The use of an educational video during informed consent in an HIV clinical trial in Haiti.
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.
Joseph
Patrice
P
Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, GHESKIO, Port au Prince, Haiti.
Schackman
Bruce R
BR
Horwitz
Russel
R
Nerette
Sandy
S
Verdier
Rose Irene
RI
Dorsainvil
Dominique
D
Theodore
Harry
H
Ascensio
Maxi
M
Henrys
Katia
K
Wright
Peter F
PF
Johnson
Warren
W
Pape
Jean W
JW
Fitzgerald
Daniel W
DW
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