Hepatitis B Acceptability and Vaccination Incentive Trial (HAVIT)

This study has been completed.
Sponsor:
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00744289
First received: August 26, 2008
Last updated: June 14, 2011
Last verified: June 2011
  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 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 Intervention
Hepatitis B
Other: Incentive condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

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: 12 weeks ] [ 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 PWID [ Time Frame: At baseline and week 12 ] [ Designated as safety issue: No ]
  • Assess hepatitis B-related knowledge in this group [ Time Frame: At baseline and week 12 ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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, 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, New South Wales
The Kirby Institute
Sydney, New South Wales, Australia
Sponsors and Collaborators
Kirby Institute
Investigators
Principal Investigator: Lisa Maher, PhD The Kirby Institute
  More Information

No publications provided

Responsible Party: Professor Lisa Maher, The Kirby Institute
ClinicalTrials.gov Identifier: NCT00744289     History of Changes
Other Study ID Numbers: X08-0161
Study First Received: August 26, 2008
Last Updated: June 14, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Kirby Institute:
Hepatitis B
People who inject drugs
Financial incentive
Vaccine completion

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on September 30, 2014