Hepatitis C Clinical Trial
Official title:
A Randomized Trial of Vaccine Adherence in Young IDU
The purpose of this study is to compare the effects of (a) immunization setting and (b) outreach worker support on young injection drug users' (IDU) adherence to a multiple dose immunization schedule with a combined hepatitis A virus (HAV) inactivated and hepatitis B virus (HBV) recombinant vaccine.
This is a research trial consisting of a cross-sectional screening study and a prospective
cohort study (randomized, 2x2 factorial design). The primary aim of the study is to evaluate
the effects of immunization setting and outreach worker support on young IDU's adherence to
a multiple dose immunization schedule with a combined HAV and HBV vaccine. Secondarily, the
study will 1) explore the feasibility of a remote immunization network and web-based vaccine
registry to improve immunization coverage of transient young IDU, 2) examine the effect of
hepatitis C virus (HCV) infection in vaccine effectiveness, and 3) assess behavior change
and vaccine attitudes in young IDU participating in a preventive vaccine trial.
Subjects in the screening study complete an interview, receive counseling and testing for
HIV, HAV, HBV and HCV, and return in one week for test results and risk reduction
counseling. Subjects eligible for the cohort study receive their first immunizations at
enrollment and then are randomized to receive subsequent vaccines at either a set of syringe
exchange programs (SEP) or at a public health adult immunization clinic (AIC). Subjects also
are randomized to receive vaccine reminders from an outreach worker or no outreach worker
support. Each subject receives a total of 4 immunizations over 6 months. Follow up visits
include interviews, counseling, and viral testing. Study participation is for 12 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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