An interventional study of SLATE II in HIV/AIDS and Antiretroviral Therapy, sponsored by Boston University. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Boston University · Not applicable, Interventional, and Treatment
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Among 10 studies in Acquired Immunodeficiency Syndrome by Boston University — 1 open to participants now, 1 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Boston University.
Among the 10 studies in Acquired Immunodeficiency Syndrome by Boston University, this one is the only one that started in 2018, is one of 7 with no phase, and was the 8th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →1 of the 10 studies in Acquired Immunodeficiency Syndrome by Boston University is open now, in 1 country. Recruiting first, the newest first:
Boston University · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
This study's enrollment of 600 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 360 across the 8 interventional studies, 177 across the 2 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
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Boston University is the lead sponsor of 271 studies on the registry; 37 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Acquired Immunodeficiency Syndrome by Boston University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The standard arm will be referred to standard care after study enrollment.
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
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
Time frame: 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
Time frame: 8 months after study enrollment
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
Time frame: 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
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
Viral suppression stratified by TB symptom status at baseline
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
Retention 12 months after enrollment, allowing 1 month for initiation and 1 month for making and recording data from 12-month visit.
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
Patients who screen in and screen out of algorithm in intervention arm
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 day after enrollment
LAM test results
Proportion of symptomatic patients who test positive for TB using the LAM test
Time frame: 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
Time frame: 1 week after enrollment
Costs to patients
Costs to patients of ART initiation under standard and intervention procedures
Time frame: 14 months after study enrollment (end of followup)
Costs to providers
Costs to providers of ART initiation under standard and intervention procedures
Time frame: 14 months after study enrollment (end of followup)
Differences from SLATE I
Comparison of results of SLATE II study to SLATE I study
Time frame: 14 months after study enrollment (end of followup)
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: After protocol closure, which will occur approximately one year after all study outcomes have been reached.
Ran from Mar 2018 to primary completion in Aug 2019, 17 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 17 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →