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A Randomized Trial of Vaccine Adherence in Young Injection Drug Users - 1
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2005
First Received: October 25, 2005   Last Updated: November 3, 2005   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Vaccine series completion

Secondary Outcome Measures:
  • Hepatitis B Surface Antibodies
  • Reduction of Risk Behavior (Sexual, Drug, & Health)
  • Vaccine attitudes
  • Hepatitis A Antibodies

Estimated Enrollment: 300
Study Start Date: August 2004
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244374

Contacts
Contact: Jamye L Ford, M.A. (415)476-9296 ext 287

Locations
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    
Sponsors and Collaborators
Investigators
Principal Investigator: Paula J Lum, M.D., M.P.H. University of California, San Francisco
  More Information

No publications provided

Study ID Numbers: NIDA-17476-1, R01-17476-1
Study First Received: October 25, 2005
Last Updated: November 3, 2005
ClinicalTrials.gov Identifier: NCT00244374     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Disorders of Environmental Origin
Hepatitis, Viral, Human
Picornaviridae Infections
Hepadnaviridae Infections
Hepatitis
Virus Diseases
Digestive System Diseases
Mental Disorders
Hepatitis B
Substance-Related Disorders
Hepatitis A
DNA Virus Infections
Hepatitis C
Enterovirus Infections
Substance Abuse, Intravenous

ClinicalTrials.gov processed this record on February 08, 2010