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Introduction: The WHO recommends antiretroviral treatment (ART) for all HIV-positive patients regardless of CD4 count or disease stage, referred to as "Early Access to ART for All" (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government-managed public health system with the aim to examine the "real world" impact of EAAA on care retention and viral suppression. Methods: In this stepped-wedge randomized controlled trial, 14 public sector health facilities in Eswatini were paired and randomly assigned to stepwise transition from standard of care (SoC) to EAAA. ART-na€ ıve participants ≥18 years who were not pregnant or breastfeeding were eligible for enrolment. We used Cox proportional hazard models with censoring at clinic transition to estimate the effects of EAAA on retention in care and retention and viral suppression combined. Results: Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1Á60, 95% CI: 1Á15 to 2Á21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05, p < 0.001). We also identified significant gaps in current health systems ability to provide viral load (VL) monitoring with 80% participants in SoC and 66% in EAAA having a missing VL at last contact. Conclusions: The observed improvement in retention in care and on the combined retention and viral suppression provides an important co-benefit of EAAA to HIV-positive adults themselves, at least in the short term. Our results from this "real world" health systems trial strongly support EAAA for Eswatini and countries with similar HIV epidemics and health systems. VL monitoring needs to be scaled up for appropriate care management.

ObjectivesCurrent 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.MethodsMaxART 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%).ResultsBetween 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).ConclusionThere 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.

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