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).