Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial
Identifieur interne : 000997 ( Pmc/Curation ); précédent : 000996; suivant : 000998Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial
Auteurs : Webster Mavhu [Zimbabwe, Royaume-Uni] ; Nicola Willis [Zimbabwe] ; Juliet Mufuka [Zimbabwe] ; Collin Mangenah [Zimbabwe] ; Kudzanayi Mvududu [Zimbabwe] ; Sarah Bernays ; Walter Mangezi [Zimbabwe] ; Tsitsi Apollo [Zimbabwe] ; Ricardo Araya [Royaume-Uni] ; Helen A. Weiss [Royaume-Uni] ; Frances M. Cowan [Zimbabwe, Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2017.
Abstract
World Health Organization (WHO) adolescent HIV-testing and treatment guidelines recommend community-based interventions to support antiretroviral therapy (ART) adherence and retention in care, while acknowledging that the evidence to support this recommendation is weak. This cluster randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a psychosocial, community-based intervention on HIV-related and psychosocial outcomes.
We are conducting the trial in two districts. Sixteen clinics were randomized to either enhanced ART-adherence support or standard of care. Eligible individuals (HIV-positive adolescents aged 13–19 years and eligible for ART) in both arms receive ART and adherence support provided by adult counselors and nursing staff. Adolescents in the intervention arm additionally attend a monthly support group, are allocated to a designated community adolescent treatment supporter, and followed up through a short message service (SMS) and calls plus home visits. The type and frequency of contact is determined by whether the adolescent is “stable” or in need of enhanced support. Stable adolescents receive a monthly home visit plus a weekly, individualized SMS. An additional home visit is conducted if participants miss a scheduled clinic appointment or support-group meeting. Participants in need of further, enhanced, support receive bi-weekly home visits, weekly phone calls and daily SMS. Caregivers of adolescents in the intervention arm attend a caregiver support group. Trial outcomes are assessed through a clinical, behavioral and psychological assessment conducted at baseline and after 48 and 96 weeks. The primary outcome is the proportion who have died or have virological failure (viral load ≥1000 copies/ml) at 96 weeks. Secondary outcomes include virological failure at 48 weeks, retention in care (proportion of missed visits) and psychosocial outcomes at both time points. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cluster randomized trials, including a flowchart.
This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely.
Pan African Clinical Trial Registry database, registration number
Url:
DOI: 10.1186/s13063-017-2198-7
PubMed: 29052529
PubMed Central: 5649065
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Sarah Bernays<affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>School of Public Health,</institution><institution>University of Sydney,</institution></institution-wrap>Sydney, NSW Australia</nlm:aff><wicri:noCountry code="subfield">NSW Australia</wicri:noCountry></affiliation>Le document en format XML
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Australia</wicri:noCountry></affiliation></author><author><name sortKey="Mangezi, Walter" sort="Mangezi, Walter" uniqKey="Mangezi W" first="Walter" last="Mangezi">Walter Mangezi</name><affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0572 0760</institution-id><institution-id institution-id-type="GRID">grid.13001.33</institution-id><institution>Department of Psychiatry,</institution><institution>University of Zimbabwe College of Health Sciences,</institution></institution-wrap>Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>Harare</wicri:regionArea></affiliation></author><author><name sortKey="Apollo, Tsitsi" sort="Apollo, Tsitsi" uniqKey="Apollo T" first="Tsitsi" last="Apollo">Tsitsi Apollo</name><affiliation wicri:level="1"><nlm:aff id="Aff6">AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe</nlm:aff><country 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type="wicri:source">PMC</idno><idno type="pmid">29052529</idno><idno type="pmc">5649065</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5649065</idno><idno type="RBID">PMC:5649065</idno><idno type="doi">10.1186/s13063-017-2198-7</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">000998</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000998</idno><idno type="wicri:Area/Pmc/Curation">000997</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000997</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial</title><author><name sortKey="Mavhu, Webster" sort="Mavhu, Webster" uniqKey="Mavhu W" first="Webster" last="Mavhu">Webster Mavhu</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.463169.f</institution-id><institution>Centre for Sexual Health and HIV/AIDS Research (CeSHHAR),</institution></institution-wrap>9 Monmouth Road, Avondale West, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>9 Monmouth Road, Avondale West, Harare</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 9764</institution-id><institution-id institution-id-type="GRID">grid.48004.38</institution-id><institution>Department of International Public Health,</institution><institution>Liverpool School of Tropical Medicine,</institution></institution-wrap>Liverpool, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liverpool</wicri:regionArea></affiliation></author><author><name sortKey="Willis, Nicola" sort="Willis, Nicola" uniqKey="Willis N" first="Nicola" last="Willis">Nicola Willis</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Africaid, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>Africaid, Harare</wicri:regionArea></affiliation></author><author><name sortKey="Mufuka, Juliet" sort="Mufuka, Juliet" uniqKey="Mufuka J" first="Juliet" last="Mufuka">Juliet Mufuka</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.463169.f</institution-id><institution>Centre for Sexual Health and HIV/AIDS Research (CeSHHAR),</institution></institution-wrap>9 Monmouth Road, Avondale West, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>9 Monmouth Road, Avondale West, Harare</wicri:regionArea></affiliation></author><author><name sortKey="Mangenah, Collin" sort="Mangenah, Collin" uniqKey="Mangenah C" first="Collin" last="Mangenah">Collin Mangenah</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.463169.f</institution-id><institution>Centre for Sexual Health and HIV/AIDS Research (CeSHHAR),</institution></institution-wrap>9 Monmouth Road, Avondale West, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>9 Monmouth Road, Avondale West, Harare</wicri:regionArea></affiliation></author><author><name sortKey="Mvududu, Kudzanayi" sort="Mvududu, Kudzanayi" uniqKey="Mvududu K" first="Kudzanayi" last="Mvududu">Kudzanayi Mvududu</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.463169.f</institution-id><institution>Centre for Sexual Health and HIV/AIDS Research (CeSHHAR),</institution></institution-wrap>9 Monmouth Road, Avondale West, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>9 Monmouth Road, Avondale West, Harare</wicri:regionArea></affiliation></author><author><name sortKey="Bernays, Sarah" sort="Bernays, Sarah" uniqKey="Bernays S" first="Sarah" last="Bernays">Sarah Bernays</name><affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>School of Public Health,</institution><institution>University of Sydney,</institution></institution-wrap>Sydney, NSW Australia</nlm:aff><wicri:noCountry code="subfield">NSW Australia</wicri:noCountry></affiliation></author><author><name sortKey="Mangezi, Walter" sort="Mangezi, Walter" uniqKey="Mangezi W" first="Walter" last="Mangezi">Walter Mangezi</name><affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0572 0760</institution-id><institution-id institution-id-type="GRID">grid.13001.33</institution-id><institution>Department of Psychiatry,</institution><institution>University of Zimbabwe College of Health Sciences,</institution></institution-wrap>Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>Harare</wicri:regionArea></affiliation></author><author><name sortKey="Apollo, Tsitsi" sort="Apollo, Tsitsi" uniqKey="Apollo T" first="Tsitsi" last="Apollo">Tsitsi Apollo</name><affiliation wicri:level="1"><nlm:aff id="Aff6">AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>AIDS and TB Unit, Ministry of Health and Child Care, Harare</wicri:regionArea></affiliation></author><author><name sortKey="Araya, Ricardo" sort="Araya, Ricardo" uniqKey="Araya R" first="Ricardo" last="Araya">Ricardo Araya</name><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2322 6764</institution-id><institution-id institution-id-type="GRID">grid.13097.3c</institution-id><institution>Health Services and Population Research Department,</institution><institution>King’s College London,</institution></institution-wrap>London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London</wicri:regionArea></affiliation></author><author><name sortKey="Weiss, Helen A" sort="Weiss, Helen A" uniqKey="Weiss H" first="Helen A." last="Weiss">Helen A. Weiss</name><affiliation wicri:level="1"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0425 469X</institution-id><institution-id institution-id-type="GRID">grid.8991.9</institution-id><institution>MRC Tropical Epidemiology Group,</institution><institution>London School of Hygiene and Tropical Medicine,</institution></institution-wrap>London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London</wicri:regionArea></affiliation></author><author><name sortKey="Cowan, Frances M" sort="Cowan, Frances M" uniqKey="Cowan F" first="Frances M." last="Cowan">Frances M. Cowan</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.463169.f</institution-id><institution>Centre for Sexual Health and HIV/AIDS Research (CeSHHAR),</institution></institution-wrap>9 Monmouth Road, Avondale West, Harare, Zimbabwe</nlm:aff><country xml:lang="fr">Zimbabwe</country><wicri:regionArea>9 Monmouth Road, Avondale West, Harare</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 9764</institution-id><institution-id institution-id-type="GRID">grid.48004.38</institution-id><institution>Department of International Public Health,</institution><institution>Liverpool School of Tropical Medicine,</institution></institution-wrap>Liverpool, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Liverpool</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p id="Par1">World Health Organization (WHO) adolescent HIV-testing and treatment guidelines recommend community-based interventions to support antiretroviral therapy (ART) adherence and retention in care, while acknowledging that the evidence to support this recommendation is weak. This cluster randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a psychosocial, community-based intervention on HIV-related and psychosocial outcomes.</p></sec><sec><title>Methods/design</title><p id="Par2">We are conducting the trial in two districts. Sixteen clinics were randomized to either enhanced ART-adherence support or standard of care. Eligible individuals (HIV-positive adolescents aged 13–19 years and eligible for ART) in both arms receive ART and adherence support provided by adult counselors and nursing staff. Adolescents in the intervention arm additionally attend a monthly support group, are allocated to a designated community adolescent treatment supporter, and followed up through a short message service (SMS) and calls plus home visits. The type and frequency of contact is determined by whether the adolescent is “stable” or in need of enhanced support. Stable adolescents receive a monthly home visit plus a weekly, individualized SMS. An additional home visit is conducted if participants miss a scheduled clinic appointment or support-group meeting. Participants in need of further, enhanced, support receive bi-weekly home visits, weekly phone calls and daily SMS. Caregivers of adolescents in the intervention arm attend a caregiver support group. Trial outcomes are assessed through a clinical, behavioral and psychological assessment conducted at baseline and after 48 and 96 weeks. The primary outcome is the proportion who have died or have virological failure (viral load ≥1000 copies/ml) at 96 weeks. Secondary outcomes include virological failure at 48 weeks, retention in care (proportion of missed visits) and psychosocial outcomes at both time points. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cluster randomized trials, including a flowchart.</p></sec><sec><title>Discussion</title><p id="Par3">This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely.</p></sec><sec><title>Trial registration</title><p id="Par4">Pan African Clinical Trial Registry database, registration number <ext-link ext-link-type="uri" xlink:href="http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201609001767322">PACTR201609001767322</ext-link> (the Zvandiri trial). Retrospectively registered on 5 September 2016.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Makadzange, At" uniqKey="Makadzange A">AT Makadzange</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nachega, Jb" uniqKey="Nachega J">JB Nachega</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bygrave, H" uniqKey="Bygrave H">H Bygrave</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bangsberg, Dr" uniqKey="Bangsberg D">DR Bangsberg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Paterson, Dl" uniqKey="Paterson D">DL Paterson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mullen, J" 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-id journal-id-type="iso-abbrev">Trials</journal-id><journal-title-group><journal-title>Trials</journal-title></journal-title-group><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">29052529</article-id><article-id pub-id-type="pmc">5649065</article-id><article-id pub-id-type="publisher-id">2198</article-id><article-id pub-id-type="doi">10.1186/s13063-017-2198-7</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0003-1881-4398</contrib-id><name><surname>Mavhu</surname><given-names>Webster</given-names></name><address><phone>+263 4 333 393</phone><email>wmavhu@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Willis</surname><given-names>Nicola</given-names></name><address><email>nicola@zvandiri.org</email></address><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Mufuka</surname><given-names>Juliet</given-names></name><address><email>jmufuka10@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Mangenah</surname><given-names>Collin</given-names></name><address><email>cmangenah1@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Mvududu</surname><given-names>Kudzanayi</given-names></name><address><email>smvududu@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bernays</surname><given-names>Sarah</given-names></name><address><email>sarah.bernays@sydney.edu.au</email></address><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Mangezi</surname><given-names>Walter</given-names></name><address><email>wmangezi@yahoo.co.uk</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Apollo</surname><given-names>Tsitsi</given-names></name><address><email>tsitsiapollo2@gmail.com</email></address><xref ref-type="aff" rid="Aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Araya</surname><given-names>Ricardo</given-names></name><address><email>ricardo.araya@kcl.ac.uk</email></address><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Weiss</surname><given-names>Helen A.</given-names></name><address><email>helen.weiss@lshtm.ac.uk</email></address><xref ref-type="aff" rid="Aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Cowan</surname><given-names>Frances M.</given-names></name><address><email>frances.cowan@lstmed.ac.uk</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="GRID">grid.463169.f</institution-id><institution>Centre for Sexual Health and HIV/AIDS Research (CeSHHAR),</institution></institution-wrap>9 Monmouth Road, Avondale West, Harare, Zimbabwe</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 9764</institution-id><institution-id institution-id-type="GRID">grid.48004.38</institution-id><institution>Department of International Public Health,</institution><institution>Liverpool School of Tropical Medicine,</institution></institution-wrap>Liverpool, UK</aff><aff id="Aff3"><label>3</label>Africaid, Harare, Zimbabwe</aff><aff id="Aff4"><label>4</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id><institution-id institution-id-type="GRID">grid.1013.3</institution-id><institution>School of Public Health,</institution><institution>University of Sydney,</institution></institution-wrap>Sydney, NSW Australia</aff><aff id="Aff5"><label>5</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0572 0760</institution-id><institution-id institution-id-type="GRID">grid.13001.33</institution-id><institution>Department of Psychiatry,</institution><institution>University of Zimbabwe College of Health Sciences,</institution></institution-wrap>Harare, Zimbabwe</aff><aff id="Aff6"><label>6</label>AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe</aff><aff id="Aff7"><label>7</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2322 6764</institution-id><institution-id institution-id-type="GRID">grid.13097.3c</institution-id><institution>Health Services and Population Research Department,</institution><institution>King’s College London,</institution></institution-wrap>London, UK</aff><aff id="Aff8"><label>8</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0425 469X</institution-id><institution-id institution-id-type="GRID">grid.8991.9</institution-id><institution>MRC Tropical Epidemiology Group,</institution><institution>London School of Hygiene and Tropical Medicine,</institution></institution-wrap>London, UK</aff></contrib-group><pub-date pub-type="epub"><day>20</day><month>10</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>20</day><month>10</month><year>2017</year></pub-date><pub-date pub-type="collection"><year>2017</year></pub-date><volume>18</volume><elocation-id>478</elocation-id><history><date date-type="received"><day>16</day><month>3</month><year>2017</year></date><date date-type="accepted"><day>18</day><month>9</month><year>2017</year></date></history><permissions><copyright-statement>© The Author(s). 2017</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p id="Par1">World Health Organization (WHO) adolescent HIV-testing and treatment guidelines recommend community-based interventions to support antiretroviral therapy (ART) adherence and retention in care, while acknowledging that the evidence to support this recommendation is weak. This cluster randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a psychosocial, community-based intervention on HIV-related and psychosocial outcomes.</p></sec><sec><title>Methods/design</title><p id="Par2">We are conducting the trial in two districts. Sixteen clinics were randomized to either enhanced ART-adherence support or standard of care. Eligible individuals (HIV-positive adolescents aged 13–19 years and eligible for ART) in both arms receive ART and adherence support provided by adult counselors and nursing staff. Adolescents in the intervention arm additionally attend a monthly support group, are allocated to a designated community adolescent treatment supporter, and followed up through a short message service (SMS) and calls plus home visits. The type and frequency of contact is determined by whether the adolescent is “stable” or in need of enhanced support. Stable adolescents receive a monthly home visit plus a weekly, individualized SMS. An additional home visit is conducted if participants miss a scheduled clinic appointment or support-group meeting. Participants in need of further, enhanced, support receive bi-weekly home visits, weekly phone calls and daily SMS. Caregivers of adolescents in the intervention arm attend a caregiver support group. Trial outcomes are assessed through a clinical, behavioral and psychological assessment conducted at baseline and after 48 and 96 weeks. The primary outcome is the proportion who have died or have virological failure (viral load ≥1000 copies/ml) at 96 weeks. Secondary outcomes include virological failure at 48 weeks, retention in care (proportion of missed visits) and psychosocial outcomes at both time points. Statistical analyses will be conducted and reported in line with CONSORT guidelines for cluster randomized trials, including a flowchart.</p></sec><sec><title>Discussion</title><p id="Par3">This study provides a unique opportunity to generate evidence of the impact of the on-going Zvandiri program, for adolescents living with HIV, on virological failure and psychosocial outcomes as delivered in a real-world setting. If found to reduce rates of treatment failure, this would strengthen support for further scale-up across Zimbabwe and likely the region more widely.</p></sec><sec><title>Trial registration</title><p id="Par4">Pan African Clinical Trial Registry database, registration number <ext-link ext-link-type="uri" xlink:href="http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201609001767322">PACTR201609001767322</ext-link> (the Zvandiri trial). Retrospectively registered on 5 September 2016.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>HIV</kwd><kwd>Antiretroviral therapy</kwd><kwd>Adolescents</kwd><kwd>Adherence</kwd><kwd>Zimbabwe</kwd><kwd>Psychosocial</kwd><kwd>Community-based</kwd></kwd-group><funding-group><award-group><funding-source><institution>ViiV Healthcare’s Positive Action for Adolescents Programme (Registered in England and Wales No. 06990358).</institution></funding-source></award-group></funding-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2017</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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