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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
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
Kenya Medical Research Institute
Information provided by (Responsible Party):
Sydney Rosen, Boston University

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
HIV Other: SLATE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1077 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Treatment initiation [ Time Frame: 28 days after study enrollment ]
    Proportion of patients initiated on ART within 28 days of study enrollment

  2. 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


Secondary Outcome Measures :
  1. Initiation within 14 days [ Time Frame: 14 days after study enrollment ]
    Proportion of patients who initiate ART within 14 days of study enrollment

  2. 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

  3. One-year retention in care [ Time Frame: 14 months after study enrollment ]
    Retention defined as > 1 month late for last scheduled visit

  4. One-year retention in care [ Time Frame: 16 months after study enrollment ]
    Retention defined as > 3 months late for last scheduled visit

  5. 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

  6. SLATE ineligibility reasons [ Time Frame: Study enrollment ]
    Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm

  7. Time to initiation [ Time Frame: 8 months ]
    Average time to ART initiation (days) for each arm


Other Outcome Measures:
  1. Patient preferences [ Time Frame: Study enrollment ]
    Patient preferences on the speed and timing of ART initiation

  2. Patient costs [ Time Frame: 8 months ]
    Costs to patients of ART initiation under standard and intervention procedures

  3. Provider costs [ Time Frame: 8 months ]
    Costs to providers of ART initiation under standard and intervention procedures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Kenya
Kenya Medical Research Institute/Walter Reed Projects
Kericho, Kericho County, Kenya
South Africa
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
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Principal Investigator: Sydney Rosen Boston University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sydney Rosen, Principal Investigator, Boston University
ClinicalTrials.gov Identifier: NCT02891135     History of Changes
Other Study ID Numbers: H-35634
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sydney Rosen, Boston University:
WHO 'Treat all" Antiretroviral Guidelines
Simplified Algorithm for Treatment Eligibility (SLATE)
Additional relevant MeSH terms:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents