Simplified Algorithm for Treatment Eligibility

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV

Conditions
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HIV

Intervention / Treatment
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* Other: SLATE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV. | |
| Experimental: Intervention<br>Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE). | Other: SLATE<br>* Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WHO 'Treat all Antiretroviral Guidelines, Simplified Algorithm for Treatment Eligibility (SLATE)