Background: The World Health Organization recommends offering antiretroviral treatment (ART) to all HIV-positive individuals regardless of CD4 count or disease stage, known as “universal test and treat” (UTT). However, the health systems effects of UTT implementation are unknown. We investigated the effect of UTT on retention and viral suppression in the world''s first UTT implementation trial in a government-managed health system.
Methods: In this stepped-wedge randomized controlled trial, fourteen public sector health facilities in Swaziland were paired and randomly assigned to transition in four-month steps from implementing the current national standard of care (SoC) to providing ART under UTT. ART-naïve clients ≥ 18 years who were not pregnant or breastfeeding were eligible for enrollment. We used Cox proportional hazard models with censoring of follow-up at clinic transition to measure the effects of UTT on our two primary endpoints: retention and viral suppression after ART initiation. The trial is registered with (NCT02909218).
Results: Between September 2014 and August 2017, 3405 clients (62% women, median age 33 years (IQR:28-42)) were enrolled. Under SoC, 12-month retention and post ART initiation viral load suppression rates were 80% (95% CI): 77-83) and 4% (95% CI: 2-7), respectively, compared to 86% (95% CI: 83-88) and 79% (95% CI: 75-83) under UTT. 75% of clients were missing viral load at the 6-month time window following ART initiation; they were considered unsuppressed. Compared to SoC, UTT had a modest effect on retention (hazard ratio (HR) 1.60, 95% CI 1.15-2.21) and a large effect on viral suppression among those retained 6 months after ART initiation (HR: 14.51, 95% CI: 7.31-28.79) (Table 1). The UTT effect on the combined endpoint of retention and viral suppression was also substantial (HR 4.88, 95% CI 2.96-8.05).
Conclusions: Adopting UTT improves the performance of the health system in providing ART to people living with HIV. The observed improvement in retention and viral suppression, key indicators of ART success, provides an important co-benefit of UTT. Our results from this “real world” health systems trial strongly support the scale-up of UTT in Swaziland and countries with similar HIV epidemics and health systems.

EndpointCrude HR (95%CI)p-valueAdjusted HR (95%CI)p-value
Retention1.60 (1.15-2.21)0.0051.94 (1.33-2.82)0.0006
Viral suppression14.51 (7.31-28.79)<0.000122.08 (7.91-61.59)<0.0001
Combined endpoint (retention and viral suppression)4.88 (2.96-8.05)<0.00016.90 (3.11-15.31)<0.0001
[Primary endpoints for MaxART universal test and treat health systems trial]