Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped-wedge randomized trial
Identifieur interne : 000651 ( Main/Exploration ); précédent : 000650; suivant : 000652Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped-wedge randomized trial
Auteurs : Fiona J. Walsh [États-Unis] ; Till B Rnighausen [États-Unis, Afrique du Sud, Allemagne] ; Wim Delva [Afrique du Sud, Belgique] ; Yvette Fleming [Pays-Bas] ; Gavin Khumalo [Swaziland] ; Charlotte L. Lejeune [Swaziland] ; Sikhathele Mazibuko [Swaziland] ; Charmaine Khudzie Mlambo [Swaziland] ; Ria Reis [Pays-Bas, Afrique du Sud] ; Donna Spiegelman [États-Unis] ; Mandisa Zwane [Zimbabwe] ; Velephi Okello [Swaziland]Source :
- Trials [ 1745-6215 ] ; 2017.
Abstract
There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as “treatment as prevention” or “universal test and treat”) is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The
This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland’s Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year.
Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period.
A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling.
A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa.
ClinicalTrials.gov,
The online version of this article (doi:10.1186/s13063-017-2128-8) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-017-2128-8
PubMed: 28821264
PubMed Central: 5563033
Affiliations:
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<institution></institution>
<institution>University of Amsterdam,</institution>
</institution-wrap>
Amsterdam, The Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Amsterdam</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff14"><institution-wrap><institution-id institution-id-type="ISNI">0000000089452978</institution-id>
<institution-id institution-id-type="GRID">grid.10419.3d</institution-id>
<institution></institution>
<institution>Leiden University Medical Center,</institution>
</institution-wrap>
Leiden, The Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Leiden</wicri:regionArea>
</affiliation>
<affiliation wicri:level="1"><nlm:aff id="Aff15"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1937 1151</institution-id>
<institution-id institution-id-type="GRID">grid.7836.a</institution-id>
<institution></institution>
<institution>Children’s Institute, University of Cape Town,</institution>
</institution-wrap>
Cape Town, South Africa</nlm:aff>
<country xml:lang="fr">Afrique du Sud</country>
<wicri:regionArea>Cape Town</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Spiegelman, Donna" sort="Spiegelman, Donna" uniqKey="Spiegelman D" first="Donna" last="Spiegelman">Donna Spiegelman</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></institution>
<institution>Harvard T.H. Chan School of Public Health,</institution>
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Boston, MA USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Zwane, Mandisa" sort="Zwane, Mandisa" uniqKey="Zwane M" first="Mandisa" last="Zwane">Mandisa Zwane</name>
<affiliation wicri:level="1"><nlm:aff id="Aff16">SAfAIDS, Harare, Zimbabwe</nlm:aff>
<country xml:lang="fr">Zimbabwe</country>
<wicri:regionArea>SAfAIDS, Harare</wicri:regionArea>
<wicri:noRegion>Harare</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Okello, Velephi" sort="Okello, Velephi" uniqKey="Okello V" first="Velephi" last="Okello">Velephi Okello</name>
<affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="GRID">grid.463475.7</institution-id>
<institution></institution>
<institution>Ministry of Health,</institution>
</institution-wrap>
Mbabane, Swaziland</nlm:aff>
<country xml:lang="fr">Swaziland</country>
<wicri:regionArea>Mbabane</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>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p id="Par1">There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as “treatment as prevention” or “universal test and treat”) is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The <italic>Max</italic>
ART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland’s public sector health system.</p>
</sec>
<sec><title>Methods</title>
<p id="Par2">This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland’s Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year.</p>
<p id="Par3">Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period.</p>
<p id="Par4">A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling.</p>
</sec>
<sec><title>Discussion</title>
<p id="Par5">A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa.</p>
</sec>
<sec><title>Trial registration</title>
<p id="Par6">ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02909218">NCT02909218</ext-link>
. Registered on 10 July 2016.</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s13063-017-2128-8) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<affiliations><list><country><li>Afrique du Sud</li>
<li>Allemagne</li>
<li>Belgique</li>
<li>Pays-Bas</li>
<li>Swaziland</li>
<li>Zimbabwe</li>
<li>États-Unis</li>
</country>
<region><li>Massachusetts</li>
</region>
</list>
<tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Walsh, Fiona J" sort="Walsh, Fiona J" uniqKey="Walsh F" first="Fiona J." last="Walsh">Fiona J. Walsh</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="Spiegelman, Donna" sort="Spiegelman, Donna" uniqKey="Spiegelman D" first="Donna" last="Spiegelman">Donna Spiegelman</name>
</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>
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<name sortKey="Delva, Wim" sort="Delva, Wim" uniqKey="Delva W" first="Wim" last="Delva">Wim Delva</name>
<name sortKey="Reis, Ria" sort="Reis, Ria" uniqKey="Reis R" first="Ria" last="Reis">Ria Reis</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="B Rnighausen, Till" sort="B Rnighausen, Till" uniqKey="B Rnighausen T" first="Till" last="B Rnighausen">Till B Rnighausen</name>
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</country>
<country name="Belgique"><noRegion><name sortKey="Delva, Wim" sort="Delva, Wim" uniqKey="Delva W" first="Wim" last="Delva">Wim Delva</name>
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<name sortKey="Delva, Wim" sort="Delva, Wim" uniqKey="Delva W" first="Wim" last="Delva">Wim Delva</name>
</country>
<country name="Pays-Bas"><noRegion><name sortKey="Fleming, Yvette" sort="Fleming, Yvette" uniqKey="Fleming Y" first="Yvette" last="Fleming">Yvette Fleming</name>
</noRegion>
<name sortKey="Reis, Ria" sort="Reis, Ria" uniqKey="Reis R" first="Ria" last="Reis">Ria Reis</name>
<name sortKey="Reis, Ria" sort="Reis, Ria" uniqKey="Reis R" first="Ria" last="Reis">Ria Reis</name>
</country>
<country name="Swaziland"><noRegion><name sortKey="Khumalo, Gavin" sort="Khumalo, Gavin" uniqKey="Khumalo G" first="Gavin" last="Khumalo">Gavin Khumalo</name>
</noRegion>
<name sortKey="Lejeune, Charlotte L" sort="Lejeune, Charlotte L" uniqKey="Lejeune C" first="Charlotte L." last="Lejeune">Charlotte L. Lejeune</name>
<name sortKey="Mazibuko, Sikhathele" sort="Mazibuko, Sikhathele" uniqKey="Mazibuko S" first="Sikhathele" last="Mazibuko">Sikhathele Mazibuko</name>
<name sortKey="Mlambo, Charmaine Khudzie" sort="Mlambo, Charmaine Khudzie" uniqKey="Mlambo C" first="Charmaine Khudzie" last="Mlambo">Charmaine Khudzie Mlambo</name>
<name sortKey="Okello, Velephi" sort="Okello, Velephi" uniqKey="Okello V" first="Velephi" last="Okello">Velephi Okello</name>
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</record>
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