Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201609001783150 Date of Approval: 16/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SIMPLIFIED ALGORITHM FOR TREATMENT ELIGIBILITY: THE SLATE STUDY
Official scientific title Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV (SIMPLIFIED ALGORITHM FOR TREATMENT ELIGIBILITY: THE SLATE STUDY)
Brief summary describing the background and objectives of the trial At a technical consultation convened in October 2015, participants 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 immediate (same-day) treatment initiation: i) symptom report, ii) medical history, iii) readiness assessment, and iv) brief physical examination. SLATE is a pragmatic, individually randomized evaluation to determine the effectiveness of the algorithm in increasing ART initiation, compared to standard care, among non-pregnant adult patients. A total of approximately 1,500 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. The study will be conducted at two healthcare facilities (clinics) in each of three countries: South Africa, Kenya, and Malawi. 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SLATE
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date 31/08/2018
Anticipated target sample size (number of participants) 960
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised After part 1 of the case report form (CRF) has been completed, patients will be randomized to the intervention or standard groups of the study. Randomization envelopes will be generated in blocks of 6 and kept at the study sites. For each enrolled patient, the study assistant will open the next envelope in sequential order, read the randomization group, and record it on the case report form. The study assistant will then inform the patient of the randomization assignment. Randomization is kept in envelopes at the study sites and only open by study staff at the point at which the patients are assigned to treatment or standard arm groups . Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SLATE N/A N/A The Simplified Algorithm for Treatment Eligibility (SLATE) uses four screens to assess whether a patient is eligible for immediate (same-day) treatment initiation: i) symptom report, ii) medical history, iii) readiness assessment, and iv) brief physical examination 480
Control Group Standard Arm N/A N/A 480 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients (>18 years) (initiating children on ART is likely to require additional information, making the SLATE algorithm less applicable to pediatric populations) 2. Confirmed HIV-positive test result at any time (may have been diagnosed previously) 3. Not currently on ART (three-drug combination) or have started ART initiation process 4. Presented at the study clinic for any HIV-related reason, including an HIV test, pre-ART monitoring, or ART initiation 1. 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) 2. Not intending to return to this clinic for further HIV care in the coming year (i.e. intends to seek further care somewhere else) 3. Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff 4. Not willing or able to provide written informed consent to participate in the study 5. Previously enrolled in the same study 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2016 Boston University CRC IRB
Ethics Committee Address
Street address City Postal code Country
25 Buick Street Room 157 Boston 02215 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/11/2016 Human Research Ethics Committee (HREC) University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Avenue, Braamfontein Johannesburg 2000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/11/2016 KENYA MEDICAL RESEARCH INSTITUTE (KEMRI)
Ethics Committee Address
Street address City Postal code Country
Nairobi Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/11/2016 The Walter Reed Army Institute of Research
Ethics Committee Address
Street address City Postal code Country
Hospital Road P.O. Box 1357 Kericho Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients initiated on ART within 28 days of study enrollment. While national guidelines recommend ART initiation within two weeks of a patient¿s first clinic visit or HIV diagnosis, recent studies suggest that 28 days is a more realistic deadline for routine care. within 28 days of study enrollment
Primary Outcome The proportion of patients who initiate ART and are alive, in care, and retained on ART eight months after study enrollment. Eight months was selected to allow up to 1 month (28 days) to initiate ART, six months of follow up after treatment initiation, and up to 1 month to return for the six-month routine clinic visit. Eight months after study enrollment.
Secondary Outcome The proportion of patients initiated on ART within 14 days of having an HIV test or enrolling in HIV care. Within 14 days of having an HIV test or enrolling in HIV care.
Secondary Outcome The proportion of patients who initiate ART and are virally suppressed eight months of having an HIV test or enrolling in HIV care between HIV-infected patients offered immediate ART initiation under the SLATE algorithm and patients offered standard ART initiation. Eight months from study enrollment
Secondary Outcome The proportion of patients who initiate ART and are alive, in care, and retained on ART 14 months after having an HIV test or enrolling in HIV care. Fourteen months extends the primary outcome endpoint, which is at 8 months, by an additional six months. 14 months after study enrollment
Secondary Outcome Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm. Date of enrollment into study
Secondary Outcome Average time to ART initiation (days) for each arm. Within 14 months from study enrollment
Secondary Outcome Patient preferences on the speed and timing of ART initiation. On date of study enrollment
Secondary Outcome Costs to patients of ART initiation under standard and intervention procedures. N/A
Secondary Outcome Costs to providers of ART initiation under standard and intervention procedures. N/A
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OR Tambo Clinic Stand 383, King Senza Gakhone Street, Diepsloot, Bryanston 2189 South Africa
Jabulane Dumane 257 Nguza St Vosloorus 1475 South Africa
Alexandra Health Centre 15 Arkwright Ave Johannesburg 2090 South Africa
Kericho County Referral Hospital P.O. Box 11 Kericho 20200 Kenya
Kapsabet County Referral Hospital P.O. Box 5, Kapsabet 30300 Kenya
Kombewa County Hospital P.O. Box 60 Kombewa 40102 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill & Melinda Gates Foundation 440 5th Ave N. Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Health Economics and Epidemiology Research Office 39 Empire Road Parktown Johannesburg 02193 South Africa Charities/Societies/Foundation
Secondary Sponsor Henry Jackson Foundation (HJF) Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
N/A
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sydney Rosen sbrosen@bu.edu 617-414-1273 Dept. Global Health, Crosstown Center 3rd flr., 801 Massachusetts Ave
City Postal code Country Position/Affiliation
Boston
Role Name Email Phone Street address
Principal Investigator Sydney Rosen sbrosen@bu.edu 617-414-1273 Dept. Global Health, Crosstown Center 3rd flr., 801 Massachusetts Ave
City Postal code Country Position/Affiliation
Boston 02118 United States of America
Role Name Email Phone Street address
Public Enquiries Alana Brennan abrennan@bu.edu 6174141179 Dept. Global Health, Crosstown Center 3rd Flr. 801 Massachusetts Ave.
City Postal code Country Position/Affiliation
Boston 02118 United States of America Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Alana Brennan abrennan@bu.edu 61741411179 Dept. Global Health, Crosstown Center 3rd Flr. 801 Massachusetts Ave.
City Postal code Country Position/Affiliation
Boston 02118 United States of America Research Scientist
REPORTING
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Result URL Hyperlinks
Changes to trial information