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Be A Hero Vaccine Preparedness Study |
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Randomized, controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials
Source:
J Acquir Immune Defic Syndr 2003 Feb 1;32(2):161-9
Authors:
Coletti AS, Heagerty P, Sheon AR, Gross M, Koblin BA, Metzger DS, Seage GR
3rd; HIV Network for Prevention Trials Vaccine Preparedness Study
Abstract:
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.
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