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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.: PACTR201307000574378 Date registered: 2013/06/27
TRIAL DESCRIPTION
Public title Evaluation of the impact of the Clinical Trials Speaking Book on Clinic Patients¿ Knowledge in Uganda
Official scientific title Evaluation of the impact of the Clinical Trials Speaking Book on Clinic Patients¿ Knowledge in Uganda
Brief summary describing the background
and objectives of the trial
Sufficient knowledge and the process of obtaining informed consent present specific challenges with low literacy patients. Our objective was to evaluate the improvement in knowledge in low-literacy patients about the process of clinical trials and the rights and responsibilities of clinical trial participants using an educational tool, the ¿Clinical Trials Speaking Book¿.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Speaking Book
Disease(s) or condition(s) being studied HIV/AIDS , Tuberculosis ,
Purpose of the trial Education/Counselling/Training
Anticipated trial start date 2009-08-03
Actual trial start date 2009-08-18
Anticipated date of last follow up 2009-11-27
Actual date of last follow up 2009-12-07
Anticipated target sample size (number of participants) 200   
Actual target sample size (number of participants) 201   
Recruitment status Completed: recruitment & data analysis 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 randomization of constant block size 4 sequential randomization list used by staff person Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Standard Informational Session 1 time group training session 2 hours Group information session to increase knowledge about clinical trials 101 Active
Experimental group Speaking Book Standard group informational session + use of Speaking Book 7 days Received standard group info session + additional session on use of Speaking Book + 7 days using Speaking Book at home 100

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Adult age 18 or above English literate Resident in Kampala, Uganda Health or other reasons prevent being able to attend or actively participate in the training intervention Does not understand risks and benefits of the study Does not consent to participate 18 Years 99 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 2009/05/05 Joint Clinical Research Centre IRB
Ethics Committee Address
Street address City Postal code Country
Plot 893 Ring Road, Butikiro House Mengo Kampala NA Uganda

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Score difference on clinical trials knowledge assessments Day 0 (after standard group informational session) Day 7
Secondary Outcome Qualitative assessment of participant experience using the Speaking Book Day 7
Secondary Outcome Qualitative assessment of health-care worker experience using the Speaking Book in research setting Day 7

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Infectious Diseases Institute Mulago Hospital coplex Kampala NA Uganda

FUNDING SOURCES
Name of source Street address City Postal code Country
Pfizer 235 East 42nd Street New York 10017 United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Infectious Diseases Institute Mulago Hospital Complex Kampala NA Uganda Company

COLLABORATORS
Name Street address City Postal code Country
Infectious Diseases Institute Mulago Hospital Complex Kampala NA Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Mr Gavin Robertson grobertson@aeras.org 27 21 442 4984 27 21 447 4806
Street address City Postal code Country Position / Affiliation
1st Floor, Old Warehouse Building, Black River Park, Fir Street Observatory, Cape Town 7925 South Africa Clinical Trials Manager
Role Name Email Phone Fax
Public Enquiries Dr Barbara Castelnuovo bcastelnuovo@idi.co.ug 256 414 307300
Street address City Postal code Country Position / Affiliation
IDI, Mulago Hospital Complex Kampala Uganda Deputy Director of Research
Role Name Email Phone Fax
Scientific Enquiries Dr Barbara Castelnuovo bcastelnuovo@idi.co.ug 256 414 307300
Street address City Postal code Country Position / Affiliation
IDI, Mulago Hospital Complex Kampala Uganda Deputy Director of Research