Many countries, including South Africa, encourage same-day initiation (SDI) of antiretroviral therapy (ART), but evidence on how to implement SDI and its impact on outcomes remains scarce. Building on the Simplified Algorithm for Treatment Eligibility trial (SLATE I), in which nearly half of participants were ineligible for same day initiation due mainly to TB symptoms, we evaluated the revised SLATE II algorithm, which allowed SDI for patients with mild TB symptoms and other less serious reasons for delay.
SLATE II was a 1:1 individually randomized trial at public outpatient clinics in Johannesburg that enrolled patients presenting for an HIV test or any HIV care but not yet on ART. Intervention arm patients were assessed with a symptom self-report, medical history, brief physical examination, and readiness questionnaire to distinguish patients eligible for immediate ART dispensing from those requiring further care, tests, or counseling before initiation. Standard arm patients received usual care. Using routine clinic records, we report initiation in 0 (same day), 7, and 28 days after study enrollment and retention in care 8 months after study enrolment.
From 3/14/18-9/21/18, we enrolled 593 adult HIV+, non-pregnant patients (median[IQR] age 35 [29-43]; 63% (n=373) female; median CD4 count 293 [133-487]). In the intervention arm, 87% initiated on the same day, compared to 38% in the standard arm (Table). Initiation was higher in the intervention vs standard arm by 7 days (91% vs 68%; RD: 23%; 95% CI: 17-29%) and 28 days (94% vs 82%; RD: 12%; 95%CI: 7-17%) after enrolment. By 8 months after study enrolment, 70% (207/296) intervention and 55% (163/297) standard arm patients had initiated ART ≤ 28 days and were retained in care (RD 15%; 95% CI 7-23%). Nearly half (140/296, 47%) of intervention arm patients reported >=1 TB symptom; 39 (13%) were severe enough to require delay for further investigation, and 6 (2%) were diagnosed with TB. No serious post-initiation adverse events were reported. Nearly all patients (98.5%) stated they would like to start same-day if possible.
More than 85% of patients presenting for HIV testing or care, including those newly diagnosed, were eligible and ready for same-day initiation under SLATE II algorithm. The algorithm increased initiation in ≤ 7 days by 28% and retention in care at 8 months by 15%, offering a practical model for implementing guidelines that can be immediately utilized.