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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: www.pactr.org

Trial no.: PACTR201303000505764 Date registered: 2013/02/19
TRIAL DESCRIPTION
Public title Impact of GneXpert MTB/RIF on TB outcomes in an ART clinic
Official scientific title Preventing TB-related adverse outcomes in patients initiating ART: the impact of Xpert MTB/RIF
Brief summary describing the background
and objectives of the trial
In December 2010, WHO recommended Xpert MTB/RIF as the first line TB diagnostic in HIV-infected patients. The impact of Xpert MTB/RIF on TB outcomes in patients initiating antiretroviral therapy(ART) is unknown.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Diagnosis
Anticipated trial start date 2011-07-25
Actual trial start date 2011-10-26
Anticipated date of last follow up 2012-06-29
Actual date of last follow up 2012-07-19
Anticipated target sample size (number of participants) 400   
Actual target sample size (number of participants) 440   
Recruitment status Closed to recruitment: follow up complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 permuted block randomisation with blocks of size four. Allocation was done in the laboratory. The code was placed in sealed opaque envelopes kept by the data manager and given to the laboratory manager in batches. The code was exposed only after specimens were assigned sequential lab numbers. Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Xpert MTB/RIF 220
Control group Fluorescent microscopy 220

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
- aged 18 years or older - HIV positive eligible for ART - on ART - on TB treatment/treated in the past 6 months - seriously ill (fever >38oC, respiratory rate >30 beats/minute and unable to walk unaided) 18 Years 100 Years 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 2011/03/28 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazoe Street Harare Zimbabwe

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adverse outcome - delayed diagnosis: TB diagnosed 30 days after recruitment - IRIS: TB diagnosed after ART initiation - early mortality: any death within the three month period
Secondary Outcome -diagnostic yield of sputum induction At analysis
Secondary Outcome Risk factors for adverse outcome At analysis
Secondary Outcome Burden of TB in asymptomatic patients At analysis

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beatrice Road Infectious Diseases Hospital Simon Mazorodze Road Harare 9999 Zimbabwe

FUNDING SOURCES
Name of source Street address City Postal code Country
Southern Africa Consortium for Research Excellence College of Health Sciences, University of Zimbabwe Harare Zimbabwe

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Professor Peter Mason Biomedical Research and Training Institute Harare Zimbabwe University

COLLABORATORS
Name Street address City Postal code Country
Reggie Mutetwa Biomedical Research and TrainingInstitute Harare Zimbabwe

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Ms Lucy Mupfumi lmupfumi@gmail.com +263-4735000 +263-4735003
Street address City Postal code Country Position / Affiliation
4th Floor NICOZ Diamond House, Samora Machel Avenue Harare 9999 Zimbabwe Research Fellow
Role Name Email Phone Fax
Scientific Enquiries Mr Reggie Mutetwa rmutetwa@gmail.com +263-4735000 +263-4735003
Street address City Postal code Country Position / Affiliation
4th Floor NICOZ Diamond House, Samora Machel Avenue Harare 9999 Zimbabwe PhD fellow, Health Innovations Unit Coordinator
Role Name Email Phone Fax
Public Enquiries Prof Peter Mason pmason@brti.co.zw +263-4735000 +263-4735003
Street address City Postal code Country Position / Affiliation
4th floor NICOZ Diamond House, Samora Machel Avenue Harare 9999 Zimbabwe Director