Revised Simplified Algorithm for Treatment Eligibility for HIV (SLATEII)

NCT03315013 | Completed

• 4 other identifiers: H-37010OPP11361584852171011
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). 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 are needed, including strategies for rapid initiation in patients with symptoms of tuberculosis, most of whom do not have active TB. In July 2017, the original SLATE study (SLATE I) completed enrollment in South Africa. One of the most striking findings of the study so far is the large proportion of patients who "screened out" of the SLATE algorithm and were referred for additional services rather than started on ART immediately. Among 298 patients assigned to the intervention arm and evaluated for immediate treatment eligibility under the SLATE algorithm, 149 (50%) screened out, two thirds of these (100/149) due to symptoms of TB. The vast majority of the TB suspects (93/100, 93%) tested negative for active TB. The SLATE II study will revise the original SLATE algorithm to provide a pathway for immediate ART initiation for some patients with TB symptoms. Under SLATE II, patients with TB symptoms will be clinically evaluated by the study nurse and will receive a urine point of care LAM (lipoarabinomannan antigen of mycobacteria) test. Those with milder symptoms and a negative LAM test will be offered immediate ART. Those with more serious symptoms and/or a positive LAM test will be asked to return the next day to receive TB test results and either immediate ART or TB treatment. All intervention arm patients (symptomatic and asymptomatic) will be asked for a sputum sample for Xpert testing, and positives will be contacted on the next day. The SLATE II algorithm will also incorporate other improvements identified from SLATE I.

Conditions

HIV/AIDS; Antiretroviral Therapy

Keywords

Antiretroviral therapy initiation; Sub-Sahara Africa; ART

Outcome Measures

Primary Outcomes (2)

• Proportion of patients initiated on ART

  % of enrolled patients initiated onto ART within one week of study enrollment, which may occur at HIV diagnosis or at a pre-ART follow-up visit

  7 days after study enrollment

• Proportion of patients initiated on ART and alive, in care, and retained

  Proportion of enrolled patients initiated on ART within 28 days of study enrollment and retained in care 8 months after study enrollment, as indicated by a clinic visit no more than 7 months after ART initiation

  8 months after study enrollment

Secondary Outcomes (14)

• Proportion of TB suspects initiated on ART within 14 days of study enrollment

  14 days after study enrollment

• Proportions of patients initiated on ART within 1, 14, and 28 days of study enrollment

  28 days after study enrollment

• Proportions of all patients and of TB suspects who initiate ART and are virally suppressed eight months after having an HIV test or enrolling in HIV care

  8 months after study enrollment

• Proportions of all patients and of TB suspects who initiate ART and are alive, in care, and retained on ART 14 months after having an HIV test or enrolling in HIV care

  14 months after 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

  1 day after study enrollment

Study Arms (2)

SLATE

EXPERIMENTAL

The SLATE arm will be administered the SLATE II algorithm and initiated on ART immediately if eligible under the algorithm. Patients not eligible under the algorithm will be referred for standard care.

Procedure: SLATE II

Standard

NO INTERVENTION

The standard arm will be referred to standard care after study enrollment.

Interventions

SLATE II PROCEDURE

The SLATE II algorithm is a series of questions and procedures that allow a study clinician to determine if antiretroviral therapy for HIV can be started immediately (same-day) or if additional care or services are needed before ART initiation.

Also known as: Revised Simplified Algorithm for Treatment Eligibility

SLATE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years) (initiating children and adolescents on ART is likely to require additional information and adherence support, making the SLATE algorithm less applicable to pediatric populations)
• Confirmed HIV-positive test result at any time (may have been diagnosed previously)
• Self-report that patient is not currently on ART and has not been prescribed ART in the past three months
• Presented at the study clinic for any HIV-related reason or other reason that led to referral for HIV testing or care

You may not qualify if:

• 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 willing to be traced by phone or in person for follow-up care if test results received after the enrollment visit indicate that further care is needed
• 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 or the SLATE I study

Sponsors & Collaborators

• Boston University: lead
• University of Witwatersrand, South Africa: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Health Economics and Epidemiology Research Office

Johannesburg, Gauteng, South Africa

Location

Related Publications (7)

• Brennan AT, Maskew M, Larson BA, Tsikhutsu I, Bii M, Vezi L, Fox MP, Venter WD, Ehrenkranz P, Rosen S. Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017-2018. J Int AIDS Soc. 2019 Sep;22(9):e25358. doi: 10.1002/jia2.25358.

  PMID: 31518058 BACKGROUND

• Brennan A, Maskew M, Larson BA, Tsikhutsu I, Bii M, Vezi L, Fox M, Venter WDF, Ehrenkranz PD, Rosen S. Prevalence of TB symptoms, diagnosis and treatment among people living with HIV (PLHIV) not on ART presenting at outpatient clinics in South Africa and Kenya: baseline results from a clinical trial. BMJ Open. 2020 Sep 6;10(9):e035794. doi: 10.1136/bmjopen-2019-035794.

  PMID: 32895266 BACKGROUND

• Scott NA, Maskew M, Fong RM, Olson IE, Brennan AT, Fox MP, Vezi L, Ehrenkranz PD, Rosen S. Patient Perspectives of Quality of the Same-Day Antiretroviral Therapy Initiation Process in Gauteng Province, South Africa: Qualitative Dominant Mixed-Methods Analysis of the SLATE II Trial. Patient. 2021 Mar;14(2):175-186. doi: 10.1007/s40271-020-00437-4.

  PMID: 32909218 BACKGROUND

• Rosen S, Maskew M, Brennan AT, Fox MP, Vezi L, Ehrenkranz PD, Venter WDF. Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation. Trials. 2018 Oct 11;19(1):548. doi: 10.1186/s13063-018-2928-5.

  PMID: 30305142 BACKGROUND

• Maskew M, Brennan AT, Fox MP, Vezi L, Venter WDF, Ehrenkranz P, Rosen S. A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial. PLoS Med. 2020 Aug 27;17(8):e1003226. doi: 10.1371/journal.pmed.1003226. eCollection 2020 Aug.

  PMID: 32853271 RESULT

• Maskew M, Parrott S, De Voux L, Sharpey-Schafer K, Crompton T, Govender AC, Pisa PT, Rosen S. Triaging Clients at Risk of Disengagement from HIV Care: Application of a Predictive Model to Clinical Trial Data in South Africa. Risk Manag Healthc Policy. 2025 May 16;18:1601-1619. doi: 10.2147/RMHP.S510666. eCollection 2025.

  PMID: 40395656 DERIVED

• Maskew M, Brennan AT, Venter WDF, Fox MP, Vezi L, Rosen S. Retention in care and viral suppression after same-day ART initiation: One-year outcomes of the SLATE I and II individually randomized clinical trials in South Africa. J Int AIDS Soc. 2021 Oct;24(10):e25825. doi: 10.1002/jia2.25825.

  PMID: 34612601 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sydney B Rosen

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, BUSPH

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 19, 2017
• Study Start: March 14, 2018
• Primary Completion: August 19, 2019
• Study Completion: December 31, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After protocol closure, which will occur approximately one year after all study outcomes have been reached.

Locations

ZA (1)