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Hepatitis B Vaccine Incentive Trial in Injecting Drug Users (IDUs) (HAVIT)

This study is not yet open for participant recruitment.
Verified by The National Centre in HIV Epidemiology and Clinical Research, August 2008

Sponsored by: The National Centre in HIV Epidemiology and Clinical Research
Information provided by: The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier: NCT00744289
  Purpose

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 Injecting Drug Users (IDUs). Using a randomised controlled trial design, the investigators will offer the 3 dose, accelerated HBV schedule to eligible IDUs 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 Intervention
Hepatitis B
Other: Incentive condition

MedlinePlus related topics:   Hepatitis    Hepatitis B   

Drug Information available for:   Hepatitis B Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Efficacy Study
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 Injecting Drug Users.

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 3 months ] [ Designated as safety issue: No ]
  • Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml [ Time Frame: At baseline and week 12 ] [ Designated as safety issue: No ]
  • Assess the acceptability of vaccines, including HBV vaccines, barriers to immunisation uptake and willingness to participate in vaccine trials among IDUs [ Time Frame: Baseline( week 0) and week 12 ] [ Designated as safety issue: No ]
  • Assess hepatitis B-related knowledge in this group [ Time Frame: Baseline( Week 0) and at week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:   200
Study Start Date:   September 2008
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm 1: No Intervention
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

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 injecting drug users (IDUs) 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 IDUs:and (iv) Assess hepatitis B−related knowledge in this group.

Research Design: A total of 200 eligible IDUs (those with no history of exposure to or 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, 7and 21 days) and will be followed up at week 12.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Aged 16 years and above.
  • Injected drugs at least once in the preceding six months.
  • No previous hepatitis B vaccination or infection including "don't know"), 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 incomplete or failed vaccinations as identified by self-report
  • 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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744289

Contacts
Contact: Lisa Maher     +61 (02) 9385 0936     lmaher@unsw.edu.au    

Locations
Australia, New South Wales
National Centre in HIV Epidemiology and Clinical Research    
      Sydney, New South Wales, Australia

Sponsors and Collaborators
The National Centre in HIV Epidemiology and Clinical Research

Investigators
Principal Investigator:     Lisa Maher     National centre in HIV Epidemiology and Clinical Research    
  More Information


Responsible Party:   National Centre in HIV Epidemiology and Clinical Research ( Associate Professor Lisa Maher )
Study ID Numbers:   X08-0161
First Received:   August 26, 2008
Last Updated:   August 28, 2008
ClinicalTrials.gov Identifier:   NCT00744289
Health Authority:   Australia: Human Research Ethics Committee

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:
Hepatitis B,  
Injecting Drug user,  
Financial Incentive,  
vaccine  
completion  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 24, 2008




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