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M94A2285.TXT
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Document 2285
DOCN M94A2285
TI HIV-vaccine trial preparations in Kigali, Rwanda.
DT 9412
AU Estey JD; Fox E; Allen S; Project San Francisco, University of
California.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):339 (abstract no. PC0292). Unique
Identifier : AIDSLINE ICA10/94370290
AB OBJECTIVE: To prepare Rwandan paramedical personnel for future HIV
vaccine trials and determine feasibility of such trials in Rwanda using
Hepatitis B vaccine in a randomized controlled study. METHODS: Rwanda is
one of four countries selected by the WHO/GPA for future HIV vaccine
trials. Feasibility and field capacity for these trials will depend on
the availability of trained and experienced Rwandan paramedical staff,
many of whom continue to be misinformed about HIV vaccine trials. To
reinforce a one-week informational seminar on vaccine trials, Project
San Francisco has begun a simulation HIV vaccine trial as practical
experience in the assessment of subject willingness to participate,
comprehension of the informed consent process, determination of subject
eligibility through medical and demographic screening methods, blinding
and randomization procedures for subjects receiving either vaccine or
placebo, subject follow-up and evaluation, and data analysis of the
vaccine's immune response in the study population. HIV-negative Rwandan
couples, discordant for HBcAb and concordant negative for HBsAg, were
selected as potential practicum study subjects. RESULTS: From 90 Rwandan
physicians, nurses, and paramedical staff participating in the initial
seminar, 20 were selected based on written exam results to participate
as trainees in the HIV vaccine trial simulation. Results from
post-practicum exams will be available in April 1994 and reflect level
of practical experience gained by trainees. Initial results regarding
trial feasibility are good. As of February 1994, 90 eligible subjects
have been identified (40% of HIV-negative couples tested for Hepatitis
B), 60 of whom have confirmed their participation in the initial
screening process. DISCUSSION: The HIV vaccine trial simulation will
help verify that all elements, including procedures, materials, and
trained paramedical staff are in place to conduct larger vaccine trials
with HIV-vaccine. The Hepatitis B practicum will not only familiarize
essential paramedical staff with the operational issues involved in
conducting a randomized clinical trial, but will provide important
information regarding the feasibility of such trials in the Rwandan
population.
DE Allied Health Personnel/EDUCATION AIDS Vaccines/*ADMINISTRATION &
DOSAGE *Developing Countries Feasibility Studies Hepatitis
B/*PREVENTION & CONTROL/TRANSMISSION Hepatitis B
Vaccines/ADMINISTRATION & DOSAGE Human HIV Infections/*PREVENTION &
CONTROL/TRANSMISSION Inservice Training Rwanda CLINICAL TRIAL
MEETING ABSTRACT RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).