An interventional study of SLATE in HIV, sponsored by Boston University. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Boston University · Not applicable, Interventional, and Treatment
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.
Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: SLATE
Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.
Treatment initiation
Proportion of patients initiated on ART within 28 days of study enrollment
Time frame: 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
Time frame: 8 months after study enrollment
Initiation within 14 days
Proportion of patients who initiate ART within 14 days of study enrollment
Time frame: 14 days after study enrollment
Viral suppression
Proportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment
Time frame: 8 months after study enrollment
One-year retention in care
Retention defined as \> 1 month late for last scheduled visit
Time frame: 14 months after study enrollment
One-year retention in care
Retention defined as \> 3 months late for last scheduled visit
Time frame: 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
Time frame: Study enrollment
SLATE ineligibility reasons
Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm
Time frame: Study enrollment
Time to initiation
Average time to ART initiation (days) for each arm
Time frame: 8 months
Patient preferences
Patient preferences on the speed and timing of ART initiation
Time frame: Study enrollment
Patient costs
Costs to patients of ART initiation under standard and intervention procedures
Time frame: 8 months
Provider costs
Costs to providers of ART initiation under standard and intervention procedures
Time frame: 8 months
Plan to share: Yes — 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.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Boston University