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Simplified Algorithm for Treatment Eligibility

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02891135
Acronym
SLATE
Enrollment
1077
Registered
2016-09-07
Start date
2017-03-06
Completion date
2020-12-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

WHO 'Treat all Antiretroviral Guidelines, Simplified Algorithm for Treatment Eligibility (SLATE)

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.

Interventions

OTHERSLATE

Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.

Sponsors

University of Witwatersrand, South Africa
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment initiation and retention8 months after study enrollmentProportion 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
Treatment initiation28 days after study enrollmentProportion of patients initiated on ART within 28 days of study enrollment

Secondary

MeasureTime frameDescription
Initiation within 14 days14 days after study enrollmentProportion of patients who initiate ART within 14 days of study enrollment
Viral suppression8 months after study enrollmentProportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment
Time to initiation8 monthsAverage time to ART initiation (days) for each arm
One-year retention in care14 months after study enrollmentRetention defined as \> 1 month late for last scheduled visit
SLATE eligibilityStudy enrollmentProportions 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 reasonsStudy enrollmentReasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm

Other

MeasureTime frameDescription
Patient preferencesStudy enrollmentPatient preferences on the speed and timing of ART initiation
Patient costs8 monthsCosts to patients of ART initiation under standard and intervention procedures
Provider costs8 monthsCosts to providers of ART initiation under standard and intervention procedures

Countries

Kenya, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026