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Randomized, Controlled Evaluation of a Prototype Informed Consent Process for HIV Vaccine Efficacy Trials

Coletti Anne S.; Heagerty, Patrick; Sheon, Amy R.; Gross, Michael; Koblin, Beryl A.; Metzger, David S.; Seage, George R. III; for the HIVNET VPS Protocol Team
JAIDS Journal of Acquired Immune Deficiency Syndromes: February 2003

Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials. A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study (VPS), a prospective cohort study of HIV seroincidence in eight U.S. metropolitan areas. Twenty percent of VPS participants were selected at random to undergo the prototype informed consent process at VPS month 3. Participants' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months. Knowledge of HIV vaccine trial concepts was low at baseline. Participation in the prototype process was associated with substantial and sustained increases in knowledge (relative risks for the 10 items, 1.04-2.26), which were of similar magnitude across HIV risk groups, race/ethnicity, and educational levels. It is recommended that the prototype informed consent process be adopted for future HIV vaccine efficacy trials as well as for clinical trials in other research areas.

This work was supported by the HIVNET, which is sponsored by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services, in part through contract N01-AI-35176 with Abt Associates, Inc., contract N01-AI-45200 with the Fred Hutchinson Cancer Research Center, and subcontracts from Abt Associates, Inc., to the Denver Department of Public Health, Fenway Community Health Center, Howard Brown Health Center, New York Blood Center, New York University Medical Center, San Francisco Department of Public Health, University of Pennsylvania, and University of Washington.

The content of this publication does not necessarily reflect the views or policies of the U.S. Department of Health and Human Services, and mention of trade names, commercial products, or organizations does not imply endorsement by the U.S. Government.

Address correspondence and reprint requests to Dr. George R. Seage III, Harvard School of Public Health, Department of Epidemiology, 677 Huntington Avenue, Boston, MA 02115, U.S.A.; e-mail:

Manuscript received month May 16, 2001; accepted October 10, 2002.

© 2003 Lippincott Williams & Wilkins, Inc.