The Use of an Educational Video During Informed Consent in an HIV Clinical Trial in Haiti
September 25, 2006
In developing countries, volunteers in HIV clinical trials "may be illiterate and unfamiliar with the conduct of medical research," the authors began, noting that explaining the contents of the consent form "is essential but can be difficult and time consuming." The researchers conducted the current study to evaluate the feasibility and effectiveness of an educational video during the informed consent process for an HIV clinical trial conducted in Port-au-Prince, Haiti.
Investigators recruited HIV-seronegative volunteers into a longitudinal cohort to study rates of high-risk sexual behavior and incidence of HIV-1 infection. Before enrollment, volunteers received information about the consent form during two educational sessions. In the first session, groups of 5-10 volunteers watched an educational video on the essential elements of the consent form. In the second session, volunteers met one-on-one with a social worker. Volunteers' comprehension was then evaluated orally through 16 true-false questions and four open-ended questions. Volunteers who failed the first evaluation were given additional education and a second evaluation.
Two-hundred and fifty volunteers received education, and 186 (74 percent) passed the first evaluation. Higher formal education was a significant predictor of passing the first evaluation (odds ratio, 1.60; 95 percent 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 those 47, 39 (83 percent) passed, and 8 (7 percent) failed the second evaluation. Overall, 225 (90 percent) of 250 volunteers passed either the first or second evaluation and were eligible to enroll in the study.
"Informed consent using an educational video ensured good comprehension in most of the volunteers," the authors concluded. "Additional educational sessions may be necessary for some participants with lower educational level."
Journal of Acquired Immune Deficiency Syndromes
08.15.2006; Vol. 42; No. 5: P. 588-591; Joseph Patrice, M.D.; Bruce R. Schackman, Ph.D.; Russel Horwitz, B.S.; Sandy Nerette, M.D.; Rose Irene Verdier, M.D.; Dominique Dorsainvil, M.D.; Harry Theodore, M.D.; Maxi Ascensio, M.S.; Katia Henrys, M.S.; Peter F. Wright, M.D.: Warren Johnson, M.D.; Jean W. Pape, M.D.
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.