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M94A2278.TXT
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1994-10-25
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Document 2278
DOCN M94A2278
TI Prophylactic vaccine trials: what is different about HIV?
DT 9412
AU Kippax S; Crawford J; National Centre for HIV Social Research, Macquarie
University,; NSW, Australia.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):340 (abstract no. PC0295). Unique
Identifier : AIDSLINE ICA10/94370297
AB OBJECTIVE: This paper examines the psycho-social aspects of Phase III
HIV vaccine trials and their impact on the design and implementation of
such trials. Its major thesis is that HIV vaccine trials are very
different from most other phase III vaccine trials because exposure to
risk of HIV infection is, in general, under individual control. This is
especially true for individuals who have extended support networks and
preventive education within their community. METHOD: This difference
with regard to 'control' between HIV and other vaccine trials has a
number of implications for the design and conduct of HIV trials. With
reference to the scientific literature on the social aspects of HIV
prevention and the recent literature examining social science
involvement in HIV vaccine trials, three major issues will be explored:
increasing the statistical power of the trial; the problem of
'blinding'; and social 'side effects' of the trial. RESULTS: Analysis
indicates that not only can the statistical power of the trial be
enhanced by a close monitoring of risk practices but it is essential to
a valid interpretation of trial outcome; that blinding may weaken the
methodological and scientific soundness of the trial; and that a number
of social 'side effects' need to be addressed.
DE AIDS Vaccines/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Clinical Trials,
Phase III/*PSYCHOLOGY/STATISTICS & NUMER DATA Health Education Human
HIV Infections/*PREVENTION & CONTROL/PSYCHOLOGY/TRANSMISSION *Patient
Acceptance of Health Care Reproducibility of Results Risk Factors
Social Support MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).