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Hepatitis B Acceptability and Vaccination Incentive Trial (HAVIT)

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ClinicalTrials.gov Identifier: NCT00744289
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Kirby Institute

Tracking Information
First Submitted Date  ICMJE August 26, 2008
First Posted Date  ICMJE August 29, 2008
Last Update Posted Date June 16, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
  • 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 ]
  • Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml) [ Time Frame: At baseline and week 12 ]
  • 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 ]
  • Assess hepatitis B-related knowledge in this group [ Time Frame: At baseline and week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
  • 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 ]
  • Identify the correlates of immunity (defined as hepatitis B surface antibody levels greater than 10 mIU/ml [ Time Frame: At baseline and week 12 ]
  • 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 ]
  • Assess hepatitis B-related knowledge in this group [ Time Frame: Baseline (week 0) and at week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatitis B Acceptability and Vaccination Incentive Trial
Official Title  ICMJE 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
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 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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE Other: Incentive condition
Receipt of a small financial incentive after the second and third dose of the hepatitis B vaccine
Study Arms  ICMJE
  • 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
    Intervention: Other: Incentive condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2011)
204
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2008)
200
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00744289
Other Study ID Numbers  ICMJE X08-0161
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Lisa Maher, The Kirby Institute
Study Sponsor  ICMJE Kirby Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa Maher, PhD Kirby Institute
PRS Account Kirby Institute
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP