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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201402000775274 Date of Registration: 21/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Multimedia informed consent trial
Official scientific title Evaluation of an alternative informed consent procedure for clinical trials conducted in The Gambia
Brief summary describing the background and objectives of the trial Obtaining valid informed consent remains the cornerstone of any research endeavour. This implies that potential study participants must be provided with necessary information in a comprehensible manner to make an informed decision to participate or not. However, a vast body of scientific literatuee suggests that only few study participants fully undertand the studies they are being enrolled into. This situation is more applicable to study participants in sub-Saharan African countries where low literacy levels are the bais of poor understanding of informed consent information. Due to this challenge, it is widely recognized that conventional informed consent procedures are insufficient in obtaining valid informed consent in developing countries. This is because complex and legthy consent forms designed by researchers do not add to the understanding of the participants. The situation is compounded in countries where English or French is not the first language, requiring translation to local languages. Translations of informed consent documents into local languages have constituted a great challenge in The Gambia as major loca languages are spoken languages; and back-translations into English to verify the correct translations are almost impossible. Therefore, there is a crucial need to develop a locally appropriate strategy for communicatin study information to clinical trial participants as a mean of obtaining informed consent. Futhrermore, there is evidence that the use of multimedia mayaddress the problem of poor understandin of study information. We designed a three stage study to develop and validate an audio digitised informed consent comprehension questionnaire; pilot a meultimedia consent tool and evlauate the effectiveness of the tool in enhancing recall "recall and understanding" of study participants about informed consent information.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Multimedia trial
Disease(s) or condition(s) being studied Informed consent comprehension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 17/06/2013
Actual trial start date 19/08/2013
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date 31/03/2014
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SSC1314 Gambia Government/Medical Research Council Joint Ethics Committee
London School of Hygiene and Tropical Medicine Ethics committee
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multimedia At first visit (Day 0), Day 7, 14, 21, 28, 35 and 42 42 days Informed consent document of a primaquine trial developed into a multimedia format integrating video, animations and audio narrations in 3 major Gambian languages: Mandinka, Wolof and Fula 150 Active-Treatment of Control Group
Control Group Written (paper) informed consent Group Day 0 42 days Written paper informed consent 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Participants must be in the planned primaquine trial at Basse and Jahaly trial sites in The Gambia; 2) Participants must be able to speak any of the 3 major Gambian languages: Mandinka, Fula or Wolof 1) Participants must not have communication or visual problems (e.g. language problems, deafness, blindness); 2) Participants must not have cognitive impairment or intellectual disability 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 30/01/2013 London School of Hygiene and Tropical Medicine Wthics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
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 31/12/2012 The Gambia Government/MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
C/o MRC Unit: The Gambia, Fajara PO Box 273, Banjul WC1E 7HT Gambia
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 30/01/2013 London School of Hygiene & Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants with ¿good recall¿ as measured by proportion of participants who succeed in selecting correct answers to the closed ended and multiple choice question items on the validated comprehension questionnaire at days 7,14 and 28 after intervention visit. days 7,14 and 28 after intervention visit
Secondary Outcome Proportion of participants with ¿good recall¿ as measured by proportion of participants who succeed in selecting correct answers to the closed ended and multiple choice question items on the validated comprehension questionnaire at days 7,14 and 28 after intervention visit. days 7,14 and 28 after intervention visit.
Secondary Outcome Acceptability and ease of use of multimedia consent tool and audio digitised comprehension questionnaire as measured by participants¿ responses during 1st and 2nd visits in the pilot study during 1st and 2nd visits in the pilot study
Secondary Outcome Acceptability and ease of use of multimedia consent tool and audio digitised questionnaire as measured by participants¿ responses in primaquine trial during focus group discussion sessions at days 35 and 42 after intervention visit. days 35 and 42 after intervention visit.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council Unit, The Gambia Atlantic Road Banjul 00220 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership 334 Laan van Nieuw Oost Indie The Hague 2593 CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council Unit, The Gambia Atlantic Road, Fajara Banjul 0220 Gambia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
European Vaccine Initiative m Neuenheimer Feld 326, Room 320 Universitatsklinikum, Heidelberg 69120 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammed Afolabi mafolabi@mrc.gm +220-7059861 , Medical Research Council Unit, Atlantic Road, Fajara, P.O Box 273
City Postal code Country Position/Affiliation
Banjul 0220 Gambia Medical Researhc Council Unit, The Gambia
Role Name Email Phone Street address
Public Enquiries Muhammed Afolabi mafolabi@mrc.gm +220-7059861 Medical Research Council Unit, Atlantic Road, Fajara, P.O Box 273
City Postal code Country Position/Affiliation
Banjul 0220 Gambia Medical Research Council Unit, The Gambia
Role Name Email Phone Street address
Scientific Enquiries Muhammed Afolabi mafolabi@mrc.gm +220-7059861 Medical Research Council Unit, Atlantic Road, Fajara, P.O Box 273
City Postal code Country Position/Affiliation
Banjul 0220 Gambia Medical Research Council Unit, The Gambia
REPORTING
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