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| Name | Class |
|---|---|
| University of Witwatersrand, South Africa | OTHER |
| Kenya Medical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLATE | Other | Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sydney Rosen | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute/Walter Reed Projects | Kericho | Kericho County | Kenya | |||
| Health Economics and Epidemiology Research Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27505444 | Background | 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. | |
| 28399160 |
| Label | URL |
|---|---|
| CROI poster with preliminary results for South Africa | View source |
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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.
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| 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 |
| 8 months |
| Provider costs | Costs to providers of ART initiation under standard and intervention procedures | 8 months |
| Johannesburg |
| Gauteng |
| South Africa |
| 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. |
| 28554939 | 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. |
| 31525187 | Result | 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. |
| 31518058 | 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. |
| 40395656 | Derived | 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. |
| 34612601 | 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. |
| 32895266 | 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. |
| CROI 2019 poster and video with primary outcome results for Kenya | View source |