DE-627 ger DE-627 rakwb eng Nadine Tschumi verfasserin aut Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). Medicine R Science Q Malebanye Lerotholi verfasserin aut Mathebe Kopo verfasserin aut Mpho Kao verfasserin aut Blaise Lukau verfasserin aut Bienvenu Nsakala verfasserin aut Ntoiseng Chejane verfasserin aut Lipontso Motaboli verfasserin aut Tristan Lee verfasserin aut Ruanne Barnabas verfasserin aut Adrienne E Shapiro verfasserin aut Alastair van Heerden verfasserin aut Thabo I Lejone verfasserin aut Alain Amstutz verfasserin aut Jennifer A Brown verfasserin aut Jesse Heitner verfasserin aut Jennifer M Belus verfasserin aut Frédérique Chammartin verfasserin aut Niklaus D Labhardt verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 17(2022), 5, p e0268100 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:17 year:2022 number:5, p e0268100 https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/article/5582e63d7c9442a9b4874f860bd81602 kostenfrei https://doi.org/10.1371/journal.pone.0268100 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2022 5, p e0268100 |
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Nadine Tschumi @@aut@@ Malebanye Lerotholi @@aut@@ Mathebe Kopo @@aut@@ Mpho Kao @@aut@@ Blaise Lukau @@aut@@ Bienvenu Nsakala @@aut@@ Ntoiseng Chejane @@aut@@ Lipontso Motaboli @@aut@@ Tristan Lee @@aut@@ Ruanne Barnabas @@aut@@ Adrienne E Shapiro @@aut@@ Alastair van Heerden @@aut@@ Thabo I Lejone @@aut@@ Alain Amstutz @@aut@@ Jennifer A Brown @@aut@@ Jesse Heitner @@aut@@ Jennifer M Belus @@aut@@ Frédérique Chammartin @@aut@@ Niklaus D Labhardt @@aut@@ |
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assessment of a viral load result-triggered automated differentiated service delivery model for people taking art in lesotho (the vital study): study protocol of a cluster-randomized trial |
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Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial. |
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<h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). |
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<h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). |
abstract_unstemmed |
<h4<Introduction</h4<To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving.<h4<Methods</h4<The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences.<h4<Expected outcomes</h4<Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving.<h4<Trial registration</h4<The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). |
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