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 unblinded trial

ABSTRACT Background Same-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 would be superior to standard care in this population. Methods and Findings We conducted an open-label randomized trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day treatment [TB medication if TB; ART if no TB]) vs. standard care. In both groups, ART was initiated two weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group). Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 229 (91.6%) were retained, and 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 218 (87.2%) were retained, and 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% vs. 67.2%; risk difference: -0.06; 95% CI: -0.15, 0.02; p=0.14). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. Conclusions In patients with TB symptoms at HIV diagnosis, same-day treatment is not associated with superior retention and viral suppression. A short delay in ART initiation, which facilitates more feasible TB testing, does not compromise outcomes. Trial Registration This study is registered with ClinicalTrials.gov NCT03154320