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).