Informed consent comprehension
Conditions
Interventions
Written (paper) informed consent Group
Sponsors
Medical Research Council Unit, The Gambia
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Gambia
Contacts
Public ContactMuhammed Afolabi
Medical Research Council Unit, The Gambia
Outcome results
None listed