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.: PACTR201307000574378 Date of Approval: 27/06/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 03/08/2009
Actual trial start date 18/08/2009
Anticipated date of last follow up 27/11/2009
Actual Last follow-up date 07/12/2009
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 201
Recruitment status Completed
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 permuted block randomization of constant block size 4 sequential randomization list used by staff person Open-label(Masking Not 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-Treatment of Control Group
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 Age Category Minimum age Maximum 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 Year(s) 99 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 05/05/2009 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 Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Infectious Diseases Institute Mulago Hospital Complex Kampala NA Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gavin Robertson grobertson@aeras.org 27 21 442 4984 1st Floor, Old Warehouse Building, Black River Park, Fir Street
City Postal code Country Position/Affiliation
Observatory, Cape Town 7925 South Africa Clinical Trials Manager
Role Name Email Phone Street address
Public Enquiries Barbara Castelnuovo bcastelnuovo@idi.co.ug 256 414 307300 IDI, Mulago Hospital Complex
City Postal code Country Position/Affiliation
Kampala Uganda Deputy Director of Research
Role Name Email Phone Street address
Scientific Enquiries Barbara Castelnuovo bcastelnuovo@idi.co.ug 256 414 307300 IDI, Mulago Hospital Complex
City Postal code Country Position/Affiliation
Kampala Uganda Deputy Director of Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information