HIVSLATENCT02891135
Simplified Algorithm for Treatment Eligibility
A study testing SLATE in people with HIV, run by Boston University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- SLATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,077 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Mar 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
Kenya Medical Research Institute/Walter Reed Projects
Kericho, Kericho County
South Africa1 site
Health Economics and Epidemiology Research Office
Johannesburg, Gauteng
About this study
Official title: Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV
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.
- Conditions
- HIV
- Being tested
- SLATE
- Keywords
- WHO 'Treat all" Antiretroviral Guidelines, Simplified Algorithm for Treatment Eligibility (SLATE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLATEOther
Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV. |
| Intervention | Experimental | Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE). Receives: Other: SLATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment initiation
Proportion of patients initiated on ART within 28 days of study enrollment
Measured: 28 days after study enrollment
Treatment initiation and retention
Proportion of patients who initiate ART within 28 days of study enrollment and are alive, in care, and retained on ART eight months after study enrollment
Measured: 8 months after study enrollment
Secondary outcomes (7)
Initiation within 14 days
Proportion of patients who initiate ART within 14 days of study enrollment
Measured: 14 days after study enrollment
Viral suppression
Proportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment
Measured: 8 months after study enrollment
One-year retention in care
Retention defined as > 1 month late for last scheduled visit
Measured: 14 months after study enrollment
One-year retention in care
Retention defined as > 3 months late for last scheduled visit
Measured: 16 months after study enrollment
SLATE eligibility
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
Measured: Study enrollment
SLATE ineligibility reasons
Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm
Measured: Study enrollment
Time to initiation
Average time to ART initiation (days) for each arm
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start6 Mar 2017
- Primary completion23 Apr 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Sydney Rosen, Boston University
- Investigators
- Sydney Rosen, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891135
- Sponsor's protocol ID
- H-35634
- Acronym
- SLATE
- Status last verified
- Jan 2021
- First submitted
- 1 Sep 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be retained in secure study databases until completion of the study, including completion of all data analysis and report writing associated with the study and closing of the IRB-approved protocol. Study data sets and other electronic files containing study data will then have all identifiers removed and where possible will be made available for use of other researchers through a repository such as Dryad.
Publications
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.
PubMed 27505444Fox 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.
PubMed 28399160Rosen 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.
PubMed 28554939Rosen 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.
PubMed 31525187Brennan 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.
PubMed 31518058Maskew 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.
PubMed 40395656Maskew 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.
PubMed 34612601Brennan 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.
PubMed 32895266
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV
- ClinicalTrials.gov ID
- NCT02891135
- Acronym / sponsor ID
- SLATE / H-35634
- Conditions
- HIV
- Keywords
- WHO 'Treat all" Antiretroviral Guidelines, Simplified Algorithm for Treatment Eligibility (SLATE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Kenya Medical Research Institute
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV. |
| Intervention | Experimental | Other: SLATEPatients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLATEAlgorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications. | Other | Intervention |
Primary outcome
Treatment initiation
Time frame: 28 days after study enrollment
Proportion of patients initiated on ART within 28 days of study enrollment
Treatment initiation and retention
Time frame: 8 months after study enrollment
Proportion of patients who initiate ART within 28 days of study enrollment and are alive, in care, and retained on ART eight months after study enrollment
7 secondary outcomes
Initiation within 14 days
Time frame: 14 days after study enrollment
Viral suppression
Time frame: 8 months after study enrollment
One-year retention in care
Time frame: 14 months after study enrollment
One-year retention in care
Time frame: 16 months after study enrollment
SLATE eligibility
Time frame: Study enrollment
SLATE ineligibility reasons
Time frame: Study enrollment
Time to initiation
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 27505444Rosen 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.
- Background: PubMed 28399160Fox 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.
- Background: PubMed 28554939Rosen 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.
- Results publication: PubMed 31525187Rosen 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.
- Results publication: PubMed 31518058Brennan 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.
- Derived from this study: PubMed 40395656Maskew 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.
- Derived from this study: PubMed 34612601Maskew 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.
- Derived from this study: PubMed 32895266Brennan 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.
- CROI poster with preliminary results for South AfricaLink provided by the sponsor.
- CROI 2019 poster and video with primary outcome results for KenyaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be retained in secure study databases until completion of the study, including completion of all data analysis and report writing associated with the study and closing of the IRB-approved protocol. Study data sets and other electronic files containing study data will then have all identifiers removed and where possible will be made available for use of other researchers through a repository such as Dryad.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Rosen principal investigator
Boston University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLATE in people with HIV, run by Boston University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment initiation (time frame: 28 days after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02891135, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.