Patrice Joseph|Bruce R. Schackman|Russel Horwitz|Sandy Nerette|Rose Irène Verdier|Dominique Dorsainvil|Harry Théodore|Maxi Ascensio|Katia Henrys|Peter F. Wright|Warren D. Johnson|Jean W. Pape|Daniel W. Fitzgerald
The Use of an Educational Video During Informed Consent in an HIV Clinical Trial in Haiti
background research volunteers developing countries enroll hiv clinical trials may illiterate unfamiliar conduct medical research educating volunteers contents consent form essential difficult time consuming evaluated feasibility effectiveness educational video informed consent process hiv clinical trial conducted portauprince haiti methods hivseronegative volunteers recruited longitudinal cohort study rates highrisk sexual behavior incidence hiv1 infection enrollment volunteers received information consent form 2 educational sessions first session groups 5 10 volunteers viewed educational video essential elements consent form second volunteers met oneonone social worker volunteers comprehension evaluated orally 16 truefalse questions 4 openended questions volunteers failed first evaluation received additional education second evaluation results two hundred fifty volunteers received education 186 74 passed first evaluation higher formal education significant predictor passing first evaluation odds ratio 160 95 confidence interval 105244 64 failed 47 returned repeat oneonone education session second evaluation among 47 39 83 passed 8 7 failed second evaluation total 225 90 250 individuals passed either first second evaluation eligible enroll study conclusions informed consent using educational video ensured good comprehension volunteers additional educational sessions may necessary participants lower educational level