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
Abstract Background 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...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-08-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2128-8 |
| _version_ | 1818276473403867136 |
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| author | Fiona J. Walsh Till Bärnighausen Wim Delva Yvette Fleming Gavin Khumalo Charlotte L. Lejeune Sikhathele Mazibuko Charmaine Khudzie Mlambo Ria Reis Donna Spiegelman Mandisa Zwane Velephi Okello |
| author_facet | Fiona J. Walsh Till Bärnighausen Wim Delva Yvette Fleming Gavin Khumalo Charlotte L. Lejeune Sikhathele Mazibuko Charmaine Khudzie Mlambo Ria Reis Donna Spiegelman Mandisa Zwane Velephi Okello |
| author_sort | Fiona J. Walsh |
| collection | DOAJ |
| description | Abstract Background 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 MaxART 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016. |
| first_indexed | 2024-12-12T22:46:12Z |
| format | Article |
| id | doaj.art-1dadc6c6fba94fdc8f5b5cb7aaf284bc |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T22:46:12Z |
| publishDate | 2017-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1dadc6c6fba94fdc8f5b5cb7aaf284bc2022-12-22T00:09:10ZengBMCTrials1745-62152017-08-0118111010.1186/s13063-017-2128-8Impact 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 trialFiona J. Walsh0Till Bärnighausen1Wim Delva2Yvette Fleming3Gavin Khumalo4Charlotte L. Lejeune5Sikhathele Mazibuko6Charmaine Khudzie Mlambo7Ria Reis8Donna Spiegelman9Mandisa Zwane10Velephi Okello11Clinton Health Access InitiativeHarvard T.H. Chan School of Public HealthThe South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch UniversityaidsfondsSwaziland National Network of People Living with HIV/AIDS (SWANNEPHA)Clinton Health Access InitiativeMinistry of HealthClinton Health Access InitiativeUniversity of AmsterdamHarvard T.H. Chan School of Public HealthSAfAIDSMinistry of HealthAbstract Background 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 MaxART 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016.http://link.springer.com/article/10.1186/s13063-017-2128-8Antiretroviral treatmentSwazilandHIV/AIDSPrevention |
| spellingShingle | Fiona J. Walsh Till Bärnighausen Wim Delva Yvette Fleming Gavin Khumalo Charlotte L. Lejeune Sikhathele Mazibuko Charmaine Khudzie Mlambo Ria Reis Donna Spiegelman Mandisa Zwane Velephi Okello 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 Trials Antiretroviral treatment Swaziland HIV/AIDS Prevention |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Antiretroviral treatment Swaziland HIV/AIDS Prevention |
| url | http://link.springer.com/article/10.1186/s13063-017-2128-8 |
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