PT  - JOURNAL ARTICLE
AU  - Sydney Rosen
AU  - Matthew P Fox
AU  - Bruce A Larson
AU  - Alana T Brennan
AU  - Mhairi Maskew
AU  - Isaac Tsikhutsu
AU  - Margaret Bii
AU  - Peter D Ehrenkranz
AU  - WD Francois Venter
TI  - Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation
AID  - 10.1136/bmjopen-2017-016340
DP  - 2017 May 01
TA  - BMJ Open
PG  - e016340
VI  - 7
IP  - 5
4099  - http://bmjopen.bmj.com/content/7/5/e016340.short
4100  - http://bmjopen.bmj.com/content/7/5/e016340.full
SO  - BMJ Open2017 May 01; 7
AB  - Introduction African countries are rapidly adopting guidelines to offer antiretroviral therapy (ART) to all HIV-infected individuals, regardless of CD4 count. For this policy of ‘treat all’ to succeed, millions of new patients must be initiated on ART as efficiently as possible. Studies have documented high losses of treatment-eligible patients from care before they receive their first dose of antiretrovirals (ARVs), due in part to a cumbersome, resource-intensive process for treatment initiation, requiring multiple clinic visits over a several-week period.Methods and analysis The Simplified Algorithm for Treatment Eligibility (SLATE) study is an individually randomised evaluation of a simplified clinical algorithm for clinicians to reliably determine a patient’s eligibility for immediate ART initiation without waiting for laboratory results or additional clinic visits. SLATE will enrol and randomise (1:1) 960 adult, HIV-positive patients who present for HIV testing or care and are not yet on ART in South Africa and Kenya. Patients randomised to the standard arm will receive routine, standard of care ART initiation from clinic staff. Patients randomised to the intervention arm will be administered a symptom report, medical history, brief physical exam and readiness assessment. Patients who have positive (satisfactory) results for all four components of SLATE will be dispensed ARVs immediately, at the same clinic visit. Patients who have any negative results will be referred for further clinical investigation, counselling, tests or other services prior to being dispensed ARVs. After the initial visit, follow-up will be by passive medical record review. The primary outcomes will be ART initiation ≤28 days and retention in care 8 months after study enrolment.Ethics and dissemination Ethics approval has been provided by the Boston University Institutional Review Board, the University of the Witwatersrand Human Research Ethics Committee (Medical) and the KEMRI Scientific and Ethics Review Unit. Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents.Trial registration NCT02891135