Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 May 28;7(5):e016340.
doi: 10.1136/bmjopen-2017-016340.

Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation

Sydney Rosen  1   2 , Matthew P Fox  1   2   3 , Bruce A Larson  1 , Alana T Brennan  1   2 , Mhairi Maskew  2 , Isaac Tsikhutsu  4 , Margaret Bii  4 , Peter D Ehrenkranz  5 , Wd Francois Venter  6
Affiliations
Randomized Controlled Trial

Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation

Sydney Rosen et al. BMJ Open. .

Abstract

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.

Keywords: Africa; Antiretroviral therapy; Kenya; Randomized trial; South Africa; Treatment initiation; protocols & guidelines.

PubMed Disclaimer

Conflict of interest statement

Competing interests: PDE is an employee of the Bill & Melinda Gates Foundation, which is funding this work. WDFV sits on antiretroviral initiation guideline committees, both local and international. WDFV has accepted speaking honoraria from multiple manufacturers of antiretrovirals and is on several of their advisory boards. The remaining authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Adapted from Rosen S, Fox MP, Larson B, Sow PS, Ehrenkranz PD, Venter F, Manabe Y, Kaplan J, for the Models for Accelerating Treatment Initiation Technical Consultation. Accelerating the uptake and timing of antiretroviral therapy initiation in sub-Saharan Africa: an operations research agenda. PLoS Med 2016; 13: e1002106. DOI:10.1371/journal.pmed.1002106 (CC BY 4.0). ART, antiretroviral therapy; CrAg, cryptococcal antigen; TB, tuberculosis.
Figure 2
Figure 2
Study flow diagram. ART, antiretroviral therapy; ARV, antiretroviral; SLATE, Simplified Algorithm for Treatment Eligibility.
See this image and copyright information in PMC

References

    1. World Health Organization. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. Geneva: World Health Organization, 2015. - PubMed
    1. Barnabas RV, Bendavid E, Bershteyn A, et al. . HIV mortality by care cascade stage and implications for universal ART eligibility. Conference on Retroviruses and Opportunistic Infections, Boston;22–25 Feb 2016;. http://www.croiconference.org/sessions/hiv-mortality-care-cascade-stage-...
    1. Lahuerta M, Ue F, Hoffman S, et al. . The problem of late ART initiation in Sub-Saharan Africa: a transient aspect of scale-up or a long-term phenomenon? J Health Care Poor Underserved 2013;24:359–83. 10.1353/hpu.2013.0014 - DOI - PMC - PubMed
    1. Iwuji CC, Orne-Gliemann J, Larmarange J, et al. . Uptake of home-based HIV testing, linkage to care, and community attitudes about ART in rural KwaZulu-Natal, South Africa: Descriptive results from the first phase of the ANRS 12249 TasP cluster-randomised trial. PLoS Med 2016;13:e1002107 10.1371/journal.pmed.1002107 - DOI - PMC - PubMed
    1. Govindasamy D, Ford N, Kranzer K. Risk factors, barriers and facilitators for linkage to ART care in sub-Saharan Africa: a systematic review. AIDS 2012;26:2059–67. 10.1097/QAD.0b013e3283578b9b - DOI - PubMed

Publication types

Substances

Associated data