Simplified Algorithm for Treatment Eligibility

NCT02891135 | Completed

• 1 other identifier: H-35634
• Study Type: interventional
• Target: 1,077
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

HIV

Keywords

WHO 'Treat all" Antiretroviral Guidelines; Simplified Algorithm for Treatment Eligibility (SLATE)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Initiation within 14 days

  14 days after study enrollment

• Viral suppression

  8 months after study enrollment

• One-year retention in care

  14 months after study enrollment

• One-year retention in care

  16 months after study enrollment

• SLATE eligibility

  Study enrollment

Other Outcomes (3)

• Patient preferences

  Study enrollment

• Patient costs

  8 months

• Provider costs

  8 months

Study Arms (2)

Standard

NO INTERVENTION

Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV.

Intervention

EXPERIMENTAL

Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE).

Other: SLATE

Interventions

SLATE OTHER

Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• University of Witwatersrand, South Africa: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (2)

Kenya Medical Research Institute/Walter Reed Projects

Kericho, Kericho County, Kenya

Location

Health Economics and Epidemiology Research Office

Johannesburg, Gauteng, South Africa

Location

Related Publications (8)

• 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.

  PMID: 27505444 BACKGROUND

• 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.

  PMID: 28399160 BACKGROUND

• 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.

  PMID: 28554939 BACKGROUND

• 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.

  PMID: 31525187 RESULT

• 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.

  PMID: 31518058 RESULT

• Maskew M, Parrott S, De Voux L, Sharpey-Schafer K, Crompton T, Govender AC, Pisa PT, Rosen S. Triaging Clients at Risk of Disengagement from HIV Care: Application of a Predictive Model to Clinical Trial Data in South Africa. Risk Manag Healthc Policy. 2025 May 16;18:1601-1619. doi: 10.2147/RMHP.S510666. eCollection 2025.

  PMID: 40395656 DERIVED

• 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.

  PMID: 34612601 DERIVED

• 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.

  PMID: 32895266 DERIVED

Related Links

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

Study Officials

• Sydney Rosen

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 7, 2016
• Study Start: March 6, 2017
• Primary Completion: April 23, 2018
• Study Completion: December 31, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1); KE (1)