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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00244374 |
Purpose
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.
| Condition | Intervention |
|
Adherence Community Outreach HIV Risk Behaviors Hepatitis A Vaccines Hepatitis B Vaccines Hepatitis C Needle-Exchange Programs Substance Abuse, Intravenous |
Behavioral: Needle-Exchange Programs |
| MedlinePlus related topics: | Hepatitis Hepatitis A Hepatitis B Hepatitis C |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | A Randomized Trial of Vaccine Adherence in Young IDU |
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2004 |
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.
Eligibility
| Ages Eligible for Study: | 14 Years to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Jamye L Ford, M.A. | (415)476-9296 ext 287 |
| United States, California | |||||
| University of California San Francisco Medical Cen | Recruiting | ||||
| San Francisco, California, United States, 94143 0939 | |||||
| Contact: Jamye L Ford, M.A. 415-476-4082 ext 287 jford@php.ucsf.edu | |||||
| Principal Investigator: | Paula J Lum, M.D., M.P.H. | University of California, San Francisco |
More Information
| Study ID Numbers: | NIDA-17476-1, R01-17476-1 |
| First Received: | October 25, 2005 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00244374 |
| Health Authority: | United States: Federal Government |
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