|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201402000775274 |
|
Date of registration:
|
21/02/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Multimedia informed consent trial
|
|
Scientific title:
|
Evaluation of an alternative informed consent procedure for clinical trials conducted in The Gambia |
|
Date of first enrolment:
|
17/06/2013 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=775 |
|
Study type:
|
Interventional |
|
Study design:
|
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
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Gambia
| | | | | | | |
|
Contacts
|
|
Name:
|
Muhammed
Afolabi |
|
Address:
|
Medical Research Council Unit, Atlantic Road, Fajara, P.O Box 273
0220
Banjul
Gambia |
|
Telephone:
|
+220-7059861 |
|
Email:
|
mafolabi@mrc.gm |
|
Affiliation:
|
Medical Research Council Unit, The Gambia |
|
|
Name:
|
Muhammed
Afolabi |
|
Address:
|
Medical Research Council Unit, Atlantic Road, Fajara, P.O Box 273
0220
Banjul
Gambia |
|
Telephone:
|
+220-7059861 |
|
Email:
|
mafolabi@mrc.gm |
|
Affiliation:
|
Medical Research Council Unit, The Gambia |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
18 Year(s)
Age maximum:
99 Year(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Informed consent comprehension
|
Informed consent comprehension
|
|
Intervention(s)
|
|
|
|
Multimedia
|
|
Written (paper) informed consent Group
|
|
Primary Outcome(s)
|
|
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.
|
|
Secondary Outcome(s)
|
|
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.
|
|
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
|
|
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.
|
|
Source(s) of Monetary Support
|
|
European and Developing Countries Clinical Trials Partnership
|
|
Ethics review
|
Status: Approved
Approval date: 31/12/2012
Contact:
The Gambia Government/MRC Joint Ethics Committee
|
Status: Approved
Approval date: 30/01/2013
Contact:
London School of Hygiene & Tropical Medicine
|
Status: Approved
Approval date: 30/01/2013
Contact:
London School of Hygiene and Tropical Medicine Wthics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|