Simplified Algorithm for Treatment Eligibility (SLATE)

Boston University

Status

Completed

Conditions

HIV

Treatments

Other: SLATE

Study type

Interventional

Funder types

Other

Identifiers

NCT02891135

H-35634

Details and patient eligibility

About

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.

Enrollment

1,077 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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