RecruitingACTRN12612001308886

The B-VAX Project: Providing hepatitis B vaccinations through assertive outreach to people who inject drugs.

A randomised controlled trial evaluating the efficacy of the standard vs. the accelerated HBV vaccine schedule and HBV vaccine completion rates amongst people who inject drugs.

Sponsor

The Burnet Institute

Enrollment

150 participants

Start Date

Oct 24, 2012

Study Type

Interventional

Conditions

The Hepatitis B Virus (HBV).

Summary

The B-VAX Project proposes to support an accredited nurse immuniser to deliver the HBV vaccine to approximately 150 PWID 'in the field' (Footscray, Frankston and Melbourne Central Business District) by using assertive outreach methods and contingency management (small motivational cash incentives) to maximize vaccination course completion. The study will be designed as a randomised control trial (RCT) that will compare the efficacy of two differing vaccine schedules. PWID who have been serologically confirmed as susceptible to HBV infection will be identified from the Melbourne Injecting Cohort Study (MIX) and approached to participate. Consenting participants have already established good rapport with the field researchers, increasing their likelihood to participate in the study. Consenting participants will be randomly allocated to either of the two arms of the study and be provided with the HBV vaccine adhering to either the standard schedule of vaccine delivery at 0, 1 & 6 months, or an opportunistic accelerated schedule, receiving the vaccine at a minimum of 0, 7 & 21 days, with a booster dose 12 months after the third vaccine at ~21 days depending on their immune response to the first three doses. Participants will also be provided with health promotion and prevention education. Participants will have a blood test after each vaccine dose and 6 weeks after the completion of the vaccine schedule to determine their body's immunological response to the vaccine. A sub- set of participants will be invited to answer questions exploring the enablers and barriers for HBV vaccination in a set of open ended questions. The MIX Study: Monash University Project Number: CF09/1262 - 2009000591 DH HREC Project Reference Number: 83/06

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two different schedules for delivering the hepatitis B vaccine to people who inject drugs — a group at high risk of catching hepatitis B. One schedule follows the standard timing (0, 1, and 6 months), while the other is faster (0, 7, and 21 days) to improve the chances that people in this population complete the full course. Researchers will also use small cash incentives and outreach workers to help people complete their vaccinations. You may be eligible if: - You are 18 years or older and inject drugs - You are already enrolled in the Burnet Institute cohort study (MIX Study) - Your blood tests show you are not immune to hepatitis B (you have not been vaccinated or previously infected) You may NOT be eligible if: - Your blood tests show you are already immune to hepatitis B (through past infection or vaccination) - You are not currently enrolled in a Burnet Institute cohort study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intramuscular (IM) provision of the Engerix-B hepatitis B virus (HBV) vaccine (20 micro g. hepatitis B surface antigen recombinant, pre- filled 1.0ml syringe) to eligible participants adhering to a standard schedule of 0, 1 & 6 months. The same vaccine dose will be administered at each timepoint. Participants will be reimbursed $15 and also have serology taken at each vaccine encounter to test for an immune response to the vaccine. Participants will participate in a quantitative questionnaire at baseline. A small sub-set of the sample will be purposefully selected to participate in a qualitative questionnaire at baseline and third vaccine encounter and will be reimbursed an additional $15 for this.

Locations(1)

VIC, Australia

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ACTRN12612001308886