Outcomes
AIDS, TB, death, virologic failure, Deaths
ADVERSE EVENTS, AIDS
The primary outcome was the proportion of participants retained in care with HIV-1 RNA <200 copies/mL at 48 weeks after enrollment, with intention to treat (ITT) analysis, with a prespecified window of +/− 12 weeks; missing test results were considered virologic failures. Secondary outcomes included: 48-week HIV-1 RNA cut-offs of <50 copies/mL and <1,000 copies/mL; all-cause mortality, new Division of AIDS Grade 3 or 4 adverse events that were at least a 1-day increase above baseline, adherence as measured by medication possession ratio (proportion of days ART was dispensed within the study period), virologic failure with switch to second-line ART, and TB diagnosis after ART initiation (all throughout the 48-week study period); incidence of IRIS during the 12 weeks after ART initiation; and sensitivity of spot and early morning Xpert Ultra. Bacteriologically confirmed (BAC+) TB required confirmation by molecular testing or culture. Empiric TB was defined as symptoms and chest radiograph consistent with TB, without BAC+ confirmation. Participants were considered retained if they attended the 48-week visit. LTFU was defined as lost to care without known death; those who returned for at least 1 visit after missing the 48-week visit were classified as returned to care. Deaths were defined by family report; death certificates are not available in Haiti. Transfer was defined as documented transfer to an outside clinic.