This application is to support the continued training of Dr Daniel Fitzgerald as an international clinical investigator. The applicant will continue clinical research started during the first three years of Fogarty support in HIV prevention and in practical public health interventions for sexually transmitted diseases. Also, as an extension of previous work, the applicant will conduct a study of the informed consent process for an HIV prevention clinical trial in Haiti. The applicant will continue to be mentored by Dr. Warren Johnson (Cornell) and Dr Jean Pape (GHESKIO Center Haiti). In addition, Dr Thomas Murray (Hastings Center in Bioethics) and Dr Paul Farmer (Harvard, Social Sciences) will serve as advisors. The proposed research is based upon two hypotheses 1) The informed consent process for HIV prevention trials in a developing country can be made more efficient by the use of media aids such as videos and printed brochures. 2) In Haiti, research subjects' autonomy to voluntarily consent is limited by factors such as the influence of family and community leaders. lack of primary health care, and misconceptions about the meaning of signing a consent form.
The specific aims are: 1) to conduct a randomized controlled study comparing research subjects' comprehension of a consent form for an HIV prevention protocol in Haiti after being randomly assigned to receive information about the study by one of two different educational methods. 2) to identify and to characterize through behavioral research techniques factors that limit developing country research subjects' autonomy during the informed consent process for HIV prevention studies. The identification of optimal methods to inform research subjects in Haiti and the characterization of factors that may limit autonomy will allow improvements in the informed consent process for HIV clinical trials in Haiti. This in turn will help establish guidelines for informed consent and protect the rights of research subjects involved in HIV clinical trials in Haiti and other developing countries.
