Simplified Algorithm for Treatment Eligibility (SLATE)
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|ClinicalTrials.gov Identifier: NCT02891135|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : August 1, 2019
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|
|HIV||Other: SLATE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1077 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV|
|Actual Study Start Date :||March 6, 2017|
|Actual Primary Completion Date :||April 23, 2018|
|Estimated Study Completion Date :||July 31, 2020|
No Intervention: Standard
Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV.
Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE).
Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.
- Treatment initiation [ Time Frame: 28 days after study enrollment ]Proportion of patients initiated on ART within 28 days of study enrollment
- Treatment initiation and retention [ Time Frame: 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
- Initiation within 14 days [ Time Frame: 14 days after study enrollment ]Proportion of patients who initiate ART within 14 days of study enrollment
- Viral suppression [ Time Frame: 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 [ Time Frame: 14 months after study enrollment ]Retention defined as > 1 month late for last scheduled visit
- One-year retention in care [ Time Frame: 16 months after study enrollment ]Retention defined as > 3 months late for last scheduled visit
- SLATE eligibility [ Time Frame: 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 [ Time Frame: Study enrollment ]Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm
- Time to initiation [ Time Frame: 8 months ]Average time to ART initiation (days) for each arm
- Patient preferences [ Time Frame: Study enrollment ]Patient preferences on the speed and timing of ART initiation
- Patient costs [ Time Frame: 8 months ]Costs to patients of ART initiation under standard and intervention procedures
- Provider costs [ Time Frame: 8 months ]Costs to providers of ART initiation under standard and intervention procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891135
|Kenya Medical Research Institute/Walter Reed Projects|
|Kericho, Kericho County, Kenya|
|Health Economics and Epidemiology Research Office|
|Johannesburg, Gauteng, South Africa|
|Principal Investigator:||Sydney Rosen||Boston University|