Simplified clinical algorithm for identifying patients eligible for same-day HIV treatment initiation (SLATE): Results from an individually randomized trial in South Africa and Kenya

Abstract

BackgroundThe World Health Organization recommends "same-day" initiation of antiretroviral therapy (ART) for HIV patients who are eligible and ready. Identifying efficient, safe, and feasible procedures for determining same-day eligibility and readiness is now a priority. The Simplified Algorithm for Treatment Eligibility (SLATE) study evaluated a clinical algorithm that allows healthcare workers to determine eligibility for same-day treatment and to initiate ART at the patient’s first clinic visit.Methods and findingsSLATE was an individually randomized trial at three outpatient clinics in urban settlements in Johannesburg, South Africa and three hospital clinics in western Kenya. Adult, nonpregnant, HIV-positive, ambulatory patients presenting for any HIV care, including HIV testing, but not yet on ART were enrolled and randomized to the SLATE algorithm arm or standard care. The SLATE algorithm used four screening tools—a symptom self-report, medical history questionnaire, physical examination, and readiness assessment—to ascertain eligibility for same-day initiation or refer for further care. Follow-up was by record review, and analysis was conducted by country. We report primary outcomes of 1) ART initiation ≤28 days and 2) initiation ≤28 days and retention in care ≤8 months of enrollment. From March 7, 2017 to April 17, 2018, we enrolled 600 patients (median [IQR] age 34 [29–40] and CD4 count 286 [128–490]; 63% female) in South Africa and 477 patients in Kenya (median [IQR] age 35 [29–43] and CD4 count 283 [117–541]; 58% female). In the intervention arm, 78% of patients initiated ≤28 days in South Africa, compared to 68% in the standard arm (risk difference [RD] [95% confidence interval (CI)] 10% [3%–17%]); in Kenya, 94% of intervention-arm patients initiated ≤28 days compared to 89% in the standard arm (6% [0.5%–11%]). By 8 months in South Africa, 161/298 (54%) intervention-arm patients had initiated and were retained, compared to 146/302 (48%) in the standard arm (6% [(2% to 14%]). By 8 months in Kenya, the corresponding retention outcomes were identical in both arms (137/240 [57%] of intervention-arm patients and 136/237 [57%] of standard-arm patients). Limitations of the trial included limited geographic representativeness, exclusion of patients too ill to participate, missing viral load data, greater study fidelity to the algorithm than might be achieved in standard care, and secular changes in standard care over the course of the study.ConclusionsIn South Africa, the SLATE algorithm increased uptake of ART within 28 days by 10% and showed a numerical increase (6%) in retention at 8 months. In Kenya, the algorithm increased uptake of ART within 28 days by 6% but found no difference in retention at 8 months. Eight-month retention was poor in both arms and both countries. These results suggest that a simple structured algorithm for same-day treatment initiation procedures is feasible and can increase and accelerate ART uptake but that early retention on treatment remains problematic.Trial registrationClini...

Patient-mix, programmatic characteristics, retention and predictors of attrition among patients starting antiretroviral therapy (ART) before and after the implementation of HIV “Treat All” in Zimbabwe

“…In a study conducted in Eswatini, the percentage of patients who never returned after the first same-day ART initiation visit doubled (from 3 to 6%) during the "Treat All" period [10]. In clinical trials, same-day ART initiation has shown either no difference or a positive effect on retention [34][35][36][37]. Few studies having been conducted to date to assess the real-world effects of same-day ART initiation [38], a call for further research.…”

A Cascade of Interventions to Promote Adherence to Antiretroviral Therapy in African Countries

“…Among adults presenting for HIV testing or care, but not on ART, 78% initiated ART within 28 days versus 68% in SoC (RR = 1.15) in the South African sample, while 94% initiated ART versus 89% in SoC (RR = 1.06) in the Kenyan sample. However, retention at 8 months was poor in both arms and countries [28]. Facility-based counselling to promote immediate ART initiation was also assessed in South Africa using an approach developed by Médicins Sans Frontières.…”

Immediate Antiretroviral Therapy: The Need for a Health Equity Approach

“…A recent meta-analysis, for example, highlighted an increase in loss to follow-up in some cases [ 19 ]. In South Africa and Kenya, Rosen et al conducted a study in which they randomized newly diagnosed patients with HIV to an intervention called SLATE (Simplified Algorithm for Treatment Eligibility), which involved conducting a patient history, a physical exam, and a readiness assessment for same-day initiation versus usual care [ 12 ]. The SLATE intervention increased ART uptake at 1 month, however, there was no effect on retention in care at 8 months in either South Africa or Kenya [ 12 ].…”

“…In South Africa and Kenya, Rosen et al conducted a study in which they randomized newly diagnosed patients with HIV to an intervention called SLATE (Simplified Algorithm for Treatment Eligibility), which involved conducting a patient history, a physical exam, and a readiness assessment for same-day initiation versus usual care [ 12 ]. The SLATE intervention increased ART uptake at 1 month, however, there was no effect on retention in care at 8 months in either South Africa or Kenya [ 12 ]. A more recent observational study from France showed that newly diagnosed patients starting ART less than 9 days after HIV diagnosis had higher loss to follow-up at 1 year than those who had started ART greater than 90 days after HIV diagnosis [ 13 ].…”

“…While iART has led to generally positive short-term outcomes, including time to viral load suppression and time to linkage to care, the impact of iART on long-term outcomes, including ART adherence and retention in care, is still under exploration [ 9 , 10 , 11 ]. Indeed, some studies have shown negative impacts on retention in care among patients who receive iART [ 12 , 13 , 14 ].…”