title: The use of an educational video during informed consent in an HIV clinical trial in Haiti.
abstract: BACKGROUND
  Research volunteers from developing countries who enroll in HIV clinical trials may be illiterate and unfamiliar with the conduct of medical research. Educating volunteers about the contents of the consent form is essential but can be difficult and time consuming. We evaluated the feasibility and effectiveness of an educational video during the informed consent process for an HIV clinical trial conducted in Port-au-Prince, Haiti.
  
  
  METHODS
  HIV-seronegative volunteers were recruited into a longitudinal cohort to study rates of high-risk sexual behavior and incidence of HIV-1 infection. Before enrollment, all volunteers received information about the consent form during 2 educational sessions. In the first session, groups of 5 to 10 volunteers viewed an educational video on the essential elements of the consent form. In the second, the volunteers met one-on-one with a social worker. Volunteers' comprehension was then evaluated orally by 16 true-false questions and 4 open-ended questions. Volunteers who failed the first evaluation received additional education and had a second evaluation.
  
  
  RESULTS
  Two hundred fifty volunteers received education, and 186 (74%) passed the first evaluation. Higher formal education was a significant predictor of passing the first evaluation (odds ratio, 1.60; 95% confidence interval, 1.05-2.44). Of the 64 who failed, 47 returned for a repeat one-on-one education session and a second evaluation. Among these 47, 39 (83%) passed, and 8 (7%) failed the second evaluation. In total, 225 (90%) of 250 individuals passed either the first or second evaluation and were eligible to enroll in the study.
  
  
  CONCLUSIONS
  Informed consent using an educational video ensured good comprehension in most of the volunteers. Additional educational sessions may be necessary for some participants with lower educational level.
authors.affiliation: Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, GHESKIO, Port au Prince, Haiti.
authors.forename: Patrice
authors.initials: P
authors.lastname: Joseph
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Schackman
authors.forename: Russel
authors.initials: R
authors.lastname: Horwitz
authors.forename: Sandy
authors.initials: S
authors.lastname: Nerette
authors.forename: Rose Irene
authors.initials: RI
authors.lastname: Verdier
authors.forename: Dominique
authors.initials: D
authors.lastname: Dorsainvil
authors.forename: Harry
authors.initials: H
authors.lastname: Theodore
authors.forename: Maxi
authors.initials: M
authors.lastname: Ascensio
authors.forename: Katia
authors.initials: K
authors.lastname: Henrys
authors.forename: Peter F
authors.initials: PF
authors.lastname: Wright
authors.forename: Warren
authors.initials: W
authors.lastname: Johnson
authors.forename: Jean W
authors.initials: JW
authors.lastname: Pape
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Fitzgerald
mesh_terms: D000328:Adult; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission; D006205:Haiti; D006801:Humans; D007258:Informed Consent; D007407:Interviews as Topic; D008137:Longitudinal Studies; D008297:Male; D010353:Patient Education as Topic / Q000379:methods*; D014741:Video Recording