Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi

Media type: E-Article
Title: Same-day versus rapid ART initiation in HIV-positive individuals presenting with symptoms of tuberculosis: Protocol for an open-label randomized non-inferiority trial in Lesotho and Malawi
Contributor: Gerber, Felix; Semphere, Robina; Lukau, Blaise; Mahlatsi, Palesa; Mtenga, Timeo; Lee, Tristan; Kohler, Maurus; Glass, Tracy Renée; Amstutz, Alain; Molatelle, Mamello; MacPherson, Peter; Marake, Nthuseng Bridgett; Nliwasa, Marriot; Ayakaka, Irene; Burke, Rachael; Labhardt, Niklaus
Published: Public Library of Science (PLoS), 2024
Published in: PLOS ONE, 19 (2024) 2, Seite e0288944
Language: English
DOI: 10.1371/journal.pone.0288944
ISSN: 1932-6203
Origination:
University thesis:
Footnote:
Description: <jats:sec id="sec001"> <jats:title>Background</jats:title> <jats:p>In absence of contraindications, same-day initiation (SDI) of antiretroviral therapy (ART) is recommended for people testing HIV-positive who are ready to start treatment. Until 2021, World Health Organization (WHO) guidelines considered the presence of TB symptoms (presumptive TB) a contraindication to SDI due to the risk of TB-immune reconstitution inflammatory syndrome (TB-IRIS). To reduce TB-IRIS risk, ART initiation was recommended to be postponed until results of TB investigations were available, and TB treatment initiated if active TB was confirmed. In 2021, the WHO guidelines changed to recommending SDI even in the presence of TB symptoms without awaiting results of TB investigations based on the assumption that TB investigations often unnecessarily delay ART initiation, increasing the risk for pre-ART attrition from care, and noting that the clinical relevance of TB-IRIS outside the central nervous system remains unclear. However, this guideline change was not based on conclusive evidence, and it remains unclear whether SDI of ART or TB test results should be prioritized in people with HIV (PWH) and presumptive TB.</jats:p> </jats:sec> <jats:sec id="sec002"> <jats:title>Design and methods</jats:title> <jats:p>SaDAPT is an open-label, pragmatic, parallel, 1:1 individually randomized, non-inferiority trial comparing two strategies for the timing of ART initiation in PWH with presumptive TB (“ART first” versus “TB results first”). PWH in Lesotho and Malawi, aged 12 years and older (re)initiating ART who have at least one TB symptom (cough, fever, night sweats or weight loss) and no signs of intracranial infection are eligible. After a baseline assessment, participants in the “ART first” arm will be offered SDI of ART, while those in the “TB results first” arm will be offered ART only after active TB has been confirmed or refuted. We hypothesize that the “ART first” approach is safe and non-inferior to the “TB results first” approach with regard to HIV viral suppression (<400 copies/ml) six months after enrolment. Secondary outcomes include retention in care and adverse events consistent with TB-IRIS.</jats:p> </jats:sec> <jats:sec id="sec003"> <jats:title>Expected outcomes</jats:title> <jats:p>SaDAPT will provide evidence on the safety and effects of SDI of ART in PWH with presumptive TB in a pragmatic clinical trial setting.</jats:p> </jats:sec> <jats:sec id="sec004"> <jats:title>Trial registration</jats:title> <jats:p>The trial has been registered on clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT05452616" xlink:type="simple">NCT05452616</jats:ext-link>; July 11 2022).</jats:p> </jats:sec>
Access State: Open Access

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