The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania
Identifieur interne : 000131 ( Main/Exploration ); précédent : 000130; suivant : 000132The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania
Auteurs : Pascal Geldsetzer [États-Unis] ; Joel M. Francis [Tanzanie, États-Unis] ; Nzovu Ulenga [Tanzanie] ; David Sando [États-Unis] ; Irene A. Lema [Tanzanie] ; Eric Mboggo [Tanzanie] ; Maria Vaikath [États-Unis] ; Happiness Koda [Tanzanie] ; Sharon Lwezaula [Tanzanie] ; Janice Hu [États-Unis] ; Ramadhani A. Noor [États-Unis, Tanzanie] ; Ibironke Olofin [États-Unis] ; Elysia Larson [États-Unis] ; Wafaie Fawzi [États-Unis] ; Till B Rnighausen [États-Unis, Allemagne, Afrique du Sud]Source :
- BMC Health Services Research [ 1472-6963 ] ; 2017.
Descripteurs français
- KwdFr :
- Acceptation des soins par le patient, Agents antiVIH (usage thérapeutique), Agents de santé communautaire (normes), Agents de santé communautaire (organisation et administration), Analyse de regroupements, Connaissances, attitudes et pratiques en santé, Humains, Infections à VIH (), Infections à VIH (traitement médicamenteux), Infections à VIH (virologie), Plan de recherche, Recherche sur les services de santé, Services de santé communautaires (normes), Services de santé communautaires (organisation et administration), Tanzanie, Éducation pour la santé (normes), Éducation pour la santé (organisation et administration).
- MESH :
- normes : Agents de santé communautaire, Services de santé communautaires, Éducation pour la santé.
- organisation et administration : Agents de santé communautaire, Services de santé communautaires, Éducation pour la santé.
- traitement médicamenteux : Infections à VIH.
- usage thérapeutique : Agents antiVIH.
- virologie : Infections à VIH.
- Acceptation des soins par le patient, Analyse de regroupements, Connaissances, attitudes et pratiques en santé, Humains, Infections à VIH, Plan de recherche, Recherche sur les services de santé, Tanzanie.
English descriptors
- KwdEn :
- Anti-HIV Agents (therapeutic use), Cluster Analysis, Community Health Services (organization & administration), Community Health Services (standards), Community Health Workers (organization & administration), Community Health Workers (standards), HIV Infections (drug therapy), HIV Infections (prevention & control), HIV Infections (virology), Health Education (organization & administration), Health Education (standards), Health Knowledge, Attitudes, Practice, Health Services Research, Humans, Patient Acceptance of Health Care, Research Design, Tanzania.
- MESH :
- chemical , therapeutic use : Anti-HIV Agents.
- drug therapy : HIV Infections.
- organization & administration : Community Health Services, Community Health Workers, Health Education.
- prevention & control : HIV Infections.
- standards : Community Health Services, Community Health Workers, Health Education.
- virology : HIV Infections.
- Cluster Analysis, Health Knowledge, Attitudes, Practice, Health Services Research, Humans, Patient Acceptance of Health Care, Research Design, Tanzania.
Abstract
Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression.
This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points.
As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients’ healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility- to community-based healthcare workers.
ClinicalTrials.gov:
The online version of this article (doi:10.1186/s12913-017-2032-7) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s12913-017-2032-7
PubMed: 28228134
PubMed Central: 5322683
Affiliations:
- Afrique du Sud, Allemagne, Tanzanie, États-Unis
- Bade-Wurtemberg, Caroline du Nord, District de Karlsruhe, Massachusetts
- Heidelberg
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Le document en format XML
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Chan School of Public Health,</institution></institution-wrap>677 Huntington Avenue, Boston, MA 02115 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>677 Huntington Avenue, Boston</wicri:cityArea></affiliation></author><author><name sortKey="B Rnighausen, Till" sort="B Rnighausen, Till" uniqKey="B Rnighausen T" first="Till" last="B Rnighausen">Till B Rnighausen</name><affiliation wicri:level="2"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">000000041936754X</institution-id><institution-id institution-id-type="GRID">grid.38142.3c</institution-id><institution>Department of Global Health and Population,</institution><institution>Harvard T.H. Chan School of Public Health,</institution></institution-wrap>665 Huntington Avenue, Boston, MA 02115 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>665 Huntington Avenue, Boston</wicri:cityArea></affiliation><affiliation wicri:level="3"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2190 4373</institution-id><institution-id institution-id-type="GRID">grid.7700.0</institution-id><institution>Institute for Public Health, Faculty of Medicine,</institution><institution>Heidelberg University,</institution></institution-wrap>Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Im Neuenheimer Feld 130.3, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff8">Africa Health Research Institute, Mtubatuba 3935, KwaZulu-Natal, South Africa</nlm:aff><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Africa Health Research Institute, Mtubatuba 3935, KwaZulu-Natal</wicri:regionArea><wicri:noRegion>KwaZulu-Natal</wicri:noRegion></affiliation></author></analytic><series><title level="j">BMC Health Services Research</title><idno type="eISSN">1472-6963</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anti-HIV Agents (therapeutic use)</term><term>Cluster Analysis</term><term>Community Health Services (organization & administration)</term><term>Community Health Services (standards)</term><term>Community Health Workers (organization & administration)</term><term>Community Health Workers (standards)</term><term>HIV Infections (drug therapy)</term><term>HIV Infections (prevention & control)</term><term>HIV Infections (virology)</term><term>Health Education (organization & administration)</term><term>Health Education (standards)</term><term>Health Knowledge, Attitudes, Practice</term><term>Health Services Research</term><term>Humans</term><term>Patient Acceptance of Health Care</term><term>Research Design</term><term>Tanzania</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Acceptation des soins par le patient</term><term>Agents antiVIH (usage thérapeutique)</term><term>Agents de santé communautaire (normes)</term><term>Agents de santé communautaire (organisation et administration)</term><term>Analyse de regroupements</term><term>Connaissances, attitudes et pratiques en santé</term><term>Humains</term><term>Infections à VIH ()</term><term>Infections à VIH (traitement médicamenteux)</term><term>Infections à VIH (virologie)</term><term>Plan de recherche</term><term>Recherche sur les services de santé</term><term>Services de santé communautaires (normes)</term><term>Services de santé communautaires (organisation et administration)</term><term>Tanzanie</term><term>Éducation pour la santé (normes)</term><term>Éducation pour la santé (organisation et administration)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-HIV Agents</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Agents de santé communautaire</term><term>Services de santé communautaires</term><term>Éducation pour la santé</term></keywords><keywords scheme="MESH" qualifier="organisation et administration" xml:lang="fr"><term>Agents de santé communautaire</term><term>Services de santé communautaires</term><term>Éducation pour la santé</term></keywords><keywords scheme="MESH" qualifier="organization & administration" xml:lang="en"><term>Community Health Services</term><term>Community Health Workers</term><term>Health Education</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Community Health Services</term><term>Community Health Workers</term><term>Health Education</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à VIH</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Agents antiVIH</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Infections à VIH</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Cluster Analysis</term><term>Health Knowledge, Attitudes, Practice</term><term>Health Services Research</term><term>Humans</term><term>Patient Acceptance of Health Care</term><term>Research Design</term><term>Tanzania</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Acceptation des soins par le patient</term><term>Analyse de regroupements</term><term>Connaissances, attitudes et pratiques en santé</term><term>Humains</term><term>Infections à VIH</term><term>Plan de recherche</term><term>Recherche sur les services de santé</term><term>Tanzanie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression.</p></sec><sec><title>Methods</title><p>This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points.</p></sec><sec><title>Discussion</title><p>As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients’ healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility- to community-based healthcare workers.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02711293">NCT02711293</ext-link>. Registration date: 16 March 2016.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s12913-017-2032-7) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Hontelez, J" uniqKey="Hontelez J">J Hontelez</name></author><author><name sortKey="Chang, A" uniqKey="Chang A">A Chang</name></author><author><name sortKey="Ogbuoji, O" uniqKey="Ogbuoji O">O Ogbuoji</name></author><author><name sortKey="Vlas, S" uniqKey="Vlas S">S Vlas</name></author><author><name sortKey="B Rnighausen, T" uniqKey="B Rnighausen T">T Bärnighausen</name></author><author><name sortKey="Atun, R" uniqKey="Atun R">R 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Pool</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Fox, Mp" uniqKey="Fox M">MP Fox</name></author><author><name sortKey="Rosen, S" uniqKey="Rosen S">S Rosen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Woodd, Sl" uniqKey="Woodd S">SL Woodd</name></author><author><name sortKey="Grosskurth, H" uniqKey="Grosskurth H">H Grosskurth</name></author><author><name sortKey="Levin, J" uniqKey="Levin J">J Levin</name></author><author><name sortKey="Amuron, B" uniqKey="Amuron B">B Amuron</name></author><author><name sortKey="Namara, G" uniqKey="Namara G">G Namara</name></author><author><name sortKey="Birunghi, J" uniqKey="Birunghi J">J Birunghi</name></author><author><name sortKey="Coutinho, A" uniqKey="Coutinho A">A Coutinho</name></author><author><name sortKey="Jaffar, S" uniqKey="Jaffar S">S Jaffar</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Afrique du Sud</li><li>Allemagne</li><li>Tanzanie</li><li>États-Unis</li></country><region><li>Bade-Wurtemberg</li><li>Caroline du Nord</li><li>District de Karlsruhe</li><li>Massachusetts</li></region><settlement><li>Heidelberg</li></settlement></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Geldsetzer, Pascal" sort="Geldsetzer, Pascal" uniqKey="Geldsetzer P" first="Pascal" last="Geldsetzer">Pascal Geldsetzer</name></region><name sortKey="B Rnighausen, Till" sort="B Rnighausen, Till" uniqKey="B Rnighausen T" first="Till" last="B Rnighausen">Till B Rnighausen</name><name sortKey="Fawzi, Wafaie" sort="Fawzi, Wafaie" uniqKey="Fawzi W" first="Wafaie" last="Fawzi">Wafaie Fawzi</name><name sortKey="Fawzi, Wafaie" sort="Fawzi, Wafaie" uniqKey="Fawzi W" first="Wafaie" last="Fawzi">Wafaie Fawzi</name><name sortKey="Fawzi, Wafaie" sort="Fawzi, Wafaie" uniqKey="Fawzi W" first="Wafaie" last="Fawzi">Wafaie Fawzi</name><name sortKey="Francis, Joel M" sort="Francis, Joel M" uniqKey="Francis J" first="Joel M." last="Francis">Joel M. Francis</name><name sortKey="Hu, Janice" sort="Hu, Janice" uniqKey="Hu J" first="Janice" last="Hu">Janice Hu</name><name sortKey="Hu, Janice" sort="Hu, Janice" uniqKey="Hu J" first="Janice" last="Hu">Janice Hu</name><name sortKey="Larson, Elysia" sort="Larson, Elysia" uniqKey="Larson E" first="Elysia" last="Larson">Elysia Larson</name><name sortKey="Noor, Ramadhani A" sort="Noor, Ramadhani A" uniqKey="Noor R" first="Ramadhani A." last="Noor">Ramadhani A. Noor</name><name sortKey="Noor, Ramadhani A" sort="Noor, Ramadhani A" uniqKey="Noor R" first="Ramadhani A." last="Noor">Ramadhani A. Noor</name><name sortKey="Olofin, Ibironke" sort="Olofin, Ibironke" uniqKey="Olofin I" first="Ibironke" last="Olofin">Ibironke Olofin</name><name sortKey="Sando, David" sort="Sando, David" uniqKey="Sando D" first="David" last="Sando">David Sando</name><name sortKey="Vaikath, Maria" sort="Vaikath, Maria" uniqKey="Vaikath M" first="Maria" last="Vaikath">Maria Vaikath</name></country><country name="Tanzanie"><noRegion><name sortKey="Francis, Joel M" sort="Francis, Joel M" uniqKey="Francis J" first="Joel M." last="Francis">Joel M. Francis</name></noRegion><name sortKey="Francis, Joel M" sort="Francis, Joel M" uniqKey="Francis J" first="Joel M." last="Francis">Joel M. Francis</name><name sortKey="Koda, Happiness" sort="Koda, Happiness" uniqKey="Koda H" first="Happiness" last="Koda">Happiness Koda</name><name sortKey="Lema, Irene A" sort="Lema, Irene A" uniqKey="Lema I" first="Irene A." last="Lema">Irene A. Lema</name><name sortKey="Lwezaula, Sharon" sort="Lwezaula, Sharon" uniqKey="Lwezaula S" first="Sharon" last="Lwezaula">Sharon Lwezaula</name><name sortKey="Mboggo, Eric" sort="Mboggo, Eric" uniqKey="Mboggo E" first="Eric" last="Mboggo">Eric Mboggo</name><name sortKey="Noor, Ramadhani A" sort="Noor, Ramadhani A" uniqKey="Noor R" first="Ramadhani A." last="Noor">Ramadhani A. Noor</name><name sortKey="Ulenga, Nzovu" sort="Ulenga, Nzovu" uniqKey="Ulenga N" first="Nzovu" last="Ulenga">Nzovu Ulenga</name></country><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="B Rnighausen, Till" sort="B Rnighausen, Till" uniqKey="B Rnighausen T" first="Till" last="B Rnighausen">Till B Rnighausen</name></region></country><country name="Afrique du Sud"><noRegion><name sortKey="B Rnighausen, Till" sort="B Rnighausen, Till" uniqKey="B Rnighausen T" first="Till" last="B Rnighausen">Till B Rnighausen</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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