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.

Sydney Rosen,Alana T Brennan,Mhairi Maskew,Willem D F Venter,Bruce A Larson,Isaac Tsikhutsu,Lungisile Vezi,Matthew P Fox,Margaret Bii,Marie-Louise Newell

doi:10.1371/journal.pmed.1002912

Sydney Rosen, Alana T Brennan + Show 8 more

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https://doi.org/10.1371/journal.pmed.1002912

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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 registrationClinicaltrials.gov NCT02891135, registered September 1, 2016. First participant enrolled March 6, 2017 in South Africa and July 13, 2017 in Kenya.

Highlights

In July 2017, the World Health Organization (WHO) revised its guidelines for antiretroviral therapy (ART) for HIV to recommend “same-day” treatment initiation whenever possible and “rapid” initiation for all HIV-positive patients [1]
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
Despite the recommendations, initiation still usually requires 2–4 clinic visits before medications are dispensed, and there is little guidance on how to implement same-day initiation, in particular on exactly how to determine if a patient is eligible and ready to start treatment and how to provide the specific services required for ART initiation in a single clinic visit

Summary

Introduction

In July 2017, the World Health Organization (WHO) revised its guidelines for antiretroviral therapy (ART) for HIV to recommend “same-day” treatment initiation (on day of diagnosis) whenever possible and “rapid” initiation (within 7 days of diagnosis) for all HIV-positive patients [1]. The guidelines cited evidence from clinical trials suggesting that offering treatment to patients at their first clinical encounter has the potential to increase relative uptake of ART within 90 days by 30% and from observational studies that showed an overall relative increase of 53%. These studies varied widely from one another in the clinical approaches used, intervention design (same-day initiation or rapid initiation), and the populations studied [1]. 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

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