Anne Coletti|Patrick J. Heagerty|Amy R. Sheon|Michael L. Gross|Beryl A. Koblin|David Metzger|George R. Seage
Randomized, Controlled Evaluation of a Prototype Informed Consent Process for HIV Vaccine Efficacy Trials
Family Health International 360|Fred Hutch Cancer Center|University of Michigan–Ann Arbor|National Institute of Allergy and Infectious Diseases|New York Blood Center|University of Pennsylvania|Harvard University|University of Pennsylvania|Harvard University Press
procedures must developed ensure valid informed consent obtained participants hiv vaccine efficacy trials prototype informed consent process evaluated among 4892 persons high risk hiv infection hiv network prevention trials vaccine preparedness study vps prospective cohort study hiv seroincidence eight us metropolitan areas twenty percent vps participants selected random undergo prototype informed consent process vps month 3 participants knowledge 10 key hiv vaccine trial concepts willingness participate hiv vaccine efficacy trials assessed compared baseline semiannually thereafter 18 months knowledge hiv vaccine trial concepts low baseline participation prototype process associated substantial sustained increases knowledge relative risks 10 items 104226 similar magnitude across hiv risk groups raceethnicity educational levels recommended prototype informed consent process adopted future hiv vaccine efficacy trials well clinical trials research areas