A Randomized Trial of Vaccine Adherence in Young Injection Drug Users

Not Applicable

Completed

Conditions: Medication Adherence
Substance Abuse, Intravenous
Risk Behavior
Hepatitis A
Hepatitis B
Hepatitis C

Interventions: Biological: Hepatitis A & B vaccine
Behavioral: AIC
Behavioral: Outreach
Behavioral: SEP

Registration Number: NCT00244374

Lead Sponsor: University of California, San Francisco

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 546

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
AIC, Hepatitis A & B vaccine	Hepatitis A & B vaccine	Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
AIC, Hepatitis A & B vaccine	AIC	Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
AIC, Outreach, Hepatitis A & B vaccine	Hepatitis A & B vaccine	AIC + outreach: Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
AIC, Outreach, Hepatitis A & B vaccine	Outreach	AIC + outreach: Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
AIC, Outreach, Hepatitis A & B vaccine	AIC	AIC + outreach: Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
SEP, Hepatitis A & B vaccine	Hepatitis A & B vaccine	SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
SEP, Hepatitis A & B vaccine	SEP	SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
SEP, Outreach, Hepatitis A & B vaccine	Hepatitis A & B vaccine	Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
SEP, Outreach, Hepatitis A & B vaccine	Outreach	Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
SEP, Outreach, Hepatitis A & B vaccine	SEP	Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations

Primary Outcome Measures

Name	Time	Method
Vaccine Series Completion	12 months	The primary outcome was the completion of the four-dose vaccine series in a 12 month period.

Secondary Outcome Measures

Name	Time	Method
HIV Vaccine Trial Willingness	Baseline	We assessed knowledge about vaccine trials and willingness to participate in preventive HIV vaccine trials by asking the question: "How willing would you be to join a study of a vaccine to prevent HIV infection, if the study were to start tomorrow?". Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing).
HIV Vaccine Trial Knowledge	Baseline	Participants were asked if they agreed or disagreed with or were unsure of each of eight statements about HIV vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET). 1. Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative. 2. Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance). 3. Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies. 4. Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe. 5. Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies. 6. HIV vaccines will never affect a person's HIV test results. 7. An HIV vaccine can infect a person with HIV disease. 8. People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects.
Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses	12 months	To examine the effect of hepatitis C virus (HCV) infection on vaccine effectiveness, we compared anti-HBs (antibody to the hepatitis B surface antigen) seroconversion after three vaccine doses between anti-HCV (antibody to the hepatitis C virus) positive and anti-HCV negative participants.
Viral Transmission Risk Behavior Association With Travel	Baseline	In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel in the 3 months prior to baseline and behaviors occurring in the 30 days prior to baseline, such as drug and alcohol and sexual behaviors, that may facilitate the spread of viral infections.