Simplified Algorithm for Treatment Eligibility (SLATE)

Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: SLATE

• Study Type: Interventional
• Enrollment (Actual): 1077
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kericho County
    • Kericho, Kericho County, Kenya
      • Kenya Medical Research Institute/Walter Reed Projects
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Health Economics and Epidemiology Research Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (>18 years) (initiating children on ART is likely to require additional information, making the SLATE algorithm less applicable to pediatric populations)
• Confirmed HIV-positive test result at any time (may have been diagnosed previously)
• Not currently on ART (three-drug combination)
• Presented at the study clinic for any HIV-related reason, including an HIV test, pre-ART monitoring, or ART initiation

Exclusion Criteria:

• Pregnant (pregnancy is an exclusion criterion because treatment guidelines for pregnant women differ from those for non-pregnant adults; most pregnant women are diagnosed with HIV and initiated on ART in antenatal clinics, not general adult HIV clinics)
• Not intending to return to this clinic for further HIV care in the coming year (i.e. intends to seek further care somewhere else)
• Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
• Not willing or able to provide written informed consent to participate in the study
• Previously enrolled in the same study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV.
Experimental: Intervention; Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE).	Other: SLATE; Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment initiation	Proportion of patients initiated on ART within 28 days of study enrollment	28 days after study enrollment
Treatment initiation and retention	Proportion of patients who initiate ART within 28 days of study enrollment and are alive, in care, and retained on ART eight months after study enrollment	8 months after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation within 14 days	Proportion of patients who initiate ART within 14 days of study enrollment	14 days after study enrollment
Viral suppression	Proportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment	8 months after study enrollment
One-year retention in care	Retention defined as > 1 month late for last scheduled visit	14 months after study enrollment
One-year retention in care	Retention defined as > 3 months late for last scheduled visit	16 months after study enrollment
SLATE eligibility	Proportions of HIV-positive patients presenting at study clinics and not yet on ART who are eligible and ineligible for immediate initiation using SLATE algorithm criteria	Study enrollment
SLATE ineligibility reasons	Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm	Study enrollment
Time to initiation	Average time to ART initiation (days) for each arm	8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preferences	Patient preferences on the speed and timing of ART initiation	Study enrollment
Patient costs	Costs to patients of ART initiation under standard and intervention procedures	8 months
Provider costs	Costs to providers of ART initiation under standard and intervention procedures	8 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: University of Witwatersrand, South Africa; Kenya Medical Research Institute

Publications and helpful links

General Publications

• Rosen S, Fox MP, Larson BA, Sow PS, Ehrenkranz PD, Venter F, Manabe YC, Kaplan J; Models for Accelerating Treatment Initiation (MATI) Technical Consultation. Accelerating the Uptake and Timing of Antiretroviral Therapy Initiation in Sub-Saharan Africa: An Operations Research Agenda. PLoS Med. 2016 Aug 9;13(8):e1002106. doi: 10.1371/journal.pmed.1002106. eCollection 2016 Aug.
• Fox MP, Rosen S. A new cascade of HIV care for the era of "treat all". PLoS Med. 2017 Apr 11;14(4):e1002268. doi: 10.1371/journal.pmed.1002268. eCollection 2017 Apr.
• Rosen S, Fox MP, Larson BA, Brennan AT, Maskew M, Tsikhutsu I, Bii M, Ehrenkranz PD, Venter WF. Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation. BMJ Open. 2017 May 28;7(5):e016340. doi: 10.1136/bmjopen-2017-016340.
• Rosen S, Maskew M, Larson BA, Brennan AT, Tsikhutsu I, Fox MP, Vezi L, Bii M, Venter WDF. 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. PLoS Med. 2019 Sep 16;16(9):e1002912. doi: 10.1371/journal.pmed.1002912. eCollection 2019 Sep.
• Brennan AT, Maskew M, Larson BA, Tsikhutsu I, Bii M, Vezi L, Fox MP, Venter WD, Ehrenkranz P, Rosen S. Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017-2018. J Int AIDS Soc. 2019 Sep;22(9):e25358. doi: 10.1002/jia2.25358.
• Maskew M, Brennan AT, Venter WDF, Fox MP, Vezi L, Rosen S. 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. J Int AIDS Soc. 2021 Oct;24(10):e25825. doi: 10.1002/jia2.25825.
• Brennan A, Maskew M, Larson BA, Tsikhutsu I, Bii M, Vezi L, Fox M, Venter WDF, Ehrenkranz PD, Rosen S. 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. BMJ Open. 2020 Sep 6;10(9):e035794. doi: 10.1136/bmjopen-2019-035794.

Helpful Links

• CROI poster with preliminary results for South Africa
• AIDS 2018 poster with primary outcome results for South Africa
• CROI 2019 poster and video with primary outcome results for Kenya

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): April 23, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: WHO 'Treat all" Antiretroviral Guidelines; Simplified Algorithm for Treatment Eligibility (SLATE)
• Other Study ID Numbers: H-35634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be retained in secure study databases until completion of the study, including completion of all data analysis and report writing associated with the study and closing of the IRB-approved protocol. Study data sets and other electronic files containing study data will then have all identifiers removed and where possible will be made available for use of other researchers through a repository such as Dryad.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No