Clinical trial NCT02891135: Simplified Algorithm for Treatment Eligibility
Official title: Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: WHO 'Treat all" Antiretroviral Guidelines
Simplified Algorithm for Treatment Eligibility (SLATE)
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: Kenya Medical Research Institute
First posted: 2016-09-07
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment initiation
timeFrame: 28 days after study enrollment
measure: Treatment initiation and retention
timeFrame: 8 months after study enrollment
Secondary outcomes:
measure: Initiation within 14 days
timeFrame: 14 days after study enrollment
measure: Viral suppression
timeFrame: 8 months after study enrollment
measure: One-year retention in care
timeFrame: 14 months after study enrollment
measure: One-year retention in care
timeFrame: 16 months after study enrollment
measure: SLATE eligibility
timeFrame: Study enrollment
measure: SLATE ineligibility reasons
timeFrame: Study enrollment
measure: Time to initiation
timeFrame: 8 months
Other outcomes:
measure: Patient preferences
timeFrame: Study enrollment
measure: Patient costs
timeFrame: 8 months
measure: Provider costs
timeFrame: 8 months
Locations:
city: Kericho
country: Kenya
facility: Kenya Medical Research Institute/Walter Reed Projects
state: Kericho County
city: Johannesburg
country: South Africa
facility: Health Economics and Epidemiology Research Office
state: Gauteng
Study officials:
affiliation: Boston University
name: Sydney Rosen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen S, Fox MP, Larson BA, Sow PS, Ehrenkranz PD, Venter F, Manabe YC, Kaplan J; Models for Accelerating Treatment Initiation (MATI) Technical Consultation. Accelerating the Uptake and Timing of Antiretroviral Therapy Initiation in Sub-Saharan Africa: An Operations Research Agenda. PLoS Med. 2016 Aug 9;13(8):e1002106. doi: 10.1371/journal.pmed.1002106. eCollection 2016 Aug.
citation: Fox MP, Rosen S. A new cascade of HIV care for the era of "treat all". PLoS Med. 2017 Apr 11;14(4):e1002268. doi: 10.1371/journal.pmed.1002268. eCollection 2017 Apr.
citation: Rosen S, Fox MP, Larson BA, Brennan AT, Maskew M, Tsikhutsu I, Bii M, Ehrenkranz PD, Venter WF. Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation. BMJ Open. 2017 May 28;7(5):e016340. doi: 10.1136/bmjopen-2017-016340.
citation: Rosen S, Maskew M, Larson BA, Brennan AT, Tsikhutsu I, Fox MP, Vezi L, Bii M, Venter WDF. Simplified clinical algorithm for identifying patients eligible for same-day HIV treatment initiation (SLATE): Results from an individually randomized trial in South Africa and Kenya. PLoS Med. 2019 Sep 16;16(9):e1002912. doi: 10.1371/journal.pmed.1002912. eCollection 2019 Sep.
citation: 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.
citation: 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.
citation: 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.