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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

(2017) TRIALS. 18.
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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.
Keywords
PREVENTION, INFECTION, DESIGN, MODELS, Antiretroviral treatment, Swaziland, HIV/AIDS, Prevention

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Please use this url to cite or link to this publication:

Chicago
Walsh, Fiona J, Till Barnighausen, Wim Delva, Yvette Fleming, Gavin Khumalo, Charlotte L Lejeune, Sikhathele Mazibuko, et al. 2017. “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 18.
APA
Walsh, F. J., Barnighausen, T., Delva, W., Fleming, Y., Khumalo, G., Lejeune, C. L., Mazibuko, S., et al. (2017). 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, 18.
Vancouver
1.
Walsh FJ, Barnighausen T, Delva W, Fleming Y, Khumalo G, Lejeune CL, et al. 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. 2017;18.
MLA
Walsh, Fiona J et al. “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 18 (2017): n. pag. Print.
@article{8532838,
  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.},
  articleno    = {383},
  author       = {Walsh, Fiona J and Barnighausen, Till and Delva, Wim and Fleming, Yvette and Khumalo, Gavin and Lejeune, Charlotte L and Mazibuko, Sikhathele and Mlambo, Charmaine Khudzie and Reis, Ria and Spiegelman, Donna and Zwane, Mandisa and Okello, Velephi},
  issn         = {1745-6215},
  journal      = {TRIALS},
  keywords     = {PREVENTION,INFECTION,DESIGN,MODELS,Antiretroviral treatment,Swaziland,HIV/AIDS,Prevention},
  language     = {eng},
  pages        = {10},
  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},
  url          = {http://dx.doi.org/10.1186/s13063-017-2128-8},
  volume       = {18},
  year         = {2017},
}

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