HIV/AIDSSLATEIINCT03315013
Revised Simplified Algorithm for Treatment Eligibility for HIV (SLATEII)
A study testing SLATE II in people with HIV/AIDS and Antiretroviral Therapy, run by Boston University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Antiretroviral Therapy
- What is being tested?
- SLATE II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Mar 2018to 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 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
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 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Health Economics and Epidemiology Research Office
Johannesburg, Gauteng
About this study
Official title: Randomized Evaluation of a Revised, Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV (SLATEII)
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.
Read the detailed description
SLATE II is be a pragmatic, individually randomized evaluation to determine the effectiveness of the revised algorithm in increasing ART initiation, compared to standard care, among non-pregnant adult patients. Six hundred 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 a revised version of the SLATE screens, including the TB add-on; 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 care. Primary outcomes will be ART initiation within 7 days of study enrollment and viral suppression within 8 months of study enrollment.
The study is being conducted at three healthcare facilities (clinics) in South Africa. In September 2017, the South African National Department of Health instructed all clinics to offer same-day ART initiation to eligible patients but provided little guidance on determining eligibility. SLATE II will help to create such guidance. If successful, it will improve on the SLATE 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/AIDS, Antiretroviral Therapy
- Being tested
- SLATE II
- Keywords
- Antiretroviral therapy initiation, Sub-Sahara Africa, ART
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLATE IIProcedure or surgery
Also called Revised Simplified Algorithm for Treatment Eligibility
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: SLATE II |
| Standard | No intervention | The standard arm will be referred to standard care after study enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8 months after study enrollment
Secondary outcomes (14)
Proportion of TB suspects initiated on ART within 14 days of study enrollment
Proportion of TB suspects initiated on ART within 14 days of study enrollment
Measured: 14 days after study enrollment
Proportions of patients initiated on ART within 1, 14, and 28 days of study enrollment
Proportions of patients initiated on ART within 1, 14, and 28 days of study enrollment
Measured: 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
Viral suppression stratified by TB symptom status at baseline
Measured: 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
Retention 12 months after enrollment, allowing 1 month for initiation and 1 month for making and recording data from 12-month visit.
Measured: 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
Patients who screen in and screen out of algorithm in intervention arm
Measured: 1 day after study enrollment
Reasons for ineligibility for immediate initiation
Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm
Measured: 1 day after study enrollment
Median time to ART initiation (days) for each arm
Median and IQR time to ART initiation (days) for each arm
Measured: 28 days after study enrollment
Adverse events
Frequency and types of adverse events reported in medical records after ART initiation for each follow up period
Measured: 1, 7, 14, and 28 days after enrollment; 8 and 14 months after enrollment
Patient preferences
Patient self-reported preferences on the speed and timing of ART initiation, from questionnaires
Measured: 1 day after enrollment
LAM test results
Proportion of symptomatic patients who test positive for TB using the LAM test
Measured: 1 day after enrollment
Xpert test results
Proportions of symptomatic and asymptomatic patients who test positive for TB using Xpert MTB/RIF, among those able to produce a sputum sample
Measured: 1 week after enrollment
Costs to patients
Costs to patients of ART initiation under standard and intervention procedures
Measured: 14 months after study enrollment (end of followup)
Costs to providers
Costs to providers of ART initiation under standard and intervention procedures
Measured: 14 months after study enrollment (end of followup)
Differences from SLATE I
Comparison of results of SLATE II study to SLATE I study
Measured: 14 months after study enrollment (end of followup)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start14 Mar 2018
- Primary completion19 Aug 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Sydney Rosen, Boston University
- Investigators
- Sydney B Rosen, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315013
- Sponsor's protocol ID
- H-37010
- Other IDs
- OPP1136158, 4852, 171011
- Acronym
- SLATEII
- Status last verified
- Jan 2021
- First submitted
- 6 Oct 2017
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After protocol closure, dis-identified data generated by the study will be shared on Dryad. Data from patients' medical records do not belong to the study and cannot be shared but may be available on request from the study sites.
Publications
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.
PubMed 31518058Brennan 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 32895266Scott 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.
PubMed 32909218Rosen 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.
PubMed 30305142Maskew 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.
PubMed 32853271Maskew 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 34612601
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 Revised, Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV (SLATEII)
- ClinicalTrials.gov ID
- NCT03315013
- Acronym / sponsor ID
- SLATEII / H-37010
- Conditions
- HIV/AIDS, Antiretroviral Therapy
- Keywords
- Antiretroviral therapy initiation, Sub-Sahara Africa, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Bill and Melinda Gates Foundation
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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 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.
Detailed description
SLATE II is be a pragmatic, individually randomized evaluation to determine the effectiveness of the revised algorithm in increasing ART initiation, compared to standard care, among non-pregnant adult patients. Six hundred 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 a revised version of the SLATE screens, including the TB add-on; 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 care. Primary outcomes will be ART initiation within 7 days of study enrollment and viral suppression within 8 months of study enrollment.
The study is being conducted at three healthcare facilities (clinics) in South Africa. In September 2017, the South African National Department of Health instructed all clinics to offer same-day ART initiation to eligible patients but provided little guidance on determining eligibility. SLATE II will help to create such guidance. If successful, it will improve on the SLATE 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 |
|---|---|---|
| SLATE | Experimental | Procedure: SLATE IIThe 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. |
| Standard | No intervention | –The standard arm will be referred to standard care after study enrollment. |
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 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
Key exclusion criteria (6 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 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
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 |
|---|---|---|
| SLATE IIAlso: Revised Simplified Algorithm for Treatment EligibilityThe 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. | Procedure or surgery | SLATE |
Primary outcome
Proportion of patients initiated on ART
Time frame: 7 days after study enrollment
% 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
Proportion of patients initiated on ART and alive, in care, and retained
Time frame: 8 months after study enrollment
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
14 secondary outcomes
Proportion of TB suspects initiated on ART within 14 days of study enrollment
Time frame: 14 days after study enrollment
Proportions of patients initiated on ART within 1, 14, and 28 days of study enrollment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 day after study enrollment
Reasons for ineligibility for immediate initiation
Time frame: 1 day after study enrollment
Median time to ART initiation (days) for each arm
Time frame: 28 days after study enrollment
Adverse events
Time frame: 1, 7, 14, and 28 days after enrollment; 8 and 14 months after enrollment
Patient preferences
Time frame: 1 day after enrollment
LAM test results
Time frame: 1 day after enrollment
Xpert test results
Time frame: 1 week after enrollment
Costs to patients
Time frame: 14 months after study enrollment (end of followup)
Costs to providers
Time frame: 14 months after study enrollment (end of followup)
Differences from SLATE I
Time frame: 14 months after study enrollment (end of followup)
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 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.
- Background: 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.
- Background: PubMed 32909218Scott 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.
- Background: PubMed 30305142Rosen 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.
- Results publication: PubMed 32853271Maskew 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.
- 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.
- Individual participant dataSharing planned: Yes. After protocol closure, dis-identified data generated by the study will be shared on Dryad. Data from patients' medical records do not belong to the study and cannot be shared but may be available on request from the study sites.
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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 B Rosen principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLATE II in people with HIV/AIDS and Antiretroviral Therapy, run by Boston University at 1 site in South Africa.
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 6 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 1 site in 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?
Proportion of patients initiated on ART (time frame: 7 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 NCT03315013, which also lists 7 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.