A multimedia consent tool for research participants in the Gambia: a randomized controlled trial

• DOI: 10.2471/blt.14.146159
• Publication Date: 2015-05-01T11:20:35Z
• Authors: Muhammed Olanrewa...; Nuala McGrath; Umberto D’Alessandro; Beate Kampmann; Egeruan B Imoukhuede; Raffaella M Ravin...; Neal Alexander; Heidi J Larson; Daniel Chandramohan; Kalifa Bojang
• Keywords: Adult; Male; Research Subjects; Primaquine; Antimalarials; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Animals; Humans; Sex Distribution; Informed Consent; Research; Focus Groups; Middle Aged; Survival Analysis; Health Literacy; Malaria; Multimedia; Female; Gambia; Public aspects of medicine; RA1-1270; Comprehension

MethodsWe conducted a randomized controlled trial in Basse and Jahaly Provinces the Upper River Region Central Region, respectively, of Gambia from 15 August 2013 to 12 March 2014.The study was nested within parent -the PRINOGAM trial. 14The aim this determine optimal dosage primaquine required clear gametocytes block disease transmission asymptomatic malaria carriers.Participants were aged 1 year or older seen on day inclusion (day 0, Objective To assess effectiveness multimedia informed consent tool for adults participating clinical Gambia.Methods Adults eligible treatment (n = 311) receive information needed using either (intervention arm) standard procedure (control arm).A computerized, audio questionnaire used participants' comprehension consent.This done immediately after had been obtained (at 0) at subsequent follow-up visits (days 7, 14, 21 28).The acceptability ease use assessed focus groups.Findings On median score intervention arm 64% compared with 40% control (P 0.042).The difference remained significant all visits.Poorer independently associated female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70)and residing rather than province (OR: 0.33; 0.13-0.82).There no independent association educational level.The risk that participant's would drop half initial value lower (hazard ratio 0.22, 0.16-0.31).Overall, 70% (42/60) group participants found easy understand.Conclusion A significantly improved retention by research low levels literacy.