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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
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  • Published on:
    Authors response to comments by Tom Boyles
    • Sydney Rosen, Professor Boston University School of Public Health
    • Other Contributors:
      • Matthew Fox, Professor
      • Francois Venter, Professor

    Dear Tom,

    Thank you for your comments.

    Your first point addresses the poor negative predictive value of a TB symptom screening test. We agree that the symptom screen that is currently called for in South Africa’s national guidelines, as well as WHO’s guidelines, is inadequate in terms of both negative and positive predictive value. We do not have, and you do not propose, however, an easily-available alternative. We consulted a number of TB experts in designing the algorithm and concluded that at the time of study initiation, there was no readily available clinical prediction rule or point-of-care instrument that we could expect to be adopted at a national scale if the trial’s results are compelling. We also designed the study to adhere as closely as possible to existing national guidelines, with the main difference being the timing of the initiation process rather than its content. Our goal is an algorithm that can be incorporated into routine practice as simply as possible, in the hope of benefiting patients at a large scale.

    We also observe that initiating ART in the presence of undiagnosed TB poses the risk of delayed TB treatment (which would have been delayed anyhow, due to the patient not having symptoms) or IRIS (which, while clinically occasionally challenging, is rarely fatal, especially in this group of ambulatory and largely healthy patients). We hypothesize that the well-characterized loss to follow-up and subsequent morbidity and mortal...

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    Conflict of Interest:
    None declared.
  • Published on:
    Clinical algorithm and sample size
    • Tom Boyles, Infectious diseases specialist University of Cape Town

    Dear Sydney-
    I have a number of concerns regarding the design of the SLATE trial that I would like to share. There are two important questions regarding ART initiation in ambulatory patients that you are addressing. The first is how to appropriately screen patients for conditions that preclude immediate initiation of ART and the second is the best time to initiate ART in ambulatory patients.
    The SLATE protocol begins with addressing the first question with a step-wise algorithm to identify patients who require further investigation for a variety of clinical conditions but most notably tuberculosis and cryptococcal disease. The first stage is a standardised WHO TB symptom screen which has been shown to be have an inadequate negative predictive value in high burden settings, particularly in patients who are not on ART. Rangaka et al (Clinical Infectious Diseases 2012;55(12):1698–706) showed in a South African cohort that 8.9% of patients with a negative symptoms screen who were not on ART had culture confirmed TB. More recently Hanifa et al (CROI 2015 abstract number: 823) showed that around 5.6% of patients who were recently diagnosed with HIV had a negative symptom screen but culture confirmed TB. The SLATE algorithm provides for further assessment for TB in patients without symptoms but this relies on a symptom-guided physical exam, this is poorly defined and it is unclear how this will pick-up TB in asymptomatic patients. It is therefore likely that between 5...

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    Conflict of Interest:
    None declared.