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.: PACTR201112000327297 Date of Approval: 10/10/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RCT of home-care and routine cryptococcal meningitis screening among patients starting antiretroviral therapy with advanced disease.
Official scientific title Reduction of early morality among HIV-infected subjects starting antiretroviral therapy in Zambia and Tanzania with CD4 count<100 cells per microlite: a randomised trial involving home support and routine screening for cryptococcal meningitis.
Brief summary describing the background and objectives of the trial A two-arm individually randomised trial comparing intervention with control. Trial will be based in Dar es Salaam in Tanzania and Lusaka in Zambia. HIV-infected adult subjects with CD4 count<100 cells per microlitre, living within the catchment population of the clinic, reporting to be antiretroviral naïve and to planning on remaining in the study area for the next 6-months will be eligible for the trial. Patients requiring immediate in-patient care will be excluded from the trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) REMSTART
Disease(s) or condition(s) being studied Infections and Infestations,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/12/2011
Actual trial start date
Anticipated date of last follow up 31/10/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 2500
Actual target sample size (number of participants) 2300
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ISCTRN20410413 ISCTRN
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 Randomisation is computer generated (separately) for each country. Codes are placed in sealed envelopes and opened individually for each patient Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Accelerated initiation of ART, lay adherence support and diagnostic testing for major co-infections Four home visits Six weeks of intervention, 12 months of follow-up ART initiation immediately after CD4 result obtained for patients with CD4<100 at registration. Antigen test for cryptococcal meningitis with admission for treatment if necessary. Weekly home visits by trained lay workers to support adherence and monitor side effects. GeneXpert test for TB. 1250
Control Group Standard of Care Local standard of care, with 3 adherence visits required before ART started, followed by routine hospital visits and testing. In addition, GeneXpert TB test will be administered. 1250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
CD4<200 cells/µl Adult: >18y or more Antiretroviral naive (as reported by the patient) Planning to remain in the study area for about 6 months (as reported by the patient) Requiring immediate in-patient care/admission Living outside the catchment population of the hospital 18 Year(s) 100 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 10/08/2011 National Institute for Medical Research/Ministry of Health and Social Welfare
Ethics Committee Address
Street address City Postal code Country
P.O. Box 9653 Dar es Salaam Tanzania
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 29/08/2011 ERES Converge
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road Lusaka Zambia
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 03/10/2011 Republic of Zambia Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Ndeke House, P.O. Box 30205 Lusaka Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All-cause mortality 12 months after enrolment
Secondary Outcome Costs of the two strategies to the health service 12 months after enrollment
Secondary Outcome Patient retention on ART Regularly for 12 months
Secondary Outcome Rate of hospital admission Up to 12 months after enrollment
Secondary Outcome Frequency of outpatient attendances Up to 12 months after enrollment
Secondary Outcome Detection of tuberculosis among patients on ART and their household members Up to 12 months after enrollment
Secondary Outcome Detection of cryptococcal meningitis among patients on ART Up to 12 months after enrollment
Secondary Outcome Uptake of HIV voluntary counselling and testing and of TB screening among household member Up to 12 months after enrollment
Secondary Outcome Adherence to ART Up to 12 months after enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Teaching Hospital Nationalist Road Lusaka 10101 Zambia
Muhimbili Medical Research Centre, National Institute for Medical Research P.O. Box 3436 Dar es Salaam Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP P.O. Box 93015, The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr S. Egwaga Ministry of Health and Social Welfare Dar es Salaam Tanzania
Dr. P. Mwaba University Teaching Hospital Lusaka 10101 Zambia
Dr J. Chakaya Kenya Medical Research Institute Nairobi Kenya
Prof. S. Jaffar London School of Hygiene and Tropical Medicine London WC1E 7HT United Kingdom
Dr G. Roscigno Foundation for Innovative New Diagnostics Geneva 1202 Switzerland
Prof. A. Zumla University College London London W1 4JF United Kingdom
Prof. L. Lindqvist Karolinska University Hospital, Huddinge Stockholm SE-14186 Sweden
Prof. T. Harrison St Georges Medical School London SW17 0RE United Kingdom
Prof. A. Pym South African Medical Research Council Durban 4001 South Africa
Dr M. Joloba Makerere University Medical School Kampala Uganda
Dr S. Mfinanga Muhimbili Medical Research Centre, National Institute for Medical Research Dar es Salaam Tanzania
Prof. S. Banoo Management Sciences for Health Johannesburg 2017 South Africa
Dr C. Bottomley London School of Hygiene and Tropical Medicine London WC1E 7HT United Kingdom
Dr L. Guinness London School of Hygiene and Tropical Medicine London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saidi Egwaga egwagas@yahoo.co.uk +255 222 2124500 PO Box 9083
City Postal code Country Position/Affiliation
Dar es Salaam Tanzania Head of National TB and Leprosy programme
Role Name Email Phone Street address
Public Enquiries Susie Burdett susanna.burdett@lshtm.ac.uk 020 927 2703 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Research Group Administrator
Role Name Email Phone Street address
Scientific Enquiries Shabbar Jaffar shabbar.jaffar@lshtm.ac.uk 020 79272418 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor of Epidemiology
REPORTING
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