Effects of national adoption of Treat-All guidelines on pre-ART CD4 testing and viral load monitoring after ART initiation: A regression discontinuity analysis

BACKGROUND: The World Health Organization's Treat-All guidance recommends CD4 testing prior to antiretroviral treatment (ART) initiation, and routine viral load (VL) monitoring (over CD4 monitoring) for patients on ART. METHODS: We used regression discontinuity analyses to estimate changes in CD4 testing and VL monitoring among 547,837 ART-naïve patients enrolling in HIV care during 2006-2018 at 225 clinics in 26 countries where Treat-All policies were adopted. We examined CD4 testing within 12 months before and VL monitoring 6 months after ART initiation among adults (≥20 years), adolescents (10-19 years) and children (0-9 years) in low/lower-middle income countries (L/LMICs) and high/upper-middle income countries (H/UMICs). RESULTS: Treat-All adoption led to an immediate decrease in pre-ART CD4 testing among adults in L/LMICs, from 57.0% to 48.1% (-8.9 percentage points [pp]; 95% CI: -11.0, -6.8), and a small increase in in H/UMICs, from 90.1 to 91.7% (+1.6pp; 95% CI: 0.2, 3.0), with no changes among adolescents or children; decreases in pre-ART CD4 testing accelerated after Treat-All adoption in L/LMICs. In L/LMICs, VL monitoring after ART initiation was low among all patients just before Treat-All; while there was no immediate change at Treat-All adoption, VL monitoring trends significantly increased afterwards. In H/UMICs, VL monitoring increased among adults immediately after Treat-All adoption, from 58.2% to 61.1% (+2.9pp; 95% CI: 0.5, 5.4), with no significant changes among adolescents/children. CONCLUSIONS: While on-ART VL monitoring has improved in L/LMICs, Treat-All adoption has accelerated and disparately worsened suboptimal pre-ART CD4 monitoring, which may compromise care outcomes for individuals with advanced HIV