A Randomized Trial of Vaccine Adherence in Young Injection Drug Users - 1 - NCT00244374-94143 (Clinical Trial 132508)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy132508.aspx
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San Francisco |
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State:
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CA |
| Zip Code: |
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94143 |
| Conditions: |
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Adherence - Community Outreach - HIV Risk Behaviors - Hepatitis A Vaccines - Hepatitis B Vaccines - Hepatitis C - Needle-Exchange Programs - Substance Abuse, Intravenous |
| Purpose: |
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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.
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| Study summary: |
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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 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 or at a public health adult immunization clinic. 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. |
| Criteria: |
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Eligible persons for the screening study are: (a) are age <29 at screening; (b) have
injected drugs in the prior 30 days; and report neither (c) a prior positive HIV antibody
test nor (d) prior HBV immunization. Eligible persons for the vaccine study will have:
(a) participated in the screening study; (b) tested negative for HIV-1 antibody and HBV
markers in the screening study; and (c) returned for screening test results within 30 days
of testing. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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