NCT02891135: SLATE

Simplified Algorithm for Treatment Eligibility

Completed NA Last updated 22 January 2021

What this trial tests

NA trial testing SLATE in HIV in 1,077 participants. Completed in 31 December 2020.

Timeline

6 March 2017

Primary endpoint
23 April 2018

31 December 2020

Quick facts

Lead sponsor	Boston University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,077
Start date	6 March 2017
Primary completion	23 April 2018
Estimated completion	31 December 2020
Sites	2 locations across South Africa, Kenya

Drugs / interventions tested

• SLATE

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Boston University

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In its 2015 revision of the global guidelines for HIV care and treatment, the World Health Organization called for initiating lifelong antiretroviral treatment (ART) for all patients testing positive for HIV, regardless of CD4 cell count. As countries adopt the new recommendation, known as "treat all," millions of additional patients are becoming eligible for ART worldwide. In sub-Saharan Africa, where most of these patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications. Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. Simpler, more efficient, accelerated algorithms for ART initiation will be needed if "treat all" is to realize the benefits expected.

Experts have proposed a simplified clinical algorithm to screen patients for eligibility for immediate ART initiation at a patient's first clinic visit, without the use of point-of-care laboratory test technologies. The Simplified Algorithm for Treatment Eligibility (SLATE) uses four screens to assess whether a patient is eligible for same-day treatment initiation: i) symptom report, ii) medical history, iii) brief physical examination; and iv) readiness assessment. SLATE is a pragmatic, individually randomized evaluation to determine the effectiveness of the algorithm in increasing ART initiation among non-pregnant adult patients. Approximately 960 HIV-infected adult patients not yet on ART will be enrolled during a routine clinic visit and randomized to receive the intervention or standard care. Patients in the intervention arm will be administered the SLATE screens; those found eligible under the algorithm will be offered immediate treatment initiation, while those who are not eligible will be referred for standard clinic care. Patients in the standard arm will be referred for ART initiation under standard clinic procedures. All care after the initial visit will be by the clinic under standard of care. If successful, SLATE will offer a standardized approach to collecting and interpreting a minimum set of patient data that will avoid delaying treatment initiation for the majority of patients who are eligible for immediate ART, while deferring initiation in the minority who should not start immediately.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Rosen S, Maskew M, Larson BA, Brennan AT, et al · · 2019 · cited 41× · PMID 31525187 · DOI 10.1371/journal.pmed.1002912
2. 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.
   Maskew M, Brennan AT, Venter WDF, Fox MP, et al · · 2021 · cited 14× · PMID 34612601 · DOI 10.1002/jia2.25825
3. Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation.
   Rosen S, Fox MP, Larson BA, Brennan AT, et al · · 2017 · cited 14× · PMID 28554939 · DOI 10.1136/bmjopen-2017-016340
4. Prevalence of TB symptoms, diagnosis and treatment among people living with HIV (PLHIV) not on ART presenting at outpatient clinics in South Africa and Kenya: baseline results from a clinical trial.
   Brennan A, Maskew M, Larson BA, Tsikhutsu I, et al · · 2020 · cited 12× · PMID 32895266 · DOI 10.1136/bmjopen-2019-035794
5. Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017-2018.
   Brennan AT, Maskew M, Larson BA, Tsikhutsu I, et al · · 2019 · cited 12× · PMID 31518058 · DOI 10.1002/jia2.25358
6. Attaining 95-95-95 through Implementation Science: 15 Years of Insights and Best Practices from the Walter Reed Army Institute of Research's Implementation of the U.S. President's Emergency Plan for AIDS Relief.
   Lee EH, Ganesan K, Khamadi SA, Meribe SC, et al · · 2021 · cited 4× · PMID 33241783 · DOI 10.4269/ajtmh.20-0541
7. Triaging Clients at Risk of Disengagement from HIV Care: Application of a Predictive Model to Clinical Trial Data in South Africa.
   Maskew M, Parrott S, De Voux L, Sharpey-Schafer K, et al · · 2025 · cited 3× · PMID 40395656 · DOI 10.2147/rmhp.s510666
8. 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
   Maskew M, Brennan AT, Fox MP, Vezi L, et al · · 2021 · DOI 10.1101/2021.06.11.21258784