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Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation
  1. Sydney Rosen1,2,
  2. Matthew P Fox1,2,3,
  3. Bruce A Larson1,
  4. Alana T Brennan1,2,
  5. Mhairi Maskew2,
  6. Isaac Tsikhutsu4,
  7. Margaret Bii4,
  8. Peter D Ehrenkranz5,
  9. WD Francois Venter6
  1. 1 Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA
  2. 2 Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
  3. 3 Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA
  4. 4 Kenya Medical Research Institute/Walter Reed Project HIV Program, Kericho, Kenya
  5. 5 Bill & Melinda Gates Foundation, Seattle, Washington, USA
  6. 6 Wits Reproductive Health and HIV Institute, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
  1. Correspondence to Professor Sydney Rosen; sbrosen{at}bu.edu

Abstract

Introduction African countries are rapidly adopting guidelines to offer antiretroviral therapy (ART) to all HIV-infected individuals, regardless of CD4 count. For this policy of ‘treat all’ to succeed, millions of new patients must be initiated on ART as efficiently as possible. Studies have documented high losses of treatment-eligible patients from care before they receive their first dose of antiretrovirals (ARVs), due in part to a cumbersome, resource-intensive process for treatment initiation, requiring multiple clinic visits over a several-week period.

Methods and analysis The Simplified Algorithm for Treatment Eligibility (SLATE) study is an individually randomised evaluation of a simplified clinical algorithm for clinicians to reliably determine a patient’s eligibility for immediate ART initiation without waiting for laboratory results or additional clinic visits. SLATE will enrol and randomise (1:1) 960 adult, HIV-positive patients who present for HIV testing or care and are not yet on ART in South Africa and Kenya. Patients randomised to the standard arm will receive routine, standard of care ART initiation from clinic staff. Patients randomised to the intervention arm will be administered a symptom report, medical history, brief physical exam and readiness assessment. Patients who have positive (satisfactory) results for all four components of SLATE will be dispensed ARVs immediately, at the same clinic visit. Patients who have any negative results will be referred for further clinical investigation, counselling, tests or other services prior to being dispensed ARVs. After the initial visit, follow-up will be by passive medical record review. The primary outcomes will be ART initiation ≤28 days and retention in care 8 months after study enrolment.

Ethics and dissemination Ethics approval has been provided by the Boston University Institutional Review Board, the University of the Witwatersrand Human Research Ethics Committee (Medical) and the KEMRI Scientific and Ethics Review Unit. Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents.

Trial registration NCT02891135

  • Antiretroviral therapy
  • Treatment initiation
  • Africa
  • South Africa
  • Kenya
  • protocols & guidelines
  • Randomized trial

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors Conceived of and designed the work: SR, MPF, BAL, PDE and WDFV. Contributed to designing the work: ATB, MM, IT and MB. Wrote the first draft of the manuscript: SR. Reviewed and revised the manuscript: all authors. Approve the manuscript's results and conclusions: all authors. All authors have read, and confirm that they meet, ICMJE criteria for authorship.

  • Funding Funding for the work presented here was provided by the Bill & Melinda Gates Foundation under the terms of OPP1136158 to Boston University. The funders participated in the Technical Consultation reported here and are coauthors of the manuscript. The funders had no separate role, beyond that of other participants and authors, in study design, data collection and analysis, decision to publish or preparation of the manuscript. The views expressed are those of the authors and should not be construed to represent the positions of the US Army or the Department of Defense.

  • Competing interests PDE is an employee of the Bill & Melinda Gates Foundation, which is funding this work. WDFV sits on antiretroviral initiation guideline committees, both local and international. WDFV has accepted speaking honoraria from multiple manufacturers of antiretrovirals and is on several of their advisory boards. The remaining authors declare that they have no competing interests.

  • Patient consent Not applicable.

  • Ethics approval Boston University Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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