SLATE: Simplified Algorithm for Treatment Eligibility
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Treatment initiation [28 days after study enrollment]
Proportion of patients initiated on ART within 28 days of study enrollment
- Treatment initiation and retention [8 months after study enrollment]
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
Secondary Outcome Measures
- Initiation within 14 days [14 days after study enrollment]
Proportion of patients who initiate ART within 14 days of study enrollment
- Viral suppression [8 months after study enrollment]
Proportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment
- One-year retention in care [14 months after study enrollment]
Retention defined as > 1 month late for last scheduled visit
- One-year retention in care [16 months after study enrollment]
Retention defined as > 3 months late for last scheduled visit
- SLATE eligibility [Study enrollment]
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
- SLATE ineligibility reasons [Study enrollment]
Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm
- Time to initiation [8 months]
Average time to ART initiation (days) for each arm
Other Outcome Measures
- Patient preferences [Study enrollment]
Patient preferences on the speed and timing of ART initiation
- Patient costs [8 months]
Costs to patients of ART initiation under standard and intervention procedures
- Provider costs [8 months]
Costs to providers of ART initiation under standard and intervention procedures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (>18 years) (initiating children on ART is likely to require additional information, making the SLATE algorithm less applicable to pediatric populations)
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Confirmed HIV-positive test result at any time (may have been diagnosed previously)
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Not currently on ART (three-drug combination)
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Presented at the study clinic for any HIV-related reason, including an HIV test, pre-ART monitoring, or ART initiation
Exclusion Criteria:
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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)
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Not intending to return to this clinic for further HIV care in the coming year (i.e. intends to seek further care somewhere else)
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Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
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Not willing or able to provide written informed consent to participate in the study
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Previously enrolled in the same study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kenya Medical Research Institute/Walter Reed Projects | Kericho | Kericho County | Kenya | |
| 2 | Health Economics and Epidemiology Research Office | Johannesburg | Gauteng | South Africa |
Sponsors and Collaborators
- Boston University
- University of Witwatersrand, South Africa
- Kenya Medical Research Institute
Investigators
- Principal Investigator: Sydney Rosen, Boston University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- 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
Publications
- 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, 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.
- H-35634