Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation

Rosen, Sydney; Fox, Matthew P.; Larson, Bruce A.; Brennan, Alana T.; Maskew, Mhairi; Tsikhutsu, Isaac; Bii, Margaret; Ehrenkranz, Peter; Venter, François

doi:10.1136/bmjopen-2017-016340

Cited by 15 publications

(32 citation statements)

References 16 publications

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“…We identified three ongoing studies (Rosen 2017; PACTR201706002322546a; Sikazwe 2018). For more details about ongoing studies see the Characteristics of ongoing studies section.…”

Section: Resultsmentioning

confidence: 99%

Rapid initiation of antiretroviral therapy for people living with HIV

Urdiales

Johnson

Smith

et al. 2019

Cochrane Database of Systematic Reviews

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Background Despite antiretroviral therapy (ART) being widely available, HIV continues to cause substantial illness and premature death in low‐and‐middle‐income countries. High rates of loss to follow‐up after HIV diagnosis can delay people starting ART. Starting ART within seven days of HIV diagnosis (rapid ART initiation) could reduce loss to follow‐up, improve virological suppression rates, and reduce mortality. Objectives To assess the effects of interventions for rapid initiation of ART (defined as offering ART within seven days of HIV diagnosis) on treatment outcomes and mortality in people living with HIV. We also aimed to describe the characteristics of rapid ART interventions used in the included studies. Search methods We searched CENTRAL, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, and four other databases up to 14 August 2018. There was no restriction on date, language, or publication status. We also searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, and websites for unpublished literature, including conference abstracts. Selection criteria We included randomized controlled trials (RCTs) that compared rapid ART versus standard care in people living with HIV. Children, adults, and adolescents from any setting were eligible for inclusion. Data collection and analysis Two review authors independently assessed the eligibility of the studies identified in the search, assessed the risk of bias and extracted data. The primary outcomes were mortality and virological suppression at 12 months. We have presented all outcomes using risk ratios (RR), with 95% confidence intervals (CIs). Where appropriate, we pooled the results in meta‐analysis. We assessed the certainty of the evidence using the GRADE approach. Main results We included seven studies with 18,011 participants in the review. All studies were carried out in low‐ and middle‐income countries in adults aged 18 years old or older. Only one study included pregnant women. In all the studies, the rapid ART intervention was offered as part of a package that included several cointerventions targeting individuals, health workers and health system processes delivered alongside rapid ART that aimed to facilitate uptake and adherence to ART. Comparing rapid ART with standard initiation probably results in greater viral suppression at 12 months (RR 1.18, 95% CI 1.10 to 1.27; 2719 participants, 4 studies; moderate‐certainty evidence) and better ART uptake at 12 months (RR 1.09, 95% CI 1.06 to 1.12; 3713 participants, 4 studies; moderate‐certainty evidence), and may improve retention in care at 12 months (RR 1.22, 95% CI 1.11 to 1.35; 5001 participants, 6 studies; low‐certainty evidence). Rapid ART initiation was associated with a lower mortality estimate, however the CIs included n...

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“…We identified three ongoing studies (Rosen 2017; PACTR201706002322546a; Sikazwe 2018). For more details about ongoing studies see the Characteristics of ongoing studies section.…”

Section: Resultsmentioning

confidence: 99%

Rapid initiation of antiretroviral therapy for people living with HIV

Urdiales

Johnson

Smith

et al. 2019

Cochrane Database of Systematic Reviews

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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%

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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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“…Obligating these patients to start treatment before they are ready may lead to these patients being lost to follow up. This finding reaffirms the need for screening for and establishing patient readiness before starting ART [24]. Thus, though the expansion of Treat All nationally in Nigeria will entail early initiation of the vast majority of PLHIV on ART, there should be support for identifying and working with PLHIV who may need longer to be ready to initiate ART, in order to avoid attrition.…”

Section: Discussionmentioning

confidence: 62%

Health workers’ perspectives on the outcomes, enablers, and barriers to the implementation of HIV “Treat All” guidelines in Abuja Nigeria

Odafe

Stafford

Aliyu

et al. 2019

Preprint

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Introduction To improve access to lifesaving treatment for all people living with HIV (PLHIV), Nigeria implemented the Treat All guidelines in 2016. However, health workers' perspectives on the implementation of the guidelines have not been evaluated. Methods We conducted in-depth interviews to explore health workers' perspectives on the Treat All guidelines. Using purposive sampling, 20 health workers providing HIV patient care were recruited from six primary health care hospitals in Abuja to participate in semi-structured interviews. Data exploration was conducted using thematic content analysis. Results The five main themes that emerged were (1) the perceived benefits of guidelines use, (2) the perceived disadvantages of using the guidelines, (3) reported patients' response to guideline change, (4) perceived barriers/enablers to guideline use and (5) health workers' recommendations for improvement. Health workers perceived that the implementation of the Treat All guidelines has considerably improved patient care, particularly in increasing access to skilled health care, reducing stress on patients, and increasing hope for a better health outcome among patients. Other perceived benefits were reduced mortality, reduced pre-treatment attrition, reduction in delays between case detection and initiation on treatment. Perceived major disadvantages were increased workload and overcrowded clinics. Health workers reported that most patients were willing to start treatment early. Perceived key factors enabling guidelines use were health workers' interest, patient benefits, training and availability of tools for implementation of guidelines, government supervisory visits and hospital management support. Perceived key barriers were poverty, inadequate human resources, lack of familiarity with guidelines, and lack of consistent supply of HIV test kits at some sites. Conclusions Implementation of the Treat All guidelines led to perceived improvement in patient care. Further improvements could be achieved by implementing an efficient supply chain system for HIV rapid test kits, and through guidelines distribution and training. Additionally, implementing differentiated approaches that decongest clinics, and programs that economically empower patients could improve access to treatment.

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Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation

Cited by 15 publications

References 16 publications

Rapid initiation of antiretroviral therapy for people living with HIV

Rapid initiation of antiretroviral therapy for people living with HIV

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

Health workers’ perspectives on the outcomes, enablers, and barriers to the implementation of HIV “Treat All” guidelines in Abuja Nigeria

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