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Hepatitis B Acceptability and Vaccination Incentive Trial (HAVIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744289
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : June 16, 2011
Information provided by:
Kirby Institute

Brief Summary:


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 randomised controlled trial design, the investigators will offer the 3 dose, accelerated HBV schedule to eligible PWID allocated to either a standard of care or incentive condition. Participants allocated to the incentive condition will receive a small incentive payment after the second and third dose of the vaccine. It is hypothesized that the proportion of participants who complete the vaccine series in the incentive payment arm will be higher compared to the non-incentive payment arm (standard of care).

Condition or disease Intervention/treatment Phase
Hepatitis B Other: Incentive condition Not Applicable

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, hepatitis B coverage remains low among Australian people who inject drugs (PWID) and little is known about attitudes to immunisation, barriers to uptake and willingness to participate in vaccine trials among this group. Candidate vaccines for hepatitis C virus (HCV) and HIV are currently in development and HBV immunisation provides a surrogate for examining strategies to deliver vaccines to this group.

Secondary objectives of this trial are to (i) assess the cost effectiveness of the interventions; (ii) identify the correlates of immunity in this group; (iii) assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID; and (iv) assess hepatitis B-related knowledge in this group.

Research Design: A total of 200 eligible PWID or people at risk of initiating injecting (those with no history of exposure to or receipt of more than one vaccination against HBV) will be recruited and interviewed prior to randomisation on a 1:1 basis (100 per arm) to either the (1) control (standard of care) or (2) incentive conditions. All participants will be offered the 3 dose accelerated vaccine schedule (20ug at 0, 7 and 21 days) and will be followed up at week 12.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial to Evaluate the Effectiveness of a Small Financial Incentive After the Second and Third Dose of a Hepatitis B Vaccine, on Vaccine Completion in People Who Inject Drugs
Study Start Date : September 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Arm 1
Participants in Arm 1 will not receive any financial incentive after the second and third dose of hepatitis B vaccine have been administered.
Arm 2
Participants in Arm 2 will receive a small financial incentive after the second and third dose of the hepatitis B vaccine
Other: Incentive condition
Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine

Primary Outcome Measures :
  1. Determine, relative to a 'standard of care' control condition, the efficacy of incentive payments to increase HBV vaccine completion using an accelerated schedule (0, 7, and 21 days). [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Assess the relative cost effectiveness of standard care compared to incentive payments as methods of improving rates of successful vaccine series completion and vaccine-induced immunity [ Time Frame: 12 weeks ]
  2. Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml) [ Time Frame: At baseline and week 12 ]
  3. Assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among PWID [ Time Frame: At baseline and week 12 ]
  4. Assess hepatitis B-related knowledge in this group [ Time Frame: At baseline and week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744289

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Australia, New South Wales
The Kirby Institute
Sydney, New South Wales, Australia
Sponsors and Collaborators
Kirby Institute
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Principal Investigator: Lisa Maher, PhD Kirby Institute
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Responsible Party: Professor Lisa Maher, The Kirby Institute Identifier: NCT00744289    
Other Study ID Numbers: X08-0161
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011
Keywords provided by Kirby Institute:
Hepatitis B
People who inject drugs
Financial incentive
Vaccine completion
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections