Status:
COMPLETED
Hepatitis B Acceptability and Vaccination Incentive Trial
Lead Sponsor:
Kirby Institute
Conditions:
Hepatitis B
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Aims: This prospective trial seeks to investigate the efficacy of a financial incentive in increasing the uptake and completion of the HBV vaccine series among people who inject drugs (PWID). Using a...
Detailed Description
Injecting drug use is the leading exposure category for notifications of newly acquired hepatitis B virus (HBV) infection in Australia. Despite the existence of a safe and efficacious vaccine, hepatit...
Eligibility Criteria
Inclusion
- Aged 16 years and above.
- Injected drugs at least once in the preceding six months, OR (i) Use of any illegal/non-prescription drug apart from cannabis (e.g., speed, coke, ice, heroin) in the last three months, AND (ii) Spent time with 2 or more people who inject drugs on a weekly or more frequent basis in the last three months.
- No previous hepatitis B infection, and a maximum of one previous dose of hepatitis B vaccination, or unknown infection and vaccination status, based on self-report and, where available, medical records
- Ability to provide informed consent, to be randomized and attend vaccinations over a period of three weeks and to attend follow-up at 12 weeks post-randomisation.
Exclusion
- Evidence of natural or vaccine-induced immunity.
- Previous exposure or two+ vaccinations (as identified by self-report), where HBV surface antibody \>= 10 mIU/ml
- Serious mental or physical illness or disability likely to impact on capacity to complete the study procedures
- Insufficient English language skills that will impair ability to give informed consent or provide reliable responses to study interviews /questionnaires
- Human Immunodeficiency Virus infection
- Refusal to be vaccinated against Hepatitis B Virus (HBV)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00744289
Start Date
September 1 2008
End Date
May 1 2011
Last Update
June 16 2011
Active Locations (1)
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1
The Kirby Institute
Sydney, New South Wales, Australia