A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
Condition: Medication Adherence; Substance Abuse, Intravenous; Risk Behavior; Hepatitis A; Hepatitis B; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis; Substance-Related Disorders; Substance Abuse, Intravenous
Study type: Interventional

Summary: 
      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.
    

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 (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.
    

Intervention name(s): Hepatitis A & B vaccine; Outreach; AIC; SEP
Intervention type(s): Biological; Behavioral; Behavioral; Behavioral
Intervention description(s): Each subject will receive a total of 4 immunizations over 6 months on a 0-1-2-6 month schedule. At the initial visit, subjects>18 years of age will receive the Twinrix vaccine and subjects<18 years of age will receive the Engerix-B vaccine. Cohort subjects>18 years found to have HAV antibody at screening will receive Engerix-B for their remaining 3 immunizations. All subjects will receive: an immunization record with the first vaccine dose entered and the dates the next doses are due; helpful hints for remembering vaccine appointments; and written instructions on where and how to get immunized outside of SF.; Outreach worker vaccine adherence support: Half of cohort subjects will be assigned to outreach worker vaccine adherence support and will meet with their outreach workers from Haight Ashbury Youth Outreach Team (HAYOT) and Glide Health Services on the day of vaccine cohort study enrollment. Intensive vaccination tracking and in-person outreach support will begin one week before the second and third vaccine doses are due, and again two weeks before the fourth dose is due.; The Adult Immunization Clinic (AIC) is a public low-cost vaccine clinic located centrally at 101 Grove Street in the lobby of the San Francisco Department of Public Health (SFDPH). The clinic is open from Monday-Friday 9 a.m. to 4 p.m. Nurses at the AIC will be available 40 hours/week to administer free immunizations to study subjects.; Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6. Research nurses will provide 16 hours/week of vaccine administration services at SEPs well attended by young IDU. The San Francisco Needle Exchange (SFNE) serves primarily youth and young adults on Mondays, Wednesdays, and Fridays from 5-7 p.m. in an indoor location in the Haight-Ashbury district. A study nurse will be at SFNE for a total of 6 hours per week. HIV Prevention Project (HPP) sites also operate for 2 hrs each (Tues, Thu, Fri, Sat). Medical services are provided either in a clinic setting at indoor sites (6th Street) or at outdoor sites (Hemlock Alley, Duboce). A study nurse will attend each of these 5 weekly sites for a total of 10 hours/week.
Other intervention name(s): Twinrix; Engerix-B; Haight Ashbury Youth Outreach Team (HAYOT); Glide Health Services; Adult Immunization Clinic (AIC); San Francisco Department of Public Health (SFDPH); syringe exchange; needle exchange; harm reduction; San Francisco Needle Exchange (SFNE); HIV Prevention Project (HPP)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention