Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT02891135
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simplified Algorithm for Treatment Eligibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1077}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient preferences', 'timeFrame': 'Study enrollment', 'description': 'Patient preferences on the speed and timing of ART initiation'}, {'measure': 'Patient costs', 'timeFrame': '8 months', 'description': 'Costs to patients of ART initiation under standard and intervention procedures'}, {'measure': 'Provider costs', 'timeFrame': '8 months', 'description': 'Costs to providers of ART initiation under standard and intervention procedures'}], 'primaryOutcomes': [{'measure': 'Treatment initiation', 'timeFrame': '28 days after study enrollment', 'description': 'Proportion of patients initiated on ART within 28 days of study enrollment'}, {'measure': 'Treatment initiation and retention', 'timeFrame': '8 months after study enrollment', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Initiation within 14 days', 'timeFrame': '14 days after study enrollment', 'description': 'Proportion of patients who initiate ART within 14 days of study enrollment'}, {'measure': 'Viral suppression', 'timeFrame': '8 months after study enrollment', 'description': 'Proportion of patients who are virally suppressed according to local guidelines within 8 months of study enrollment'}, {'measure': 'One-year retention in care', 'timeFrame': '14 months after study enrollment', 'description': 'Retention defined as \\> 1 month late for last scheduled visit'}, {'measure': 'One-year retention in care', 'timeFrame': '16 months after study enrollment', 'description': 'Retention defined as \\> 3 months late for last scheduled visit'}, {'measure': 'SLATE eligibility', 'timeFrame': 'Study enrollment', 'description': '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'}, {'measure': 'SLATE ineligibility reasons', 'timeFrame': 'Study enrollment', 'description': 'Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm'}, {'measure': 'Time to initiation', 'timeFrame': '8 months', 'description': 'Average time to ART initiation (days) for each arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WHO \'Treat all" Antiretroviral Guidelines', 'Simplified Algorithm for Treatment Eligibility (SLATE)'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '27505444', 'type': 'BACKGROUND', '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.'}, {'pmid': '28399160', 'type': 'BACKGROUND', '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.'}, {'pmid': '28554939', 'type': 'BACKGROUND', '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.'}, {'pmid': '31525187', 'type': 'RESULT', '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.'}, {'pmid': '31518058', 'type': 'RESULT', '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.'}, {'pmid': '40395656', 'type': 'DERIVED', 'citation': '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': '34612601', 'type': 'DERIVED', '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.'}, {'pmid': '32895266', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.croiconference.org/sessions/same-day-art-initiation-slate-trial-south-africa-preliminary-results', 'label': 'CROI poster with preliminary results for South Africa'}, {'url': 'http://www.croiconference.org/sessions/same-day-art-initiation-slate-trial-kenya-preliminary-results', 'label': 'CROI 2019 poster and video with primary outcome results for Kenya'}]}, 'descriptionModule': {'briefSummary': '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.\n\nExperts 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 years) (initiating children on ART is likely to require additional information, making the SLATE algorithm less applicable to pediatric populations)\n* Confirmed HIV-positive test result at any time (may have been diagnosed previously)\n* Not currently on ART (three-drug combination)\n* Presented at the study clinic for any HIV-related reason, including an HIV test, pre-ART monitoring, or ART initiation\n\nExclusion Criteria:\n\n* 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)\n* Not intending to return to this clinic for further HIV care in the coming year (i.e. intends to seek further care somewhere else)\n* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff\n* Not willing or able to provide written informed consent to participate in the study\n* Previously enrolled in the same study'}, 'identificationModule': {'nctId': 'NCT02891135', 'acronym': 'SLATE', 'briefTitle': 'Simplified Algorithm for Treatment Eligibility', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV', 'orgStudyIdInfo': {'id': 'H-35634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'Patients randomized to the standard arm will receive standard procedures for initiating antiretroviral therapy for HIV.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients randomized to the intervention arm will be offered immediate treatment initiation under the intervention algorithm (SLATE).', 'interventionNames': ['Other: SLATE']}], 'interventions': [{'name': 'SLATE', 'type': 'OTHER', 'description': 'Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kericho', 'state': 'Kericho County', 'country': 'Kenya', 'facility': 'Kenya Medical Research Institute/Walter Reed Projects', 'geoPoint': {'lat': -0.36774, 'lon': 35.28314}}, {'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Health Economics and Epidemiology Research Office', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Sydney Rosen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Witwatersrand, South Africa', 'class': 'OTHER'}, {'name': 'Kenya Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sydney Rosen', 'investigatorAffiliation': 'Boston University'}}}}