Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation

Rosen, Sydney; Maskew, Mhairi; Brennan, Alana T.; Fox, Matthew P.; Vezi, Lungisile; Ehrenkranz, Peter; Venter, François

doi:10.1186/s13063-018-2928-5

Cited by 15 publications

(26 citation statements)

References 22 publications

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“…More intensive and concerted efforts are needed in order to initiate ART immediately among people newly diagnosed and to initiate/re‐initiate ART for those with known status who are out of care . Recent same‐day ART programmes have demonstrated dramatic increase in ART initiation, as well as retention and viral load suppression, among clients who had their ART started as soon as possible after their first engagement in care, with simplified clinical algorithm which does not need availability of comprehensive laboratory results .…”

Section: Discussionmentioning

confidence: 99%

Linkages to HIV confirmatory testing and antiretroviral therapy after online, supervised, HIV self‐testing among Thai men who have sex with men and transgender women

et al. 2020

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Introduction Online, supervised, HIV self‐testing has potential to reach men who have sex with men (MSM) and transgender women (TGW) who never tested before and who had high HIV‐positive yield. We studied linkages to HIV confirmatory test and antiretroviral therapy (ART) initiation among Thai MSM and TGW who chose online and/or offline platforms for HIV testing and factors associated with unsuccessful linkages. Methods MSM and TGW were enrolled from Bangkok Metropolitan Region and Pattaya during December 2015 to June 2017 and followed for 12 months. Participants could choose between: 1) offline HIV counselling and testing (Offline group), 2) online pre‐test counselling and offline HIV testing (Mixed group) and 3) online counselling and online, supervised, HIV self‐testing (Online group). Sociodemographic data, risk behaviour and social network use characteristics were collected by self‐administered questionnaires. Linkages to HIV confirmatory testing and/or ART initiation were collected from participants who tested reactive/positive at baseline and during study follow‐up. Modified Poisson regression models identified covariates for poor retention and unsuccessful ART initiation. Results Of 465 MSM and 99 TGW, 200 self‐selected the Offline group, 156 the Mixed group and 208 the Online group. The Online group demonstrated highest HIV prevalence (15.0% vs. 13.0% vs. 3.4%) and high HIV incidence (5.1 vs. 8.3 vs. 3.2 per 100 person‐years), compared to the Offline and Mixed groups. Among 60 baseline HIV positive and 18 seroconversion participants, successful ART initiation in the Online group (52.8%) was lower than the Offline (84.8%) and Mixed groups (77.8%). Factors associated with unsuccessful ART initiation included choosing to be in the Online group (aRR 3.94, 95% CI 1.07 to 14.52), <17 years old at first sex (aRR 3.02, 95% CI 1.15 to 7.92), amphetamine‐type stimulants use in the past six months (aRR 3.6, 95% CI 1.22 to 10.64) and no/single sex partner (aRR 3.84, 95%CI 1.36 to 10.83) in the past six months. Conclusions Online, supervised, HIV self‐testing allowed more MSM and TGW to know their HIV status. However, linkages to confirmatory test and ART initiation once tested HIV‐reactive are key challenges. Alternative options to bring HIV test confirmation, prevention and ART services to these individuals after HIV self‐testing are needed.

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Section: Discussionmentioning

confidence: 99%

Linkages to HIV confirmatory testing and antiretroviral therapy after online, supervised, HIV self‐testing among Thai men who have sex with men and transgender women

et al. 2020

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“…The Simplified Algorithm for Treatment Eligibility (SLATE) trials in South Africa and Kenya are multicenter, non‐blinded, individually randomized (1:1), pragmatic trials evaluating simple, standardized algorithms to determine eligibility for same‐day initiation of ART without relying on laboratory results, point of care tests or multiple clinic visits . The initial SLATE trial in both countries, called SLATE I (NCT02891135), was designed to address the concerns of clinicians and programme managers in 2015, when the algorithm was first proposed .…”

Section: Methodsmentioning

confidence: 99%

“…In South Africa, study sites were primary health clinics serving urban informal and formal communities in the Johannesburg and Ekurhuleni metropolitan areas. Patient inclusion and exclusion criteria for study eligibility are detailed in published protocols . Those enrolled were non‐pregnant, HIV‐infected adults (18+ years) not currently on ART and willing to provide written informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…In Kenya (SLATE I), the study was powered to detect a 15% difference in the primary outcome of initiation of ART within 28 days and alive, in care and retained on ART 8 months after study enrolment. We aimed for a sample size of 240 per arm (480 total) in Kenya and 300 per arm (600 total) in South Africa .…”

Section: Methodsmentioning

confidence: 99%

“…SLATE I and II included a baseline questionnaire eliciting basic demographic and other information about prior HIV care. Patients in the intervention arms were assessed for eligibility for same‐day ART initiation by a study clinician using the SLATE I (Kenya) or SLATE II (South Africa) algorithm . The algorithm consisted of four screens: (1) symptoms, (2) recent medical history, (3) physical conditions and (4) treatment readiness.…”

Section: Methodsmentioning

confidence: 99%

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Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017‐2018

et al. 2019

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Introduction Many African countries have had at least two years’ experience with universal treatment eligibility for HIV. The literature contains few descriptions, though, of populations starting treatment since adoption of universal eligibility. Using baseline data from a clinical trial of same‐day ART initiation, we describe the populations presenting for HIV testing or care at study clinics in Kenya and South Africa in 2017‐18, during the era of same‐day initiation. Methods The Simplified Algorithm for Treatment Eligibility (SLATE) trials in Kenya (SLATE I) and South Africa (SLATE II) were multicenter, non‐blinded, individually randomized, pragmatic trials evaluating simple, standardized algorithms to determine eligibility for same‐day initiation of ART without relying on laboratory results, point of care tests or multiple clinic visits. In Kenya, enrolment occurred during July 2017 to April 2018. In South Africa, enrolment occurred during March to September 2018. We describe demographic, socioeconomic and clinical characteristics of patients randomized to the same‐day initiation arm for both studies. Results and Discussion A total of 240 and 296 participants were enrolled in Kenya and South Africa. The majority were female (59% and 64% respectively), with a median age of 35 years. In both countries, most subjects were newly diagnosed with HIV on the day of enrolment (62%, 55%), believed they already had adequate knowledge to begin ART (78%, 68%), and preferred to start ART immediately (same‐day) (98% in both countries). About 40% of all patients had at least one symptom related to tuberculosis (cough, fever, night sweats, weight loss) and/or cryptococcal meningitis (continuous headache). More than a third of patients (37%, 36%) presented with advanced disease (CD4 <200 cells/mm3), a fifth presented with very advanced disease (CD4 < 100), and approximately 1 in 20 presented with very advanced disease and were asymptomatic. Conclusions Despite >2 years of universal eligibility for ART in Kenya and South Africa, in 2017‐2018 more than half of HIV‐positive patients presenting at public sector clinics were not yet aware of their status, and more than a third presented for care with advanced HIV disease. These proportions remain similar to those observed before the introduction of universal eligibility.

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Retention in care and viral suppression after same‐day ART initiation: One‐year outcomes of the SLATE I and II individually randomized clinical trials in South Africa

et al. 2021

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Introduction: Same-day initiation (SDI) of antiretroviral therapy (ART) for HIV consistently increases ART uptake, but concerns remain about higher attrition from care after initiation. We analysed 12-month retention in the SLATE SDI trials. Methods: SLATE I (Simplified Algorithms for Treatment Eligibility I, enrolment 06 March-28 July 2017) and SLATE II (enrolment 14 March-18 September 2018) were individually randomized trials at public outpatient clinics in Johannesburg that enrolled patients not yet on ART and administered the SLATE I or II algorithm. This included a symptom self-report, medical history, brief physical examination and readiness questionnaire to assess the eligibility for SDI. The studies compared the offer of SDI using the SLATE algorithms to standard of care initiation procedures. ART uptake and early retention were previously reported. Using routine clinic records, we conducted a pooled analysis of retention in care and HIV viral suppression 14 months after study enrolment, a time point equivalent to 12 months potential on ART, with an additional month allowed on either end to initiate ART and to return for the 12-month visit. Results and discussion:We enrolled 1193 study participants (standard arms, n = 599, 50%; intervention arms, n = 594, 50%) and analysed by originally assigned groups. By 14 months after enrolment, 50% of intervention arm patients and 46% of standard arm patients remained in care at the initiating site (crude risk difference 4% (95% confidence interval −1%-10%); crude relative risk 1.10 (0.97-1.23), with similar viral suppression between arms. Observed attrition from care at site by 14 months was high in both study arms, but we found no evidence that the offer of SDI led to greater overall attrition or lower rates of viral suppression 1 year after starting ART and may have generated small improvements. SDI may have shifted some attrition from before to after dispensing of the first dose of medication. Conclusions: An offer of SDI of ART, following a carefully designed protocol to identify patients who are eligible and ready to start treatment, is not inherently associated with an overall increase in patient attrition from care and leads to similar rates of viral suppression.

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Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation

Cited by 15 publications

References 22 publications

Linkages to HIV confirmatory testing and antiretroviral therapy after online, supervised, HIV self‐testing among Thai men who have sex with men and transgender women

Linkages to HIV confirmatory testing and antiretroviral therapy after online, supervised, HIV self‐testing among Thai men who have sex with men and transgender women

Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017‐2018

Retention in care and viral suppression after same‐day ART initiation: One‐year outcomes of the SLATE I and II individually randomized clinical trials in South Africa

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