Simplified Algorithm for Treatment Eligibility

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: SLATE

• Registration Number: NCT02891135
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Study Start: 2017-03-06
• Primary Completion: 2018-04-23
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1077

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	SLATE	Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE).

Primary Outcome Measures

Name	Time	Method
Treatment initiation	28 days after study enrollment	Proportion of patients initiated on ART within 28 days of study enrollment
Treatment initiation and retention	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

Name	Time	Method
Viral suppression	8 months after study enrollment	Proportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment
Initiation within 14 days	14 days after study enrollment	Proportion of patients who initiate ART within 14 days of study enrollment
One-year retention in care	16 months after study enrollment	Retention defined as \> 3 months late for last scheduled visit
SLATE eligibility	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	Study enrollment	Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm
Time to initiation	8 months	Average time to ART initiation (days) for each arm

Trial Locations

Locations (2)

Kenya Medical Research Institute/Walter Reed Projects; 🇰🇪 Kericho, Kericho County, Kenya

Health Economics and Epidemiology Research Office; 🇿🇦 Johannesburg, Gauteng, South Africa