Early Initiation of Fast-Track Care for Persons Living with HIV Initiating Dolutegravir-Based Regimens during a Period of Severe Civil Unrest in Port-au-Prince, Haiti

Abstract

ABSTRACTIntroductionDifferentiated service delivery (DSD) models have been widely implemented for patients who are established in HIV care. However, DSD has rarely been offered to those newly diagnosed with HIV. We conducted a study to assess the effectiveness of early fast-track care during the COVID-19 pandemic and a period of severe civil unrest at GHESKIO, in Haiti.MethodsWe conducted a pilot randomized trial among adults presenting with World Health Organization Stage 1 or 2 disease at HIV diagnosis to determine whether early fast-track care (at eight to 12 weeks after same-day HIV testing and ART initiation) was associated with superior outcomes, compared with standard care (deferred eligibility for fast-track care). All participants received tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD), and HIV-1 RNA <200 copies/mL was required prior to initiating fast-track care. The primary outcome was 48-week HIV-1 RNA <200 copies/mL, with intention-to-treat analysis.ResultsFrom December 13, 2020, to August 19, 2022, 247 participants were randomized; 2 met protocol-specified criteria for late exclusions, leaving a study population of 245 (standard: 116; early fast-track: 129). All participants initiated TLD on the day of HIV diagnosis. In the standard group, 2 (1.7%) died, 106 (91.4%) were retained in care, and 78 (67.2%) received 48-week viral load testing; 66 (84.6% of those tested; 56.9% of those randomized) had HIV-1 RNA <200 copies/mL. In the early fast-track group, 1 (0.8%) died, 112 (86.8%) were retained in care, and 87 (67.4%) received 48-week viral load testing; 79 (90.8% of those tested; 61.2% of those randomized) had 48-week HIV-1 RNA <200 copies/mL. There was no difference in primary outcome (48-week HIV-1 RNA <200 copies/mL) between the early fast-track and standard groups (61.2% vs. 56.9%; RD: 0.043; 95% CI: -0.080, 0.167).ConclusionsThe provision of fast-track care as early as 8 weeks after TLD initiation is associated with high levels of retention in care and viral suppression in a setting of severe civil unrest, with no difference in outcome compared to deferred eligibility for fast-track care. Completion of 48-week viral load testing was suboptimal; low-cost point-of-care testing capacity may facilitate completion of viral load testing in this setting.