A Randomized Trial of Vaccine Adherence in Young Injection Drug Users (UFO VAX)

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Behavioral: Outreach; Behavioral: SEP; Biological: Hepatitis A & B vaccine; Behavioral: AIC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00244374

NIDA-17476-1

R01DA017476 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 546 patients

Sex: All

Ages: 14 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (screening study):

• age 14-29 at screening
• injected drugs in the prior 30 days

Exclusion Criteria (screening study):

• Prior positive HIV antibody test
• Prior HBV immunization

Inclusion Criteria (vaccine cohort):

• participated in the screening study
• tested negative for HIV-1 antibody and HBV markers in the screening study
• returned for screening test results within 30 days of testing

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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546 participants in 4 patient groups

AIC, Hepatitis A & B vaccine

Experimental group

Description:

Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.

Treatment:

Behavioral: AIC

Biological: Hepatitis A & B vaccine

AIC, Outreach, Hepatitis A & B vaccine

Experimental group

Description:

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

Treatment:

Behavioral: AIC

Biological: Hepatitis A & B vaccine

Behavioral: Outreach

SEP, Hepatitis A & B vaccine

Experimental group

Description:

SEP only: Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.

Treatment:

Behavioral: SEP

Biological: Hepatitis A & B vaccine

SEP, Outreach, Hepatitis A & B vaccine

Experimental group

Description:

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

Treatment:

Behavioral: SEP

Biological: Hepatitis A & B vaccine

Behavioral: Outreach