Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules

Yale University595 enrolled

Overview

The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

595

Conditions

Hepatitis B

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Demonstrate evidence of recent injection drug use (injection stigmata), * 18 years of age or older, * Screened for and found susceptible to HBV * Able to provide informed consent. Exclusion Criteria: * Evidence of intoxication that prevented provision of informed consent.

Locations (3)

Hispanic Health Council

Hartford, Connecticut, United States

DePaul University

Chicago, Illinois, United States

Case Western Reserve Universtiy

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Vaccine Efficacy

Time frame: 8 months from study enrollment

Secondary Outcomes

Vaccine completion rate

Time frame: 8 months from study enrollment

Association of exchange status with completion

Time frame: 8 months from study enrollment