Mortality under early access to antiretroviral therapy vs. Eswatini's national standard of care: the MaxART clustered randomized stepped-wedge trial.

OBJECTIVES: Current WHO guidelines recommend the treatment of all HIV-infected individuals with antiretroviral therapy (ART) to improve survival and quality of life, and decrease infection of others. MaxART is the first implementation trial of this strategy embedded within a government-managed health system, and assesses mortality as a secondary outcome. Because primary findings strongly supported scale-up of the 'treat all' strategy (hereafter Treat All), this analysis examines mortality as an additional indicator of its impact. METHODS: MaxART was conducted in 14 Eswatinian health clinics through a clinic-based stepped-wedge design, by transitioning clinics from then-national standard of care (SoC) to the Treat All intervention. All-cause, disease-related, and HIV-related mortality were analysed using the Cox proportional hazards model, censoring SoC participants at clinic transition. Median follow-up time among study participants was 292 days. There were 36/2034 deaths in SoC (1.77%) and 49/1371 deaths in Treat All (3.57%). RESULTS: Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and Treat All interventions, respectively, the multivariable-adjusted 12-month all-cause mortality rates were 1.42% [95% confidence interval (CI): 0.66-2.17] and 1.60% (95% CI: 0.78-2.40), disease-related mortality rates were 1.02% (95% CI: 0.40-1.64) and 1.10% (95% CI: 0.46-1.73), and HIV-related mortality rates were 1.03% (95% CI: 0.40-1.65) and 0.99% (95% CI: 0.40-1.58). Treat All had no impact on all-cause [hazard ratio (HR) = 1.12, 95% CI: 0.58-2.18, P = 0.73], disease-related (HR = 1.04, 95% CI: 0.52-2.11, P = 0.90), or HIV-related mortality (HR = 0.93, 95% CI: 0.46-1.87, P = 0.83). CONCLUSION: There was no immediate benefit of the Treat All strategy on mortality, nor evidence of harm. Longer follow-up of participants is needed to establish long-term consequences.

High completion rates of isoniazid preventive therapy among persons living with HIV in Swaziland.

SETTING: Five human immunodeficiency virus (HIV) care facilities in Swaziland. OBJECTIVE: To assess adherence and treatment completion of a 6-month course of isoniazid preventive therapy (IPT) provided to HIV-infected patients through a self-selected model of facility-based, community-based or peer-supported IPT delivery coordinated with antiretroviral refills. DESIGN: Prospective cohort study. RESULTS: Between February and August 2015, we enrolled 908 patients, with follow-up until February 2016. Most were female (66.2%), with a median age of 38 years (interquartile range 31-45). Most (n = 797, 87.8%) chose facility-based delivery, 111 (12.2%) selected community-based delivery, and none selected peer-supported delivery. Adherence was high in both cohorts; among those with available data, 794 (94.8%) reported taking at least 80% of their IPT (P > 0.05). Twenty-two patients screened positive for tuberculosis (TB) at any visit; all had TB excluded and most continued IPT. In total, 812 (89.4%) patients completed treatment: 711 (89.2%) were on facility-based and 111 (91.0%) on community-based IPT (P > 0.05). No confirmed treatment failures occurred. Few patients discontinued IPT (6.3%) or were lost to follow-up (4.1%). CONCLUSION: Self-selected IPT delivery aligned with HIV care achieved high rates of adherence and treatment completion. This model may improve outcomes by simplifying clinic visits and conferring agency to the patient, and may be readily implemented in similar high TB-HIV burden settings.