PLoS Medicine (Jun 2023)

Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti.

  • Nancy Dorvil,
  • Vanessa R Rivera,
  • Cynthia Riviere,
  • Richard Berman,
  • Patrice Severe,
  • Heejung Bang,
  • Kerlyne Lavoile,
  • Jessy G Devieux,
  • Mikerlyne Faustin,
  • Giovanni Saintyl,
  • Maria Duran Mendicuti,
  • Samuel Pierre,
  • Alexandra Apollon,
  • Emelyne Dumond,
  • Guyrlaine Pierre Louis Forestal,
  • Vanessa Rouzier,
  • Adias Marcelin,
  • Margaret L McNairy,
  • Kathleen F Walsh,
  • Kathryn Dupnik,
  • Lindsey K Reif,
  • Anthony L Byrne,
  • Stephanie Bousleiman,
  • Eli Orvis,
  • Patrice Joseph,
  • Pierre-Yves Cremieux,
  • Jean William Pape,
  • Serena P Koenig

DOI
https://doi.org/10.1371/journal.pmed.1004246
Journal volume & issue
Vol. 20, no. 6
p. e1004246

Abstract

Read online

BackgroundSame-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population.Methods and findingsWe conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA ConclusionsIn patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes.Trial registrationThis study is registered with ClinicalTrials.gov NCT03154320.