Study intervention for the standard and same-day treatment groups.
TB, OIs
CLINICAL SYNDROME, OPPORTUNISTIC INFECTIONS, OIS
In the standard group, participants with a clinical syndrome and chest radiograph that were highly suspicious for TB initiated same-day TB treatment, without Xpert Ultra results. The remaining participants received neither ART nor TB medication on day 0. All were discharged home with co-trimoxazole prophylaxis, as well as symptomatic therapy as clinically indicated. On day 2, participants brought an early morning specimen to the laboratory for a second Xpert Ultra test and liquid mycobacterial culture and received the results of their first Xpert Ultra and baseline laboratory tests. Those with positive Xpert Ultra tests initiated same-day treatment; those with negative tests underwent continued evaluation for other opportunistic infections (OIs) as clinically indicated. On day 7, those who had not initiated TB treatment started ART; initially this was day 10, but in April 2018 it was changed to day 7 to reflect changes in standard of care. Those with TB initiated ART after completing 2 weeks of TB treatment, in accordance with WHO guidelines [The same-day group received same-day (day 0) evaluation for TB, including Xpert Ultra results. This required immediate transport of sputum specimens to the central lab, prompt testing, and a phone call to study staff with test results. The study physician reviewed all clinical data and made a same-day determination about whether each participant had TB. All participants were discharged from the day 0 visit with either TB medication or ART, as well as co-trimoxazole prophylaxis, and symptomatic therapy as clinically indicated. On day 2, participants brought an early morning specimen to the laboratory for a second Xpert Ultra test and liquid mycobacterial culture, and received the results of their baseline laboratory tests, as for the standard group. Those with TB initiated ART after completing 2 weeks of TB treatment [Other than the timing of availability of Xpert Ultra test results, and the timing of TB and ART treatment initiation, the same care was provided to both groups. First-line ART included efavirenz (EFV), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) until December 2018, when dolutegravir (DTG) became available. During 2019, all participants on EFV-based regimens were switched to DTG-based regimens, regardless of viral load results, in accordance with national guidelines. TB was treated with standard therapy in accordance with WHO guidelines [Retention activities were similar to those provided for all PLWH at GHESKIO. Community health workers (CHWs) made reminder phone calls in advance of each visit, and after missed visits, with home visits for participants who could not be reached by phone. Participants received a transportation subsidy of 100 Haitian gourdes ($US 1.00) and a phone card (valued at 100 Haitian gourdes) at each visit. Participants were counseled about the importance of adhering to therapy and of returning to clinic when they had symptoms.